CN1723981A - Novel use of extractive of Momordica grosvenori as adjuvant drug for preparing medicine - Google Patents
Novel use of extractive of Momordica grosvenori as adjuvant drug for preparing medicine Download PDFInfo
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- CN1723981A CN1723981A CN 200510019066 CN200510019066A CN1723981A CN 1723981 A CN1723981 A CN 1723981A CN 200510019066 CN200510019066 CN 200510019066 CN 200510019066 A CN200510019066 A CN 200510019066A CN 1723981 A CN1723981 A CN 1723981A
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- Prior art keywords
- fructus momordicae
- tablet
- extract
- adjuvant
- momordicae extract
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- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 1
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- 210000004681 ovum Anatomy 0.000 description 1
- SOQBVABWOPYFQZ-UHFFFAOYSA-N oxygen(2-);titanium(4+) Chemical class [O-2].[O-2].[Ti+4] SOQBVABWOPYFQZ-UHFFFAOYSA-N 0.000 description 1
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- YWPVROCHNBYFTP-OSHKXICASA-N rubusoside Chemical compound O([C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O YWPVROCHNBYFTP-OSHKXICASA-N 0.000 description 1
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
Landscapes
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
An application of the extract of monordica Grosvenori in preparing the medicinal additive for improving the stability of medicine and elongating its storage time is disclosed. Said medicinal additive is used to replace cane sugar, rebaudiose, etc to make the medicine suitable for diabetic and baby (for preventing decayed tooth).
Description
Technical field
The present invention relates to a kind of excipient substance, particularly with the new purposes of plant extract as excipient substance.
Background technology
Fructus Momordicae, (Momordica grosvenori swingle), the fruit that belongs to Cucurbitaceae herbaceous perennial vine plant, it is the southern endemic plant of China, mainly originate in backlands district, osmanthus, Guangxi, some subtropical zones on the south the Changjiang river also have wild on a small quantity, but are best with the geographic Fructus Momordicae in Guilin.Fructus Momordicae is cool in nature, sweet in the mouth, nontoxic, and sugariness height, heat are low, fresh and sweet good to eat, nontoxic, and edible safety has the effect of nourishing the lung to arrest cough, removing heat from blood laxation, the past disease that is used for the treatment of various respiratory system, digestive system among the people.According to relevant document record, the Fructus Momordicae dry fruit contains total sugar 25.17～38.31%, wherein contains fructose 10.20～17.55%, glucose 5.71～15.19%, protein content 8.67～13.35%; Contain 313.3～510.4 milligrams of vitamin Cs in every 100g fruit; Fructus Momordicae kernel oil content 41.1%, wherein oleic acid and linoleic acid account for 73.2% of total fatty acids; Fructus Momordicae also contains Momordia grosvenori aglycone, ten several amino acids, fatty oil, mannitol, flavone compound, trace element etc.Momordia grosvenori aglycone sugariness in the Fructus Momordicae is high, wherein mogroside (molecular formula C
60H
102O
29, English name: mogroside V) be important composition.Momordia grosvenori aglycone belongs to the pure natural product, sweet 300 times of sweetness ratio sucrose, and heat is low, lighter color, good water solubility.When Momordia grosvenori aglycone content greater than 80% the time, compare with 5% sucrose solution, 0.001% solution sugariness is greater than 200 times, when reaching identical sugariness, heat only is 1/50th of a sucrose.Momordia grosvenori aglycone heats 25h continuously in 100 ℃ neutral aqueous solution, or still is not destroyed in the medium-term and long-term heating of 120 ℃ of air, and heat stability is very good.Momordia grosvenori aglycone deposit separately or with other material mixed storages, fermentation can not take place in 18 months and go mouldy, it is little that Momordia grosvenori aglycone is influenced by acid-base value, preserves any variation can not take place in 2 years in pH2.0～10.0 scopes.
The past Fructus Momordicae eats as Chinese medicine and beverage dry fruit for a long time, and people also add as sweeting agent with Fructus Momordicae extract in food industry in recent years, as making confection, cookies, herbal tea.But scientific and technical literature is not by retrieval seen the open report that is used for the medicine adjuvant relevant for Fructus Momordicae or Fructus Momordicae extract.
About excipient substance, we are through the retrieval scientific and technical literature, retrieve followingly, now take passages some documents about solid drugs (tablet, capsule, granule, pill etc.) and liquid medicine (oral liquid, syrup, injection etc.) employed new adjuvant and technical progress:
1.[autograph] pharmaceutic adjuvant research new development---biodegradable polymer [author] Huo Mei Rong Zhou Jianping [machine thing .2003,1 (4) .-246-251[digest] in recent years, biodegradable polymer more and more attracts attention in the drug delivery system research field, and partial polymer has been applied to various dosage forms.This paper has summarized the latest developments of researchs such as chitosan, polyesters, block copolymer, cationic polymer, polymer-medicine, intelligent polymer and in the application of pharmaceutical field.Biodegradable polymer has a extensive future as newtype drug transmission system material.
2, application [author] Cui Shanfeng [mechanism] the Zhejiang medical profession technical college of the new adjuvant of several medicaments in [autograph] injection, [periodical name] Heilungkiang medical science .2002,26 (10) .-777-777[digests] at present, high molecular polymer, polysaccharide, animals and plants are extracted materials such as class, because its viscosity and rheological properties are good.Biodegradable in vivo and having no side effect.Extensively development at home and abroad, development and application selects for use these new adjuvants can reach the alleviation of medicine, and controlled release is located release.Estimate that new adjuvant will play a significant role in medical industry.Sargassum polysaccharides Sargassum polysaccharides and polylactic acid have been introduced in the article as the new adjuvant of medicament, point out that polylactic acid is a natural active matter, belong to a class Sargassum extract, obtain easily, its preparation is pollution-free, excellent biological compatibility is arranged, nontoxic, also show anticoagulant active, anti-tumor activity and antiviral activity.Sargassum polysaccharides is a class biological adsorption agent efficiently, generally on the preparation also can be used as the microencapsulation material as thickening agent and emulsifying agent, and medicine is carried out behind the microencapsulation drug administration by injection again, the rate of release of control medicine.Polylactic acid is nontoxic, with organize reactionless, biodegradable, catabolite is not detained in biological tissue.
3, the Chinese pharmacy information .2002 of [autograph] China medicine and health product supplementary material intermediate Application and Development and market new trend [author] Qi Jicheng [mechanism] not quite clear [periodical name], 18 (5) .[key words] Chinese Medicine starch sugar ester starch alkenyl succinate sugar ester health product supplementary material intermediate Application and Development market new trends [digest] are raw material with starch, preparation starch sugar ester and starch alkenyl succinate sugar ester, as the adjuvant of Chinese medicine or health product, be the new developing direction of China's pharmaceutic adjuvant.
4, [autograph] different excipient and prescription influence [author] Wang Xiuliang that Chinese medicine spray drying extract powder is granulated is to [mechanism] Xiangye No. 2 Hospital of Central South University clinical pharmacy researchs department such as big heros, [periodical name] Chinese patent medicine .2002,24 (2) .[digests] purpose: the influence that research different auxiliary material and prescription are granulated to Chinese medicine spray drying extract powder, seek best granulation prescription.Method: use the granulation complexity, the granule yield, melting, hygroscopicity, critical relative humidity etc. are estimated different auxiliary material and prescription to particulate influence, and are screened suitable prescription for investigating index.The result: supplementary product kind and prescription can obviously reduce the hygroscopicity of extract powder, and in granulation complexity and granule yield, there is notable difference the melting aspect between each group, but hygroscopicity difference is not obvious between each group.Conclusion: critical relative humidity (CRH) can be selected 2 kinds of prescriptions 65% when following; (1) extract powder-sucrose-micropowder silica gel (500: 115: 25) or) 2) extract powder-sucrose-microcrystalline Cellulose-micropowder silica gel (50: 77.5: 25: 37.5).
5, application [author] Li Baohong [1] Chen Jianhai [mechanism] [1] No.1 Mmilitary Medical University, Chinese PLA such as [2] of the new adjuvant of several medicaments in [autograph] slow releasing tablet, Pharmacy Department, Nanfan Hospital, [2] Health Section of No.1 Mmilitary Medical University, Chinese PLA, [periodical name] Acta Pharmaceutica Sinica .2001 of PLA, 17 (4) .-207-210[digests] this paper reported in the pharmaceutical preparation application scenario of several new adjuvants in the slow releasing tablet, at present, the high molecular polymer adjuvant, the polysaccharide adjuvant, moving, plant extract class adjuvant etc., be used widely abroad, domestic in development and exploitation, this paper mainly introduces xanthan gum, sodium alginate, calcium alginate, carbomer, chitins etc. are as the characteristic of the new adjuvant of medicament sustained-release tablets, the problem that should note in effect and the use etc., these new drugs are that viscosity and rheological properties are good with the common ground of adjuvant, have no side effect, calcium alginate still can be used as the durative action preparation slow releasing tablet, the slow preparation that chitin is made carries out the conlon targeting release that coating can reach medicine to medicine, should note its kind according to the difference of medicine when selecting these new pharmaceutic adjuvants for use, consumption, release medium etc., in a word, new adjuvant will play a significant role in medical industry.
6, the general pharmacology of [autograph] pharmaceutic adjuvant chitosan is learned preclinical medicine portion of research [author] Li Hua [1] Kuai Zhenggen [1] Kuang Lixiang [2] [mechanism] [1] Anhui Medical College; [2] Inst., of Clinical Pharmacology, Anhui Medical Univ.; [periodical name] Anhui medicine .2004,8 (2) .-95-96[digests] general pharmacological action of purpose research pharmaceutic adjuvant chitosan.Method chitosan 0.5% (gL^-1) po mice and rat are observed spontaneous activity and the pole-climbing behavior of administration front and back different time mice, and the blood pressure of rat, heart rate, ECG T wave and respiratory frequency.Self comparing before and after the administration as a result, between the administration group, relatively, P all＞0.05 between administration group and the matched group.The conclusion chitosan does not have obvious influence at this dosage to the cardiovascular system of the nervous system of mice, rat the respiratory system of unifying.Chitosan is a class natural polysaccharide that extensively is present in the crustacean shell; derive and next solable matter through deacetylation by chitin; be the natural biological macromolecular material; biological good; easily be absorbed by the body; when passing through skin, oral cavity, mucosa delivery as pharmaceutical carrier; can reach the purpose of slow release, lasting administration; do the microcapsule preparation that the capsule material can be used for sensitive materials; chitosan particle has the ability that forms gel layer in low pH medium; chitosan itself also has antiacid and the antiulcer effect, can produce the certain protection effect to body as adjuvant.Result of study shows, the pharmaceutic adjuvant chitosan does not have obvious influence to the cardiovascular system of mice nervous system, rat the respiratory system of unifying, and can be used as pharmaceutic adjuvant, is worthy of popularization.
7, [autograph] stilbene moon, the full Ji of screening [author] Guo Jianpeng [1] Jin Zaijiu [1] of tablets of reducing blood fat pharmaceutical necessities was apt to pharmaceutical college of [1] Piao Meixiang [2] Zheng Zhiyu [1] Cui Jinghao [1] Li Fenglong [1] [mechanism] [1] Yanbian University, [2] Pharmacy department of Yanji social spirit specialized hospital, [periodical name] medical journal .2003 of Yanbian University, 26 (3) .-173-176[digests] [purpose] screening stilbene moon tablets of reducing blood fat pharmaceutical necessities .[method] with tablet appearance, hardness, disintegration and friability etc. are analyzed .[result for index to test recipe] diluent selects Icing Sugar for use, absorbent is selected adjuvant X for use, binding agent is selected microcrystalline Cellulose for use, disintegrating agent is selected the tablet of low-substituted hydroxypropyl cellulose for use, good moldability is applicable to that the molding of stilbene moon tablets of reducing blood fat is write out a prescription.
8, the research [author] of [autograph] refreshment dispersible tablet adjuvant Du keeps the journal .2003 of Beijing University of Chinese Medicine of clever Li Yun paddy Wu Qing Zhang Yanzhao [mechanism] Beijing University Of Chinese Medicine Traditional Chinese Medicine College [periodical name], 26 (6) .-55-56, the 78[digest] purpose preferred refreshment dispersible tablet supplementary product kind and proportioning.Method is that index carries out preferably stripping curve being carried out the match of different equations with molten diffusing time and accumulation stripping percentage rate.The formulation and technology of the best is pregelatinized Starch as a result: lactose (1: 2) and principal agent ratio are (1: 1), and disintegrating agent is crospolyvinylpyrrolidone (in add 2%, add 5%), and lubricant is magnesium stearate (0.5%).Conclusion gained dispersible tablet disintegration, fineness of dispersion meet version " Chinese pharmacopoeia requirement in 2000.Stripping curve is near Weibull distribution.
From above-mentioned literature to, excipient substance mainly is divided into solid adjuvant material and Auxiliary Liquid Material at present, solid adjuvant material commonly used has disintegrating agent, adhesive, filler, diluent, antiseptic, coating materials, capsule, add sucrose in general diluent that adopts and the coating materials mostly, the adding lactose that has now, chitosan can make the medicine production process mechanical performance better, also can alleviate the discomfort of medicine mouthfeel.Auxiliary Liquid Material generally also is added with materials such as sucrose, Aspartame, glucose, antiseptic.
We also recognize in retrieval, the adjuvant that adopts in Western medicine at present is generally by the standard of some developed countries in the world, its disintegrating agent, adhesive, filler, diluent, coating materials, capsule generally can not go wrong, but for China, products such as a lot of production Chinese medicinal tablets, granule, pill are arranged, the quality of Chinese medicine directly affects the treatment, particularly decoction pieces and granule, keeping is the key link of ensuring drug quality, the keeping that contains sugared Chinese medicine tablet processed product that has, especially difficulty.Through honey, vinegar, steam, boil, after the processing of adjuvant concocts, water content is relative with sugar content to be improved, some adjuvant becomes the nutrient substance of entomophthora, this is the goods moisture absorption, mouldy, infested, the major reason that goes bad.The contained composition complexity of processed product in addition, character is different, requires maintaining requirement to have nothing in common with each other.Therefore, the prepared slices of Chinese crude drugs after the process of preparing Chinese medicine are bigger than the storage of medical material difficulty of not concocting, and condition is poor.So, we from a lot of documents, introduce for make herbal species take care of easily, nonhygroscopic, not mouldy, insect-free, never degenerate, changed accessory formula, adding antiseptic, the anti-blushing agent that has or introduce up-to-date adhesive, the material that so just causes some to influence pharmacological property has side effects at human body.
In addition, the disadvantage that present solid adjuvant material and Auxiliary Liquid Material add sucrose is the easy moisture absorption, mouldy, infested, rotten, the more important thing is that these contain the sucrose medicine diabetics is caused that easily blood glucose increases, dental caries easily takes place in child administration, so bibliographical information selects for use chitosan or dextrinosan, fructooligosaccharide, Folium Stevlae Rebaudianae, Aspartame etc. to replace sucrose.But the sweeting agent that has influences the pharmacological action and the drug effect of medicine, and the sweeting agent cost that has is higher, and as dextrinosan, fructooligosaccharide, production capacity is limited at present; And Aspartame is the artificial synthesis edulcorant, short sweetness, and the water solublity of the steviosin that extracts from Folium Stevlae Rebaudianae and smell bad can not get liking of most of people.
Summary of the invention
The inventor is through studying present pharmaceutic adjuvant, the composition and the application of Fructus Momordicae have also been studied simultaneously, and with Fructus Momordicae extract, perhaps Fructus Momordicae extract separates the Momordia grosvenori aglycone that obtains and (claims mogroside in the past, now unitedly call Momordia grosvenori aglycone, do not claim mogroside) be used for pharmaceutic adjuvant, attempt place of sucrose or other sweeting agent and partially filled material and join tablet, capsule, the adjuvant of solid drugs such as granule or pill, and as liquid medicine: oral liquid, syrup, sugar part of decoction or mixture, do not influence the pharmacological action and the drug effect of medicine again, good water solubility has played ideal effect.
Fructus Momordicae extract of the present invention is as follows as the application technology scheme in the preparation excipient substance:
Excipient substance of the present invention comprises solid drugs adjuvant and liquid medicine adjuvant, and Fructus Momordicae extract is as one of composition in the excipient substance.
Fructus Momordicae extract comprises water extract, extractive with organic solvent, perhaps the merging thing of water extract and extractive with organic solvent.Described extract must contain Momordia grosvenori aglycone, on the general industry in the Fructus Momordicae extract quality percentage composition of Momordia grosvenori aglycone be 50-99.8%.Also can directly use and pure separate the Momordia grosvenori aglycone that obtains from Fructus Momordicae extract, preferred mogroside, pure Momordia grosvenori aglycone finished product content is 90-99.8% on the general industry.
Above-described solid drugs comprises tablet, granule, pill, capsule, and wherein tablet comprises dispersible tablet again, chewable tablet, Sublingual tablet, lip Jia sheet, oral cavity disintegration tablet; Capsule comprises hard capsule, soft capsule, enteric coated capsule.
Above-described liquid medicine comprises oral liquid, syrup, decoction, mixture.
Described Fructus Momordicae extract adds mass content in solid drugs adjuvant or the liquid medicine adjuvant and accounts for 0.5-30% in the whole supplementary material, or the Momordia grosvenori aglycone of 0.1-10% (with the solid masses cubage, below identical).Changing a kind of saying is: contain solid Fructus Momordicae extract 0.5-30% in the excipient substance, perhaps contain the solid Momordia grosvenori aglycone of 0.1-10%.
The preparation method of Fructus Momordicae extract of the present invention or Momordia grosvenori aglycone:
The preparation method of Fructus Momordicae extract or Momordia grosvenori aglycone obtains according to the method for open source literature introduction.Extract generally is that water intaking is carried and the bonded concentrated solution of alcohol extraction, perhaps is dried to the product of powder.The preparation of Momordia grosvenori aglycone can be found in the literature, as the method for following bibliographical information:
1, [autograph] technical study [author] Li Jun of the Fructus Momordicae glucoside being extracted with Orthogonal Method, Lu Cheng, the chemistry world .1999 of Guangxi Normal University's [periodical name], 40 (2) .-92-94[digests] adopt Orthogonal Experiment and Design that the ethanol extraction technology of Fructus Momordicae glucoside in the Fructus Momordicae has been carried out systematic study, preferred technological parameter, the result shows; With 30 times of 30% ethanol that raw material is heavy, extracting 3h under 75-80 ℃ of slight boiling condition is optimum condition.
2.[autograph] refining research [author] Liu Zhongdong of mogroside (V), Zhengzhou Grain College [periodical name] ion exchange and absorption .1999,15 (4) .[digests] utilize domestic resin to study the process for purification of mogroside (V).4. process for extracting rubusoside of fruit of Gorsvenor Momordica, Chinese patent: application (patent) number: 02128065.7 application (patent right) people: Hongye Green Vegetable Product LLC, Guilin address: the QiXing, Guilin City, GuangXi Zhuang Autonomous nationality District district executes No. 6 summaries in home road: the present invention is with the Fructus Momordicae fragmentation, add alcoholic solution, under 30～60 ℃ of temperature, soaked 5～15 hours.Filter to get filtrate, temperature is reduced to 20～35 ℃, and filtrate is sent into three kinds of membrane separation assemblies through compression pump order under 0.01～0.2MPa operating pressure; The first order is held back and is isolated spissated Fructus Momordicae fiber, protein, pectin and impurity, is used to make organic fertilizer; The second level is spissated Momordica-Glycosides solution, through vacuum drying, gets the Momordica-Glycosides product; The third level is spissated momordica grosvenori polysaccharide and trace element, is the Fructus Momordicae massecuite; The residual filtrate recycling use.
3. method Chinese patent that from Fructus Momordicae, extracts Momordica-Glycosides: application (patent) number: 03117430.2, application (patent right) people: Guilin Laiyin Biological Product Co., Ltd address: No. 18 summaries in Xiangjiang Rd., Xing'an County, Guilin, Guangxi Zhuang Autonomous Region: the present invention relates to a kind of method of from Fructus Momordicae, extracting Momordica-Glycosides, be to be raw material with the fresh Fructus Momordicae, with water is extraction solvent, adopting microfiltration, ultrafiltration, nanofiltration is main extraction process, and wherein micro-filtration membrane adopts the microporous filter membrane in 0.05 μ m～0.3 μ m aperture; It is 20000～80000 hollow fiber ultrafiltration membrane that ultrafilter membrane adopts the relative molecular weight that dams; It is that 100～400 NF membrane or RO reverse osmosis equipment concentrate that the relative molecular weight that dams is adopted in nanofiltration.
4. title: the method application (patent) of extraction separation multiple components number from Fructus Momordicae: 02113548.7 application (patent right) people: location, He Wei level land: eight Li Jie economic and technological development zone, Guilin City, Guangxi Zhuang Autonomous Region Guilin strength company summary: a kind of from Fructus Momordicae the method for extraction separation multiple components, be that the broken Fructus Momordicae of water reuse aqueous alkali processing afterwards obtains extracting solution, handle through aliphatic alcohol again and obtain precipitate (I) and lysate (II), precipitate (I) through the resin anion (R.A.) post again bound fat alcohol processing purification obtain momordica grosvenori polysaccharide.Lysate (II) is through polyamide resin column, and the effluent from post is handled purification through macroporous resin column bound fat alcohol again and obtained Momordica-Glycosides.By the composition that polyamide resin column adsorbs, concentrate drying promptly obtains grosvenor momordica flavonoid after alkaline fat alcohol washes out.
5[autograph] microwave-assisted extracts [mechanism] the South China Science ﹠ Engineering University food and the biological engineering institutes such as the refined Li Lin in research [author] multitude sea of Fructus Momordicae Saponin, [periodical name] Food Science .2003,24 (2) .-92-95[key words] to extract Fructus Momordicae Saponin Fructus Momordicae process conditions medical, edibles [digest] be raw material with the dried fructus momordicae to microwave-assisted, under the microwave radiation condition, with water is solvent extraction Fructus Momordicae Saponin, investigated microwave power, microwave irradiation time, solid-to-liquid ratio, extraction time, extract the influence of factors on extraction rate such as progression, the optimum extraction process condition of determining is: microwave power is 638W, and microwave irradiation time is 25min, and solid-to-liquid ratio is 1: 30, the water-bath extraction time is 2h, and extraction progression is secondary.
6.[autograph] macroporous adsorbent resin extracts [mechanism] the South China Science ﹠ Engineering University food and the biological engineering institutes such as the refined Li Lin in research [author] multitude sea of Fructus Momordicae Saponin, [periodical name] food industry science and technology .2003,24 (2) .-19-21[digests] studied the method that macroporous adsorbent resin extracts the Fructus Momordicae Saponin, concentration, pH and the salt ionic concentration of screening, Fructus Momordicae Saponin solution that comprises resin determined suitable absorption and desorption condition to the influence of adsorption process and the selection of strippant.
From composition and sugar content, Momordia grosvenori aglycone is better than Fructus Momordicae extract quality, the purity height, so Fructus Momordicae extract is fit to production granule, medicinal tea, pill, and Momordia grosvenori aglycone is more suitable for producing tablet, capsule, coating powder, oral liquid, syrup, mixture etc.
Outstanding substantive distinguishing features compared with prior art of the present invention and obvious improvement are:
1. replace existing sucrose with Fructus Momordicae extract or from the Momordia grosvenori aglycone that the Fructus Momordicae extract separation obtains, steviosin, sweeting agents such as aspartame, do not change the pharmacological action and the drug effect of former medicine, but can make medicine, make Chinese medicinal tablet, granule, pill product be not easy the moisture absorption, mouldy, infested, rotten especially, make the resting period of medicine permanent, steady quality.
2. existing contain the sucrose medicine diabetics is caused that easily blood glucose increases, dental caries easily takes place in child administration, can avoid these shortcomings with Fructus Momordicae extract.
3. consumption is few, good water solubility, and sweet taste is pure, does not have toxic and side effects, and cost is lower.
4. the Capsules that has at present (capsule shells) after adding Fructus Momordicae extract, has changed the mouthfeel of capsule shells because prescription is unreasonable, and major part has the taste of plastics when oral, and mouthfeel is poor, does not change its original characteristic.
5. when Fructus Momordicae extract being added to the raw material of coating powder, do not use sucrose, do not influence efficacy of drugs yet, and the medical coating powder of this material, film-coated chemical property are stable, environmental protection, widely applicable, cost performance is high, no physiology toxicity;
6, can thoroughly improve Chinese medicine attribute complicated and changeable, solid preparation heat-resistingly be resisted cold, wearability is good, humidity resistance is strong, hot strength is high, toughness is good, glossiness is high, gas barrier is strong; Product stability is good, the storage life is long, good solubleness, can antibiotic and sterilizing, thereby the anti-variable color of ultraviolet radiation preventing makes coated product taking conveniences such as tablet.
7. at present a lot of tablets, as dispersible tablet, chewable tablet, Sublingual tablet, lip Jia sheet, oral cavity disintegration tablet all are to go into stomach through the oral cavity, and the employing synthetic sweetener that the sweeting agent that adopts has, mouthfeel is not so good, so the adding Fructus Momordicae extract can be with these tablet seasonings, mouthfeel is improved greatly.
8, Fructus Momordicae extract and medicament mixed directly can be granulated, can not add other adjuvant, reduce the gross weight of Chinese medicine.The trend that meets modern Chinese medicine pharmacy development " triple effect ", " three is little ".
The specific embodiment
Embodiment 1
The preparation of Chinese medicinal tablet, in medicinal tablet and granule, pill, add Fructus Momordicae extract, quality accounts for the 0.5-30% in the additive of tablet, the perhaps mogroside of 0.1-10%, concrete example application: with Chinese medical concrete 200 grams, the filler that adds dextrin 50-100 gram, as modified starch or dextrin, carboxymethyl starch or calcium hydrogen phosphate, 10 gram disintegrating agent carboxylics, as the Edible material of sodium carboxymethylcellulose pyce, hydroxypropyl cellulose or other tool water swellings, 10 gram lubricants, as magnesium stearate etc., Fructus Momordicae extracts extractum 5 grams, makes granule, tabletting.
Embodiment 2
The preparation of sweet taste Capsules shell is meant the mogroside that has added 0.2-3% in the Capsules material, makes enteric coated capsule have sweet taste.Concrete example application: the proportioning of its glue is as follows: gelatin or carrageenan or chitosan 10%-20%, reinforcing agent carboxymethyl starch or hydroxypropyl cellulose 2.0%-5.0%, sodium lauryl sulphate 0.02%-0.026%, glycerol (wetting agent) 0.15%-0.20%, Fructus Momordicae extract 0.1-5%, also can get 96% Momordia grosvenori aglycone 0.1-3%, surplus is a water, above-mentioned material is stirred, method for making by conventional capsule is made Capsules, and this Capsules is applicable to Western medicine or Chinese medicine; Good stability is convenient to permanent storage.
Embodiment 3
The preparation of sweetish film coated tablet: be meant and in the thin film dress material, added 0.5% mogroside, make film-coat have sweet taste.Concrete example application: get 10 kilograms of Nano titanium dioxides; 60 kilograms hypromellose, 10 kilograms polyvinyl alcohol, 4 kilograms of yellow colorants; Fructus Momordicae extract 0.5-2 kilogram also can be got Momordia grosvenori aglycone 0.1-0.5 kilogram, places mixer to stir 20 clocks above-mentioned raw materials, makes its abundant mix homogeneously, adds 10 kilograms 8 kilograms of glycerol, tweens, mixes 25 minutes, obtains even batch mixing; Above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; Dried batch mixing taken out, puts coldly pulverize again; Obtain finished product---the exsiccant sweetish thin film medical coating material that contains nano material through cross screening at the 60-80 order.
Embodiment 4
The preparation of no cane sugar type oral liquid: make on the basis of oral liquid at Chinese medicine or Western medicine, not with sucrose, with the 0.5-20% Fructus Momordicae extract substituting saccharose that accounts for the solution gross mass, perhaps the Momordia grosvenori aglycone with 0.2-3% replaces for sucrose, obtains the no cane sugar type oral liquid.Concrete example application: Chinese medicine powder is broken into coarse powder, extracts three times with 65% alcohol heating reflux, each 2 hours, merge extractive liquid, filtered filtrate for later use; Medicinal residues after the filtration decoct with water secondary, and each 2 hours, collecting decoction, filter, it is 1.12--1.16 (80 degree) that filtrate is concentrated into relative density, puts cold, add 2 times of ethanol, stir evenly, left standstill 48 hours, filter, filtrate and ethanol extract merge, and reclaim ethanol, add 300 milliliters in water, mixing adds 67 milliliters of 50% Ovum Gallus domesticus album solution, stir evenly, boil, filter, filtrate adds 80% mogroside, 2 grams, adds water to 980 milliliters, adds food preservative 3 grams, boil, filter, adjust 1000 milliliters of total amounts, stir evenly, embedding promptly gets * * Chinese medicine oral liquid.
Embodiment 5
The preparation of no cane sugar type syrup agent is made on the basis of concentrated solution at Chinese medicine or Western medicine, and not with sucrose, with the 1-8% Fructus Momordicae extract substituting saccharose that accounts for the solution gross mass, perhaps the Momordia grosvenori aglycone with 0.2-3% replaces for sucrose, obtains the no cane sugar type oral liquid.Concrete example application: Radix Isatidis, Flos Lonicerae with water extraction 1-3 hour, are filtered, be concentrated into the concentrated solution that contains solid content 30%, add 92% mogroside 1-3%, obtain children's's cough syrup that relieves inflammation or internal heat.
Embodiment 6
Sweetish soft capsule preparation is meant the mogroside that has added 0.2-3% in the soft capsule material, makes soft capsule have sweet taste.Concrete example application: a kind of soft capsule, be to be made of softgel shell and capsulation solution, the percentage by weight that wherein contains each component in the capsule shells is: glycerol or gelatin 40-45%, glycerol 10-12%, Polyethylene Glycol 25-32%, Methyl p-hydroxybenzoate 0.5,, distilled water, surplus, the percentage by weight that contains each component in the capsulation solution is: mogroside 0.2-3%, Polyethylene Glycol 70-85, propylene glycol 2-8.
Embodiment 7
The preparation of sweetish enteric coated capsule: be meant the mogroside that in the enteric coated capsule material, has added 0.2-3%, make enteric coated capsule have sweet taste.Concrete example application: enteric solubility II, III acrylic resin are joined in the distilled water, transferring PH with inorganic base is 7-8, make II, III acrylic resin reach molten entirely, add pharmagel again, water-soluble heating is dissolved gelatin and is stirred evenly, add an amount of plasticizer, suspending agent and pigment then, and 1% mogroside and make glue, promptly available capsule mould dips in glue and once makes enteric coated capsule.
Embodiment 8
The preparation of medicine pill, add Fructus Momordicae extract in bolus of drug, quality accounts for the 0.5-10% in the granule adjuvant, concrete example application: with the selection of 100 kilograms of Chinese medicines processes, wash, chopping, adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree, and (add 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, debris continues to concentrate), get concentrated solution, add Fructus Momordicae extract, also mangosteen powder can be broken to below 500 orders by total weight of material 0.5-20%, sieve, make the Chinese medicine concentrated pill with mixed with excipients, water-honeyed pill, the big honeyed pills product.
Embodiment 9
The preparation of granule, add Fructus Momordicae extract at medicinal granule, quality accounts for the 0.5-20% in the granule adjuvant, concrete example application: with the selection of 100 kilograms of Chinese medicines processes, wash, chopping, add 6～10 times of water gagings by the per kilogram medical material and decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree, and (add 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, debris continues to concentrate), get concentrated solution, add Fructus Momordicae extract 5-10%, lactose 50～90%, dextrin 50～70% is made granule, drying promptly obtains product.
Embodiment 10
The preparation of no cane sugar type dispersible tablet: make on the basis of dispersible tablet at Chinese medicine or Western medicine, not with sucrose or other sweeting agent, with the 0.5-20% Fructus Momordicae extract substituting saccharose that accounts for the solution gross mass, perhaps the Momordia grosvenori aglycone with 0.2-3% replaces for sucrose, obtains the no cane sugar type dispersible tablet.Concrete example application: the weight of arasaponin dispersible tablet raw material consists of: arasaponin 100 grams, lactose 80 grams, mannitol 50 grams, hypromellose 30 grams, polyvinyl alcohol 20 grams, magnesium stearate 5 grams, 98% Momordia grosvenori aglycone 3 grams.Carry out tabletting, promptly get dispersible tablet.
Embodiment 11
The preparation of no cane sugar type chewable tablet: make on the basis of chewable tablet at Chinese medicine or Western medicine, not with sucrose or other sweeting agent, with the 0.5-20% Fructus Momordicae extract substituting saccharose that accounts for the solution gross mass, perhaps the Momordia grosvenori aglycone with 0.2-3% replaces for sucrose, obtains the no cane sugar type chewable tablet.Concrete example application: the preparation method of Radix Isatidis chewable tablet, extract earlier effective ingredient of isatis root, concentrate, drying under reduced pressure, powder process, sugar, adding 0.5-20% Fructus Momordicae extract replace sweeting agent, perhaps the Momordia grosvenori aglycone replacement with 0.2-3% stirs into soft material for sweeting agent, natural flavours and extract powder, suppresses out qualified tablet by tablet machine again.
Embodiment 11
The preparation of no cane sugar type Sublingual tablet: make on the basis of Sublingual tablet at Chinese medicine or Western medicine, not with sucrose or other sweeting agent, replace sweeting agent with the 0.5-20% Fructus Momordicae extract that accounts for the solution gross mass, perhaps the Momordia grosvenori aglycone with 0.2-3% replaces for sweeting agent, obtains the no cane sugar type Sublingual tablet.Concrete example application: adopt weakly acidic aqueous solution to extract the plant coarse powder, filtrate adds the centrifugal removal water-solubility impurity of ethanol precipitation after concentrating, and reclaims ethanol, and extractum is dissolved in water, and with ammonia adjust pH to 9, chloroform extraction, column chromatography is refining; Plant extract with a solvent method or a fusion method prepared composition prose style free from parallelism, is made the dispersion Sublingual tablet.
Embodiment 12
The preparation of Chinese medicine decoction adds Fructus Momordicae extract at the medicine decoction, and quality accounts for the 0.5-10% in the granule adjuvant, concrete example application: as decoction for Resuscitation: Radix Aconiti Lateralis Preparata (system) 300 grams, and Rhizoma Zingiberis 200 grams, Radix Glycyrrhizae Preparata 300 restrains.More than three flavors, Radix Aconiti Lateralis Preparata, Radix Glycyrrhizae decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, merge the secondary decocting liquid, filter.Rhizoma Zingiberis is extracted volatile oil with vapor distillation, and device is preserved in addition, and Rhizoma Zingiberis Recens dregs decocts with water 1 hour again, and the aqueous solution after decocting liquid and the distillation merges, filter, the decocting liquid with Radix Aconiti Lateralis Preparata, Radix Glycyrrhizae merges again, is concentrated into about 400 milliliters, puts cold, add 1200 milliliters of ethanol, stir evenly, left standstill 24 hours, filter, reclaim under reduced pressure becomes thick paste, adds water and dilutes in right amount, and cold preservation 24 hours filters, add 95% Momordia grosvenori aglycone 3 grams, an amount of and above-mentioned volatile oil of antiseptic adds water to 1000 milliliters, stirs evenly, embedding, sterilization, promptly.
Embodiment 13
The preparation of herb mixture adds Fructus Momordicae extract at drug mixture, and quality accounts for the 0.5-10% in the granule adjuvant, concrete example application: as building middle mixture for a short time, select Ramulus Cinnamomi 111 grams, the Radix Paeoniae Alba 222 grams, Radix Glycyrrhizae Preparata 74 grams, Rhizoma Zingiberis Recens 111 grams, Fructus Jujubae 111 grams.More than 5 flavors, Ramulus Cinnamomi extracts volatile oil, the aqueous solution after distillation device is in addition collected; Medicinal residues and Radix Glycyrrhizae Preparata, Fructus Jujubae decoct with water secondary, each 2 hours, merge the secondary decocting liquid, filter, the aqueous solution after filtrate and the distillation merges, and is concentrated into about 560 milliliters, the Radix Paeoniae Alba, Rhizoma Zingiberis Recens are made solvent according to the percolation under fluid extract and the extractum item with Diluted Alcohol, soak after 24 hours and carry out percolation, the collection liquid of filtering merges with above-mentioned medicinal liquid after reclaiming ethanol, leaves standstill, filter, add Momordia grosvenori aglycone 3 grams, add sodium benzoate 3 gram and Ramulus Cinnamomi Volatile oils, adjust total amount to 1000 milliliter, stir evenly, promptly.
Embodiment 14
The preparation of Chinese medicine medicinal tea adds Fructus Momordicae extract at the medicine medicinal tea, and quality accounts for the 0.5-10% in the granule adjuvant, concrete example application: as infantile common cold tea, get Herba Pogostemonis 75 grams, Flos Chrysanthemi 75 grams, Fructus Forsythiae 75 grams, Folium Isatidis 125 grams, Radix Isatidis 75 grams, Radix Rehmanniae 75 grams, Cortex Lycii 75 grams, Radix Cynanchi Atrati 75 grams, Herba Menthae 50 grams, Gypsum Fibrosum 125 grams.More than 10 flavors, get Gypsum Fibrosum 25 gram, Radix Isatidis 75 grams are ground into fine powder; Radix Rehmanniae, Radix Cynanchi Atrati, Cortex Lycii, Gypsum Fibrosum 100 grams decoct with water secondary, and 3 hours for the first time, 1 hour for the second time, merge the secondary decocting liquid, filter; Flos Chrysanthemi, Folium Isatidis hot dipping secondary, 2 hours for the first time, 1 hour for the second time, merge leachate, filter; Herba Pogostemonis, Herba Menthae, Fructus Forsythiae extract volatile oil, and its aqueous solution filters, and filtrate and above two decocting liquids merge, and filtrate is concentrated into the clear paste that relative density is 1.30--1.35 (50 degree); Qinghuo reagent and an amount of dextrin add 2 gram Momordia grosvenori aglycones, make granule, and drying adds volatile oil, mixing, and briquetting, promptly.
Embodiment 15
The simple preparation of adding the Fructus Momordicae extract granule, only add Fructus Momordicae extract at medicinal granule, do not add other granule adjuvant, concrete example application: in preparation Lonicera flower mango granule, 100 kilograms of Chinese medicines processes are chosen, wash, chopping, add 6～10 times of water gagings by the per kilogram medical material and decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree, and (add 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, debris continues to concentrate), get concentrated solution, add Fructus Momordicae extract 5-30%, make granule, drying promptly obtains product.
Concrete parametric measurement:
The comparison of the various indexs of medicine tablet behind the table 1 employing Fructus Momordicae extract
The mouldy situation of project moisture absorption situation goes bad the situation resting period
Commonly contain easy mouldy 6 months rotten 6-12 months of the easy moisture absorption of sugar-tablet agent
(adding Fructus Momordicae extract) tablet is difficult for the moisture absorption and never degenerated 2 years in 1 year not mouldy 2 years
Contain sugared granule and opened the easy moisture absorption in back 1 year
(adding Fructus Momordicae extract) granule is difficult for the moisture absorption and never degenerated 2 years in 1 year not mouldy 1 year
Claims (5)
1, Fructus Momordicae extract is as the application in the preparation excipient substance.
2, Fructus Momordicae extract according to claim 1 is as the application in the preparation excipient substance, and it is characterized in that: described Fructus Momordicae extract comprises water extract, extractive with organic solvent, perhaps the merging thing of water extract and extractive with organic solvent; Perhaps separate the Momordia grosvenori aglycone that obtains from Fructus Momordicae extract; The mass content that described extract contains Momordia grosvenori aglycone is 50-99.8%, and the mass content of described Momordia grosvenori aglycone is 90-99.8%.
3, Fructus Momordicae extract according to claim 1 is as the application in the preparation excipient substance, it is characterized in that: described excipient substance comprises solid drugs and liquid medicine adjuvant, described solid drugs comprises the adjuvant in tablet, granule, pill or Capsules shell or the capsule, tablet wherein comprises Film coated tablets, enteric coated tablet, dispersible tablet, chewable tablet, Sublingual tablet, lip Jia sheet or oral cavity disintegration tablet; Capsule wherein comprises hard capsule, soft capsule or enteric coated capsule; Described liquid medicine comprises oral liquid, syrup, decoction or mixture.
4, Fructus Momordicae extract according to claim 1 is characterized in that as the application in the preparation excipient substance: the mass content in Fructus Momordicae extract adding solid drugs or the liquid medicine adjuvant accounts for the 0.5-30% in the excipient substance.
5, Fructus Momordicae extract according to claim 1 is characterized in that as the application of preparation in the excipient substance: separate the Momordia grosvenori aglycone that obtains from Fructus Momordicae extract and add mass content solid drugs or the liquid medicine adjuvant and account for 0.1-10% in the excipient substance.
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