CN1994378A - Compound formulation for treating icteric viral hepatitis and method for preparing same - Google Patents
Compound formulation for treating icteric viral hepatitis and method for preparing same Download PDFInfo
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- CN1994378A CN1994378A CN 200610161536 CN200610161536A CN1994378A CN 1994378 A CN1994378 A CN 1994378A CN 200610161536 CN200610161536 CN 200610161536 CN 200610161536 A CN200610161536 A CN 200610161536A CN 1994378 A CN1994378 A CN 1994378A
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Abstract
The invention relates to a method for producing the drug that treats icteric viral hepatitis, wherein said agent is formed by capilary Artemisia, radix bupleuri, kuh-seng, rheum officinale, and isatis leaf. And the production comprises that: distilling capilary Artemisia, radix bupleuri via steam to extract benzene; mixing distilled solution with slag, kuh-seng and isatis lea to be boiled in water; concentrating; adding alcohol to make alcohol content 70%; freezing and filtering, recycling alcohol, adding water and freezing, filtering; adding rheum officinale and water to boil; concentrating; adding alcohol, freezing, filtering, recycling alcohol, adding water and freezing, filtering, mixing with kuh-seng filter solution, concentrating into paste; adding benzene and findings, via general method to prepare agent. The invention has proved that its icteric viral hepatitis cure rate can reach 48. 76% while whole efficiency can reach 88. 43%.
Description
One, technical field
The present invention relates to the field of Chinese medicines, specifically relating to the Chinese herbal medicine is a kind of compound preparation for the treatment of icteric viral hepatitis that raw material prepares and preparation method thereof.
Two, background technology
Viral hepatitis is the infectious disease that is caused by hepatitis virus, serious harm human health and influence work capacity, and all there is growth trend in the primary disease whole world in recent years, and China is the viral hepatitis district occurred frequently.
Whole nation viral hepatitis Epidemiological study second time result by Ministry of Public Health hepatitis control leading group tissue confirms that China is the high popular district of first, second, third type and other viral hepatitis.Total prevalence rate of hepatitis A is 80.9% among the hepatitis crowd, and rural area and city are respectively 84.1% and 72.8%, and the hepatitis B prevalence rate is 9.75%.There are more than 4,000 ten thousand hepatitis in the whole nation every year, and more than 100,003,000 ten thousand hepatitis virus carriers are arranged.And according to up-to-date, hepatitis and hepatitis virus carrier's quantity is in continuous increase, and the Chinese government pays much attention to the prevention of hepatopathy and treatment work.Improve China people's body health quality by developing methods such as new treatment hepatitis medicament and anti-hepatitis vaccine, have very important significance.The medicament categories for the treatment of hepatitis in the market is a lot, and the medicine that is used for jaundice eliminating mainly contains Yinzhihuang Injection, armillarisin A, diammonium glycyrrhizinate, tiopronin tablets etc., but have that curative effect is sure, side effect is little concurrently, taking convenience, price economy few in number.The medicine of state's internal therapy viral hepatitis all exists curative effect and remains to be revalued, and untoward reaction is more, has been subjected to bigger restriction in clinical use.The research of antiviral drugs both at home and abroad still is in the starting stage, up to the present, an antiviral specific medicament is not arranged also.But viral infection is a serious clinical problem, it is widely distributed in the world, and may cause serious consequence, and chronic infection is to be in interactional dynamic process between virus, hepatocyte and the human body immune system, and some Chinese medicine just can be regulated the function of each system of human body, makes it to reach dynamic balance state.Hepatitis patient is mostly with the icteric index height, and the characteristics that the transaminase is high still do not have specific therapy to viral hepatitis both at home and abroad at present, and curative effect is also not ideal enough.Therefore, development determined curative effect, antiviral hepatitis medicament that degree of safety is big have favorable social and economic benefits.
This prescription is through clinical research, and the result shows that treatment icterohepatitis obvious effective rate is 39.67%, and cure rate is 48.76%, and total effective rate is 88.43%.And medication is safer, and untoward reaction is few.
Three, summary of the invention
1. goal of the invention
(1) the purpose of this invention is to provide a kind of compound Chinese medicinal preparation for the treatment of icteric viral hepatitis, make things convenient for hospital clinical to use and patient uses, applicable to the patient of the state of an illness in various degree, not only safe but also effective simultaneously.
(2) another object of the present invention provides the preparation method of compound preparation.
2. technical scheme
(1) a kind of compound preparation for the treatment of icteric viral hepatitis, it is by the made medicament of following raw materials by weight proportions:
Herba Artemisiae Scopariae 450-1200, HERBA BUPLEURL 450-1200, Radix Sophorae Flavescentis 150-400, Radix Et Rhizoma Rhei 200-500, Folium Isatidis 350-1000.
(2) side separates
Herba Artemisiae Scopariae in the side, bitter in the mouth, suffering, cold nature is returned liver, gallbladder, spleen, stomach warp, and have the effect of clearing away damp-heat, jaundice eliminating subcutaneous ulcer preferably, and can promote biliary secretion and drainage, be to be monarch drug; HERBA BUPLEURL have induce sweat bring down a fever, the function of dispersing the stagnated live-QI to relieve the stagnation of QI, yang invigorating, go into the liver and gall warp, can go the liver and gall excess-fire, be aided with minister; Folium Isatidis has the function of clearing away heat,cooling blood and removing toxin; Radix Et Rhizoma Rhei has purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, clots absorbing removing mass, is equipped with Radix Et Rhizoma Rhei in the side and can has clearing away heat-fire assistant and make it merit; Radix Sophorae Flavescentis has the function of heat clearing and damp drying, diuresis, parasite killing, cures mainly cards such as hematodiarrhoea, jaundice urine retention, and is main strong with its dampness effect in the side, makes it the removing dampness and eliminating jaundice subcutaneous ulcer.
Above-mentioned compound preparation can be said any dosage form except that aqueous injection on the pharmaceutics.
Above-mentioned compound preparation is tablet, granule, capsule or oral liquid.
A kind of preparation method for the treatment of the compound preparation of icteric viral hepatitis, its preparation process is as follows:
(1) getting Herba Artemisiae Scopariae, HERBA BUPLEURL, to add water, vapor distillation, collection volatile oil standby;
(2) aqueous solution after the above-mentioned distillation and medicinal residues and Radix Sophorae Flavescentis, Folium Isatidis are decocted with water after merging, decocting liquid adds ethanol, cold preservation, filtration, recovery ethanol after concentrating, and adds cold preservation behind the water, filters filtrate for later use;
(3) get Radix Et Rhizoma Rhei and decoct with water, decocting liquid concentrates the back, adds ethanol, cold preservation, filtration, recovery ethanol, add water-cooled and hide filtration, with the filtrate of filtrate and step (2) merge, concentrate, spray drying, add above-mentioned volatile oil and appropriate amount of auxiliary materials or correctives after, promptly can be made into preparation of the present invention.
In the above-mentioned steps 1 the added water yield be the medical material amount 4-8 doubly.
Decoct with water 2-3 time in the above-mentioned steps 2, each 1-2 hour, being concentrated into relative density behind the collecting decoction was 1.12-1.14,25-40 ℃ of mensuration, add ethanol and make pure content reach 70%, after 0-4 ℃ of cold preservation 48-60 hour, filter, reclaim ethanol, add suitable quantity of water to 0.8g crude drug/ml.
Getting Radix Et Rhizoma Rhei in the above-mentioned steps 3 decocts with water 2-3 time, each 1-2 hour, being concentrated into relative density after merging decocts is 1.06-1.08,25 ℃ of-40 ℃ of mensuration, add ethanol and make and contain alcohol amount and reach 70%, at 0-4 ℃ of cold preservation 48-60 hour, filter, reclaim ethanol, add suitable quantity of water to 0.25g crude drug/ml,, filter at 0-4 ℃ of cold preservation 48-60 hour.
The application of compound preparation of the present invention in preparation treatment icteric viral hepatitis medicine.
3. beneficial effect
Prescription of the present invention has the function of clearing away heat-damp and promoting diuresis, promoting the function of the gallbladder to alleviate jaundice, dispersing the stagnated live-QI to relieve the stagnation of QI and adjusting immunity, through clinical research, estimate it to icterohepatitis patient jaundice eliminating subcutaneous ulcer and the effect and the safety thereof of falling enzyme, the result shows, cure rate is 48.76%, and total effective rate is 88.43%.Compare with similar medicine, evident in efficacy, safety is good.
Four, the specific embodiment
Embodiment 1. takes by weighing crude drug by following weight proportion:
Herba Artemisiae Scopariae 833.3g, HERBA BUPLEURL 833.3g, Radix Sophorae Flavescentis 266.7g, Radix Et Rhizoma Rhei 333.3g, Folium Isatidis 625g
Above five tastes medicine, Herba Artemisiae Scopariae, HERBA BUPLEURL add 4 times of water gagings, steam distillation, collect volatile oil, distillation rear solution and medicinal residues, Radix Sophorae Flavescentis, Folium Isatidis decoct with water secondary, each 1.5 hours, collecting decoction, being concentrated into relative density is 1.12～1.14 (25 ℃), adds ethanol and makes and contain alcohol amount and reach 70%, cold preservation 48 hours (0～4 ℃), filter, reclaim ethanol, add suitable quantity of water (0.8g crude drug/ml), cold preservation 48 hours (0～4 ℃) filters; Radix Et Rhizoma Rhei decocts with water secondary, each 1.5 hours, collecting decoction, being concentrated into relative density is 1.06～1.08 (25 ℃ of surveys), adds ethanol and makes that to contain alcohol amount be 70%, cold preservation 48 hours (0～4 ℃), filter, reclaim ethanol, add suitable quantity of water (0.25g crude drug/ml), cold preservation 48 hours (0～4 ℃), filter, filtrates such as filtrate and above-mentioned Radix Sophorae Flavescentis are merged, and being concentrated into relative density is 1.10～1.12 (25 ℃), spray drying, add volatile oil and an amount of dextrin, Icing Sugar granulation, 1000g is made in cold drying, promptly gets granule.
Embodiment 2. takes by weighing raw material by following weight proportion:
Herba Artemisiae Scopariae 250g HERBA BUPLEURL 250g Radix Sophorae Flavescentis 80g
Radix Et Rhizoma Rhei 100g Folium Isatidis 187g.
Above five tastes medicine, Herba Artemisiae Scopariae, HERBA BUPLEURL add 4 times of water gagings, steam distillation, collect volatile oil, distillation rear solution and medicinal residues, Radix Sophorae Flavescentis and Folium Isatidis decoct with water secondary, each 1.5 hours, collecting decoction, being concentrated into relative density is 1.12～1.14, (25 ℃) add ethanol to be made and contains alcohol amount and reach 70%, cold preservation 48 hours (0～4 ℃), filter, reclaim ethanol, add suitable quantity of water (0.8g crude drug/ml), cold preservation 48 hours (0～4 ℃) filters; Radix Et Rhizoma Rhei decocts with water secondary, and each 1.5 hours, collecting decoction, being concentrated into relative density is 1.06～1.08 (25 ℃), adds ethanol and makes that to contain alcohol amount be 70%, cold preservation 48 hours (0～4 ℃), filter, reclaim ethanol, add suitable quantity of water (0.25g crude drug/ml), cold preservation 48 hours (0～4 ℃) filters, and filtrates such as filtrate and above-mentioned Radix Sophorae Flavescentis are merged, being concentrated into relative density is 1.10-1.12 (25 ℃), adds an amount of correctives, adjusts volume to 1000ml, embedding, sterilization promptly gets oral liquid.
The research of embodiment 3. pharmacology tests
Prove that through pharmacological experiment study this prescription has the pharmacological action that promotes rat bile secretion and bilirubin output increase, and the mice body is had immunoloregulation function.In pharmacodynamic study, discovery can induce the mouse macrophage function, obviously recovers cyclophosphamide and suppresses mouse insole DTH reaction, has the function that promotes the cell panimmunity.When rat was carried out the function of gallbladder promoting test, discovery can make bile secretion obviously increase, and bilirubin is discharged to be increased, for clinical promoting the function of the gallbladder to alleviate jaundice provides scientific basis.
In the drug efficacy study of oral agents, with this square preparation concentrated solution 5g, 10g, 20g (being equivalent to the crude drug amount)/kg, to mouse stomach, the result shows certain hepatoprotective effect.
The oral acute liver damage result of the test of mice shows: this square preparation concentrated solution 5g, and 10g and 20g (being equivalent to the crude drug amount)/kg can significantly reduce carbon tetrachloride and poison mice serum ALT and AST value; And significantly reduce the D-galactosamine hydrochlorate and poison mice serum ALT value; Also can obviously improve the pathological change that carbon tetrachloride and D-galactosamine hydrochlorate poison the mouse liver tissue.Prompting: this prescription has protective effect to the mouse liver toxic lesion.
Oral agents is to the excretory influence of rat bile, the result shows: rat liver secretion of bile and bilirubin all obviously increase than reaching the normal saline matched group before the administration, persistent period is about 1～2 hour, shows that this prescription has certain function of gallbladder promoting and promotes bilirubinic discharge effect in the unit interval.
The The acute toxicity tests of mice shows: the LD50 of oral square preparation is 87.63g/kg (being equivalent to the crude drug amount), its 95% credible 78.68～97.6g/kg that is limited to.Appearance activity immediately increases after the poisoning mice administration, and perpendicular hair trembles, and later flesh is opened lax, hypopnea, and the ptosis, dead in the administration 24 hours.Survival mice was observed 7 days continuously, and feed, breathing, heart rate and defecation are not seen abnormal response, and the mice that becomes celestial does not find that main organs has macroscopic pathologic to change.
In order to ensure the clinical oral administration drug safety, done the oral long term toxication of rat, system evaluation has been carried out in the safety of this prescription oral formulations.Behind rat continuous 180 days oral 0.5/kgd, 1.6g/kgd, the 5.0g/kgd, outward appearance sign, behavioral activity, feces character, hematuria routine, hepatic and renal function there is no obvious influence; Main parenchymal viscera and tissue are not seen obvious pathological change.
Embodiment 4. clinical experimental studies
Carry out clinical trial with this prescription, include 122 routine jaundice cases in, the result shows, 59 examples of fully recovering (48.76%), produce effects 48 examples (39.67%), progressive 11 examples (9.09%), total effective rate 88.43%.The result shows, this prescription jaundice eliminating aspect the treatment icterohepatitis is remarkable, and it is rapid to fall enzyme, no obvious adverse reaction.
In a word, this prescription meets theory of Chinese medical science fully, has clearing away heat-damp and promoting diuresis, the function of soothing the liver jaundice eliminating.Studies have shown that its treatment icteric viral hepatitis determined curative effect through clinical observation, at jaundice eliminating, fall enzyme, improve aspect symptom and the sign evident in efficacyly, safety is good, for more effective treatment viral hepatitis provides clinical use of new generation indispensable medication.
Claims (8)
1, a kind of compound preparation for the treatment of icteric viral hepatitis, it is by the made medicament of following raw materials by weight proportions:
Herba Artemisiae Scopariae 450-1200, HERBA BUPLEURL 450-1200, Radix Sophorae Flavescentis 150-400, Radix Et Rhizoma Rhei 200-500, Folium Isatidis 350-1000.
2, compound preparation according to claim 1 is characterized in that said preparation is said any dosage form except that aqueous injection on the pharmaceutics.
3, compound preparation according to claim 1 is characterized in that said preparation is tablet, granule, capsule or oral liquid.
4, a kind of method for preparing the described compound preparation of claim 1, its preparation process is as follows:
(1) getting Herba Artemisiae Scopariae, HERBA BUPLEURL, to add water, vapor distillation, collection volatile oil standby;
(2) aqueous solution after the above-mentioned distillation and medicinal residues and Radix Sophorae Flavescentis, Folium Isatidis are decocted with water after merging, decocting liquid adds ethanol, cold preservation, filtration, recovery ethanol after concentrating, and adds cold preservation behind the water, filters filtrate for later use;
(3) get Radix Et Rhizoma Rhei and decoct with water, decocting liquid concentrates the back, adds ethanol, cold preservation, filtration, recovery ethanol, add water-cooled and hide filtration, with the filtrate of filtrate and step (2) merge, concentrate, spray drying, add above-mentioned volatile oil and appropriate amount of auxiliary materials or correctives after, promptly can be made into preparation of the present invention.
5, preparation method according to claim 4 is characterized in that the added water yield of step 1 is 4-8 a times of medical material amount.
6, preparation method according to claim 4, it is characterized in that decocting with water 2-3 time in the step 2, each 1-2 hour, being concentrated into relative density behind the collecting decoction is 1.12-1.14,25-40 ℃ of mensuration, add ethanol and make pure content reach 70%, after 0-4 ℃ of cold preservation 48-60 hour, filter, reclaim ethanol, add suitable quantity of water to 0.8g crude drug/ml.
7, preparation method according to claim 4, it is characterized in that getting in step 3 Radix Et Rhizoma Rhei decocts with water 2-3 time, each 1-2 hour, being concentrated into relative density after merging decocts was 1.06-1.08,25 ℃ of-40 ℃ of mensuration, add ethanol and make that to contain alcohol amount be 70%, at 0-4 ℃ of cold preservation 48-60 hour, filter, reclaim ethanol, add suitable quantity of water to 0.25g crude drug/ml, at 0-4 ℃ of cold preservation 48-60 hour, filter.
8, the application of compound preparation as claimed in claim 1 in preparation treatment icteric viral hepatitis medicine.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200610161536 CN1994378A (en) | 2006-12-27 | 2006-12-27 | Compound formulation for treating icteric viral hepatitis and method for preparing same |
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| CN 200610161536 CN1994378A (en) | 2006-12-27 | 2006-12-27 | Compound formulation for treating icteric viral hepatitis and method for preparing same |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102228648A (en) * | 2011-06-27 | 2011-11-02 | 武红莲 | Chinese medicinal composition for treating icterohepatitis |
| EP2402020A1 (en) * | 2010-07-01 | 2012-01-04 | Industrial Technology Research Institute | Pharmaceutical composition comprising extracts of Bupleurum with immunomodulating function |
| US8597693B2 (en) | 2010-07-01 | 2013-12-03 | Industrial Technology Research Institute | Pharmaceutical composition with immunomodulating function |
| CN107812049A (en) * | 2017-11-21 | 2018-03-20 | 姚元艳 | Pharmaceutical composition for treating icteric hepatitis and its production and use |
| CN110960601A (en) * | 2019-12-20 | 2020-04-07 | 雷允上药业集团有限公司 | Traditional Chinese medicine composition for treating fat metabolism disorder disease and application thereof |
| CN111228368A (en) * | 2020-02-28 | 2020-06-05 | 雷允上药业集团有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating novel coronavirus combined liver injury |
| CN115300565A (en) * | 2021-05-06 | 2022-11-08 | 常熟雷允上制药有限公司 | Application of pharmaceutical composition in treating or preventing autoimmune liver injury |
-
2006
- 2006-12-27 CN CN 200610161536 patent/CN1994378A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2402020A1 (en) * | 2010-07-01 | 2012-01-04 | Industrial Technology Research Institute | Pharmaceutical composition comprising extracts of Bupleurum with immunomodulating function |
| US8597693B2 (en) | 2010-07-01 | 2013-12-03 | Industrial Technology Research Institute | Pharmaceutical composition with immunomodulating function |
| CN102228648A (en) * | 2011-06-27 | 2011-11-02 | 武红莲 | Chinese medicinal composition for treating icterohepatitis |
| CN102228648B (en) * | 2011-06-27 | 2012-09-26 | 武红莲 | Chinese medicinal composition for treating icterohepatitis |
| CN107812049A (en) * | 2017-11-21 | 2018-03-20 | 姚元艳 | Pharmaceutical composition for treating icteric hepatitis and its production and use |
| CN110960601A (en) * | 2019-12-20 | 2020-04-07 | 雷允上药业集团有限公司 | Traditional Chinese medicine composition for treating fat metabolism disorder disease and application thereof |
| CN111228368A (en) * | 2020-02-28 | 2020-06-05 | 雷允上药业集团有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating novel coronavirus combined liver injury |
| CN111228368B (en) * | 2020-02-28 | 2022-04-12 | 雷允上药业集团有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating novel coronavirus combined liver injury |
| CN115300565A (en) * | 2021-05-06 | 2022-11-08 | 常熟雷允上制药有限公司 | Application of pharmaceutical composition in treating or preventing autoimmune liver injury |
| CN115300565B (en) * | 2021-05-06 | 2023-06-16 | 常熟雷允上制药有限公司 | Use of pharmaceutical compositions for the treatment or prevention of autoimmune liver injury |
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Open date: 20070711 |