CN102204960A - Chinese medicinal composition for treating hepatopathy and preparation method thereof - Google Patents
Chinese medicinal composition for treating hepatopathy and preparation method thereof Download PDFInfo
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- CN102204960A CN102204960A CN 201110141134 CN201110141134A CN102204960A CN 102204960 A CN102204960 A CN 102204960A CN 201110141134 CN201110141134 CN 201110141134 CN 201110141134 A CN201110141134 A CN 201110141134A CN 102204960 A CN102204960 A CN 102204960A
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Abstract
The invention discloses a Chinese medicinal composition for treating hepatopathy and a preparation method thereof. The Chinese medicinal composition for treating hepatopathy is prepared from the following Chinese medicinal raw materials and auxiliary materials: 4 to 12 parts of silymarin, 30 to 90 parts of north schizandra fruit, 5 to 15 parts of beta-cyclodextrin, 8 to 30 parts of starch, 5 to 15 parts of aerosil and 5 to 15 parts of sodium carboxymethyl starch. The preparation method comprises the following steps of: crushing the north schizandra fruit into crude powder; extracting active ingredients from the crude powder by supercritical carbon dioxide fluid extraction; reducing the pressure to separate out to obtain an extractum; crushing the extractum into 150 to 250-mesh fine powder; adding the silymarin, the starch, the aerosil and the sodium carboxymethyl starch into the fine powder and mixing uniformly; wrapping the mixture with the beta-cyclodextrin; and prilling, drying and palletizing to obtain the Chinese medicinal composition. The Chinese medicinal composition has the advantages of high purity, quick dissolving, small administration dose, simple preparation process, safe production, no pollution to environment and low production cost.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of hepatopathy, especially relate to a kind of liver-benefiting kidney-nourishing that has, Chinese medicine composition of detoxifying, removing dampness function and preparation method thereof.
Background technology
According to statistics, nearly in the world 3.5 hundred million hepatitis B viruss (HBV) the infected, wherein China just has 1.2 hundred million, and the prevalence rate of chronic hepatitis B is 0.1%-1%.Accumulative total is existing and in the past, and the existing population over half of China stands HBV and infect, and annual chronic HbsAg carrying rate is about 0.24%; Annual morbidity is 2,30/,100,000, and annual nearly 1,000,000 people in the whole world die from the disease that HBV causes.The 75%-85% primary hepatoma infects relevant with HBV.Estimate that according to World Health Organization (WHO) the whole world has 1.7 hundred million people to infect hepatitis C virus (HCV) approximately, in western countries, hepatitis C is the main cause that causes hepatic disease, hepatic fibrosis, hepatocarcinoma.
Chronic hepatitis B and chronic hepatitis C do not have satisfied medicine so far.Interferon and lamivudine therapy are the methods of recommending the treatment chronic hepatitis B at present in the world, and the patient of about 30%-50% can obtain the alleviation on virusology, liver function and the liver histological.The chronic hepatitis C available interference plain and (or) the virazole treatment, yet with interferon and lamivudine drug combination, its relapse rate is still higher, takes for a long time can cause drug resistance, bring out virus variation, and has serious adverse, and expense is very expensive.
For this reason, seek a kind of determined curative effect, quality controllable liver-benefiting kidney-nourishing, the detoxifying, removing dampness medicine is imperative.
Summary of the invention
The technical problem to be solved in the present invention is, provides a kind of liver-benefiting kidney-nourishing, detoxifying, removing dampness, and production technology is simple and easy, production safety, environmentally safe, quality index is easily controlled, cheap, easy to use, Chinese medicine composition of the treatment hepatopathy of determined curative effect and preparation method thereof.
The technical scheme that the present invention solves its technical problem employing is that it is made by following parts by weight of Chinese traditional medicine crude drug and adjuvant: silymarin 4-12 part, Radix Schisandrae Bicoloris core 30-90 part, beta-schardinger dextrin-5-15 part, starch 8-30 part, micropowder silica gel 5-15 part, carboxymethyl starch sodium 5-15 part.
Preferred weight proportion is: 60 parts of Radix Schisandrae Bicoloris core, 8 parts of silymarin, 19 parts of starch, 10 parts of micropowder silica gels, 10 parts of carboxymethyl starch sodium, 10 parts of beta-schardinger dextrin-s.
Its capsule preparation method thereof may further comprise the steps: Radix Schisandrae Bicoloris core is ground into coarse powder, adopt the supercritical carbon dioxide extraction method to extract its effective active composition, the extraction process condition is as follows: the preferred 25MPa of extracting pressure 24-26MPa(), extraction temperature 34-36 ℃ (preferred 35 ℃), the 110-130 minute extraction time (preferred 120 minutes), preferred 4.0 MPa of separator pressure 3.8-4.2MPa(), separator temperature 37-39 ℃ (preferred 38 ℃), carbon dioxide flow is the preferred 100L/H of 98-102L/H(), extraction finishes, and system pressure is reduced to normal pressure, and extract is separated out, get extractum, with extract dry, be ground into 150-250 order fine powder then, add silymarin, starch, micropowder silica gel, the carboxymethyl starch sodium mixing, adopt beta-cyclodextrin inclusion compound, granulate drying, granulate, incapsulate.
Can also adopt known method to make other known dosage form (as granule etc.).
Radix Schisandrae Bicoloris core is that [main active is a lignanoid to magnoliaceae schisandra for Schisandra chinensis (Turcz.) Bail1., the kernel of dry mature fruit through removing the peel.Studies show that lignanoid also has anticancer, anti AIDS virus HIV, antagonism platelet activating factor PAF and suppresses various active such as aldose reductase except that having function for protecting liver and reducing enzyme activity.Studies show that lignanoid's content of Radix Schisandrae Bicoloris core is 4 times of Radix Schisandrae Bicoloris kind skin, is raw material so prescription of the present invention is selected Radix Schisandrae Bicoloris core for use.
Because lignanoid is fat-soluble stronger, extracting strong fat-soluble Fructus Schisandrae Chinensis lignanoid (as schisandrin B) with traditional handicraft (generally being solvent with ethanol) can be not exclusively, and the quality of the pharmaceutical preparations also is difficult to guarantee.The present invention adopts the supercritical carbon dioxide extraction technology, it is good to have selectivity, active component extraction efficiency height, advantage such as easy and simple to handle, reduced the traditional pretreatment procedure of Radix Schisandrae Bicoloris, simultaneously in use stable, nontoxic because of CO2, do not burn, safe, free from environmental pollution, thereby reduced production cost; Adopt the beta-cyclodextrin inclusion compound technology, can improve the dissolution of effective ingredient silibinin in the silymarin, improve bioavailability.
The present invention's capsule product purity height, dissolving is fast, and taking dose is little, the adverse drug taste in the time of can overcoming conventional dosage forms simultaneously and take.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
Present embodiment composition weight proportioning: get 60 parts of Radix Schisandrae Bicoloris core, 8 parts of silymarin, 19 parts of starch, 10 parts of micropowder silica gels, 10 parts of carboxymethyl starch sodium, 10 parts of beta-schardinger dextrin-s.
Preparation: get Radix Schisandrae Bicoloris core 60 parts by weight of crushed and become coarse powder, adopt supercritical carbon dioxide extraction (extracting pressure 25MPa, 35 ℃ of extraction temperature, 120 minutes extraction time, separator pressure 4MPa, 38 ℃ of separator temperatures, carbon dioxide flow is 100L/H), extraction finishes, system pressure is reduced to normal pressure, and extract is separated out, and gets extractum, then with extract dry, be ground into 200 order fine powders, add 8 parts of silymarin, 19 parts of starch, 10 parts of micropowder silica gels, 10 parts of mixings of carboxymethyl starch sodium adopt 10 parts of enclose of beta-schardinger dextrin-, granulate, dry, granulate is made capsule.
The method of inspection:
[discriminating]
(1) get the about 3g of this product content, porphyrize, precision takes by weighing 0.5g, adds ethyl acetate 10ml, and supersound process 20min filters, and gets filtrate as need testing solution.Other gets the silibinin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2010 B) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with toluene-Ethyl formate-formic acid (10:6:1) is developing solvent, launches, and takes out, dry, spray is with 5% ferric chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get filtrate 5ml under the discriminating (1), evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets deoxyschizandrin, schisandrin B reference substance, adds methanol and makes the mixed solution that every 1ml contains 0.5mg, in contrast product solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2010 B) test, draw each 5 μ l of above-mentioned two kinds of solution, put in same silica gel G F respectively
254On the lamellae, be developing solvent, launch, take out, dry, put under the ultra-violet lamp (254 nm) and inspect with the upper solution of petroleum ether (60～90 ℃)-ethyl acetate-formic acid (15:5:1).In the test sample chromatograph, with reference substance chromatograph relevant position on, show the speckle of same color.
[inspection] should meet every regulation relevant under the capsule item (an appendix I of Chinese Pharmacopoeia version in 2010 L).
[assay]
Silymarin is measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2010 D).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; With methanol-water (55:45) is mobile phase; The detection wavelength is 287nm; Flow velocity is 1ml/min; 40 ℃ of column temperatures.Number of theoretical plate calculates by the silibinin peak should be not less than 4000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the silibinin reference substance, adds methanol and make every 1ml and contain 50 μ g solution, promptly.
This product under the content uniformity item is got in the preparation of need testing solution, and porphyrize is got the about 0.5g of fine powder, the accurate title, decide, and puts in the tool plug conical flask, accurate methanol 1000 ml that add, close plug claims to decide weight, supersound process (power 300W, frequency 25KHz) 30 min are put coldly, claim to decide weight again, supply the weight that subtracts mistake with methanol, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively need testing solution and each the 10 μ l of reference substance solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Every moisture silibin that flies of this product is with silibinin (C
25H
22O
10) meter, must not be less than 5.2mg.
Radix Schisandrae Bicoloris is measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2010 D).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Methanol-water (60: 40) is a mobile phase; The detection wavelength is 250nm; Number of theoretical plate calculates by the schisandrin peak should be not less than 3000.
The preparation precision of reference substance solution takes by weighing the schisandrin reference substance, adds methanol and makes the solution that contains 50 μ g among every 1ml, promptly.
This product under the content uniformity item is got in the preparation of need testing solution, and porphyrize is got about 0.1g, and accurate the title decides, and puts in the 25 ml measuring bottles, add the about 23ml of methanol, close plug, supersound process (300W, frequency 25KHz) 30 min are put cold, add methanol and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively need testing solution and each the 10 μ l of reference substance solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Every of this product contains Radix Schisandrae Bicoloris with schisandrin (C
24H
32O
7) meter, be no less than 0.95mg.
Chinese medicinal capsule agent of the present invention and former compound liver-benepitino remedy sheet clinical efficacy are relatively
1, case is selected: alcoholic fatty liver, simple obese fatty liver and viral hepatitis be totally 143 examples, and the Chinese medicinal capsule agent of establishing invention is the treatment group, and former compound liver-benepitino remedy sheet is a matched group.73 examples are organized in treatment, wherein male 65 examples, women 8 examples, 48 years old mean age.Matched group 70 examples, wherein male 64 examples, women 6 examples, 46 years old mean age.
2, observational technique
Treatment group compound liver-benepitino remedy capsule, one time 3,3 times on the one, one after each meal continues 2 months, follow-up observation is 6 months after the drug withdrawal.
Matched group compound liver-benepitino remedy sheet, one time 4,3 times on the one, one after each meal continues 2 months, follow-up observation is 6 months after the drug withdrawal.
By being responsible for the doctor treatment group and matched group are observed corresponding clinical manifestation, biochemical indicator, B ultrasonic and untoward reaction occurred and record before, during and after treatment.
Statistical procedures: The data t value check between group, there is significance P＜0.05 for difference.
3, result
3.1 improve subjective symptoms
Treatment group: hepatalgia 52 examples before the treatment, abdominal distention 45 examples, poor appetite 46 examples, weak 53 examples; Treatment back hepatalgia 15 examples, abdominal distention 10 examples, poor appetite 7 examples, weak 9 examples.Effective percentage: hepatalgia 71.1%, abdominal distention 77.8%, poor appetite 84.8%, weak 83%.
Matched group: hepatalgia 44 examples before the treatment, abdominal distention 37 examples, poor appetite 35 examples, weak 40 examples; Treatment back hepatalgia 27 examples, abdominal distention 18 examples, poor appetite 12 examples, weak 24 examples.Effective percentage: hepatalgia 38.6%, abdominal distention 51.4%, poor appetite 65.7%, weak 40%.With the effective percentage 71.1～83% of compound liver-benepitino remedy capsule for treating group to improving above-mentioned subjective symptoms, and between the matched group effective percentage 38.6～65.7%, P＜O.O1, there is notable difference in the two.
3.2 to improving the curative effect of liver function index
Can find out that from last table Y-GT, GPT, GOT, ALP all have obvious curative effects than matched group to the compound liver-benepitino remedy capsule for treating in the blood to reducing.
Three, Chinese medicinal capsule agent of the present invention and former compound liver-benepitino remedy sheet schisandrin content, dose and the comparison of disintegration
| ? | Content (every, contain schisandrin) | Dose (g/ day) | Disintegration (minute) |
| Chinese medicinal capsule agent of the present invention | ≥0.95mg | 3×3×0.27=2.43 | 15 |
| Former compound liver-benepitino remedy sheet | ≥0.5mg | 4×3×0.4=4.8 | 45 |
The comparison shows that Chinese medicinal capsule agent product provided by the invention extracts fully, the product purity height, dissolving is fast, and taking dose is little.
Claims (3)
1. Chinese medicine composition for the treatment of hepatopathy, it is characterized in that, make: silymarin 4-12 part, Radix Schisandrae Bicoloris core 30-90 part, beta-schardinger dextrin-5-15 part, starch 8-30 part, micropowder silica gel 5-15 part, carboxymethyl starch sodium 5-15 part by following parts by weight of Chinese traditional medicine crude drug and adjuvant.
2. the Chinese medicine composition of treatment hepatopathy according to claim 1, it is characterized in that, make: 60 parts of Radix Schisandrae Bicoloris core, 8 parts of silymarin, 19 parts of starch, 10 parts of micropowder silica gels, 10 parts of carboxymethyl starch sodium, 10 parts of beta-schardinger dextrin-s by following parts by weight of Chinese traditional medicine crude drug and adjuvant.
3. the capsule preparation method thereof of the Chinese medicine composition of a treatment hepatopathy as claimed in claim 1, it is characterized in that, may further comprise the steps: Radix Schisandrae Bicoloris core is ground into coarse powder, adopts the supercritical carbon dioxide extraction method to extract its effective active composition, the extraction process condition is as follows: extracting pressure 24-26MPa, extraction temperature 34-36 ℃, 110-130 minute extraction time, separator pressure 3.8-4.2MPa, separator temperature 37-39 ℃, carbon dioxide flow is 98-102L/H, extraction finishes, and system pressure is reduced to normal pressure, and extract is separated out, get extractum, with extract dry, again extract powder is broken into 150-250 order fine powder then, adds silymarin, starch, micropowder silica gel, the carboxymethyl starch sodium mixing, adopt beta-cyclodextrin inclusion compound, granulate drying, granulate, incapsulate.
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| CN 201110141134 CN102204960A (en) | 2011-05-30 | 2011-05-30 | Chinese medicinal composition for treating hepatopathy and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614239A (en) * | 2012-04-25 | 2012-08-01 | 晨光生物科技集团天津有限公司 | Silymarin compound nanoparticle and preparation method thereof |
| CN105795247A (en) * | 2014-12-29 | 2016-07-27 | 伊启棒（天津）科技发展有限公司 | Health food for improving fatty liver |
| CN105795176A (en) * | 2014-12-29 | 2016-07-27 | 伊启棒（天津）科技发展有限公司 | Preparation method of health food for improving fatty liver |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101606974A (en) * | 2009-07-24 | 2009-12-23 | 吉林紫鑫药业股份有限公司 | A kind of pharmaceutical composition that is used for the treatment of acute and chronic hepatitis |
-
2011
- 2011-05-30 CN CN 201110141134 patent/CN102204960A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101606974A (en) * | 2009-07-24 | 2009-12-23 | 吉林紫鑫药业股份有限公司 | A kind of pharmaceutical composition that is used for the treatment of acute and chronic hepatitis |
Non-Patent Citations (2)
| Title |
|---|
| 《中国优秀硕士学位论文全文数据库》 20090415 徐佐旗 五味子综合利用的初步研究 48~55 3 , * |
| 《中国优秀硕士学位论文全文数据库》 20091115 蔺莉莉 护肝片新工艺和质量标准的研究 21~25 1-3 , * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614239A (en) * | 2012-04-25 | 2012-08-01 | 晨光生物科技集团天津有限公司 | Silymarin compound nanoparticle and preparation method thereof |
| CN102614239B (en) * | 2012-04-25 | 2013-11-06 | 晨光生物科技集团天津有限公司 | Silymarin compound nanoparticle and preparation method thereof |
| CN105795247A (en) * | 2014-12-29 | 2016-07-27 | 伊启棒（天津）科技发展有限公司 | Health food for improving fatty liver |
| CN105795176A (en) * | 2014-12-29 | 2016-07-27 | 伊启棒（天津）科技发展有限公司 | Preparation method of health food for improving fatty liver |
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Application publication date: 20111005 |