CN103599449A - Liuwei Anxiao pharmaceutical composition and application of preparation thereof in preparation of drug for treating alcoholic hepatitis - Google Patents
Liuwei Anxiao pharmaceutical composition and application of preparation thereof in preparation of drug for treating alcoholic hepatitis Download PDFInfo
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Abstract
The invention discloses a Liuwei Anxiao pharmaceutical composition and application of a preparation thereof in preparation of a drug for treating alcoholic hepatitis. The Liuwei Anxiao pharmaceutical composition comprises six medicine ingredients, namely, Tibet inula root, rheum officinale, rhizoma kaempferiae, fumed gypsum, fructus chebulae and tronae. The clinical test shows that the Liuwei Anxiao pharmaceutical composition can protect alcoholic liver injury and can also obviously improve AST (Aspartate Transaminase), ALT (Alanine Aminotransferase), GGT (Gamma Glutamyl Transpeptidase), TBiL (Total Bilirubin) and other biochemical indexes.
Description
Technical field
The present invention relates to the application in preparation treatment alcoholic hepatitis medicine of Liuwei Anxiao pharmaceutical composition and preparation thereof, belong to field of medicaments.
Background technology
Alcoholic hepatitis is a Clinical typing of alcoholic liver disease, it is one group of clinical pathology syndrome that a large amount of necrosis of hepatocyte in a short time cause, can occur in or the basis without liver cirrhosis on, main manifestations is that Serum ALT, AST raise and serum total bilirubin obviously increases, and can raise with heating, peripheral blood neutrophil.
The topmost clinical manifestation of alcoholic hepatitis is to occur rapidly jaundice, and other sings and symptoms comprises that heating, ascites, near-end are of flaccid muscles etc., and hepatic encephalopathy can appear in serious symptom alcoholic hepatitis patient.Conventionally, alcoholic hepatitis patient's liver increases, liver is touched a tender spot the positive.Laboratory research shows, the sex expression of alcoholic hepatitis patient characteristic is: the normal >2 of AST times Upper Limit of Normal Value, but >300U/ml seldom.And Serum ALT is lower, the common >2 of AST/ALT, but this feature is not had specificity and a susceptiveness.Peripheral blood leucocyte, neutrophil count, serum total bilirubin and INR (intemationalnormalized ratio.INR) raise simultaneously.Serum creatinine level raises, and indication prognosis mala, because this is usually indicating the generation of hepatorenal syndrome and even dead closing on.
Liuwei Anxiao is loose is the classical proved recipe of Tibetanmedicine, and the clinical practice history of existing more than 100 years, is comprised of Radix Inulae, Radix Et Rhizoma Rhei, Rhizoma Kaempferiae, calcine calcite, Fructus Chebulae, Tronae so far.Function cures mainly as stomach function regulating spleen invigorating, consumer product dredge stasis, promoting blood circulation and stopping pain.For incoordination between the spleen and stomach, the stomachache distension due to stopping in stagnating, dyspepsia, constipation dysmenorrhea.LIUWEIANXIAO JIAONANG with prescription is recorded in version < < Pharmacopoeia of People's Republic of China > > in 2010.
Through patent retrieval, with totally 7 of Liuwei Anxiao lively stock Patents, 1 design patent wherein, 6 patents of invention.In patent of invention, preparation class has 5, has respectively the preparation method of pill, tablet, nanometer formulation, Traditional Chinese medicine preparation-Liuwei Anxiao Pills, gastric motility Chinese medicine preparation.In tablet, pill, main employing is steamed and is put forward technology, has effectively retained volatile ingredient, has improved medicine stability.Nanometer formulation mainly adopts nanometer medical material to be dried and to be made by microwave extracting, concentrating under reduced pressure, the spraying of supersonic jet technology.Traditional Chinese medicine preparation-Liuwei Anxiao Pills changes sterilization process, adopts Co 60 irradiation process.Gastric motility Chinese medicine preparation adopts percolation, concentrated, dry etc. technology is refining forms, and strengthens gastric motility.Quality control class has 1, adopts TLC method to differentiate each medical material in prescription, and adopts HPLC method to carry out assay to emodin, chrysophanic acid, chrysophanol, physcione, aloe-emodin.
Through consulting the data bases such as Wei Pu, CNKI, retrieve altogether 24 pieces of this product pertinent literatures, wherein clinical practice class has 12 pieces, relates generally to the application of the aspects such as constipation, peptic ulcer, gastroesophageal reflux disease, diabetic gastroparesis, pain relieving.Mechanism Study has 1 piece.Quality testing class has 10 pieces, the main component of surveying is alantolactone, isoalantolactone, emodin and chrysophanol, the method adopting is mainly TLC, HPLC, and the Spectrophotometric Determination anthraquinone component wherein using in Quantitative Analysis of Anthraquinon in Liuwei ' anxiao Capsule document is more novel.Produce 1 piece of processing procedure, its document is that in Ma Nuoxi decoction particles, Radix Inulae decocting boils the impact of controlling alantolactone content.
Above-mentioned patent and document etc. have no the correlational study report of Liuwei Anxiao pharmaceutical composition and the application of preparation in preparation treatment alcoholic hepatitis medicine thereof.
Summary of the invention
The object of this invention is to provide the application in preparation treatment alcoholic hepatitis medicine of Liuwei Anxiao pharmaceutical composition and preparation thereof.Technical scheme of the present invention is as follows:
The application in preparation treatment alcoholic hepatitis medicine of Liuwei Anxiao pharmaceutical composition and preparation thereof, wherein said Liuwei Anxiao pharmaceutical composition is comprised of the crude drug of following weight portion:
Radix Inulae 50 weight portions, Radix Et Rhizoma Rhei 200 weight portions, Rhizoma Kaempferiae 100 weight portions, calcine calcite 250 weight portions, Fructus Chebulae's 150 weight portions, Tronae 300 weight portions.
Described Liuwei Anxiao pharmaceutical composition and preparation thereof are according to crude drug formula, and the various adjuvants that add after crushed pharmaceutics to allow, make tablet, granule, capsule, powder or pill on pharmaceutics.
Described Liuwei Anxiao pharmaceutical composition and preparation thereof are to prepare active component according to crude drug formula, the more various adjuvants that add pharmaceutics to allow, and make tablet, granule, capsule, powder or pill on pharmaceutics.
The described step of preparing active component is as follows:
(1) by crude drug, form and get Radix Inulae, Radix Et Rhizoma Rhei, Rhizoma Kaempferiae, Fructus Chebulae totally 4 taste medical materials, with 70% alcohol reflux 2 times, each extraction time is 2 hours, each solvent load is 10 times of volumes of medical material weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A decompression recycling ethanol, concentrated, drying under reduced pressure, obtains extract A;
(2) step (1) is obtained to the Tronae of medicinal residues A and crude drug composition, the calcine calcite that crude drug forms half, use water boiling and extraction 2 times, each 2 hours, each amount of water is 20 times of volumes of calcite weight, filter, extracting solution concentrate drying, obtains extract B;
(3) the calcine calcite that extract A, extract B and crude drug is formed to half is pulverized and is mixed, and obtains.
In preparing active component step, described recovery ethanol and concentration technology parameter are 60～70 ℃ ,-0.07～-0.09Mpa; The technological parameter of drying under reduced pressure is 70 ℃ ,-0.08～-0.09Mpa, and the pharmacy that is that other is not specified is produced upper habitual parameter or method.
The unit corresponding relation of the weight portion described in this method and parts by volume is g/ml or kg/l.
The application in preparation treatment alcoholic hepatitis medicine of described Liuwei Anxiao pharmaceutical composition and preparation thereof and chemical drugs or Chinese medicine or natural drug.
Beneficial effect: in the application for the treatment of field of Liuwei Anxiao and preparation thereof, people know it for stomachache distension, dyspepsia, constipation, the treatment of dysmenorrhea etc., evident in efficacy, clinical practice is extensive.
The present invention has overcome the technology prejudice of above-mentioned application aspect, by clinical observation, finds, Liuwei Anxiao pharmaceutical composition and preparation thereof are significantly improved for AST, ALT, the biochemical indicator such as GGT, TBiL of alcoholic hepatitis, and total effective rate is up to more than 75%.
The specific embodiment
Following embodiment is for illustrating the preparation of Liuwei Anxiao pharmaceutical composition of the present invention and preparation thereof, but it does not form any restriction to scope of the present invention.
The preparation of experimental example 1, Liuwei Anxiao pharmaceutical composition and preparation thereof
1, prescription: Radix Inulae 75g, Radix Et Rhizoma Rhei 300g, Rhizoma Kaempferiae 150g, calcine calcite 375g, Fructus Chebulae 225g, Tronae 450g;
2, active fraction preparation
(1) by crude drug, form and get Radix Inulae, Radix Et Rhizoma Rhei, Rhizoma Kaempferiae, Fructus Chebulae totally 4 taste medical materials, with 70% alcohol reflux 2 times, each extraction time is 2 hours, each solvent load is 10 times of volumes of medical material weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A decompression recycling ethanol, concentrated, dry, obtain extract A;
(2) step (1) is obtained to Tronae that medicinal residues A and crude drug form, crude drug forms the calcine calcite of half, by water boiling and extraction 2 times, each 2 hours, each amount of water was 20 times of volumes of calcite weight, filters, extracting solution concentrate drying, obtains extract B;
(3) the calcine calcite that extract A, extract B and crude drug is formed to half is pulverized and is mixed, and obtains.
3, preparation
(1) above-mentioned active fraction preparation is become to 500 of LIUWEIANXIAO JIAONANG, every is equivalent to 3.05g medical material, taking dose be one time 1,2～3 times on the one.
(2) above-mentioned active fraction preparation is become to 500 of Liuwei Anxiao Film coated tablets, every is equivalent to 3.05g medical material, taking dose be one time 1,2～3 times on the one.
(3) above-mentioned active fraction preparation is become to 500 of Liuwei Anxiao coated tablets, every is equivalent to 3.05g medical material, taking dose be one time 1,2～3 times on the one.
The clinical observation of experimental example 2, treatment alcoholic hepatitis
Essence for a better understanding of the present invention, below by pharmacological testing and clinical observation test, proves the effect aspect " treatment alcoholic hepatitis " of Liuwei Anxiao pharmaceutical composition and preparation thereof, illustrates that it is in the new application of pharmaceutical field.
Case enters group standard
According in October, 2010, the diagnostic criteria of the alcoholic liver disease that Chinese Medical Association's hepatopathy branch's fatty liver and alcoholic liver disease group are formulated enters group:
1) long-term history of drinking history, generally surpasses 5 years, amounts to ethanol amount, male >=40g/d, women >=20g/d, or heavy drinking history (>80g/d) in 2 weeks;
2) aspartate amino transferase (AST) rising amplitude is obviously greater than alanine aminotransferase (ALT) rising amplitude, and AST/ALT >=2;
3) get rid of the hepatitis that other causes of disease cause;
4) treat front 1 monthly not with excessively obviously falling enzyme medicine.
Test grouping
MethodsThe cases enrolled is successively divided into two groups at random according to being admitted to hospital: test group 60 examples, and matched group 60 examples, GP TH all obtains patient and family members agree to, liver zymetology indicator difference not statistically significant before the sex of two groups, age, the course of disease, iconography and treatment.
The scheme of taking medicine: advise patient's teetotalism during treatment, suitably reduce energy intake.Test group patient gives the capsule of experimental example 1, oral, one time 1,3 times on the one, 4 weeks courses for the treatment of.Matched group patient gives former preparation Liuwei Anxiao San，Jin He Tibetan medicine limited company, and lot number 20121209 is oral, a 3g, 3 times on the one, 4 weeks courses for the treatment of.
Observation index
Curative effect evaluation index
1) sings and symptoms: comprise weak, anorexia, uncomfortable liver area, hepatosplenomegaly etc.
2) liver function: aspartate amino transferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT), total bilirubin (TBiL).
Safety indexes
Hematuria is conventional, renal function
Curative effect judging standard
Effective: cardinal symptom and sign disappear, and liver function recovery is normal;
Effective: cardinal symptom and sign are obviously improved, ALT, AST, GGT, TBiL decline 75%;
Invalid: not reach above-mentioned standard.
Obvious effective rate and effective percentage add up to total effective rate.
Statistical procedures:
Application SPSSl7.0 statistical software carries out statistical analysis, two sample rates relatively use chi-square criterion, index determining result is relatively checked with t.Clinical observation result of the test and curative effect relatively in Table 1, table 2.
Table 1 clinical observation result of the test
Note: with before treatment, compare, * * P<0.01
Table 1 result shows: after treatment, 4 liver function indexs of two groups of patients have all obtained extremely significantly improving (P<0.01), and test group effect is more remarkable, point out two kinds of LIUWEIANXIAO ZHIJI all can reduce liver function biochemical indicator, and LIUWEIANXIAO JIAONANG effect prepared by embodiment is more excellent.
Table 2 liang group Clinical efficacy comparison [n]
| Group | n | Effective | Effectively | Invalid | Total effective rate (%) |
| Matched group | 60 | 38 | 8 | 14 | 76.7 |
| Test group | 60 | 42 | 11 | 7 | 88.3* |
χ
2check, with matched group comparison, * P<0.05
Table 2 shows: the loose total effective rate of Liuwei Anxiao is 76.7%; Embodiment 1 LIUWEIANXIAO JIAONANG group total effective rate is 88.3%.Prompting Liuwei Anxiao is loose all can be used for treating alcoholic hepatitis with embodiment 1 LIUWEIANXIAO JIAONANG, and embodiment 1 LIUWEIANXIAO JIAONANG treatment alcoholic hepatitis clinical efficacy is significantly better than Liuwei Anxiao loose (P<0.05).
In addition, before and after patient takes medicine, renal function, hematuria routine all within normal range, and have no obvious untoward reaction, point out this medicine clinical practice safe.
Following examples all can realize the effect of above-mentioned experimental example.
Embodiment 1, Liuwei Anxiao fall apart, and every gram is equivalent to 1g medical material, for alcoholic hepatitis, and taking dose: every day 2～3 times, each 3g.
Embodiment 2, LIUWEIANXIAO JIAONANG, every is equivalent to 0.5g medical material, for alcoholic hepatitis, taking dose: every day 2～3 times, each 6.
Embodiment 3, six component medicine, every is equivalent to 0.51g medical material, for alcoholic hepatitis, taking dose: every day 2～3 times, each 6.
Embodiment 4, LIUWEIANXIAO JIAONANG, every is equivalent to 3.05g medical material, for alcoholic hepatitis, taking dose be one time 1,2～3 times on the one.
Embodiment 5, Liuwei Anxiao Film coated tablets, every is equivalent to 3.05g medical material, for alcoholic hepatitis, taking dose be one time 1,2～3 times on the one.
Embodiment 6, Liuwei Anxiao coated tablet, every is equivalent to 3.05g medical material, for alcoholic hepatitis, taking dose be one time 1,2～3 times on the one.
Claims (6)
1. Liuwei Anxiao pharmaceutical composition and preparation thereof the application in preparation treatment alcoholic hepatitis medicine, wherein said Liuwei Anxiao pharmaceutical composition is comprised of the crude drug of following weight portion:
Radix Inulae 50 weight portions, Radix Et Rhizoma Rhei 200 weight portions, Rhizoma Kaempferiae 100 weight portions, calcine calcite 250 weight portions, Fructus Chebulae's 150 weight portions, Tronae 300 weight portions.
2. Liuwei Anxiao pharmaceutical composition according to claim 1 and preparation thereof the application in preparation treatment alcoholic hepatitis medicine, it is characterized in that, described Liuwei Anxiao pharmaceutical composition and preparation thereof are according to crude drug formula, the various adjuvants that add after crushed pharmaceutics to allow, make tablet, granule, capsule, powder or pill on pharmaceutics.
3. Liuwei Anxiao pharmaceutical composition according to claim 1 and preparation thereof the application in preparation treatment alcoholic hepatitis medicine, it is characterized in that, described Liuwei Anxiao pharmaceutical composition and preparation thereof are to prepare active component according to crude drug formula, the various adjuvants that add again pharmaceutics to allow, make tablet, granule, capsule, powder or pill on pharmaceutics.
4. Liuwei Anxiao pharmaceutical composition according to claim 3 and preparation thereof the application in preparation treatment alcoholic hepatitis medicine, is characterized in that, the described step of preparing active component is as follows:
(1) by crude drug, form and get Radix Inulae, Radix Et Rhizoma Rhei, Rhizoma Kaempferiae, Fructus Chebulae totally 4 taste medical materials, with 70% alcohol reflux 2 times, each extraction time is 2 hours, each solvent load is 10 times of volumes of medical material weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A decompression recycling ethanol, concentrated, drying under reduced pressure, obtains extract A;
(2) step (1) is obtained to the Tronae of medicinal residues A and crude drug composition, the calcine calcite that crude drug forms half, use water boiling and extraction 2 times, each 2 hours, each amount of water is 20 times of volumes of calcite weight, filter, extracting solution concentrate drying, obtains extract B;
(3) the calcine calcite that extract A, extract B and crude drug is formed to half is pulverized and is mixed, and obtains;
The unit corresponding relation of described weight and volume is g/ml or kg/l.
5. Liuwei Anxiao pharmaceutical composition according to claim 4 and preparation thereof the application in preparation treatment alcoholic hepatitis medicine, it is characterized in that, in preparing active component step, described recovery ethanol and concentrated technological parameter are 60～70 ℃ ,-0.07～-0.09Mpa; The technological parameter of described drying under reduced pressure is 70 ℃ ,-0.08～-0.09Mpa.
6. according to the Liuwei Anxiao pharmaceutical composition described in claim 1 or 2 or 3 and preparation and chemical drugs or Chinese medicine or the application of natural drug in preparation treatment alcoholic hepatitis medicine.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106310071A (en) * | 2015-07-07 | 2017-01-11 | 山东金诃药物研究开发有限公司 | Liuwei-Anxiao gastric floating tablet and preparation method thereof |
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| CN101444606A (en) * | 2008-12-26 | 2009-06-03 | 贵州信邦制药股份有限公司 | Quality control method for Liuwei Anxiao traditional Chinese medicine preparation |
| CN102526574A (en) * | 2011-12-28 | 2012-07-04 | 江西青春康源制药有限公司 | Traditional Chinese medicine preparation-Liuwei Anxiao Pills and preparing method thereof |
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| CN106310071A (en) * | 2015-07-07 | 2017-01-11 | 山东金诃药物研究开发有限公司 | Liuwei-Anxiao gastric floating tablet and preparation method thereof |
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Address after: The 250101 Ji'nan Road, Shandong province hi tech Development Zone, No. 322 room 501-506 Applicant after: Shandong Jin He drug development research company limited Address before: The 250101 Ji'nan Road, Shandong province hi tech Development Zone, No. 322 room 501-506 Applicant before: Shandong ARURA Pharmaceutical Research & Development Co., Ltd. |
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Effective date of registration: 20171201 Address after: 810003, No. two, No. 22, Xining Road, Qinghai, Qinghai Province Patentee after: JINHE TIBETAN MEDICINE CO., LTD. Address before: The 250101 Ji'nan Road, Shandong province hi tech Development Zone, No. 322 room 501-506 Patentee before: Shandong Jin He drug development research company limited |