CN1231250C - Chinese medicine preparation for treating acute and chronic pharyngitis, preparing method thereof - Google Patents
Chinese medicine preparation for treating acute and chronic pharyngitis, preparing method thereof Download PDFInfo
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Abstract
Description
技术领域technical field
本发明涉及一种治疗急、慢性咽炎的中药制剂及其制备方法,具体说是一种以天然中草药为原料制成的治疗急性咽炎和慢性咽炎的纯中药制剂及其制备方法。The invention relates to a traditional Chinese medicine preparation for treating acute and chronic pharyngitis and a preparation method thereof, in particular to a pure Chinese medicinal preparation for treating acute and chronic pharyngitis made from natural Chinese herbal medicines and a preparation method thereof.
背景技术Background technique
咽炎,属中医“喉痹”范畴,是临床的常见病、多发病。咽炎分为急性咽炎和慢性咽炎两种。Pharyngitis belongs to the category of "throat numbness" in traditional Chinese medicine, and is a common clinical disease and frequently-occurring disease. Pharyngitis is divided into two kinds of acute pharyngitis and chronic pharyngitis.
急性咽炎主要因为病毒、病菌感染,或多种物理化学因素刺激引起咽粘膜、粘膜下组织、淋巴组织的急性充血肿胀,疼痛等炎性反应。Acute pharyngitis is mainly due to viral, bacterial infection, or a variety of physical and chemical factors to stimulate acute congestion, swelling, pain and other inflammatory reactions in the pharyngeal mucosa, submucosal tissue, and lymphoid tissue.
慢性咽炎是因为急性咽炎的反复发作;口腔、鼻腔疾患或长期遭受物理、化学因素刺激和多种全身性慢性痰病等引起咽部粘膜、粘膜下组织、淋巴组织弥漫性炎症。Chronic pharyngitis is caused by repeated episodes of acute pharyngitis; oral and nasal cavity diseases or long-term physical and chemical stimulation and various systemic chronic phlegm diseases cause diffuse inflammation of the pharyngeal mucosa, submucosal tissue, and lymphoid tissue.
中医把急、慢性咽炎纳入喉痹范畴,认为发病机理为外感风热、上蒸咽喉;风寒外袭、郁肺化热、上壅咽喉;饮食不节、烟酒过度、湿热内生、肺胃蕴热、熏蒸咽喉或劳伤过度、脏腑失调、虚火上炎、熏燎咽喉所致。急性咽炎多属风热喉痹,慢性咽炎多属阴虚喉痹。急性咽炎反复发作,经久不愈,造成肺肾阴虚、津亏液少,则会演变为慢性咽炎。久治不愈,会导致病情加重,影响人的身体健康。Traditional Chinese medicine puts acute and chronic pharyngitis into the category of sore throat, and believes that the pathogenesis is exogenous wind-heat, steaming the throat; Accumulation of heat, fumigation of the throat or overstrain, visceral imbalance, inflammation of the deficiency fire, and fumigation of the throat. Acute pharyngitis mostly belongs to wind-heat sore throat, and chronic pharyngitis mostly belongs to yin deficiency sore throat. Acute pharyngitis recurs and persists for a long time, causing lung and kidney yin deficiency and lack of body fluid, and then it will develop into chronic pharyngitis. If left untreated for a long time, it will lead to aggravation of the disease and affect people's health.
目前,市售治疗咽炎的药剂颇多,有丸剂,片剂,还有液态的喷雾剂。原材料不甚相同,配伍更不一致,制作方法多较复杂,其制备的药物有的有副作用,有的药物长期使用后,各种病毒细菌会产生耐药性,因此疗效不够理想,治愈率不高。有些中成药也存在治标不治本,只治急性、不治慢性等不足。如现有的“冬灵草”、“六神丸”、“喉疾丸”均不能达到根治的目的。At present, there are many commercially available medicaments for the treatment of pharyngitis, including pills, tablets, and liquid sprays. The raw materials are not the same, the compatibility is even more inconsistent, and the production methods are more complicated. Some of the prepared drugs have side effects. After long-term use of some drugs, various viruses and bacteria will develop drug resistance. Therefore, the curative effect is not satisfactory and the cure rate is not high. . Some Chinese patent medicines also have the shortcomings of treating the symptoms but not the root cause, only treating the acute, not chronic. All can not reach the purpose of radical cure as existing " winter spirit grass ", " Liushen pill ", " throat disease pill ".
发明内容Contents of the invention
本发明的目的在于克服上述现有药物的不足之处,提供一种治疗急性、慢性咽炎的中药制剂及其制备方法,该中药制剂具有清热解毒、利咽开音、生津除烦、消积化滞的功效,尤其用于治疗肺胃热盛所致的咽喉肿痛。本发明的中药制剂具有解热、镇痛、抗炎的药理作用,既能治疗急性咽炎,又能治疗慢性咽炎。The purpose of the present invention is to overcome the shortcomings of the above-mentioned existing medicines, and provide a traditional Chinese medicine preparation for treating acute and chronic pharyngitis and a preparation method thereof. It has the effect of stagnation, especially for the treatment of sore throat caused by excessive heat in the lung and stomach. The traditional Chinese medicine preparation of the invention has the pharmacological effects of antipyretic, analgesic and anti-inflammation, and can not only treat acute pharyngitis, but also treat chronic pharyngitis.
本发明的一方面提供了一种治疗急性、慢性咽炎的中药制剂,其由土牛膝、岗梅根和甘草按以下重量份配比制备而成:One aspect of the present invention provides a traditional Chinese medicine preparation for treating acute and chronic pharyngitis, which is prepared from Achyranthes bidentata, Glycyrrhiza officinalis and Radix Glycyrrhiza in the following proportions by weight:
土牛膝 45-60,Achyranthes 45-60,
岗梅根 70-85,Gang Megan 70-85,
甘草 8-12。Licorice 8-12.
本发明优选的一种治疗急性、慢性咽炎的中药制剂,其由土牛膝、岗梅根和甘草按以下重量份配比制备而成:A preferred traditional Chinese medicine preparation for treating acute and chronic pharyngitis of the present invention is prepared from Achyranthes bidentata, Radix Glycyrrhizae and Radix Glycyrrhizae according to the following proportions by weight:
土牛膝 50-55,Soil achyranthes 50-55,
岗梅根 75-80,Gang Megan 75-80,
甘草 8-12。Licorice 8-12.
本发明最优选的一种治疗急性、慢性咽炎的中药制剂,其由土牛膝、岗梅根和甘草按以下重量份配比制备而成:The most preferred traditional Chinese medicine preparation for treating acute and chronic pharyngitis of the present invention is prepared from Achyranthes bidentata, Radix Glycyrrhizae and Radix Glycyrrhizae according to the following proportions by weight:
土牛膝 53,Soil Achyranthes 53,
岗梅根 77,Gang Megan 77,
甘草 10。Licorice 10.
本发明的一种治疗急性、慢性咽炎的中药制剂,其可按常规方法制成各种剂型,包括口服液、胶囊、片剂、软胶囊、颗粒剂、口含片、散剂、喷雾剂、丸剂或滴丸等。A traditional Chinese medicine preparation for treating acute and chronic pharyngitis according to the present invention can be made into various dosage forms according to conventional methods, including oral liquid, capsule, tablet, soft capsule, granule, buccal tablet, powder, spray and pill Or drop pills, etc.
在各种剂型中,优选一种由下述方法制成的口服液,该制备方法为:Among various dosage forms, preferably a kind of oral liquid made by following method, this preparation method is:
A.将土牛膝、岗梅根和甘草加3-6倍量水煎煮两次,第一次2-2.5小时,第二次1.5-2小时;A. Decoct Achyranthes bidentata, Gangmeigen and licorice twice with 3-6 times the amount of water, the first time is 2-2.5 hours, and the second time is 1.5-2 hours;
B.过滤,合并滤液,并浓缩,加50-60%乙醇浸泡10-15小时,过滤,回收乙醇,加水至所需量,并加一定量的防腐剂;B. Filter, combine the filtrates, and concentrate, add 50-60% ethanol to soak for 10-15 hours, filter, recover ethanol, add water to the required amount, and add a certain amount of preservative;
C.分装成成品。C. Subpackage into finished products.
具体服用方法和用量:口服,每日三次,每次10-20ml。急性咽炎连续3天为一疗程,慢性咽炎连续7天为一疗程。Specific administration method and dosage: take orally, three times a day, 10-20ml each time. Acute pharyngitis is a course of treatment for 3 consecutive days, and chronic pharyngitis is a course of treatment for 7 consecutive days.
在各种剂型中,还优选一种由下述方法制成的胶囊,该制备方法为:In various dosage forms, also preferably a kind of capsule made by following method, this preparation method is:
A.将土牛膝、岗梅根和甘草经生药处理后混合,加3-6倍量水煮,提取2次,第一次2-2.5小时、第二次1.5-2小时;A. Mix Achyranthes bidentata, Plum Root and licorice after crude drug treatment, add 3-6 times the amount of water to boil, extract 2 times, the first time is 2-2.5 hours, and the second time is 1.5-2 hours;
B.过滤,合并二次滤液,浓缩;B. filter, combine secondary filtrate, concentrate;
C.加50-60%乙醇浸泡10-15小时,过滤,回收乙醇,滤液浓缩,喷雾干燥成细粉;C. Add 50-60% ethanol to soak for 10-15 hours, filter, recover ethanol, concentrate the filtrate, spray dry into fine powder;
D.细粉加入适量淀粉、微晶纤维,混合均匀,分装入胶囊壳中,即成成品。D. Add appropriate amount of starch and microcrystalline fiber to the fine powder, mix evenly, divide into capsule shells, and the finished product is formed.
本发明中药制剂中的各味中药均为天然药材。方中的土牛膝味涩微甘,性温,无毒。其生于山野村边路旁旷地,或人工栽培。一或二年生草本。茎粗壮直立,多分枝,稍呈方形,多少被毛,高二、三尺,基部带木质,节膨木似牛膝,叶对生,椭圆形,长二、三寸,有短刚毛,全绿,先端尖,基部楔形,有叶柄。夏秋抽穗状花序,密被绒毛,花小,绿色,开后倒反紧贴花轴,有刚硬实锐苞片二枚,易缀附衣物。All the traditional Chinese medicines in the Chinese medicine preparation of the present invention are natural medicinal materials. The Achyranthes bidentata in the prescription is astringent and slightly sweet, warm in nature and non-toxic. It is born in open fields beside roads in mountain villages, or cultivated artificially. Annual or biennial herbs. The stem is thick and upright, much branched, slightly square, more or less hairy, two or three feet high, woody at the base, knotted wood like achyranthes, opposite leaves, oval, two or three inches long, with short bristles, all green , apex pointed, base cuneate, with petiole. Spikes in summer and autumn, densely covered with downy hairs, small, green flowers, clinging to the flower axis after opening, with two hard and sharp bracts, easy to attach to clothes.
本发明的一种治疗急性、慢性咽炎的中药制剂是由三种中草药制备而成,其组方科学、合理,协同性好,疗效非常显著,克服了现有组方药味多、工艺复杂、疗效不显著等缺点。A traditional Chinese medicine preparation for treating acute and chronic pharyngitis of the present invention is prepared from three kinds of Chinese herbal medicines. No obvious disadvantages.
具体实施方式Detailed ways
以下采用实施例具体说明本发明的一种治疗急性、慢性咽炎的中药制剂及其制备方法。A kind of Chinese medicine preparation for the treatment of acute and chronic pharyngitis of the present invention and its preparation method are specifically described below by using the examples.
实施例1Example 1
一种治疗急性、慢性咽炎的口服液,其由土牛膝、岗梅根和甘草按以下重量制备而成:An oral liquid for treating acute and chronic pharyngitis, which is prepared by the following weights:
土牛膝 815克,Ox knee 815 grams,
岗梅根 1175克,Gang Megan 1175g,
甘草 153克。Licorice 153 grams.
上述口服液的制备工艺如下:The preparation technology of above-mentioned oral liquid is as follows:
A.将土牛膝、岗梅根和甘草加5倍量水煎煮两次,第一次2小时,第二次2小时;A. Decoct Achyranthes bidentata, Gangmegen and licorice twice with 5 times the amount of water, the first time is 2 hours, and the second time is 2 hours;
B.过滤,合并滤液,并浓缩,加50-60%乙醇浸泡10-15小时,过滤,回收乙醇,加水至1000ml;加0.5克尼泊金;B. Filtrate, combine the filtrate, and concentrate, add 50-60% ethanol to soak for 10-15 hours, filter, recover ethanol, add water to 1000ml; add 0.5 g of paraben;
C.分装成100ml。C. Divide into 100ml.
实施例2Example 2
一种治疗急性、慢性咽炎的药物胶囊,其由土牛膝、岗梅根和甘草按以下重量制备而成:A medicine capsule for treating acute and chronic pharyngitis, which is prepared by the following weights:
土牛膝 2650克,Soil ox knee 2650 grams,
岗梅根 3900克,Gang Megan 3900g,
甘草 500克。Licorice 500 grams.
上述胶囊的制备工艺如下:The preparation technology of above-mentioned capsule is as follows:
A.将土牛膝、岗梅根和甘草经生药处理后混合,加4倍量水煮,提取2次,第一次2小时、第二次2小时;A. Mix Achyranthes bidentata, Plum Root and Licorice after crude drug treatment, add 4 times the amount of water to boil, extract twice, the first time for 2 hours, and the second time for 2 hours;
B.过滤,合并二次滤液,浓缩;B. filter, combine secondary filtrate, concentrate;
C.加50-60%乙醇浸泡12小时,过滤,回收乙醇,滤液浓缩,喷雾干燥成细粉;C. Add 50-60% ethanol to soak for 12 hours, filter, recover ethanol, concentrate the filtrate, and spray dry it into a fine powder;
D.细粉加入适量淀粉、微晶纤维,混合均匀,分装入1000粒胶囊,包装即得。D. Add appropriate amount of starch and microcrystalline fiber to the fine powder, mix evenly, divide into 1000 capsules, and pack.
以下通过药效学试验进一步说明本发明的一种治疗急性、慢性咽炎的中药制剂的药效作用:Further illustrate the drug effect of a kind of Chinese medicine preparation for the treatment of acute and chronic pharyngitis of the present invention by pharmacodynamic test below:
1实验材料1 Experimental materials
1.1药物与试剂本发明的中药制剂(商品名:利咽方)由广东高盛医药发展有限公司提供,褐色粉末,每g相当于原生药4.8g。草珊瑚含片,江中制药厂产品。阿司匹林,徐州恩华药业有限公司。高活性酵母,The Mc-DougallsKitchen,Englangd。其它均为市售分析纯试剂。1.1 Drugs and reagents The traditional Chinese medicine preparation (trade name: Liyan Fang) of the present invention is provided by Guangdong Gaosheng Pharmaceutical Development Co., Ltd., and is a brown powder, and each g is equivalent to 4.8g of the original drug. Caoshanhu buccal tablets, produced by Jiangzhong Pharmaceutical Factory. Aspirin was purchased from Xuzhou Enhua Pharmaceutical Co., Ltd. Highly Active Yeast, The Mc-DougallsKitchen, Englandd. Others are commercially available analytical reagents.
1.2动物NIH小鼠(合格证号:01A018),体重17~21g;SD大鼠(合格证号:01A017),体重180~220g。均由广东省医学实验动物中心提供。1.2 Animals NIH mice (certificate number: 01A018), body weight 17-21 g; SD rats (certificate number: 01A017), body weight 180-220 g. All were provided by the Guangdong Medical Experimental Animal Center.
1.3仪器GJ-8402型热板测痛仪,浙江白石科学仪器厂。7550型分光光度计,惠普上海分析仪器有限公司。日本奥姆龙数字显示体温表。1.3 Instruments GJ-8402 Hot Plate Pain Tester, Zhejiang Baishi Scientific Instrument Factory. 7550 spectrophotometer, Hewlett-Packard Shanghai Analytical Instrument Co., Ltd. Japanese Omron digital display thermometer.
2方法与结果2 Methods and results
2.1对鲜酵母人工发热的影响取雄性SD大鼠,体重180~220g,经肛温测量,挑选肛温在36.6℃~38.3℃者50只,随机分成5组,每组10只;生理盐水组、利咽方低、中、高剂量组(2.5、5、10g/kg)、阿司匹林(0.2g/kg)组。利咽方连续给药3天,至第3天,按2ml/100g体重的剂量,用1.5%鲜酵母混悬液注射于大鼠颈背部皮下。于注射酵母后第5小时开始灌胃给药,给药后1小时开始测肛温,以后每隔1小时测量1次。大鼠始终置于室温为22℃的房间中。2.1 Effects on artificial fever of fresh yeast Male SD rats, weighing 180-220g, were measured by rectal temperature, and 50 rats with rectal temperature between 36.6°C and 38.3°C were selected and randomly divided into 5 groups, 10 rats in each group; normal saline group , Liyan prescription low, medium and high dose groups (2.5, 5, 10g/kg), aspirin (0.2g/kg) group. The Liyan Prescription was administered continuously for 3 days, and on the third day, a dose of 2ml/100g body weight was used to subcutaneously inject 1.5% fresh yeast suspension into the neck and back of rats. The intragastric administration was started 5 hours after the injection of the yeast, and the rectal temperature was measured 1 hour after the administration, and then measured every 1 hour. Rats were always placed in a room with a room temperature of 22°C.
结果见表1,利咽方对鲜酵母人工发热的大鼠有明显的退热作用(P0.001),其作用至少可维持4小时。The results are shown in Table 1. Liyan Recipe has a significant antipyretic effect on rats with artificial fever caused by fresh yeast (P<0.001), and the effect can be maintained for at least 4 hours.
2.2对热板法所致疼痛的影响取18~22g雄性小鼠,每次1只放在55±0.5℃的金属热板上,小鼠自放在热板上至出现舔后足所需时间(s)作为该鼠的痛阈值。凡舔后足时间小于5秒或大于30秒或跳跃者弃之不用。将合格的小鼠随机分成5组,每组10只,重复测其正常痛阈值,按表2剂量连续给药3天,每天1次,阴性对照组给生理盐水0.4ml/只,于末次给药后60、120、180、240分钟分别测定痛阈值,若痛阈值60秒,以60秒计算,以免烫伤动物足掌影响下次观察。动物始终置于20℃的房间中。2.2 The effect on pain caused by the hot plate method Take 18-22g male mice, put one mouse on a metal hot plate at 55±0.5°C each time, and the time required for the mice to lick their hind feet from the time they are placed on the hot plate (s) is used as the pain threshold of the mouse. Those who lick the hind feet for less than 5 seconds or more than 30 seconds or jump are discarded. Qualified mice were randomly divided into 5 groups, 10 in each group, and their normal pain thresholds were repeatedly measured. The doses in Table 2 were administered continuously for 3 days, once a day. The pain threshold was measured at 60, 120, 180, and 240 minutes after the medicine, and if the pain threshold was 60 seconds, it was calculated as 60 seconds, so as not to affect the next observation due to scalding the animal's paw. Animals were kept in a room at 20°C throughout.
结果见表2。利咽方中、高剂量对热板法所致小鼠疼痛均有显著的抑制作用,高剂量组(10g/kg)在给药后60~240分钟有显著的镇痛作用(P 0.01),中剂量组(5g/kg)在给药后60~180分钟亦有显著的镇痛作用(P 0.01)。The results are shown in Table 2. The middle and high doses of Liyan Fang have a significant inhibitory effect on the pain induced by the hot plate method in mice, and the high dose group (10g/kg) has a significant analgesic effect 60 to 240 minutes after administration (P 0.01), The middle dose group (5g/kg) also had significant analgesic effect 60-180 minutes after administration (P 0.01).
2.3对小鼠腹腔毛细血管通透性增高的影响取体重18~22g小鼠50只,随机分成5组,每组10只,连续灌胃给药4天,于末次给药后1小时,尾静脉注射浓度为1g/100ml的伊文思兰溶液0.1ml/只,并同时腹腔注射0.6%醋酸溶液0.2ml/只,20分钟后处死小鼠,剪开腹腔,用3ml蒸馏水冲洗腹腔数次,吸取腹腔洗出液约3~4ml,1000r/分钟离心5分钟,在590nm处测定吸收度值。2.3 Effects on increased permeability of the capillaries in the abdominal cavity of mice 50 mice weighing 18-22 g were randomly divided into 5 groups with 10 mice in each group. Intravenously inject 0.1ml of Evans blue solution with a concentration of 1g/100ml/mouse, and at the same time intraperitoneally inject 0.6% acetic acid solution 0.2ml/mouse, kill the mice after 20 minutes, cut the abdominal cavity, wash the abdominal cavity several times with 3ml distilled water, and draw About 3-4ml of peritoneal washings was centrifuged at 1000r/min for 5 minutes, and the absorbance value was measured at 590nm.
结果见表3,利咽方的三个剂量对H+所致的小鼠腹腔毛细血管通透性增高均有明显的抑制作用,抑制炎性渗出,与生理盐水组相比,有极显著差异(P0.01)。The results are shown in Table 3. The three doses of Liyan Prescription have obvious inhibitory effects on the increase of mouse peritoneal capillary permeability caused by H + , and inhibit inflammatory exudation. Compared with the normal saline group, there is a very significant effect. difference (P<0.01).
3讨论3 Discussion
利咽方有明显的解热、镇痛、抗炎性渗出的作用。对于大鼠鲜酵母人工发热,利咽方最高可降低体温0.8℃。对于热板法所致疼痛,利咽方可明显提高痛阈,最高可提高痛阈43.8%。利咽方还可抑制醋酸所致的小鼠腹腔毛细血管通透性的提高,抑制率可达到34.8%。药效实验结果与利咽方治疗急、慢性咽炎的临床疗效相吻合。Liyan Recipe has obvious antipyretic, analgesic and anti-inflammatory effects. For artificial fever caused by fresh yeast in rats, Liyan Formula can lower body temperature by up to 0.8°C. For the pain caused by hot plate method, Liyan Prescription can significantly increase the pain threshold, the highest pain threshold can be increased by 43.8%. Liyan Fang can also inhibit the increase of the permeability of the capillaries in the mouse peritoneal cavity caused by acetic acid, and the inhibition rate can reach 34.8%. The results of drug efficacy experiment are consistent with the clinical curative effect of Liyan Fang on acute and chronic pharyngitis.
表1,利因方对鲜酵母人工发热的影响(x±s,n=10)
与生理盐水组比较,*P 0.05,**P 0.01,***P 0.001Compared with normal saline group, *P 0.05, **P 0.01, ***P 0.001
表2 利咽方对小鼠热板法所致疼痛的影响(x±s,n=10)
与生理盐水组比较,*P 0.05,**P 0.01Compared with normal saline group, *P 0.05, **P 0.01
表3 利咽方对小鼠腹腔毛细血管通透性的影响(x±s,n=10)
与生理盐水组比较,*P 0.05,**P 0.01Compared with normal saline group, *P 0.05, **P 0.01
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