CN1686351A - Medicine for treating gynecopathy inflammation and its production method - Google Patents
Medicine for treating gynecopathy inflammation and its production method Download PDFInfo
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Abstract
本发明涉及一种治疗妇科炎症的药物及其生产方法,它由各占总量7.2~17.2份的金刚刺、马鞭草、夏枯草、金樱根;各占总量2.3~12.3份的穿心莲、延胡索、功劳木、香附;占总量0.5~10.4份的当归;占总量9.5~19.4份的鸡血藤制成,其生产方法是:粉碎+提油包合+醇提+水提制成稠膏(部分穿心莲用乙醇提取或水提取则将剩余穿心莲粉碎后加入混匀)后按药剂学要求制成该药物。本发明药物具有清热解毒、活血化瘀、行气止痛之功效,对子宫内膜炎、附件炎、盆腔炎属瘀毒内结证、气滞血瘀证、湿热瘀滞型妇科炎症患者有较好的治疗作用。临床试验证明该药物安全可靠,未发现明显不良反应和毒副作用。The invention relates to a medicine for treating gynecological inflammation and a production method thereof, which comprises 7.2 to 17.2 parts of diamond thorn, verbena, Prunella vulgaris and Rosa japonica root, each accounting for 2.3 to 12.3 parts of Andrographis paniculata, Yanhusuo, Gonggongmu, Cyperus cyperus; angelica accounting for 0.5-10.4 parts of the total; made of Caulis Spatholobus accounting for 9.5-19.4 parts of the total. The production method is: crushing + oil extraction inclusion + alcohol extraction + water extraction to make thick Paste (part of Andrographis paniculata is extracted with ethanol or water, and the rest of Andrographis paniculata is crushed and then added and mixed) to make the medicine according to the requirements of pharmacy. The medicine of the present invention has the effects of clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, promoting qi circulation and relieving pain, and is effective for patients with endometritis, adnexitis, and pelvic inflammatory disease belonging to stasis toxin syndrome, qi stagnation and blood stasis syndrome, and gynecological inflammation of damp-heat stagnation type. Good therapeutic effect. Clinical trials have proved that the drug is safe and reliable, and no obvious adverse reactions and toxic side effects have been found.
Description
技术领域technical field
本发明涉及一种治疗妇科炎症的药物,特别是涉及治疗子宫内膜炎、附件炎、盆腔炎属瘀毒内结证、气滞血瘀证、湿热瘀滞型妇科炎症的药物及其生产方法。The invention relates to a medicine for treating gynecological inflammation, in particular to a medicine for treating endometritis, adnexitis, pelvic inflammatory disease belonging to blood stasis syndrome, qi stagnation and blood stasis syndrome, and damp-heat stasis type gynecological inflammation and its production method .
背景技术Background technique
妇科炎症指的是女性内生殖器及其周围的结缔组织、盆腔腹膜发生的炎症,可分为急性和慢性两类,临床急、慢性妇科炎症其病理改变包括子宫内膜炎、子宫肌炎、输卵管卵巢炎、盆腔结缔组织炎及盆腔腹膜炎,其中输卵管卵巢炎最常见,当机体免疫功能下降、内分泌发生变化或外源性致病菌侵入,均可导致炎症的发生。子宫内膜炎为病原体经胎盘剥离面侵入,扩散到子宫蜕膜层而引起的炎症,多发生于宫腔手术、流产及产后;附件炎又称输卵管卵巢炎,为卵巢与发炎的输卵管伞端粘连而发生卵巢周围炎。以上炎症常在劳累、性交后、排便时加重及月经前后加重。Gynecological inflammation refers to the inflammation of female internal genitalia and its surrounding connective tissue and pelvic peritoneum, which can be divided into acute and chronic types. Ovarian inflammation, pelvic connective tissue inflammation, and pelvic peritonitis, among which salpingo-oophoritis is the most common, can lead to inflammation when the body's immune function declines, endocrine changes, or exogenous pathogenic bacteria invade. Endometritis is an inflammation caused by pathogens invading through the detachment surface of the placenta and spreading to the decidual layer of the uterus, which mostly occurs in uterine surgery, abortion and postpartum; Adhesion and periovarian inflammation occurs. The above inflammations are often aggravated after fatigue, after sexual intercourse, during defecation, and before and after menstruation.
我国传统中医对妇科炎症的治疗有很多论著,也记载了不少治疗妇科炎症的中药方剂,这些方剂根据妇科炎症的不同病症而有所不同,是我国中医药宝库重要组成之一。现代中医理论也在充分总结、挖掘和利用古代中医学说,许多科学论著也提出了大量的中医治疗妇科炎症的方法和药物,对中医治疗妇科炎症起了较好的指导作用。这几年来一些药厂和中医药研究所也推出了一些治疗妇科炎症的中成药,但这些中成药有的价格较高,病人难以接受,有的针对性不强,疗效不如人意,只起辅助治疗作用。There are many treatises on the treatment of gynecological inflammation in traditional Chinese medicine in my country, and many traditional Chinese medicine prescriptions for the treatment of gynecological inflammation are also recorded. Modern TCM theories are also fully summarizing, excavating and utilizing ancient TCM theories. Many scientific treatises have also proposed a large number of TCM methods and medicines for treating gynecological inflammation, which have played a better guiding role in TCM treatment of gynecological inflammation. Over the past few years, some pharmaceutical companies and Chinese medicine research institutes have also launched some Chinese patent medicines for treating gynecological inflammation, but some of these Chinese patent medicines are expensive and unacceptable to patients, and some are not very targeted and have unsatisfactory curative effects. Therapeutic effect.
发明内容Contents of the invention
本发明的目的是提供一种对妇科炎症针对性强、疗效显著、组方不复杂、价格适中的中成药及其生产方法。The object of the present invention is to provide a Chinese patent medicine with strong pertinence to gynecological inflammation, remarkable curative effect, uncomplicated prescription and moderate price and its production method.
本发明人在长期的医学实践中,从祖国传统医学理论出发,经过多年研究,筛选了几十种中药方剂,反复比较,从中精选出一些药物并组方,进行了药效学、药理学、以及临床等研究实验,最终发明了一种疗效好、药源广泛、价格适中、生产工艺先进可行的中成药,其原料的主要活性成分和重量含量如下:In the long-term medical practice, starting from the traditional medical theory of the motherland, the inventor screened dozens of traditional Chinese medicine prescriptions after years of research, compared them repeatedly, selected some medicines from them and formulated prescriptions, and carried out pharmacodynamics, pharmacology, etc. , and clinical research experiments, and finally invented a Chinese patent medicine with good curative effect, wide range of drug sources, moderate price, advanced and feasible production technology. The main active ingredients and weight content of the raw materials are as follows:
金刚刺4.2~17.2 马鞭草4.2~17.2 穿心莲2.3~12.3 当 归0.5~10.4 鸡血藤6.5~19.4Diamond thorn 4.2~17.2 Verbena 4.2~17.2 Andrographis 2.3~12.3 Angelica 0.5~10.4 Millipede 6.5~19.4
延胡索2.3~12.3 夏枯草4.2~17.2 功劳木2.3~12.3 金樱根4.2~17.2 香 附2.3~12.3Corydalis 2.3~12.3 Prunella vulgaris 4.2~17.2 Gonggong wood 2.3~12.3 Golden cherry root 4.2~17.2 Cyperus 2.3~12.3
上述中药可以从《中国药典》和其它中药手册中查到其别名、拉丁名以及产地、用法,为了了解本发明治疗疾病的机理,现对处方中各味中药的功效及其在处方中的作用阐述如下:马鞭草、穿心莲清热解毒、凉血散瘀、利水消肿,共为君药;金刚刺、夏枯草、功劳木三药相配为臣药,共助君药清热消炎、利湿止带、化瘀消癥之效;当归、鸡血藤、金樱根共具补益肝肾、固精养血调经、化瘀消炎为佐,以兼顾其本,调动机体免疫力,协同君臣药,共达清热、去湿、化瘀之效。延胡索、香附疏肝行气止痛为使。诸药合用,共奏清热利湿,养血调经,活血化瘀,行气止痛之效。Above-mentioned Chinese medicine can find its another name, Latin name and place of origin, usage from " Chinese Pharmacopoeia " and other Chinese medicine handbooks, in order to understand the mechanism of the present invention's disease treatment, now to the effect of each flavor Chinese medicine in the prescription and its effect in the prescription The description is as follows: Verbena and Andrographis paniculata can clear away heat and detoxify, cool blood and disperse blood stasis, diuresis and detumescence, and they are the king medicine together; Diamond thorn, Prunella vulgaris, and Gonglaomu are combined together as the minister medicine, which can help the king medicine to clear away heat and inflammation, relieve dampness and stop belt, The effect of dispelling blood stasis and eliminating symptoms; Angelica, Spatholobus Spatholobus and Rosa Rosa root together have the functions of nourishing the liver and kidney, solidifying essence, nourishing blood and regulating menstruation, dispelling stasis and reducing inflammation, taking into account the basics, mobilizing the body's immunity, and synergizing with monarch and minister medicines to achieve heat-clearing, The effect of removing dampness and removing blood stasis. Corydalis Corydalis and Rhizoma Rhizoma Cyperi soothe the liver, promote Qi and relieve pain. All medicines share the effect of clearing heat and dampness, nourishing blood and regulating menstruation, promoting blood circulation and removing blood stasis, promoting qi circulation and relieving pain.
本发明的中药组合物最佳质量份数含量为:The optimum mass fraction content of Chinese medicine composition of the present invention is:
金刚刺6~12 马鞭草6~12 穿心莲4~8 当 归3~6 鸡血藤8~16Diamond thorn 6~12 Verbena 6~12 Andrographis 4~8 Angelica 3~6 Millipede 8~16
延胡索4~8 夏枯草6~12 功劳木4~8 金樱根8~16 香 附4~8Corydalis 4~8 Prunella vulgaris 6~12 Gongluomu 4~8 Golden Cherry Root 8~16 Fragrance Attachment 4~8
本发明的中药组合物的成分和质量最佳含量也可以采用以下配比(重量份):The composition of Chinese medicine composition of the present invention and quality optimum content also can adopt following proportioning (weight part):
金刚刺3.35 马鞭草3.35 穿心莲2 当 归1.5 鸡血藤4Diamond thorn 3.35 Verbena 3.35 Andrographis 2 Angelica 1.5 Millipede 4
延胡索2 夏枯草3.35 功劳木2 金樱根4 香 附2Corydalis 2 Prunella vulgaris 3.35 Gonggong wood 2 Golden cherry root 4 Fragrance Attached 2
上述组合物可以作为中医院治疗妇科炎症的处方,供病人煎汤服用;更适合现代制药企业提取其有效成分,制成胶囊剂、片剂、颗粒剂、缓释胶囊、软胶囊、滴丸、口服液等药剂学上的任何剂型,具体生产方法如下:The above-mentioned composition can be used as a prescription for treating gynecological inflammation in a traditional Chinese medicine hospital, and can be taken by decocting soup for patients; it is more suitable for modern pharmaceutical companies to extract its active ingredients and make capsules, tablets, granules, sustained-release capsules, soft capsules, dripping pills, Any pharmaceutical dosage form such as oral liquid, the specific production method is as follows:
1、胶囊剂的生产方法:1. The production method of capsules:
(1)取穿心莲总量的7/25,用超微粉碎技术将其粉碎成细粉,用100℃~120℃高压蒸汽灭菌30~60分钟,得中间产品A;(1) Take 7/25 of the total amount of Andrographis paniculata, pulverize it into fine powder with superfine pulverization technology, and sterilize it with high-pressure steam at 100°C-120°C for 30-60 minutes to obtain intermediate product A;
(2)当归、香附,加3~8倍量水,用水蒸气蒸馏法提取挥发油2~4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B;蒸馏后的水溶液C备用;药渣D移交醇提工序。(2) Angelica and Rhizoma Cyperi, add 3 to 8 times the amount of water, extract the volatile oil with steam distillation for 2 to 4 hours, collect the oily distillate (medicine residue and alcohol extraction process), separate, take the volatile oil, and use β-cyclopaste Fine clathrate, after drying, weigh to obtain the intermediate product B; the distilled aqueous solution C for future use; dregs D is handed over to the alcohol extraction process.
(3)药渣D加3~8倍量45%~75%乙醇回流提取2~4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E。(3) Add 3 to 8 times the amount of 45% to 75% ethanol to the dregs D and extract under reflux for 2 to 4 hours, filter the extract, recover the ethanol from the filtrate and concentrate to obtain thick ointment E.
(4)将上述醇提后的药渣与剩余的穿心莲及金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加3~8倍量的水,加热提取两次,每次1~3小时,得水提部分F。(4) Add 3 to 8 times the amount of water to the above alcohol-extracted medicinal residues and the remaining Andrographis paniculata and Vajra thorn, Verbena, Millae Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa japonica root, and heat and extract twice , 1 to 3 hours each time to obtain the water extraction part F.
(5)将C、E和F混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉G。(5) Mix C, E and F, add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder G.
(6)取中间产品干膏粉G制粒,干燥,加入中间产品B与适量辅料混匀,装胶囊,铝箔包装,分装,得成品胶囊剂。(6) Take the intermediate product dry cream powder G, granulate, dry, add intermediate product B and appropriate amount of auxiliary materials, mix evenly, pack into capsules, pack in aluminum foil, and pack separately to obtain finished capsules.
或者按以下方法生产:Or produce as follows:
(1)取穿心莲总量的7/25,用超微粉碎技术将其粉碎成细粉,用100℃~120℃高压蒸汽灭菌30~60分钟,得中间产品A;(1) Take 7/25 of the total amount of Andrographis paniculata, pulverize it into fine powder with superfine pulverization technology, and sterilize it with high-pressure steam at 100°C-120°C for 30-60 minutes to obtain intermediate product A;
(2)当归、香附,加3~8倍量水,用水蒸气蒸馏法提取挥发油2~4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B;蒸馏后的水溶液C备用;药渣D移交醇提工序。(2) Angelica and Rhizoma Cyperi, add 3 to 8 times the amount of water, extract the volatile oil with steam distillation for 2 to 4 hours, collect the oily distillate (medicine residue and alcohol extraction process), separate, take the volatile oil, and use β-cyclopaste Fine clathrate, after drying, weigh to obtain the intermediate product B; the distilled aqueous solution C for future use; dregs D is handed over to the alcohol extraction process.
(3)药渣D与穿心莲、功劳木、马鞭草一起加3~8倍量45~75%乙醇回流提取2~4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E,药渣F移交水提工序。(3) Add 3-8 times the amount of 45-75% ethanol to reflux extraction for 2-4 hours with the dregs D, andrographis paniculata, gonglaoji, and verbena, then filter the extract, recover the ethanol and concentrate the filtrate to obtain thick ointment E. The slag F is handed over to the water extraction process.
(4)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加3~8倍量的水,然后加入上述醇提后的药渣F,加热提取两次,每次1~3小时,得水提部分G。(4) Add 3 to 8 times the amount of water together with King Kong thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root, then add the above-mentioned medicinal residue F after alcohol extraction, heat and extract twice, 1 to 3 hours each time , to obtain the water extraction part G.
(5)将C、E和G混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉H。(5) Mix C, E and G, add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder H.
(6)取中间产品干膏粉H制粒,干燥,加入中间产品B与适量辅料混匀,装胶囊,铝箔包装,分装,得成品胶囊剂。(6) Take the dry cream powder H of the intermediate product, granulate it, dry it, add the intermediate product B and appropriate amount of auxiliary materials, mix evenly, pack into capsules, pack in aluminum foil, and pack separately to obtain finished capsules.
以上所述的辅料为硬酯酸镁,或者是符合国际和国家标准规定的其它辅料,加入量为干颗粒的0.3-1%。The adjuvant mentioned above is magnesium stearate, or other adjuvants that meet international and national standards, and the addition amount is 0.3-1% of the dry granules.
2、软胶囊剂的生产方法:2, the production method of soft capsule:
(1)当归、香附加3~8倍量水,用水蒸气蒸馏法提取挥发油2~4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 3 to 8 times the amount of water to Chinese angelica and incense, extract the volatile oil by steam distillation for 2 to 4 hours, collect the oily distillate (drug residue alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加3~8倍量45~75%乙醇回流提取2~4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Add 3-8 times the amount of 45-75% ethanol to reflux extraction for 2-4 hours together with Andrographis paniculata, Gonglaojia, and Verbena. Slag E is handed over to the water extraction process.
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加3~8倍量的水,然后加入上述醇提后的药渣E,加热提取两次,每次1~3小时,得水提部分F。(3) Add 3 to 8 times the amount of water together with King Kong thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root, then add the above-mentioned medicinal residue E after alcohol extraction, and heat and extract twice, 1 to 3 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)取中间产品干浸膏粉G和A、植物油、蜂蜡按1∶1∶0.02制成混悬物H,以明胶∶甘油∶水为1∶0.35∶0.9的比例制备胶皮,然后将混悬物H灌装压制成软胶囊,25℃以下定型,用乙醇洗去软胶囊外表油层,于25℃以下干燥,取出即得成品软胶囊剂。(5) Take the intermediate product dry extract powder G and A, vegetable oil, and beeswax to make a suspension H at a ratio of 1:1:0.02, prepare a rubber with a ratio of gelatin:glycerin:water of 1:0.35:0.9, and then mix the mixture Suspension H is filled and compressed into soft capsules, shaped at a temperature below 25°C, washed with ethanol to remove the oil layer on the surface of the soft capsules, dried at a temperature below 25°C, and taken out to obtain the finished soft capsules.
3、缓释胶囊剂的生产方法:3. Production method of sustained-release capsules:
(1)当归、香附加3~8倍量水,用水蒸气蒸馏法提取挥发油2~4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 3 to 8 times the amount of water to Chinese angelica and incense, extract the volatile oil by steam distillation for 2 to 4 hours, collect the oily distillate (drug residue alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加3~8倍量45~75%乙醇回流提取2~4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Add 3-8 times the amount of 45-75% ethanol to reflux extraction for 2-4 hours together with Andrographis paniculata, Gonglaojia, and Verbena. Slag E is handed over to the water extraction process.
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加3~8倍量的水,然后加入上述醇提后的药渣E,加热提取两次,每次1~3小时,得水提部分F。(3) Add 3 to 8 times the amount of water together with King Kong thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root, then add the above-mentioned medicinal residue E after alcohol extraction, and heat and extract twice, 1 to 3 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)按中间产品干浸膏粉G和A的总量,加入0.5~5%的鲸蜡或其它阻滞剂包衣,分别制成2、4、6、8小时缓释小丸,每种小丸用不同色泽区分,混合均匀后装入空胶囊中,包装成盒或热压成铝塑板,得到成品缓释胶囊剂。(5) According to the total amount of the dry extract powder G and A of the intermediate product, add 0.5% to 5% of spermaceti or other blocker coating, and make slow-release pellets for 2, 4, 6, and 8 hours respectively. The pellets are distinguished by different colors, mixed evenly, put into empty capsules, packed into boxes or hot-pressed into aluminum-plastic plates to obtain finished sustained-release capsules.
4、滴丸剂的生产方法:4. The production method of dropping pills:
(1)当归、香附加3~8倍量水,用水蒸气蒸馏法提取挥发油24小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 3 to 8 times the amount of water to Chinese angelica and incense, extract the volatile oil by steam distillation for 24 hours, collect the oil-containing distillate (drug residue alcohol extraction process), separate, take the volatile oil, and clathrate it with β-cyclodextrin, After drying, weigh to obtain the intermediate product A; the distilled aqueous solution B for future use; and the dregs C to be handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加3~8倍量45~75%乙醇回流提取2~4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Add 3-8 times the amount of 45-75% ethanol to reflux extraction for 2-4 hours together with Andrographis paniculata, Gonglaojia, and Verbena. Slag E is handed over to the water extraction process.
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加3~8倍量的水,然后加入上述醇提后的药渣E,加热提取两次,每次1~3小时,得水提部分F。(3) Add 3 to 8 times the amount of water together with King Kong thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root, then add the above-mentioned medicinal residue E after alcohol extraction, and heat and extract twice, 1 to 3 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)将聚乙二醇6000加热熔融,再取中间产品A和G加入,搅匀,转移至滴丸装置上,86℃密闭保温,用10℃~15℃液体石蜡或其它液体作冷却剂,用50滴/分速度进行滴制,即得成品滴丸剂。(5) Heat and melt polyethylene glycol 6000, then add the intermediate products A and G, stir well, transfer to the dropping pill device, keep it sealed at 86°C, and use 10°C~15°C liquid paraffin or other liquids as coolants , dripping at a speed of 50 drops/min to obtain finished pills.
5、片剂的生产方法:5. Production method of tablet:
(1)取穿心莲总量的7/25粉碎成细粉,用100℃~120℃高压蒸汽灭菌30~60分钟,得中间产品A;(1) Take 7/25 of the total amount of Andrographis paniculata, pulverize it into fine powder, and sterilize it with high-pressure steam at 100°C-120°C for 30-60 minutes to obtain intermediate product A;
(2)当归、香附加3~8倍量水,用水蒸气蒸馏法提取挥发油2~4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B1;蒸馏后的水溶液C1备用;药渣D1移交醇提工序。(2) Add 3 to 8 times the amount of water to angelica and cypress, extract the volatile oil by steam distillation for 2 to 4 hours, collect the oily distillate (drug residue alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin combined, dried, and weighed to obtain an intermediate product B 1 ; the distilled aqueous solution C 1 is ready for use; and the dregs D 1 are handed over to the alcohol extraction process.
(3)药渣D1加3~8倍量45~75%乙醇回流提取2~4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E1。(3) Add 3 to 8 times the amount of 45 to 75% ethanol to the dregs D 1 for reflux extraction for 2 to 4 hours, filter the extract, recover the ethanol from the filtrate and concentrate to obtain a thick ointment E 1 .
(4)将上述醇提后的药渣与剩余的穿心莲及金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加3~8倍量的水,加热提取两次,每次1~3小时,得水提部分F1。(4) Add 3 to 8 times the amount of water to the above alcohol-extracted medicinal residues and the remaining Andrographis paniculata and Vajra thorn, Verbena, Millae Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa japonica root, and heat and extract twice , each time for 1-3 hours to obtain the water-extracted fraction F 1 .
(5)将C1、E1和F1混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉G1。(5) Mix C 1 , E 1 and F 1 , add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder G 1 .
(6)取中间产品干膏粉G1制粒,干燥,加入B1与适量辅料混匀,压片,包糖衣或薄膜衣,包装,得成品片剂。(6) Take the dry cream powder G1 of the intermediate product, granulate it, dry it, add B1 and mix with appropriate amount of auxiliary materials, press into tablets, coat with sugar or film, and pack to obtain finished tablets.
6、颗粒剂的生产方法:6. Production method of granules:
(1)当归、香附加3~8倍量水,用水蒸气蒸馏法提取挥发油2~4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 3 to 8 times the amount of water to Chinese angelica and incense, extract the volatile oil by steam distillation for 2 to 4 hours, collect the oily distillate (drug residue alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加3~8倍量45~75%乙醇回流提取2~4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E。(2) Add 3-8 times the amount of 45-75% ethanol to reflux extraction for 2-4 hours together with Andrographis paniculata, Gonglaojia, and Verbena. Slag E.
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加3~8倍量的水,然后加入上述醇提后的药渣E,加热提取两次,每次1~3小时,得水提部分F。(3) Add 3 to 8 times the amount of water together with King Kong thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root, then add the above-mentioned medicinal residue E after alcohol extraction, and heat and extract twice, 1 to 3 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)取中间产品干膏粉G与适量辅料混匀,制粒,干燥,和A混匀,分装,得成品颗粒剂。(5) Take the intermediate product dry paste powder G and mix with appropriate amount of auxiliary materials, granulate, dry, mix with A, pack separately, and obtain finished granules.
7、口服液的生产方法:7. Production method of oral liquid:
(1)当归、香附,加3~8倍量水,用水蒸气蒸馏法提取挥发油2~4小时,收集含油蒸馏液,分离,得挥发油B3;蒸馏后的水溶液C3备用;药渣D3移交醇提工序。(1) Angelica and Rhizoma Cyperi, add 3 to 8 times the amount of water, extract the volatile oil by steam distillation for 2 to 4 hours, collect the oily distillate, separate to obtain the volatile oil B 3 ; the distilled aqueous solution C 3 for later use; dregs D 3 Transfer to the alcohol extraction process.
(2)药渣D3加3~8倍量45~75%乙醇回流提取2~4小时,提取液滤过,滤液回收乙醇得醇提部分E3。(2) Add 3 to 8 times the amount of 45 to 75% ethanol to the medicinal dregs D 3 for reflux extraction for 2 to 4 hours, filter the extract, recover the ethanol from the filtrate to obtain the alcohol extraction fraction E 3 .
(3)将上述醇提后的药渣与穿心莲、金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加3~8倍量的水,加热提取两次,每次1~3小时,得水提部分F3。(3) Add 3 to 8 times the amount of water to the above-mentioned medicinal residue after alcohol extraction, Andrographis paniculata, Vajra thorn, Verbena, Caulis Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa Radix, and heat and extract twice, each After 1-3 hours, the water-extracted fraction F 3 is obtained.
(4)将C3、E3和F3混合浓缩,得相对密度1.05~1.20/55~60℃的中间产品流浸膏G3。(4) Mix and concentrate C 3 , E 3 and F 3 to obtain an intermediate product liquid extract G3 with a relative density of 1.05-1.20/55-60°C.
(5)取中间产品B3和G3与适量糖浆或蜂蜜混匀,灭菌,灌装,得成品口服液剂。(5) Mix intermediate products B 3 and G 3 with appropriate amount of syrup or honey, sterilize and fill to obtain finished oral liquid.
其它剂型如丸剂、膏剂、含片等,可以参考药典或中药制备方法进行。Other dosage forms such as pills, ointments, buccal tablets, etc. can be prepared with reference to the Pharmacopoeia or traditional Chinese medicine preparation methods.
上述中药组合物的提取方法给出了提油包合+醇提+水提,除了用提油包合+醇提+水提以外,还可以采用微波、超声波提取、二氧化碳超临界提取或者其它中药制剂的提取方法,这些提取方法在科技文献中已经有报道,制药企业可以根据具体实际情况采用提取方法,其目的是将该药物组成药材中的有效成分提取,做成医药上的任意剂型,就可以提供给病人服用。The extraction method of the above-mentioned traditional Chinese medicine composition provides oil extraction inclusion + alcohol extraction + water extraction. In addition to oil extraction inclusion + alcohol extraction + water extraction, microwave, ultrasonic extraction, carbon dioxide supercritical extraction or other traditional Chinese medicines can also be used. Extraction methods of preparations, these extraction methods have been reported in scientific and technological literature, pharmaceutical companies can use extraction methods according to specific actual conditions, the purpose is to extract the active ingredients in the medicinal materials of the drug composition, and make it into any dosage form in medicine. available to patients.
服用方法:How to use:
胶囊剂,一日3次,一次4粒,每粒0.37克;Capsules, 3 times a day, 4 capsules each time, 0.37 grams per capsule;
软胶囊剂,口服,一次2粒,一日3次;Soft capsules, orally, 2 capsules at a time, 3 times a day;
缓释胶囊,口服,一次2粒,一日1-2次,每粒0.7克;Sustained-release capsules, oral, 2 capsules at a time, 1-2 times a day, 0.7 grams per capsule;
滴丸剂,口服,一次10粒,一日3次;Dropping pills, orally, 10 capsules at a time, 3 times a day;
颗粒剂,一日2次,每次1袋,每袋8克;Granules, 2 times a day, 1 bag each time, 8 grams per bag;
片剂,一日3次,一次6片,每片0.45克;Tablets, 3 times a day, 6 tablets each time, 0.45 grams per tablet;
口服液,每日3次,每次10ml。Oral solution, 3 times a day, 10ml each time.
本发明与已有技术相比,其突出的实质性特点和显著的进步是:Compared with the prior art, the present invention's outstanding substantive features and remarkable progress are:
本发明在中医药理论指导下优选了上述中药,加以科学配伍、制作,使各药物相互配合、能最大限度地保证该产品合理组方的整体效应和药物作用的发挥,诸药合用,共奏清热利湿,养血调经,活血化瘀,行气止痛之效。Under the guidance of the theory of traditional Chinese medicine, the present invention optimizes the above-mentioned traditional Chinese medicines, adds scientific compatibility and preparation, makes each medicine cooperate with each other, and can ensure the overall effect of the reasonable prescription of the product and the exertion of the medicine effect to the greatest extent, and all the medicines are used in combination to achieve a good result. Clearing heat and dampness, nourishing blood and regulating menstruation, promoting blood circulation and removing blood stasis, promoting qi circulation and relieving pain.
1、经临床验证,本发明有抗菌、抗炎、镇痛作用:本品稀释度为1∶160时对金黄色葡萄球菌有杀灭作用;稀释度为1∶5时对乙型溶血性链球菌、厌氧链球菌、大肠杆菌有杀灭作用;稀释度为1∶10时作用20分钟对淋球菌有杀灭作用;对角叉菜胶所致大白鼠足肿胀、巴豆油所致耳廓肿胀、棉球所致肉芽组织增生及醋酸所致腹膜炎均有明显的抑制作用,亦能提高小白鼠热板反应痛阈,减少小白鼠扭体反应次数。1. Through clinical verification, the present invention has antibacterial, anti-inflammatory and analgesic effects: when the dilution of this product is 1:160, it has a killing effect on Staphylococcus aureus; It can kill cocci, anaerobic streptococcus and Escherichia coli; when the dilution ratio is 1:10, it can kill Neisseria gonorrhoeae for 20 minutes; it can kill rat paw swelling caused by carrageenan and auricle caused by croton oil Swelling, granulation tissue hyperplasia caused by cotton balls, and peritonitis caused by acetic acid all have obvious inhibitory effects, and can also increase the pain threshold of hot plate reactions in mice and reduce the number of writhing reactions in mice.
2、原料易得,组方科学,生产工艺先进,可操作性强,产品价格适中,适合工业化生产。2. The raw materials are easy to obtain, the formula is scientific, the production technology is advanced, the operability is strong, the product price is moderate, and it is suitable for industrial production.
3、生产工艺采用粉碎、提油包合、醇提、水提及相应的灭菌方法,提油包合保证了当归、香附有效成份挥发油的提取及保存、醇提步骤(提取穿心莲的有效成份酯类等;马鞭草的甙类等;功劳木的生物碱、鞣质等;当归、香附有效成份挥发油等),因而产品有效成分含量高,生物利用度高,且不易变质,保存期长。3. The production process adopts the corresponding sterilization methods of crushing, oil extraction and inclusion, alcohol extraction, and water mentioning. The oil extraction and inclusion ensures the extraction and preservation of the volatile oil of the active ingredients of Angelica and Rhizoma Cyperi, and the steps of alcohol extraction (effective extraction of Andrographis paniculata ingredients such as esters, etc.; glycosides of verbena, etc.; alkaloids, tannins, etc. of Gonggong wood; active ingredients of angelica and Cyperus volatile oil, etc.), so the product has high content of active ingredients, high bioavailability, and is not easy to deteriorate. long.
4、生产工艺先进,可操作性强,生产中根据各味中药的有效成分性质及制剂要求,先后采用超微粉碎技术、多效减压技术、喷雾干燥技术、三维混合技术等国际先进的制药技术和设备。4. The production technology is advanced and the operability is strong. In the production, according to the properties of the active ingredients and preparation requirements of various traditional Chinese medicines, international advanced pharmaceuticals such as ultrafine pulverization technology, multi-effect decompression technology, spray drying technology, and three-dimensional mixing technology are successively adopted. technology and equipment.
5、本发明的产品急性毒性研究及长期毒性研究的结果表明,按拟用日剂量和疗程使用本发明产品是安全的。5. The results of acute toxicity study and long-term toxicity study of the product of the present invention show that it is safe to use the product of the present invention according to the intended daily dose and course of treatment.
具体实施方式Detailed ways
以下是本发明的实施例:The following are embodiments of the invention:
实施例1Example 1
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺3.35 马鞭草3.35 穿心莲2 当 归1.5 鸡血藤4Diamond thorn 3.35 Verbena 3.35 Andrographis 2 Angelica 1.5 Millipede 4
延胡索2 夏枯草3.35 功劳木2 金樱根4 香 附2Corydalis 2 Prunella vulgaris 3.35 Gonggong wood 2 Golden cherry root 4 Fragrance Attached 2
其生产工艺流程为:Its production process is:
(1)取穿心莲总量的7/25,用超微粉碎技术将其粉碎成细粉,用110℃高压蒸汽灭菌45分钟,得中间产品A;(1) Take 7/25 of Andrographis paniculata total amount, pulverize it into fine powder with superfine pulverization technology, sterilize with 110 DEG C of high-pressure steam for 45 minutes, obtain intermediate product A;
(2)当归、香附加8倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B;蒸馏后的水溶液C备用;药渣D移交醇提工序。(2) Add 8 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 4 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product B; the distilled aqueous solution C is set aside; the dregs D is handed over to the alcohol extraction process.
(3)药渣D加3倍量50%乙醇回流提取4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E。(3) Add 3 times the amount of 50% ethanol to the medicinal dregs D and extract under reflux for 4 hours, filter the extract, recover ethanol from the filtrate and concentrate to obtain a thick ointment E.
(4)将上述醇提后的药渣与剩余的穿心莲及金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加5倍量的水,浸泡1小时,加热提取两次,每次2小时,得水提部分F。(4) Add 5 times the amount of water to the above-mentioned medicinal residue after alcohol extraction, together with the remaining Andrographis paniculata and Vajra thorn, Verbena, Millae Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa japonica root, soak for 1 hour, and heat to extract Twice, 2 hours each time, to obtain the water extraction part F.
(5)将C、E和F混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉G。(5) Mix C, E and F, add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder G.
(6)取中间产品干膏粉G制粒,干燥,加入中间产品B与适量辅料混匀,装胶囊,铝箔包装,分装,得成品,产品名称为“金香胶囊”。(6) Take the intermediate product dry cream powder G, granulate, dry, add intermediate product B and appropriate amount of auxiliary materials, mix evenly, pack into capsules, pack in aluminum foil, pack separately, and obtain the finished product. The product name is "Jinxiang Capsule".
实施例2Example 2
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺7 马鞭草7 穿心莲4 当 归3 鸡血藤8Diamond thorn 7 Verbena 7 Andrographis 4 Angelica 3 Caulis Spatholobus 8
延胡索4 夏枯草7 功劳木4 金樱根8 香 附4Corydalis 4 Prunella vulgaris 7 Gonggong wood 4 Golden cherry root 8 Fragrant attachment 4
其生产工艺流程为:Its production process is:
(1)取穿心莲总量的7/25,用超微粉碎技术将其粉碎成细粉,用120℃高压蒸汽灭菌30分钟,得中间产品A;(1) Take 7/25 of Andrographis paniculata total amount, pulverize it into fine powder with superfine pulverization technology, and sterilize with 120 DEG C of high-pressure steam for 30 minutes to obtain intermediate product A;
(2)当归、香附加3倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油3小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B;蒸馏后的水溶液C备用;药渣D移交醇提工序。(2) Add 3 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 3 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product B; the distilled aqueous solution C is set aside; the dregs D is handed over to the alcohol extraction process.
(3)药渣D与穿心莲、功劳木、马鞭草一起加3倍量75%乙醇回流提取2小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E,药渣F移交水提工序。(3) Medicinal dregs D, andrographis paniculata, gonglaozhi, and verbena were extracted with 3 times the amount of 75% ethanol under reflux for 2 hours, the extract was filtered, and the filtrate recovered ethanol and concentrated to obtain thick ointment E, and medicinal dregs F were handed over to the water extraction process .
(4)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加4倍量的水,浸泡1小时,然后加入上述醇提后的药渣F,加热提取两次,每次2.5小时,得水提部分G。(4) Combine Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 4 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue F after alcohol extraction, heat and extract twice, 2.5 hours each time , to obtain the water extraction part G.
(5)将C、E和G混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉H。(5) Mix C, E and G, add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder H.
(6)取中间产品干膏粉H制粒,干燥,加入中间产品B与适量辅料混匀,装胶囊,铝箔包装,分装,得成品,产品名称为“金香胶囊”。(6) Take the dry paste powder H of the intermediate product, granulate it, dry it, add the intermediate product B and mix it with appropriate amount of auxiliary materials, pack it into capsules, pack it in aluminum foil, and pack it separately to obtain the finished product, the product name is "Jinxiang Capsule".
实施例3Example 3
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺9 马鞭草9 穿心莲6 当 归4 鸡血藤12Vajra thorn9 Verbena 9 Andrographis 6 Angelica 4 Spathiphyllum 12
延胡索6 夏枯草9 功劳木6 金樱根12 香 附6Corydalis 6 Prunella vulgaris 9 Gonggong wood 6 Golden cherry root 12 Fragrance Attached 6
其生产工艺流程为:Its production process is:
(1)取穿心莲总量的7/25,用超微粉碎技术将其粉碎成细粉,用120℃高压蒸汽灭菌30分钟,得中间产品A;(1) Take 7/25 of Andrographis paniculata total amount, pulverize it into fine powder with superfine pulverization technology, and sterilize with 120 DEG C of high-pressure steam for 30 minutes to obtain intermediate product A;
(2)当归、香附,加6倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B;蒸馏后的水溶液C备用;药渣D移交醇提工序。(2) Angelica and Rhizoma Cyperi, add 6 times the amount of water, soak for 1 hour, extract the volatile oil with steam distillation for 2 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and use β-cyclopaste Fine clathrate, after drying, weigh to obtain the intermediate product B; the distilled aqueous solution C for future use; dregs D is handed over to the alcohol extraction process.
(3)药渣D加6倍量60%乙醇回流提取3小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E。(3) Add 6 times the amount of 60% ethanol to the medicinal dregs D and extract under reflux for 3 hours, filter the extract, recover ethanol from the filtrate and concentrate to obtain a thick ointment E.
(4)将上述醇提后的药渣与剩余的穿心莲及金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加6倍量的水,浸泡1小时,加热提取两次,每次3小时,得水提部分F。(4) Add 6 times the amount of water to the above-mentioned medicinal residue after alcohol extraction, together with the remaining Andrographis paniculata and Vajra thorn, Verbena, Millae Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa japonica root, soak for 1 hour, and heat to extract Twice, 3 hours each time, to obtain the water extraction part F.
(5)将C、E和F混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉G。(5) Mix C, E and F, add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder G.
(6)取中间产品干膏粉G制粒,干燥,加入中间产品B与适量辅料混匀,装胶囊,铝箔包装,分装,得成品,产品名称为“金香胶囊”。(6) Take the intermediate product dry cream powder G, granulate, dry, add intermediate product B and appropriate amount of auxiliary materials, mix evenly, pack into capsules, pack in aluminum foil, pack separately, and obtain the finished product. The product name is "Jinxiang Capsule".
实施例4Example 4
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺12 马鞭草12 穿心莲8 当 归6 鸡血藤16Diamond thorn 12 Verbena 12 Andrographis 8 Angelica 6 Spathiphyllum 16
延胡索8 夏枯草12 功劳木8 金樱根16 香 附8Corydalis 8 Prunella vulgaris 12 Gonggong wood 8 Golden cherry root 16 Fragrance with 8
其生产工艺流程为:Its production process is:
(1)取穿心莲总量的7/25,用超微粉碎技术将其粉碎成细粉,用115℃高压蒸汽灭菌60分钟,得中间产品A;(1) Take 7/25 of Andrographis paniculata total amount, pulverize it into fine powder with superfine pulverization technology, sterilize with 115 ℃ of high-pressure steam for 60 minutes, obtain intermediate product A;
(2)当归、香附,加6倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B;蒸馏后的水溶液C备用;药渣D移交醇提工序。(2) Angelica and Rhizoma Cyperi, add 6 times the amount of water, soak for 1 hour, extract the volatile oil with steam distillation for 2 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and use β-cyclopaste Fine clathrate, after drying, weigh to obtain the intermediate product B; the distilled aqueous solution C for future use; dregs D is handed over to the alcohol extraction process.
(3)药渣D与穿心莲、功劳木、马鞭草一起加6倍量60%乙醇回流提取3小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E,药渣F移交水提工序。(3) Herbal dregs D, andrographis paniculata, gonglaozhi, and verbena were added together with 6 times the amount of 60% ethanol for reflux extraction for 3 hours, the extract was filtered, and the filtrate was recovered with ethanol and concentrated to obtain thick ointment E, and herbal dregs F were handed over to the water extraction process .
(4)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加6倍量的水,浸泡1小时,然后加入上述醇提后的药渣F,加热提取两次,每次3小时,得水提部分G。(4) Add diamond thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 6 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue F after alcohol extraction, heat and extract twice, 3 hours each time , to obtain the water extraction part G.
(5)将C、E和G混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉H。(5) Mix C, E and G, add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder H.
(6)取中间产品干膏粉H制粒,干燥,加入中间产品B与适量辅料混匀,装胶囊,铝箔包装,分装,得成品,产品名称为“金香胶囊”。(6) Take the dry paste powder H of the intermediate product, granulate it, dry it, add the intermediate product B and mix it with appropriate amount of auxiliary materials, pack it into capsules, pack it in aluminum foil, and pack it separately to obtain the finished product, the product name is "Jinxiang Capsule".
实施例5Example 5
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺3.35 马鞭草3.35 穿心莲2 当 归1.5 鸡血藤4Diamond thorn 3.35 Verbena 3.35 Andrographis 2 Angelica 1.5 Millipede 4
延胡索2 夏枯草3.35 功劳木2 金樱根4 香 附2Corydalis 2 Prunella vulgaris 3.35 Gonggong wood 2 Golden cherry root 4 Fragrance Attached 2
其生产工艺流程为:Its production process is:
(1)当归、香附加4倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油3.5小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 4 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 3.5 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加4倍量65%乙醇回流提取4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena are added together with 4 times the amount of 65% ethanol for reflux extraction for 4 hours, the extract is filtered, and the filtrate is recovered with ethanol and concentrated to obtain thick ointment D, and medicinal dregs E is handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加4倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次2.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 4 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 2.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)取中间产品干浸膏粉G和A、植物油、蜂蜡按1∶1∶0.02制成混悬物H,以明胶∶甘油∶水为1∶0.35∶0.9的比例制备胶皮,然后将混悬物H灌装压制成软胶囊,25℃以下定型,用乙醇洗去软胶囊外表油层,于25℃以下干燥,取出得成品,产品名称为“金香软胶囊”。(5) Take the intermediate product dry extract powder G and A, vegetable oil, and beeswax to make a suspension H at a ratio of 1:1:0.02, prepare a rubber with a ratio of gelatin:glycerin:water of 1:0.35:0.9, and then mix the mixture Suspension H is filled and pressed into soft capsules, shaped below 25°C, washed with ethanol to remove the oil layer on the surface of the soft capsules, dried below 25°C, and taken out to obtain a finished product, which is named "Jinxiang Soft Capsules".
实施例6Example 6
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺7 马鞭草7 穿心莲3.8 当 归3.1 鸡血藤8.3Diamond thorn 7 Verbena 7 Andrographis 3.8 Angelica 3.1 Millipede 8.3
延胡索4.1 夏枯草7.1 功劳木4.2 金樱根8.1 香 附4.2Corydalis 4.1 Prunella vulgaris 7.1 Gonggong wood 4.2 Golden cherry root 8.1 Fragrance with 4.2
其生产工艺流程为:Its production process is:
(1)当归、香附加8倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油3小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 8 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 3 hours, collect the oily distillate (medicine residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加4倍量55%乙醇回流提取2小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena are added together with 4 times the amount of 55% ethanol for reflux extraction for 2 hours, the extract is filtered, and the filtrate is recovered with ethanol and concentrated to obtain thick ointment D, and medicinal dregs E is handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加7倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次1.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 7 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 1.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried, and pulverized into fine powder to obtain dry cream powder G, an intermediate product.
(5)取中间产品干浸膏粉G和A、植物油、蜂蜡按1∶1∶0.02制成混悬物H,以明胶∶甘油∶水为1∶0.35∶0.9的比例制备胶皮,然后将混悬物H灌装压制成软胶囊,25℃以下定型,用乙醇洗去软胶囊外表油层,于25℃以下干燥,取出得成品,产品名称为“金香软胶囊”。(5) Take the intermediate product dry extract powder G and A, vegetable oil, and beeswax to make a suspension H at a ratio of 1:1:0.02, prepare a rubber with a ratio of gelatin:glycerin:water of 1:0.35:0.9, and then mix the mixture Suspension H is filled and compressed into soft capsules, shaped below 25°C, washed with ethanol to remove the oil layer on the surface of the soft capsules, dried below 25°C, and taken out to obtain the finished product, which is named "Jinxiang Soft Capsules".
实施例7Example 7
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺6.8 马鞭草6.7 穿心莲3.9 当 归2.9 鸡血藤8.1Diamond thorn 6.8 Verbena 6.7 Andrographis 3.9 Angelica 2.9 Millipede 8.1
延胡索3.8 夏枯草6.7 功劳木4 金樱根8 香 附4Corydalis 3.8 Prunella vulgaris 6.7 Gonggong wood 4 Golden cherry root 8 Fragrance with 4
其生产工艺流程为:Its production process is:
(1)当归、香附加5倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 5 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 4 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加8倍量65%乙醇回流提取2小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena are added together with 8 times the amount of 65% ethanol for reflux extraction for 2 hours, the extract is filtered, and the filtrate is recovered with ethanol and concentrated to obtain thick ointment D, and medicinal dregs E is handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加4倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次2.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 4 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 2.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)取中间产品干浸膏粉G和A、植物油、蜂蜡按1∶1∶0.02制成混悬物H,以明胶∶甘油∶水为1∶0.35∶0.9的比例制备胶皮,然后将混悬物H灌装压制成软胶囊,25℃以下定型,用乙醇洗去软胶囊外表油层,于25℃以下干燥,取出得成品,产品名称为“金香软胶囊”。(5) Take the intermediate product dry extract powder G and A, vegetable oil, and beeswax to make a suspension H at a ratio of 1:1:0.02, prepare a rubber with a ratio of gelatin:glycerin:water of 1:0.35:0.9, and then mix the mixture Suspension H is filled and pressed into soft capsules, shaped below 25°C, washed with ethanol to remove the oil layer on the surface of the soft capsules, dried below 25°C, and taken out to obtain a finished product, which is named "Jinxiang Soft Capsules".
实施例8Example 8
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺33 马鞭草33 穿心莲20 当 归16 鸡血藤41Diamond thorn 33 Verbena 33 Andrographis paniculata 20 Angelica 16 Spatholobus 41
延胡索21 夏枯草33 功劳木20 金樱根40 香 附19Corydalis 21 Prunella vulgaris 33 Gonggong wood 20 Golden cherry root 40 Fragrance Attached to 19
其生产工艺流程为:Its production process is:
(1)当归、香附加3倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 3 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 2 hours, collect the oily distillate (medicine residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加3倍量65%乙醇回流提取3小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena were extracted by adding 3 times the amount of 65% ethanol under reflux for 3 hours, the extract was filtered, and the filtrate recovered ethanol and concentrated to obtain thick ointment D, and medicinal dregs E were handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加8倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次3小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 8 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 3 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)按中间产品干浸膏粉G和A的总量,加入0.5~5%的鲸蜡或其它阻滞剂包衣,分别制成2、4、6、8小时缓释小丸,每种小丸用不同色泽区分,混合均匀后装入空胶囊中,包装成盒或热压成铝塑板,得成品,产品名称为“金香缓释胶囊”或“缓释金香胶囊”。(5) According to the total amount of the dry extract powder G and A of the intermediate product, add 0.5% to 5% of spermaceti or other blocker coating, and make slow-release pellets for 2, 4, 6, and 8 hours respectively. The small pills are distinguished by different colors, mixed evenly, put into empty capsules, packed into boxes or hot-pressed into aluminum-plastic plates, and the finished product is obtained. The product name is "Jinxiang sustained-release capsule" or "Slow-release Jinxiang capsule".
实施例9Example 9
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺3.35 马鞭草3.35 穿心莲2 当 归1.5 鸡血藤4Diamond thorn 3.35 Verbena 3.35 Andrographis 2 Angelica 1.5 Millipede 4
延胡索2 夏枯草3.35 功劳木2 金樱根4 香 附2Corydalis 2 Prunella vulgaris 3.35 Gonggong wood 2 Golden cherry root 4 Fragrance Attached 2
其生产工艺流程为:Its production process is:
(1)当归、香附加7倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油3小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 7 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil with steam distillation for 3 hours, collect the oily distillate (medicine residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加7倍量70%乙醇回流提取2小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaojiao, and verbena were extracted with 7 times the amount of 70% ethanol under reflux for 2 hours, the extract was filtered, and the filtrate recovered ethanol and concentrated to obtain thick ointment D, and medicinal dregs E was handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加5倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次1.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 5 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 1.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)按中间产品干浸膏粉G和A的总量,加入0.5~5%的鲸蜡或其它阻滞剂包衣,分别制成2、4、6、8小时缓释小丸,每种小丸用不同色泽区分,混合均匀后装入空胶囊中,包装成盒或热压成铝塑板,得成品,产品名称为“金香缓释胶囊”或“缓释金香胶囊”。(5) According to the total amount of the dry extract powder G and A of the intermediate product, add 0.5% to 5% of spermaceti or other blocker coating, and make slow-release pellets for 2, 4, 6, and 8 hours respectively. The small pills are distinguished by different colors, mixed evenly, put into empty capsules, packed into boxes or hot-pressed into aluminum-plastic plates, and the finished product is obtained. The product name is "Jinxiang sustained-release capsule" or "Slow-release Jinxiang capsule".
实施例10Example 10
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺33.5 马鞭草33.5 穿心莲20 当 归15 鸡血藤41Vajra thorn 33.5 Verbena 33.5 Andrographis 20 Angelica 15 Spatholobus 41
延胡索21 夏枯草33.5 功劳木21 金樱根41 香 附21Corydalis 21 Prunella vulgaris 33.5 Gonggong wood 21 Golden cherry root 41 Fragrance Attached to 21
其生产工艺流程为:Its production process is:
(1)当归、香附加8倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 8 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 4 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加8倍量55%乙醇回流提取3.5小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena are added together with 8 times the amount of 55% ethanol for reflux extraction for 3.5 hours, the extract is filtered, and the filtrate is recovered with ethanol and concentrated to obtain thick ointment D, and medicinal dregs E is handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加5倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次2.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 5 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 2.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)按中间产品干浸膏粉G和A的总量,加入0.5~5%的鲸蜡或其它阻滞剂包衣,分别制成2、4、6、8小时缓释小丸,每种小丸用不同色泽区分,混合均匀后装入空胶囊中,包装成盒或热压成铝塑板,得成品,产品名称为“金香缓释胶囊”或“缓释金香胶囊”。(5) According to the total amount of the dry extract powder G and A of the intermediate product, add 0.5% to 5% of spermaceti or other blocker coating, and make slow-release pellets for 2, 4, 6, and 8 hours respectively. The small pills are distinguished by different colors, mixed evenly, put into empty capsules, packed into boxes or hot-pressed into aluminum-plastic plates, and the finished product is obtained. The product name is "Jinxiang sustained-release capsule" or "Slow-release Jinxiang capsule".
实施例11Example 11
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺35 马鞭草35 穿心莲21 当 归16 鸡血藤42Diamond thorn 35 Verbena 35 Andrographis paniculata 21 Angelica 16 Spatholobus 42
延胡索22 夏枯草35 功劳木22 金樱根43 香 附22Corydalis 22 Prunella vulgaris 35 Gonggong wood 22 Golden cherry root 43 Fragrance Attached to 22
其生产工艺流程为:Its production process is:
(1)当归、香附加4倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2.5小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 4 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil with steam distillation for 2.5 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加3倍量70%乙醇回流提取2.5小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena were extracted with 3 times the amount of 70% ethanol under reflux for 2.5 hours, the extract was filtered, and the filtrate was recovered with ethanol and concentrated to obtain thick ointment D, and medicinal dregs E was handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加7倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次1.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 7 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 1.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)将聚乙二醇6000加热熔融,再取中间产品A和G加入,搅匀,转移至滴丸装置上,86℃密闭保温,用10℃~15℃液体石蜡或其它液体作冷却剂,用50滴/分速度进行滴制,得成品,产品名称为“金香滴丸”。(5) Heat and melt polyethylene glycol 6000, then add the intermediate products A and G, stir well, transfer to the dropping pill device, keep it sealed at 86°C, and use 10°C~15°C liquid paraffin or other liquids as coolants , drop system with 50 drops/minute speed, get finished product, product name is " Jinxiang dripping pill ".
实施例12Example 12
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺6.7 马鞭草6.7 穿心莲4 当 归3 鸡血藤8Diamond thorn 6.7 Verbena 6.7 Andrographis 4 Angelica 3 Millipede 8
延胡索4 夏枯草6.7 功劳木4 金樱根8 香 附4Corydalis 4 Prunella vulgaris 6.7 Gonggong wood 4 Golden cherry root 8 Fragrance Attached to 4
其生产工艺流程为:Its production process is:
(1)当归、香附加4倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2.5小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 4 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil with steam distillation for 2.5 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加4倍量60%乙醇回流提取3.5小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena are added together with 4 times the amount of 60% ethanol for reflux extraction for 3.5 hours, the extract is filtered, and the filtrate is recovered with ethanol and concentrated to obtain thick ointment D, and medicinal dregs E is handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加4倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次2.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 4 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 2.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)将聚乙二醇6000加热熔融,再取中间产品A和G加入,搅匀,转移至滴丸装置上,86℃密闭保温,用10℃~15℃液体石蜡或其它液体作冷却剂,用50滴/分速度进行滴制,得成品,产品名称为“金香滴丸”。(5) Heat and melt polyethylene glycol 6000, then add the intermediate products A and G, stir well, transfer to the dropping pill device, keep it sealed at 86°C, and use 10°C~15°C liquid paraffin or other liquids as coolants , drop system with 50 drops/minute speed, get finished product, product name is " Jinxiang dripping pill ".
实施例13Example 13
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺3.35 马鞭草3.35 穿心莲2 当 归1.5 鸡血藤4Diamond thorn 3.35 Verbena 3.35 Andrographis 2 Angelica 1.5 Millipede 4
延胡索2 夏枯草3.35 功劳木2 金樱根4 香 附2Corydalis 2 Prunella vulgaris 3.35 Gonggong wood 2 Golden cherry root 4 Fragrance Attached 2
其生产工艺流程为:Its production process is:
(1)当归、香附加7倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油3小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 7 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil with steam distillation for 3 hours, collect the oily distillate (medicine residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加5倍量65%乙醇回流提取2小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E移交水提工序。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena are added together with 5 times the amount of 65% ethanol for reflux extraction for 2 hours, the extract is filtered, and the filtrate is recovered with ethanol and concentrated to obtain thick ointment D, and medicinal dregs E is handed over to the water extraction process .
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加7倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次1.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 7 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 1.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)将聚乙二醇6000加热熔融,再取中间产品A和G加入,搅匀,转移至滴丸装置上,86℃密闭保温,用10℃~15℃液体石蜡或其它液体作冷却剂,用50滴/分速度进行滴制,得成品,产品名称为“金香滴丸”。(5) Heat and melt polyethylene glycol 6000, then add the intermediate products A and G, stir well, transfer to the dropping pill device, keep it sealed at 86°C, and use 10°C~15°C liquid paraffin or other liquids as coolants , drop system with 50 drops/minute speed, get finished product, product name is " Jinxiang dripping pill ".
实施例14Example 14
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺11 马鞭草11 穿心莲7 当 归5 鸡血藤14Diamond thorn 11 Verbena 11 Andrographis 7 Angelica 5 Spathiphyllum 14
延胡索7 夏枯草11 功劳木7 金樱根14 香 附7Corydalis 7 Prunella vulgaris 11 Gonggong wood 7 Golden cherry root 14 Fragrance Attached to 7
其生产工艺流程为:Its production process is:
(1)取穿心莲总量的7/25粉碎成细粉,用115℃高压蒸汽灭菌40分钟,得中间产品A1;(1) Take 7/25 of Andrographis paniculata total amount and pulverize into fine powder, sterilize with 115 DEG C of high-pressure steam for 40 minutes, obtain intermediate product A1 ;
(2)当归、香附加5倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油3小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B1;蒸馏后的水溶液C1备用;药渣D1移交醇提工序。(2) Add 5 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 3 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin combined, dried, and weighed to obtain an intermediate product B 1 ; the distilled aqueous solution C 1 is ready for use; and the dregs D 1 are handed over to the alcohol extraction process.
(3)药渣D1与剩余的穿心莲、马鞭草、功劳木加5倍量60%乙醇回流提取4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E1。(3) Medicinal dregs D 1 and the remaining Andrographis paniculata, Verbena Herb, and Gonglaojiao plus 5 times the amount of 60% ethanol were refluxed for 4 hours, the extract was filtered, and the filtrate was recovered with ethanol and concentrated to obtain a thick ointment E 1 .
(4)将上述醇提后的药渣与金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加8倍量的水,浸泡1小时,加热提取两次,每次3小时,得水提部分F1。(4) Add 8 times the amount of water to the above-mentioned alcohol-extracted medicinal residues together with King Kong thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root, soak for 1 hour, heat and extract twice, each time for 3 hours, to obtain water Mention part F1 .
(5)将C1、E1和F1混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉G1。(5) Mix C 1 , E 1 and F 1 , add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder G 1 .
(6)取中间产品干膏粉G1制粒,干燥,加入B1与适量辅料混匀,压片,包糖衣或薄膜衣,包装,得成品,产品名称为“金香片”。(6) Take the dry cream powder G1 of the intermediate product, granulate, dry, add B1 and mix with appropriate amount of auxiliary materials, press into tablets, coat with sugar or film, pack, and obtain the finished product, the product name is "Jinxiang Tablet".
实施例15Example 15
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺3.35 马鞭草3.35 穿心莲2 当 归1.5 鸡血藤4Diamond thorn 3.35 Verbena 3.35 Andrographis 2 Angelica 1.5 Millipede 4
延胡索2 夏枯草3.35 功劳木2 金樱根4 香 附2Corydalis 2 Prunella vulgaris 3.35 Gonggong wood 2 Golden cherry root 4 Fragrance Attached 2
其生产工艺流程为:Its production process is:
(1)取穿心莲总量的7/25粉碎成细粉,用120℃高压蒸汽灭菌30分钟,得中间产品A1;(1) Take 7/25 of Andrographis paniculata total amount and pulverize into fine powder, sterilize with 120 DEG C of high-pressure steam for 30 minutes, obtain intermediate product A1 ;
(2)当归、香附加5倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2.5小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B1;蒸馏后的水溶液C1备用;药渣D1移交醇提工序。(2) Add 5 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 2.5 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin combined, dried, and weighed to obtain the intermediate product B 1 ; the distilled aqueous solution C 1 for future use; and the dregs D 1 to be handed over to the alcohol extraction process.
(3)药渣D1加4倍量50%乙醇回流提取3.5小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E1。(3) Add 4 times the amount of 50% ethanol to the dregs D 1 and extract under reflux for 3.5 hours, filter the extract, recover ethanol from the filtrate and concentrate to obtain a thick ointment E 1 .
(4)将上述醇提后的药渣与剩余的穿心莲及金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加7倍量的水,浸泡1小时,加热提取两次,每次2.5小时,得水提部分F1。(4) Add 7 times the amount of water to the above-mentioned alcohol-extracted medicinal residues and the remaining Andrographis paniculata and Vajra thorn, Verbena, Millae Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa japonica root, soak for 1 hour, and heat to extract Two times, 2.5 hours each time, to obtain the water-extracted fraction F 1 .
(5)将C1、E1和F1混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉G1。(5) Mix C 1 , E 1 and F 1 , add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder G1.
(6)取中间产品干膏粉G1制粒,干燥,加入B1与适量辅料混匀,压片,包糖衣或薄膜衣,包装,得成品,产品名称为“金香片”。(6) Take the dry cream powder G1 of the intermediate product, granulate, dry, add B1 and mix with appropriate amount of auxiliary materials, press into tablets, coat with sugar or film, pack, and obtain the finished product, the product name is "Jinxiang Tablet".
实施例16Example 16
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺35 马鞭草34 穿心莲21 当 归14 鸡血藤41Diamond thorn 35 Verbena 34 Andrographis paniculata 21 Angelica 14 Caulis Spatholobus 41
延胡索20 夏枯草33 功劳木23 金樱根42 香 附19Corydalis 20 Prunella vulgaris 33 Gonggong wood 23 Golden cherry root 42 Fragrance Attached to 19
其生产工艺流程为:Its production process is:
(1)取穿心莲总量的7/25粉碎成细粉,用115℃高压蒸汽灭菌50分钟,得中间产品A1;(1) Take 7/25 of Andrographis paniculata total amount and pulverize into fine powder, sterilize with high-pressure steam at 115 DEG C for 50 minutes to obtain intermediate product A1 ;
(2)当归、香附加4倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油4小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品B1;蒸馏后的水溶液C1备用;药渣D1移交醇提工序。(2) Add 4 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 4 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin combined, dried, and weighed to obtain an intermediate product B 1 ; the distilled aqueous solution C 1 is ready for use; and the dregs D 1 are handed over to the alcohol extraction process.
(3)药渣D1加4倍量70%乙醇回流提取4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E1。(3) Add 4 times the amount of 70% ethanol to the dregs D 1 and extract under reflux for 4 hours, filter the extract, recover ethanol from the filtrate and concentrate to obtain a thick ointment E 1 .
(4)将上述醇提后的药渣与剩余的穿心莲及金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加5倍量的水,浸泡1小时,加热提取两次,每次2小时,得水提部分F1。(4) Add 5 times the amount of water to the above-mentioned medicinal residue after alcohol extraction, together with the remaining Andrographis paniculata and Vajra thorn, Verbena, Millae Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa japonica root, soak for 1 hour, and heat to extract Two times, 2 hours each time, to obtain the water-extracted fraction F 1 .
(5)将C1、E1和F1混合,加上中间产品A,干燥,粉碎成细粉,得中间产品干膏粉G1。(5) Mix C 1 , E 1 and F 1 , add intermediate product A, dry, and pulverize into fine powder to obtain intermediate product dry cream powder G 1 .
(6)取中间产品干膏粉G1制粒,干燥,加入B1与适量辅料混匀,压片,包糖衣或薄膜衣,包装,得成品,产品名称为“金香片”。(6) Take the dry cream powder G1 of the intermediate product, granulate, dry, add B1 and mix with appropriate amount of auxiliary materials, press into tablets, coat with sugar or film, pack, and obtain the finished product, the product name is "Jinxiang Tablet".
实施例17Example 17
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺3.35 马鞭草3.35 穿心莲2 当 归1.5 鸡血藤4Diamond thorn 3.35 Verbena 3.35 Andrographis 2 Angelica 1.5 Millipede 4
延胡索2 夏枯草3.35 功劳木2 金樱根4 香 附2Corydalis 2 Prunella vulgaris 3.35 Gonggong wood 2 Golden cherry root 4 Fragrance Attached 2
其生产工艺流程为:Its production process is:
(1)当归、香附加5倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 5 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 2 hours, collect the oily distillate (medicine residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加7倍量60%乙醇回流提取2.5小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena were extracted with 7 times the amount of 60% ethanol under reflux for 2.5 hours, the extract was filtered, and the filtrate was recovered with ethanol and concentrated to obtain thick ointment D and medicinal dregs E.
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加7倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次1小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 7 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 1 hour each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)取中间产品干膏粉G与适量辅料混匀,制粒,干燥,和A混匀,分装,得成品,产品名称为“金香颗粒”。(5) Take the intermediate product dry paste powder G and mix with appropriate amount of auxiliary materials, granulate, dry, mix with A, pack separately, and obtain the finished product, the product name is "Jinxiang Granules".
实施例18Example 18
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺30 马鞭草31 穿心莲19 当 归14 鸡血藤39Vajra thorn 30 Verbena 31 Andrographis 19 Angelica 14 Milletanus 39
延胡索18 夏枯草31 功劳木18 金樱根38 香 附18Corydalis 18 Prunella vulgaris 31 Gonggong wood 18 Golden cherry root 38 Fragrance Attached to 18
其生产工艺流程为:Its production process is:
(1)当归、香附加3倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 3 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 2 hours, collect the oily distillate (medicine residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加3倍量70%乙醇回流提取2小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena were extracted with 3 times the amount of 70% ethanol under reflux for 2 hours, the extract was filtered, and the filtrate was recovered with ethanol and concentrated to obtain thick ointment D and medicinal dregs E.
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加4倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次3小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 4 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 3 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)取中间产品干膏粉G与适量辅料混匀,制粒,干燥,和A混匀,分装,得成品,产品名称为“金香颗粒”。(5) Take the intermediate product dry paste powder G and mix with appropriate amount of auxiliary materials, granulate, dry, mix with A, pack separately, and obtain the finished product, the product name is "Jinxiang Granules".
实施例19Example 19
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺6.7 马鞭草6.8 穿心莲3.9 当 归2.9 鸡血藤7.9Diamond thorn 6.7 Verbena 6.8 Andrographis 3.9 Angelica 2.9 Millipede 7.9
延胡索3.8 夏枯草6.6 功劳木3.9 金樱根8.1 香 附3.8Corydalis 3.8 Prunella vulgaris 6.6 Gonggong wood 3.9 Golden cherry root 8.1 Fragrance with 3.8
其生产工艺流程为:Its production process is:
(1)当归、香附加4倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油3小时,收集含油蒸馏液(药渣交醇提工序),分离,取挥发油,用β-环糊精包合,干燥后,称重,得中间产品A;蒸馏后的水溶液B备用;药渣C移交醇提工序。(1) Add 4 times the amount of water to angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 3 hours, collect the oily distillate (drug residue and alcohol extraction process), separate, take the volatile oil, and wrap it with β-cyclodextrin Combined, dried, and weighed to obtain an intermediate product A; the distilled aqueous solution B is ready for use; the dregs C is handed over to the alcohol extraction process.
(2)药渣C与穿心莲、功劳木、马鞭草一起加4倍量55%乙醇回流提取2小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏D,药渣E。(2) Medicinal dregs C, andrographis paniculata, gonglaozhi, and verbena were extracted with 4 times the amount of 55% ethanol under reflux for 2 hours, the extract was filtered, and the filtrate was recovered with ethanol and concentrated to obtain thick ointment D and medicinal dregs E.
(3)将金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加5倍量的水,浸泡1小时,然后加入上述醇提后的药渣E,加热提取两次,每次2.5小时,得水提部分F。(3) Put Vajra thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosaceae root together, add 5 times the amount of water, soak for 1 hour, then add the above-mentioned medicinal residue E after alcohol extraction, heat and extract twice, 2.5 hours each time , to obtain the water extraction part F.
(4)将B、D和F混合浓缩,干燥,粉碎成细粉,得中间产品干膏粉G。(4) B, D and F are mixed and concentrated, dried and pulverized into fine powder to obtain the intermediate product dry cream powder G.
(5)取中间产品干膏粉G与适量辅料混匀,制粒,干燥,和A混匀,分装,得成品,产品名称为“金香颗粒”。(5) Take the intermediate product dry paste powder G and mix with appropriate amount of auxiliary materials, granulate, dry, mix with A, pack separately, and obtain the finished product, the product name is "Jinxiang Granules".
实施例20Example 20
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺168 马鞭草168 穿心莲100 当 归75 鸡血藤200Diamond thorn 168 Verbena 168 Andrographis paniculata 100 Angelica 75 Millipede 200
延胡索100 夏枯草168 功劳木100 金樱根200 香 附100Yanhusuo 100 Prunella vulgaris 168 Gonggong wood 100 Golden cherry root 200 Fragrance Attached 100
其生产工艺流程为:Its production process is:
(1)当归、香附加5倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油4小时,收集含油蒸馏液,分离,得挥发油B3;蒸馏后的水溶液C3备用;药渣D3移交醇提工序。(1) Add 5 times the amount of water to Chinese angelica and incense, soak for 1 hour, extract the volatile oil by steam distillation for 4 hours, collect the oily distillate, separate to obtain volatile oil B3 ; the distilled aqueous solution C3 for subsequent use; dregs D3 hand over Alcohol extraction process.
(2)药渣D3加4倍量60%乙醇回流提取2小时,提取液滤过,滤液回收乙醇得醇提部分E3。(2) Add 4 times the amount of 60% ethanol to the medicinal dregs D 3 for reflux extraction for 2 hours, filter the extract, recover ethanol from the filtrate to obtain the alcohol-extracted fraction E 3 .
(3)将上述醇提后的药渣与穿心莲、金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加4倍量的水,浸泡1小时,加热提取两次,每次1小时,得水提部分F3。(3) Combine the above alcohol-extracted medicinal residues with Andrographis paniculata, Vajra thorn, Verbena, Caulis Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa japonica root, add 4 times the amount of water, soak for 1 hour, and heat and extract twice , 1 hour each time to obtain the water-extracted fraction F 3 .
(4)将C3、E3和F3混合浓缩,得相对密度1.05~1.20/55~60℃的中间产品流浸膏G3。(4) Mix and concentrate C 3 , E 3 and F 3 to obtain an intermediate product liquid extract G 3 with a relative density of 1.05-1.20/55-60°C.
(5)取中间产品B3和G3与适量糖浆或蜂蜜混匀,灭菌,灌装,得成品,产品名称为“金香口服液”。(5) Take the intermediate products B 3 and G 3 and mix them with an appropriate amount of syrup or honey, sterilize and fill to obtain a finished product, the product name is "Jinxiang Oral Liquid".
实施例21Example 21
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺3.35 马鞭草3.35 穿心莲2 当 归1.5 鸡血藤4Diamond thorn 3.35 Verbena 3.35 Andrographis 2 Angelica 1.5 Millipede 4
延胡索2 夏枯草3.35 功劳木2 金樱根4 香 附2Corydalis 2 Prunella vulgaris 3.35 Gonggong wood 2 Golden cherry root 4 Fragrance Attached 2
其生产工艺流程为:Its production process is:
(1)当归、香附,加4倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油2小时,收集含油蒸馏液,分离,得挥发油B3;蒸馏后的水溶液C3备用;药渣D3移交醇提工序。(1) Angelica sinensis and Cyperus cyperi, add 4 times the amount of water, soak for 1 hour, extract the volatile oil by steam distillation for 2 hours, collect the oily distillate, separate to obtain volatile oil B3 ; distilled aqueous solution C3 for subsequent use; dregs D 3 Transfer to the alcohol extraction process.
(2)药渣D3加7倍量60%乙醇回流提取2小时,提取液滤过,滤液回收乙醇得醇提部分E3。(2) Add 7 times the amount of 60% ethanol to the medicinal dregs D 3 for reflux extraction for 2 hours, filter the extract, recover ethanol from the filtrate to obtain the alcohol-extracted fraction E 3 .
(3)将上述醇提后的药渣与穿心莲、金刚刺、马鞭草、鸡血藤、延胡索、夏枯草、功劳木、金樱根一起,加5倍量的水,浸泡1小时,加热提取两次,每次2小时,得水提部分F3。(3) Combine the above alcohol-extracted medicinal residues with Andrographis paniculata, Vajra thorn, Verbena, Caulis Spatholobus, Corydalis Corydalis, Prunella vulgaris, Gonglaomu, and Rosa japonica root, add 5 times the amount of water, soak for 1 hour, and heat and extract twice , 2 hours each time to obtain the water-extracted fraction F 3 .
(4)将C3、E3和F3混合浓缩,得相对密度1.05~1.20/55~60℃的中间产品流浸膏G3。(4) Mix and concentrate C 3 , E 3 and F 3 to obtain an intermediate product liquid extract G 3 with a relative density of 1.05-1.20/55-60°C.
(5)取中间产品B3和G3与适量糖浆或蜂蜜混匀,灭菌,灌装,得成品,产品名称为“金香口服液”。(5) Take the intermediate products B 3 and G 3 and mix them with an appropriate amount of syrup or honey, sterilize and fill to obtain a finished product, the product name is "Jinxiang Oral Liquid".
实施例22Example 22
称取以下中药成分(单位:g)Weigh the following traditional Chinese medicine ingredients (unit: g)
金刚刺40 马鞭草40 穿心莲22 当 归16 鸡血藤43Vajra thorn 40 Verbena 40 Andrographis 22 Angelica 16 Spatholobus 43
延胡索22 夏枯草40 功劳木21 金樱根44 香 附23Corydalis 22 Prunella vulgaris 40 Gonggong wood 21 Golden cherry root 44 Fragrance Attached to 23
其生产工艺流程为:Its production process is:
(1)当归、香附,加5倍量水,浸泡1小时,用水蒸气蒸馏法提取挥发油3小时,收集含油蒸馏液,分离,得挥发油B3;蒸馏后的水溶液C3备用;药渣D3移交醇提工序。(1) Radix Angelicae Sinensis and Rhizoma Cyperi, add 5 times the amount of water, soak for 1 hour, extract the volatile oil by steam distillation for 3 hours, collect the oily distillate, separate to get the volatile oil B3 ; the distilled aqueous solution C3 for subsequent use; dregs D 3 Transfer to the alcohol extraction process.
(2)药渣D3与剩余的穿心莲、马鞭草、功劳木加5倍量60%乙醇回流提取4小时,提取液滤过,滤液回收乙醇并浓缩,得稠膏E3。(2) Medicinal dregs D 3 and the remaining Andrographis paniculata, Verbena, and Gongluomu plus 5 times the amount of 60% ethanol were refluxed and extracted for 4 hours, the extract was filtered, and the filtrate was recovered with ethanol and concentrated to obtain a thick ointment E 3 .
(3)将上述醇提后的药渣与金刚刺、鸡血藤、延胡索、夏枯草、金樱根一起,加6倍量的水,浸泡1小时,加热提取两次,每次1.5小时,得水提部分F3。(3) Add 6 times the amount of water to the above alcohol-extracted medicinal residues together with King Kong thorn, Spatholobus Spatholobus, Corydalis Corydalis, Prunella vulgaris, and Rosa japonica root, soak for 1 hour, heat and extract twice, each time for 1.5 hours, to obtain water Mention part F3 .
(4)将C3、E3和F3混合浓缩,得相对密度1.05~1.20/55~60℃的中间产品流浸膏G3。(4) Mix and concentrate C 3 , E 3 and F 3 to obtain an intermediate product liquid extract G 3 with a relative density of 1.05-1.20/55-60°C.
(5)取中间产品B3和G3与适量糖浆或蜂蜜混匀,灭菌,灌装,得成品,产品名称为“金香口服液”。(5) Take the intermediate products B 3 and G 3 and mix them with an appropriate amount of syrup or honey, sterilize and fill to obtain a finished product, the product name is "Jinxiang Oral Liquid".
以下是本发明的临床研究报告:Following is the clinical research report of the present invention:
本发明药物委托省市级三家医院进行临床验证,工作步骤及实验结果如下:The medicine of the present invention entrusts three provincial and municipal hospitals to carry out clinical verification, and the working steps and experimental results are as follows:
临床资料:clinical information:
一、一般资料:1. General information:
金香胶囊组(下称治疗组)115例,金鸡胶囊组(下称对照组)69例,其中未婚者各为2例,均有妊娠人流史,其余病例均为已婚妇女。各组年龄、例数等资料见附表。There were 115 cases in the Jinxiang Capsule group (hereinafter referred to as the treatment group) and 69 cases in the Jinji Capsule group (hereinafter referred to as the control group), of which 2 cases were unmarried, all had a history of pregnancy abortion, and the rest were married women. See the attached table for the age and number of cases in each group.
二、诊断、分型及病例选择2. Diagnosis, classification and case selection
(1)症状:以少腹或腰部疼痛为主,并有下腹坠胀、腰骶酸痛,常于月经前后、劳累、房事后和排便时加重,可伴见低热、带下异常、月经不调、癥瘕,甚至造成不育。(1) Symptoms: Pain in the lower abdomen or lower back, accompanied by lower abdominal swelling and lumbosacral pain, often aggravated before and after menstruation, fatigue, after intercourse, and during defecation, accompanied by low-grade fever, abnormal leukorrhea, and irregular menstruation , lumps, and even cause infertility.
(2)妇科检查:子宫常呈后位,活动受限或粘连固定,输卵管炎时在一侧或两侧可触及条索状物,并有轻度压痛;盆腔结缔组织发炎时,子宫一侧或两侧有片状增厚、压痛;或在盆腔一侧或两侧摸到包块。(2) Gynecological examination: The uterus is often in a posterior position, with limited mobility or adhesions. In salpingitis, cords can be touched on one or both sides, and there is mild tenderness; Or there is flaky thickening and tenderness on both sides; or a mass is felt on one or both sides of the pelvic cavity.
(3)辨证分型:选择瘀毒内结证和气滞血瘀证作为观察对象。(3) Syndrome classification: select stasis toxin internal knot syndrome and qi stagnation and blood stasis syndrome as the observation objects.
瘀毒内结证证见低热起伏,小腹隐痛或胀,腰骶酸痛,经前或经期及劳累后加重,经行不调、量多,带下黄稠味臭,尿黄便干,舌质红、苔黄腻,脉滑数。Syndrome of blood stasis and toxin internal stagnation can be seen in low-grade fever ups and downs, dull pain or swelling in the lower abdomen, lumbosacral pain, aggravated before or during menstruation and after fatigue, irregular menstruation, profuse profuse discharge, thick yellow vaginal discharge, yellow urine and dry stool, tongue quality Red, yellow and greasy fur, slippery and rapid pulse.
气滞血瘀证证见少腹痛如针刺或长期隐痛,痛处不移,或伴腰痛,月经不调,经色紫黑有块,白带增多,头晕倦怠,舌质暗紫有瘀斑,苔白,脉涩或沉。Qi stagnation and blood stasis syndrome see less abdominal pain such as acupuncture or long-term dull pain, the pain does not move, or accompanied by low back pain, irregular menstruation, menstrual color purple and black with lumps, increased leucorrhea, dizziness and fatigue, dark purple tongue with ecchymosis, fur White, astringent or deep pulse.
三、观察方法3. Observation method
采用区组随机、实验对照、双盲法观察,治疗组用金香胶囊,对照组用金鸡胶囊,服法均为每次4粒,每日3次,温开水送服,连服4周,两组药物外观性状、剂量及包装完全一样,仅于药瓶瓶签以数字编码,以示区别,编码由厂家保密,试验结束时方揭晓。服药前给病人做常规体检和血常规、白带涂片等化验(白带检查为霉菌、滴虫或淋菌感染者不作为观察对象),服药后每周随诊一次。观察期间不用其它消炎抗菌药物(包括局部外用药)。Block random, experimental control, and double-blind observation were adopted. The treatment group used Jinxiang Capsules, and the control group took Jinji Capsules. The administration method was 4 capsules each time, 3 times a day, with warm water for 4 weeks. The appearance, dosage and packaging of the two groups of medicines are exactly the same, only the number codes on the labels of the medicine bottles are used to show the difference. Before taking the medicine, give the patient a routine physical examination, routine blood test, leucorrhea smear and other tests (those with leucorrhea examination showing mold, trichomonas or gonorrhea infection are not subject to observation), and follow up once a week after taking the medicine. No other anti-inflammatory and antibacterial drugs (including topical drugs) were used during the observation period.
四、疗效评定标准4. Curative effect evaluation standard
(1)近期痊愈:症状体征及妇科检查均恢复正常,见证积分减少91%以上;(1) Recovery in the near future: symptoms, signs and gynecological examination all returned to normal, and witness scores decreased by more than 91%;
(2)显效:症状体征及妇科检查明显改善,见证积分减少61%-90%以上;(2) Significant effect: Signs and symptoms and gynecological examination are significantly improved, and witness points are reduced by more than 61%-90%;
(3)好转:症状体征及妇科检查均有减轻,见证积分减少31%-60%;(3) Improvement: Symptoms and signs and gynecological examination are all relieved, and witness points are reduced by 31%-60%;
(4)无效:治疗后无改善,见证积分减少30%以下。(4) Ineffective: no improvement after treatment, and the witness points decreased by less than 30%.
五、结果5. Results
(1)治疗组、对照组各证型盆腔炎患者治疗前后见证积分差异均非常显著(P<0.01),表明两种药物对上述证型盆腔炎患者的症状体征均有明显改善作用;治疗组和对照组各证型疗效比较无显著性差异(P>0.05)。治疗组115例,小腹压痛、带下增多或黄臭、附件增厚粘连等症状明显减轻或消失者69例,痊愈显效率60.0%,总有效率92.17%;对照组69例,痊愈显效率60.87%,总有效率91.30%,两组疗效无显著性差异(P>0.05)。(1) The treatment group and the control group had significant differences in witness points before and after treatment in patients with pelvic inflammatory disease of each syndrome type (P<0.01), indicating that the two drugs had a significant improvement effect on the symptoms and signs of patients with pelvic inflammatory disease of the above syndrome types; the treatment group Compared with the control group, there was no significant difference in curative effect of each syndrome type (P>0.05). In the treatment group of 115 cases, 69 cases of lower abdominal tenderness, increased leucorrhea or yellow odor, thickened attachments and adhesions were significantly relieved or disappeared, with a marked recovery rate of 60.0% and a total effective rate of 92.17%; 69 cases in the control group, with a marked recovery rate of 60.87 %, the total effective rate was 91.30%, and there was no significant difference in curative effect between the two groups (P>0.05).
(2)治疗组两种证型疗效比较:瘀毒内结证略优于气滞血瘀证,但无显著性意义(R瘀霉<R血瘀,U=0.75,P>0.05)。(2) Comparison of curative effects of the two syndromes in the treatment group: stasis of toxin internal stagnation syndrome was slightly better than Qi stagnation and blood stasis syndrome, but there was no significant significance (R stasis mold < R blood stasis , U = 0.75, P > 0.05).
(3)阴道分泌物检查结果:治疗前治疗组51例WBC阳性(1~3个+),对照组19例阳性(1~3个+),治疗后转阴分别为10例、6例,未转阴者亦明显改善(P<0.01),两组无显著性差异(X2=0.55,P>0.05)。治疗前治疗组16例脓球阳性(1~2个+),对照组7例阳性(1~2个+),治疗后转阴分别为14例、7例,两组无显著性差异(X2=0.03,P>0.05)。(3) Results of vaginal secretion examination: 51 cases of WBC were positive (1-3+) in the treatment group before treatment, 19 cases were positive (1-3+) in the control group, and 10 cases and 6 cases turned negative after treatment, respectively. Those who did not turn negative also improved significantly (P<0.01), and there was no significant difference between the two groups (X 2 =0.55, P>0.05). Before treatment, 16 cases of pus balls in the treatment group were positive (1 to 2+), and 7 cases in the control group were positive (1 to 2+). 2 = 0.03, P > 0.05).
(4)血象变化情况:治疗前血WBC升高治疗组、对照组分别为14例、3例,治疗后恢复正常分别为13例、2例,两组有显著差异(X2=4.96,P<0.01),治疗组优于对照组。(4) Changes in blood picture: before treatment, blood WBC increased in the treatment group and the control group in 14 cases and 3 cases, respectively, and after treatment, it returned to normal in 13 cases and 2 cases, respectively. There was a significant difference between the two groups (X 2 =4.96, P <0.01), the treatment group was better than the control group.
六、毒副作用6. Toxic and side effects
治疗组115例中有5例服药后觉胸口或上腹部轻度不适,可能因个别病人服用胶囊剂型时胶囊滞留于食道内所致;对照组亦有1例出现上症;治疗组另有2例出现口咽轻度干燥。未发现明显毒副作用。Among the 115 cases in the treatment group, 5 cases felt mild discomfort in the chest or upper abdomen after taking the medicine, which may be caused by capsule retention in the esophagus when individual patients took the capsule dosage form; 1 case in the control group also developed symptoms; Cases of mild dryness of the oropharynx. No obvious toxic side effects were found.
七、结论7. Conclusion
采用金香胶囊观察治疗瘀毒内结证、气滞血瘀证盆腔炎患者共115例,结果表明该药能够明显改善患者盆腔炎症状,具有清热解毒、活血化瘀、行气止痛功效,并且能使上述证型盆腔炎所致的血WBC升高者恢复正常,同时对异常阴道分泌物有明显改善作用。结果还表明其安全,无明显毒副作用,有较好的临床推广应用价值。A total of 115 cases of pelvic inflammatory disease with syndrome of blood stasis and blood stasis were observed and treated with Jinxiang Capsules. The results showed that the drug can significantly improve the symptoms of pelvic inflammatory disease, and has the effects of clearing heat and detoxification, promoting blood circulation and removing blood stasis, promoting qi and relieving pain, and It can make the blood WBC rise caused by the above-mentioned syndrome type pelvic inflammatory disease return to normal, and at the same time, it can obviously improve the abnormal vaginal discharge. The results also show that it is safe, has no obvious toxic and side effects, and has good clinical application value.
八、典型病例8. Typical cases
例1唐某,31岁,已婚,住南宁市华强路227号。因少腹胀痛,腰骶酸痛一月余于1993年12月14日来院就诊,查宫体及附件压痛,白带色黄量中等,白带涂片WBC+++,血WBC9.6×109/L,N76%,舌淡红,苔薄黄、脉细数,见证总积分6分,诊为慢性盆腔炎瘀毒内结证,服用金香胶囊每次4粒,每日3次,连腹3周后上述症状明显减轻,4周后全部见证消失,白带WBC±,血WBC6.0×109/L,N65%,宫体及附件无压痛,疗效判定为近期痊愈。Example 1 Tang X, 31 years old, married, lives at No. 227 Huaqiang Road, Nanning City. He came to the hospital for treatment on December 14, 1993 due to abdominal pain and lumbosacral pain for more than a month. The uterine body and adnexa were tender and tender, the leucorrhea was moderately yellow in color, leucorrhea smear WBC+++, blood WBC9.6×10 9 /L, N76 %, pale red tongue, thin yellow fur, thready pulse, total witness score of 6 points, diagnosed as chronic pelvic inflammatory disease stasis toxin syndrome, taking Jinxiang Capsules 4 capsules each time, 3 times a day, after 3 weeks The above symptoms were obviously relieved, and all of them disappeared after 4 weeks. Leucorrhea WBC±, blood WBC6.0×10 9 /L, N65%, no tenderness in the uterine body and appendages, and the curative effect was judged as recovery in the near future.
例2田某,37岁,住广西水电厅,孕4产1,1993年10月12日就诊,诉少腹疼痛难忍,伴腰骶酸痛,畏寒肢冷,带下增多近半年,辨证为气滞血瘀证盆腔炎,查子宫后位常大活动欠佳,压痛+++,子宫右旁组织略增厚,压痛+++,服用金香胶囊4周后,各症消失,妇检盆器正常,获近期痊愈。Case 2 Tian, 37 years old, lived in the Guangxi Water and Electricity Department, pregnant with 4 births, went to the doctor on October 12, 1993, and complained of unbearable pain in the lower abdomen, accompanied by lumbosacral pain, chills and cold limbs, leukorrhagia increased for nearly half a year, syndrome differentiation It is pelvic inflammatory disease of qi stagnation and blood stasis syndrome, the posterior position of the uterus is often poorly moved, tenderness +++, the tissue on the right side of the uterus is slightly thickened, tenderness +++, after taking Jinxiang Capsules for 4 weeks, all symptoms disappeared, gynecological The basin detector was normal and recovered recently.
附表:金香胶囊临床验证疗效分析
注:*-P<0.01,A--治疗组,B--对照组。Note: *-P<0.01, A--treatment group, B--control group.
小结summary
以上临床资料揭示:The above clinical data revealed:
1、本发明药物具有清热解毒、活血化瘀、行气止痛之功效,对瘀毒内结证、气滞血瘀证盆腔炎患者有治疗作用。1. The medicine of the present invention has the effects of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, promoting qi circulation and relieving pain, and has therapeutic effect on patients with pelvic inflammatory disease with stagnation of toxin and internal stagnation of qi and blood stasis.
2、本发明药物治疗妇科炎症患者115例,总有效率为92.17%,疗效略优于金鸡胶囊胶囊的91.30%,从而达到本发明的最终目的。2. The medicine of the present invention treats 115 patients with gynecological inflammation, the total effective rate is 92.17%, and the curative effect is slightly better than 91.30% of Jinji Capsule, thereby reaching the ultimate goal of the present invention.
3、本品安全可靠,115例在观察期间均未发现明显不良反应和毒副作用。3. This product is safe and reliable, and no obvious adverse reactions and side effects were found in 115 cases during the observation period.
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| CN102552740A (en) * | 2012-01-06 | 2012-07-11 | 刘梅 | Chinese medicine for curing gynecological inflammations and preparation method thereof |
| CN102600399A (en) * | 2012-03-29 | 2012-07-25 | 常熟市常福有机复合肥有限公司 | Traditional Chinese medicine for treating chronic annex inflammatory mass and preparation method of traditional Chinese medicine |
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| CN1078079C (en) * | 1998-10-21 | 2002-01-23 | 株洲千金药业股份公司 | Process for preparing Chinese medicine 'Qianjin tablets' for treating gynopathy |
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| CN102552740A (en) * | 2012-01-06 | 2012-07-11 | 刘梅 | Chinese medicine for curing gynecological inflammations and preparation method thereof |
| CN102600399A (en) * | 2012-03-29 | 2012-07-25 | 常熟市常福有机复合肥有限公司 | Traditional Chinese medicine for treating chronic annex inflammatory mass and preparation method of traditional Chinese medicine |
| CN102743590A (en) * | 2012-06-17 | 2012-10-24 | 靳先玲 | Preparation method of Chinese medicine irrigation solution for treating erosive type chronic cervicitis |
| CN104814998A (en) * | 2015-05-16 | 2015-08-05 | 朱蕾 | Traditional Chinese medicine composition for treating gynecologic inflammation |
| CN105311252A (en) * | 2015-11-18 | 2016-02-10 | 姜新帅 | Medicinal liquor capable of treating enterogastritis |
| CN105748886A (en) * | 2016-04-08 | 2016-07-13 | 广州暨南生物医药研究开发基地有限公司 | Folium artemisiae argyi-containing pharmaceutical composition for treating endometritis and preparation method thereof |
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