CN102727633B - Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof Download PDFInfo
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- CN102727633B CN102727633B CN201210253430.5A CN201210253430A CN102727633B CN 102727633 B CN102727633 B CN 102727633B CN 201210253430 A CN201210253430 A CN 201210253430A CN 102727633 B CN102727633 B CN 102727633B
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Abstract
The invention discloses a pharmaceutical composition for treating chronic hepatitis B, which is a preparation prepared by raw material drugs according to the following weight ratios: 14-26 parts of immature bitter orange, 8-16 parts of bupleurum chinense, 7-13 parts of peach kernel, 7-13 parts of salvia miltiorrhiza, 10-20 parts of giant knotweed rhizome, 7-13 parts of root of herbaceous peony, 7-13 parts of rhizoma atractylodis macrocephalae, and 7-13 parts of poria cocos. The invention also provides a preparation method and an application of the pharmaceutical composition. The clinical study finds that the pharmaceutical composition can obviously improve clinical symptoms, liver function and HBV-DNA (hepatitis B virus-deoxyribonucleic acid) of liver-stagnation with spleen-deficiency type chronic hepatitis B, and has good effects of protecting liver and lowering transaminase and anti-HBV activity, thus providing a new choice for the clinical medication for treating the chronic hepatitis B.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of chronic hepatitis B and its production and use.
Background technology
Chronic hepatitis B is one of common viral hepatitis, can propagate through modes such as blood, mother and baby, damaged skin and property contacts, and be also common chronic infectious disease.According to World Health Organization (WHO) (WHO), chronic hepatitis B accounts in the global top ten disease cause of the death the 7th, and wherein 30% hepatitis B patient develops into liver cirrhosis and hepatocarcinoma the most at last, and only China just has 300,000 people to die from the disease that hepatitis B virus infection causes every year.
Current nucleoside analog and the interferon of adopting treated hepatitis B and hepatitis B virus carriers more.Wherein, the normal nucleoside analog using has Lamivudine, Adefovir Dipivoxil, Entecavir, Sebivo, tenofovir disoproxil etc., its overall security and toleration are good, but can there is rare, rare serious adverse reaction in clinical practice, as renal insufficiency, myositis, rhabdomyolysis, lactic acidosis etc., once and drug withdrawal, most of patient's hepatitis B virus DNA polymerase parameter bounce-back, higher before some ratio treatments.For these reasons, most research worker has turned to Chinese medicine by goal in research.The traditional Chinese medical science thinks, chronic hepatitis B can be divided into: (1) damp and hot middle resistance type; (2) liver-depression and spleen-insufficiency type; (3) liver-kidney yin deficiency; (4) obstruction of collaterals by blood stasis type; (5) yang deficiency of spleen and stomache (standard < < viral hepatitis Standards of Chinese Medical Syndrome Differentiation (trying) the > > formulating with reference to the Tianjin meeting in 1991 of internal medicine hepatopathy Professional Committee of China Association of Traditional Chinese Medicine).Under instruction of Chinese Medicine theory, also the Chinese prescription that has occurred in recent years more treatment hepatitis B, as hepatitis B strengthening capsule, it is comprised of Radix Polygoni Multiflori, Radix Angelicae Sinensis, Semen Astragali Complanati, Radix Salviae Miltiorrhizae, Radix Ginseng, Rhizoma Polygoni Cuspidati, Rhizoma Osmundae, Alumen, Pericarpium Granati, Herba Ephedrae, Cortex Cinnamomi multi-flavor medical material, can be used for Liver and kidney two deficiency syndrome time type hepatitis B.Chinese patent and for example: 200510098422.8, in this patent, disclose a kind of Chinese patent medicine preparation for hepatitis B liver spleen kidney deficiency, the mutual knot card of the evil poison of stagnant heat marquis, it comprises following raw material: Fructus Schisandrae Chinensis 680-900 part, Fructus Ligustri Lucidi 500-700 part, Fructus Forsythiae 300-450 part, Rhizoma Curcumae 190-300 part, Sonchus brachyotus DC. 300-450 part, Ganoderma spore powder 180-300 part.
Although it is more to treat on the market the Chinese medicine preparation of hepatitis B at present,, the significant prescribed preparation of clinical efficacy is but comparatively limited, and in the face of huge hepatitis B patient colony like this, research and development can have the new compound Chinese medicinal preparation for the treatment of chronic hepatitis B to seem particularly necessary.
Summary of the invention
The object of the present invention is to provide pharmaceutical composition of a kind of effective treatment chronic hepatitis B and its production and use.
The present invention also provides a kind of pharmaceutical composition for the treatment of chronic hepatitis B, and it is the preparation that the crude drug by following weight proportion is prepared from:
14 ~ 26 parts of Fructus Aurantii Immaturuss, 8 ~ 16 parts of Radix Bupleuri, 7 ~ 13 parts, Semen Persicae, 7 ~ 13 parts of Radix Salviae Miltiorrhizaes, 10 ~ 20 parts of Rhizoma Polygoni Cuspidati, 7 ~ 13 parts of the Radix Paeoniae Albas, 7 ~ 13 parts of the Rhizoma Atractylodis Macrocephalaes, 7 ~ 13 parts, Poria.
Further, it is the preparation that the crude drug by following weight proportion is prepared from:
20 parts of Fructus Aurantii Immaturuss, 12 parts of Radix Bupleuri, 10 parts, Semen Persicae, 10 parts of Radix Salviae Miltiorrhizaes, 15 parts of Rhizoma Polygoni Cuspidati, 10 parts of the Radix Paeoniae Albas, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 10 parts, Poria.
Wherein, the described Rhizoma Atractylodis Macrocephalae is Rhizoma Atractylodis Macrocephalae (parched).
Wherein, described pharmaceutical composition be by the medical material powder of crude drug, the water of crude drug or extractive with organic solvent are active component, add the preparation that pharmaceutically conventional adjuvant is prepared from.
Further, described preparation is oral formulations.
Further, described oral formulations is granule, capsule, powder, pill, tablet or oral liquid.
The present invention also provides the preparation method of above-mentioned pharmaceutical composition, and it comprises following operating procedure:
(1) weighting raw materials by weight ratio;
(2) crude drug is beaten to powder, add suitable adjuvant, preparation, obtains pharmaceutical composition of the present invention; Or
(3) crude drug is added after water or organic solvent extraction, add suitable adjuvant, preparation, obtains pharmaceutical composition of the present invention.
The present invention also provides the above-mentioned pharmaceutical composition purposes in the medicine of preparing the liver protecting and ALT lowering, anti-hepatitis virus, treatment chronic hepatitis B.
Further, described medicine is the medicine for the treatment of liver-depression and spleen-insufficiency type hepatitis B.
Further, described medicine is the medicine for the treatment of slight or moderate chronic hepatitis B.In pharmaceutical composition of the present invention, Fructus Aurantii Immaturus, Radix Bupleuri depressed liver-energy dispersing and QI regulating resolving depression, the liver protecting and ALT lowering, two medicines are monarch; Semen Persicae, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati blood circulation promoting and blood stasis dispelling, eliminating damp-heat, the liver protecting and ALT lowering; The Radix Paeoniae Alba, Rhizoma Atractylodis Macrocephalae (parched), the dehumidifying of Poria replenishing QI to invigorate the spleen.
Pharmaceutical composition of the present invention improves significantly to the clinical symptoms of liver-depression and spleen-insufficiency type chronic hepatitis B, liver function, BV-DNA, there is good the liver protecting and ALT lowering, the activity of anti-hepatitis virus, for treating the clinical application of chronic hepatitis B, provide new selection.
The specific embodiment
The preparation of embodiment 1 pharmaceutical composition of the present invention
Get Fructus Aurantii Immaturus 20g, Radix Bupleuri 12g, Semen Persicae 10g, Radix Salviae Miltiorrhizae 10g, Rhizoma Polygoni Cuspidati 15g, Radix Paeoniae Alba 10g, Rhizoma Atractylodis Macrocephalae (parched) 10g, Poria 10g, decocts with water after 3 times, merges decocting liquid, concentrated, then adds appropriate dextrin, granulates, and obtains granule.
The preparation of embodiment 2 pharmaceutical compositions of the present invention
Fructus Aurantii Immaturus 26g, Radix Bupleuri 8g, Semen Persicae 7g, Radix Salviae Miltiorrhizae 7g, Rhizoma Polygoni Cuspidati 10g, Radix Paeoniae Alba 7g, Rhizoma Atractylodis Macrocephalae (parched) 7g, Poria 7g, decocts with water after 3 times, merges decocting liquid, concentrated, adds appropriate dextrin, and after granulation, tabletting, obtains tablet.
The preparation of embodiment 3 pharmaceutical compositions of the present invention
Fructus Aurantii Immaturus 14g, Radix Bupleuri 16g, Semen Persicae 13g, Radix Salviae Miltiorrhizae 13g, Rhizoma Polygoni Cuspidati 20g, Radix Paeoniae Alba 13g, Rhizoma Atractylodis Macrocephalae (parched) 13g, Poria 13g, decocts with water after 3 times, merges decocting liquid, concentrated, dry, adds appropriate microcrystalline Cellulose, after mix homogeneously, encapsulated, obtains capsule.
By test example, illustrate beneficial effect of the present invention below.
The treatment of test example 1 pharmaceutical composition of the present invention to chronic hepatitis B
(1) diagnostic criteria
1. Standards of Chinese Medical Syndrome Differentiation
Standard < < viral hepatitis Standards of Chinese Medical Syndrome Differentiation (trying) the > > formulating with reference to the Tianjin meeting in 1991 of internal medicine hepatopathy Professional Committee of China Association of Traditional Chinese Medicine.
1.1 syndrome of stagnation of liver qi and spleen deficiency
Clinical manifestation is side of body rib distension pain, uncomfortable in chest heaving a deep sigh, spirit depressing, irascible temperament, the decreased food intake of receiving is few, and tastelessness is dull, gastral cavity painful abdominal mass abdominal distention, in the afternoon for very, deficiency of QI with disinclination to talk, extremity asthenia, shallow complexion, diarrhea or food indigested food, every because of take food raw food greasy and stodgy food increase the weight of, pale tongue has indentation, and tongue is white, deep and stringy pulse.
Main symptom: 1. distending pain over the hypochondrium; 2. abdominal distention loose stool.
Inferior card: 1. depressed unhappy; 2. body is tired weak; 3. pale tongue with indented margin.
Dialectical requirement: (1) possess main symptom 1., 2. person, belong to assertive evidence; (2) possess main symptom 1. and inferior card 2., 3. two persons, belong to assertive evidence; (3) possess main symptom 2. and 1. person of inferior card, belong to assertive evidence.
3. Western medicine diagnose standard and calibration
3.1 Western medicine diagnose standards
With reference to hepatopathy credit Hui Yu Chinese Medical Association of Chinese Medical Association, infect disease credit meeting and within 2005, combine formulation < < the guideline > >, actual according to this research, standard is as follows:
1. there is the positive history of hepatitis B or HBsAg over 6 months;
2. HBV DNA is positive;
3. ALT repeatedly or persistent anomaly.
3.2 disease degree calibration
With reference to Chinese Medical Association's hepatopathy credit meeting in 2000, combine the < < viral hepatitis of formulation with infectious disease with parasitic disease credit meeting and prevent and treat scheme > >, be divided into light, in, severe, specific as follows:
The lab testing intensity of anomaly reference index of chronic hepatitis
* have ready conditions and carry out the unit that CHE detects, can be with reference to this index
(2) test case selection standard
1. inclusive criteria
(1) meet viral hepatitis Chinese medical discrimination and belong to syndrome of stagnation of liver qi and spleen deficiency;
(2) meet that China's chronic hepatitis B is slight, moderate Western medicine diagnose standard person, and meet simultaneously:
1. bilirubin is normal;
2. HBeAg positive needs HBV DNA≤10
5copy/ml; Or HBeAg negative patient HBV DNA≤10
4copy/ml;
(3) age 30-40 year;
(4) in nearly February, do not take other interference medicaments;
(5) signed Informed Consent Form person;
Meet the test of being allowed for access of above condition simultaneously.
2. Excluded cases standard
(1) Chinese medical discrimination does not meet syndrome of stagnation of liver qi and spleen deficiency or is mingled with other pattern of syndrome;
(2) concurrent infection first, the third, fourth, hepatitis E, and/or infected by HIV;
(3) have except Chronic Liver medical history or the relevant clinical setting (as pigmentation disease, autoimmune hepatitis, metabolic hepatic disease, alcoholic liver disease, toxic hepatic disease, thalassemia etc.) of chronic hepatopathy of viral hepatitis;
(4) in 6 months before selected research, have and take illicit drug history or abuse of alcohol history (drink every day over the women of 20g and surpass the male of 30g every day);
(5) in 12 weeks before selected research, participated in the clinical trial of other drug;
(6) there are hepatocarcinoma, liver cirrhosis person;
(7) there is the evidence of other serious diseases such as cardiovascular and cerebrovascular vessel, have malignant tumor, or researcher thinks have other to be not suitable for participating in the situation of research;
(8) pregnancy or women breast-feeding their children;
(9) spiritedness illness, meets Chinese Spirit Obstacles classification and diagnosis (CCMD-3) standard;
(10) can not or be unwilling to sign Informed Consent Form, or do not observe research regulation;
(11) in observation process, conditions of patients increases the weight of or occurs disturbing other situations of this experiment.Meet above arbitrary person and can not enter test.
(3) Therapeutic Method
Accept altogether 326 routine liver-depression and spleen-insufficiency type chronic hepatitis B (CHB) patients for medical treatment, male 169 examples wherein, women's 147 examples; Use medicine composite for curing of the present invention (embodiment 1 preparation): Fructus Aurantii Immaturus 20g, Radix Bupleuri 12g, Semen Persicae 10g, Radix Salviae Miltiorrhizae 10g, Rhizoma Polygoni Cuspidati 15g, Radix Paeoniae Alba 10g, Rhizoma Atractylodis Macrocephalae (parched) 10g, Poria 10g; Potion on the one, mixing in water for oral taking, three times on the one; Observe before treatment, after treatment main clinic symptoms and tongue, arteries and veins, ALT, HBV-DNA change; Be 4 weeks the course for the treatment of.
(4) therapeutic outcome
Accept altogether 326 routine liver-depression and spleen-insufficiency type chronic hepatitis B (CHB) patients for medical treatment, treat after 4 weeks: effective 298 examples, invalid 28 examples, total effective rate is 91.41%, wherein:
1) treatment is after 2,3,4 weeks, and front relatively ALT declines obviously with treatment, and difference has statistical significance (P<0.05), shows that pharmaceutical composition of the present invention has significant effect of reducing enzyme levels.
2) the tcm symptom scoring for the treatment of after 2,4 weeks all declines, pharmaceutical composition of the present invention can obviously be alleviated the symptoms such as tired weak, the pale tongue with indented margin of distending pain over the hypochondrium, abdominal distention loose stool, depressed unhappy, body, and difference has statistical significance (P<0.05);
3) treatment, after 4 weeks, obviously declines with before treatment, relatively HBV-DNA is quantitative, and difference has statistical significance (P<0.05), shows that pharmaceutical composition of the present invention has certain anti-HBV effect.
In sum, pharmaceutical composition of the present invention improves significantly to the clinical symptoms of liver-depression and spleen-insufficiency type chronic hepatitis B, liver function, HBV-DNA, there is good the liver protecting and ALT lowering, the activity of anti-hepatitis virus, for treating the clinical application of chronic hepatitis B, provide new selection.
Claims (9)
1. a pharmaceutical composition for the treatment of chronic hepatitis B, is characterized in that: it is the preparation that the crude drug by following weight proportion is prepared from:
14 ~ 26 parts of Fructus Aurantii Immaturuss, 8 ~ 16 parts of Radix Bupleuri, 7 ~ 13 parts, Semen Persicae, 7 ~ 13 parts of Radix Salviae Miltiorrhizaes, 10 ~ 20 parts of Rhizoma Polygoni Cuspidati, 7 ~ 13 parts of the Radix Paeoniae Albas, 7 ~ 13 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 7 ~ 13 parts, Poria.
2. pharmaceutical composition according to claim 1, is characterized in that: it is the preparation that the crude drug by following weight proportion is prepared from:
20 parts of Fructus Aurantii Immaturuss, 12 parts of Radix Bupleuri, 10 parts, Semen Persicae, 10 parts of Radix Salviae Miltiorrhizaes, 15 parts of Rhizoma Polygoni Cuspidati, 10 parts of the Radix Paeoniae Albas, 10 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 10 parts, Poria.
3. pharmaceutical composition according to claim 1 and 2, is characterized in that: described pharmaceutical composition be by the medical material powder of crude drug, the water extract of crude drug is active component, add the preparation that pharmaceutically conventional adjuvant is prepared from.
4. pharmaceutical composition according to claim 3, is characterized in that: described preparation is oral formulations.
5. pharmaceutical composition according to claim 4, is characterized in that: described oral formulations is granule, capsule, powder, pill, tablet or oral liquid.
6. the preparation method of pharmaceutical composition claimed in claim 1, is characterized in that: it comprises following operating procedure:
(1) weighting raw materials by weight ratio;
(2) crude drug is beaten to powder, add suitable adjuvant, preparation, obtains pharmaceutical composition of the present invention; Or
(3) by after crude drug extracting in water, add suitable adjuvant, preparation, obtains pharmaceutical composition of the present invention.
7. the purposes of the pharmaceutical composition described in claim 1-5 any one in the medicine of preparing the liver protecting and ALT lowering, anti-hepatitis virus, treatment chronic hepatitis B.
8. purposes according to claim 7, is characterized in that: described medicine is the medicine for the treatment of liver-depression and spleen-insufficiency type chronic hepatitis B.
9. purposes according to claim 7, is characterized in that: described medicine is the medicine for the treatment of slight or moderate chronic hepatitis B.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201210253430.5A CN102727633B (en) | 2012-07-20 | 2012-07-20 | Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof |
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| CN201210253430.5A CN102727633B (en) | 2012-07-20 | 2012-07-20 | Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof |
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| CN102727633A CN102727633A (en) | 2012-10-17 |
| CN102727633B true CN102727633B (en) | 2014-03-19 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106267019B (en) * | 2016-09-29 | 2019-12-06 | 成都中医药大学 | Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof |
| CN108379513A (en) * | 2018-05-10 | 2018-08-10 | 朱琳 | It is a kind of to be used to treat composition of hepatitis B and preparation method thereof |
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| CN1593601A (en) * | 2004-07-12 | 2005-03-16 | 张成军 | Chinese medicinal composition for cholecystitis and preparing method thereof |
| CN1879781A (en) * | 2005-08-16 | 2006-12-20 | 何慕周 | A Chinese medicine for treating liver disease |
| CN1965979A (en) * | 2006-11-14 | 2007-05-23 | 燕晓冬 | Medicament for treating hepatitis B |
| CN101357219A (en) * | 2008-09-04 | 2009-02-04 | 兰州佛慈制药股份有限公司 | Medicine for treating chronic hepatitis b |
| CN101979072A (en) * | 2010-10-08 | 2011-02-23 | 彭世红 | Chinese medicament for treating chronic liver disease |
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2012
- 2012-07-20 CN CN201210253430.5A patent/CN102727633B/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1593601A (en) * | 2004-07-12 | 2005-03-16 | 张成军 | Chinese medicinal composition for cholecystitis and preparing method thereof |
| CN1879781A (en) * | 2005-08-16 | 2006-12-20 | 何慕周 | A Chinese medicine for treating liver disease |
| CN1965979A (en) * | 2006-11-14 | 2007-05-23 | 燕晓冬 | Medicament for treating hepatitis B |
| CN101357219A (en) * | 2008-09-04 | 2009-02-04 | 兰州佛慈制药股份有限公司 | Medicine for treating chronic hepatitis b |
| CN101979072A (en) * | 2010-10-08 | 2011-02-23 | 彭世红 | Chinese medicament for treating chronic liver disease |
Non-Patent Citations (11)
| Title |
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| .慢性乙型肝炎中医药治疗现状.《辽宁中医药大学学报》.2011,第13卷(第10期), * |
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| 何彬毓 * |
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| 吴疆 * |
| 周显华 * |
| 张传涛 * |
| 温国军 * |
| 王政 * |
| 范昕建 * |
| 陈岚 * |
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