CN1182616A - Medicine for curing viral hepatitis - Google Patents
Medicine for curing viral hepatitis Download PDFInfo
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- CN1182616A CN1182616A CN 97120174 CN97120174A CN1182616A CN 1182616 A CN1182616 A CN 1182616A CN 97120174 CN97120174 CN 97120174 CN 97120174 A CN97120174 A CN 97120174A CN 1182616 A CN1182616 A CN 1182616A
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Abstract
The present invention discloses a kind of composite medicine for curing viral hepatitis. It is composed of purple gromwell root, blackberrylily, rhizome, parasitic loranthus, root of large-flowered skullcap, garden burnet, selfheal, root tuber of aromatic turmeric, turmeric etc. 16 traditional Chinese medicinal herbs. The capsule preparation of said medicine can resist virus of hepatitis B, protect liver, reduce transaminase, abate jaundice and raise immunologic function of human body.
Description
The present invention relates to a kind of pharmaceutical composition for the treatment of hepatitis B and various viral hepatitis, also relate to medicament and production technology thereof with the said composition preparation, the raw material of medicine of the present invention is a vegetable Chinese herbal medicine, belongs to the field of Chinese medicines.
Hepatitis B is a kind of epidemic infectious diseases that China's sickness rate is the highest, propagation is the widest, harm is maximum.China's hepatitis B virus carriers surpasses 1.5 hundred million people.Existing hepatopath 1,200 ten thousand people in the whole nation.Annual about 300,000 because of the hepatopathy death toll, this has brought great loss for people ' s health and national economy.
Just present medical development situation, treatment hepatitis B and virus carrier thereof still do not have specific medicine and therapy.Even if by the antiviral drugs interferon of generally acknowledging both at home and abroad, because its expensive medicine valency can not be accepted by most patient, moreover its curative effect is also unsatisfactory.According to relevant scholar's report, this therapy effective percentage only is 43%.After the drug withdrawal, knock-on still can appear in cloudy commentaries on classics of e antigen and liver function.Although it is a lot of to be used for the treatment of the medicine of hepatitis at present, because different patients' state of an illness difference, these medicines can not satisfy the demand of all types hepatitis, and the uncertain therapeutic efficacy that has is cut, even bigger toxic and side effects occurs.Up to the present, still find no the product identical with medicine of the present invention.
The object of the invention provides a kind of broad-spectrum antiviral drugs, is used for the treatment of hepatitis B and various viral hepatitis.
The composing principle of pharmaceutical composition of the present invention is heat clearing and blood cooling, soothing liver-QI for relieving depression, invigorating the spleen and benefiting QI.Select medicine according to this rule of treatment prescription, suppress the effect of hepatitis B virus duplication with performance.The five internal organs should be with logical for suitable, and the medicine soothing liver-QI for relieving depression to guarantee the metabolism of liver and gall normal physiological, is discharged immune complex, to set upright gas, reaches enhancing human body immunity function, inducement interferon to treat the purpose of hepatitis B in conjunction with invigorating the spleen and benefiting QI.
The composition of pharmaceutical composition of the present invention is as follows by weight:
Radix Arnebiae (Radix Lithospermi) 15-30 part Rhizoma Belamcandae 15-20 part
Herba Taxilli 30-50 part Radix Scutellariae 12-20 part
Radix Sanguisorbae 15-20 part Spica Prunellae 20-30 part
Radix Gentianae 8-12 part Radix Curcumae 15-20 part
Rhizoma Curcumae Longae 10-15 part Radix Bupleuri 10-14 part
Fructus Chebulae 8-12 part Cortex Moutan 12-15 part
Semen Coicis 20-40 part Fructus Crataegi (parched to brown) 15-30 part
Radix Astragali 30-90 part Cortex Phellodendri 10-20 part
Aforementioned pharmaceutical compositions each component preferred weight ratio range is:
Radix Arnebiae (Radix Lithospermi) 10-15 part Rhizoma Belamcandae 10-15 part
Herba Taxilli 20-40 part Radix Scutellariae 10-15 part
Radix Sanguisorbae 10-15 part Spica Prunellae 10-20 part
Radix Gentianae 6-10 part Radix Curcumae 10-15 part
Rhizoma Curcumae Longae 8-12 part Radix Bupleuri 8-12 part
Fructus Chebulae 8-10 part Cortex Moutan 8-12 part
Semen Coicis 15-30 part Fructus Crataegi (parched to brown) 10-15 part
Radix Astragali 30-60 part Cortex Phellodendri 8-15 part
Aforementioned pharmaceutical compositions of the present invention, according to conventional pharmaceutical technology, can be prepared into any pharmaceutical dosage form that is suitable for clinical use, should contain the resultful medicine components of treatment in the middle of this medicament more, this is for the pharmacy personnel in this area, belong to general general knowledge, the preferred capsule formulation of medicine of the present invention.
The preparation technology of medicine capsule of the present invention is as follows:
1, forms selected Chinese medicinal material by above-mentioned batching, Semen Coicis parching to brown, Fructus Crataegi parching to brown are degree.
2, with Radix Curcumae, Rhizoma Curcumae Longae decoction pieces, collect volatile oil with steam distillation.
3, the medicinal residues of distillation back and all the other Chinese crude drugs merge, and decoction decocts twice routinely, adds water five times by the medicine total amount first, and decocting one hour is got decocting liquid, medicinal residues is added twice water again, decocts 30 minutes, discards medicinal residues, merges decocting liquid twice.
4, the medicinal liquid that merges is removed impurity after with the centrifugal settling method sedimentation.The most handy basket centrifuge or tripod pendulum type batch centrifugal carry out centrifugal.
5, the reuse filter press filters, and changes filter material, and continued operation with the clear filtrate that obtains, is condensed into extract powder at last.
6, extract powder is pulverized, volatile oil is evenly sprayed on extract powder, fully stir, granulate, encapsulated, every capsules powder charge 0.3 gram.
This operating procedure must be carried out in the room temperature subzero.
Medicine energy heat clearing and blood cooling of the present invention, dispersing the stagnated live-QI to relieve the stagnation of QI, invigorating the spleen and benefiting QI.Be used for hepatitis B virus carriers and acute or chronic hepatitis B, evident in efficacy, to take medicine four to six months, e antigen and HBV DNA negative conversion rate can reach 60-80%, and knock-on all appears in check after half a year to one year.Zoopery shows that medicine medication of the present invention has the effect of certain anti-DHB January in the duck body.The existing good function of resisting hepatitis B virus of medicine of the present invention can protect the liver, fall enzyme, jaundice eliminating and enhancing human body immunity function again.
The experimentation of the anti-DHB of experimental example medicine of the present invention
(1) materials and methods
One, animal model:
1 age in days duckling of the egg incubation that the Chongqing sheldrake of employing healthy adult produces is through abdominal cavity inoculation 0.1ml DHBVDNA positive-virus serum.After inoculating for 1 week, respectively external jugular vein blood drawing detects to filter out through dot blot hybridization and infects positive duck with the DHBV dna probe of digoxigenin labeled (labeling kit is purchased the company in German Boehringer Mannheim), raising to 1 monthly age as laboratory animal.
Two, experiment grouping and medication:
With DHBV DNA male 1 the monthly age 53 of ducks be divided into 5 groups at random:
1, virus control group: use normal saline, lumbar injection, dosage are 0.1ml//day.
2, positive drug matched group: use acyclovir (Qianjiang City, Hubei pharmaceutical factory produces, lot number 9605074) lumbar injection every day 1 time, dosage is 100mg/kg/ day.
3, medicament capsule small dose group of the present invention: dosage is 10g/kg/ day.
4, dosage group in the medicament capsule of the present invention: dosage is 20g/kg/ day.
5, the heavy dose of group of medicament capsule of the present invention: dosage is 30g/kg/ day.
Administering mode be early morning every day empty clothes gavage, the experimental drug time is January.
Three, observation index:
1, serum DHBV DNA changes situation: before medication, 2 weeks of medication, medication January, and the external jugular vein blood drawing respectively of 1 week of drug withdrawal, separation of serum is to be checked in-20 ℃ of preservations.Adopt spot hybridization, with digoxigenin-probe the serum before and after the medication is unified comparison and detection, with with the homologous plasmid DNA doubling dilution of probe after point sample on cellulose nitrate film, hybridize the spot colors that shows and be coated with shallow to be standard, relatively to come sxemiquantitative with the serum dot blot hybridization spot colors depth to be checked.
2,1 week was cutd open laboratory animal respectively extremely after drug withdrawal, respectively got the fritter hepatic tissue and was fixed in 10% formalin, made conventional H E dyeing pathologic finding.All the other liver ice tubes are transported laboratory back, and-70 ℃ of preservations for the total DNA that extracts duck liver, are made Southern Blot and detected, and analyze the effect of medicine to viral dna replication.
3, respectively organized medication January, draw blood respectively in 1 week of drug withdrawal detect Sanguis Anas domestica clear in the situation of change of glutamate pyruvate transaminase and glutamic oxaloacetic transaminase, GOT (ALT and AST).
The result
One, serum DBBV DNA titre changes situation before, during and after the medication:
Except that virus control group, capsule small dose group, the positive drug matched group, in the capsule, heavy dose of group medication January respectively with medication on the same group before relatively, all have DHBV DNA titre aggregate level to reduce acyclovir medication serum in January DBBV DNA titre wherein and extremely significantly meaning (P＜0.01) arranged statistically than the difference of serum DHBV DNA titre before the medicine on the same group; In, mass dosage capsule group medication January the difference than DNA titre before the medication on the same group significance meaning (P＜0.05) is arranged statistically; Heavy dose of group medication 2 all backs DNA titres preceding DNA titre of medication more on the same group also have significance difference (P＜0.05).But each medication group all has DHBV DNA rise phenomenon after 1 week of drug withdrawal.See Table 1.In addition, partly duck medication is arranged after serum DHBV DNA titre turn out cloudy, see Table 2 and subordinate list 1～5.
Serum DHBV DNA titre change situation before and after table 1 medication (X ± SH)
LogDHBV DNA (Pg/ul) ± SD group example number (only)
The heavy dose of group of dosage group 12 2.00 ± 1.05 2.00 ± 1.35 1.25 ± 1.36*, 1.33 ± 0.98 capsules 11 2.36 ± 1.12 1.82 ± 0.98* 1.55 ± 1.64* 2.18 ± 1.40 in medication 2 all medication drug withdrawal in January 1 all virus control groups 10 2.00 ± 1.25 2.20 ± 0.92 1.90 ± 0.74 1.90 ± 0.74 positive drug control group 10 1.80 ± 1.03 1.30 ± 1.25 1.00 ± 1.05**, 1.80 ± 1.62 capsule small dose group 10 2.00 ± 1.25 2.20 ± 1.23 2.30 ± 1.42 2.40 ± 0.97 capsules before the medication
Annotate: " * ": P＜0.05 " * * ": P＜0.01
Serum DHBV DNA titre change situation saw attached list 1～5 before and after each organized every duck medication, wherein " ++ ++ "; 10.000pg/ul; " +++": 1000pg/ul; " ++ ": 100pg/ul; "+": 10pg/ul; "-":＜1pg/ul; Last table logarithmic mean and the standard deviation of respectively organizing the DNA titre of classifying as, statistics adopts paired t-test.
2 weeks of table 2 medication, January and drug withdrawal 1 all serum DHBV DNA negative conversion rates
2 all 1 weeks of medication drug withdrawal in January of group medication
Virus control group 0.00 (0/10) 0.00 (0/10) 0.00 (0/10)
Positive drug control group 30.00 (3/10) 40.00 (4/10) 30.00 (3/10)
Capsule small dose group 0.00 (0/10) 10.00 (1/10) 0.00 (0/10)
The dosage group 8.33 (1/12) 25.00 (3/12) 16.70 (2/12) in the capsule
The heavy dose of group 0.00 (0/11) 36.36 (4/11) 18.18 (2/11) of capsule
Two, liver HE dyeing pathologic finding: each group all has vacuolar degeneration of hepatic cell, swelling in various degree, visible portal area of part and the scorching sick cellular infiltration of interlobular septum, each experimental group hepatic necrosis and hypertrophy phenomenon are seen in the end, these pathological manifestations medication groups and matched group no significant difference.
Three, hepatic tissue Southern Blot detects: in, DHBV DNA has generally than virus control group (normal saline group) and reduces in the mass dosage capsule medication hepatic tissue in January, but lax cyclic DNA (RC), covalently closed circular DNA (CCC DNA or SC DNA) reduce not obvious.
Four, medication January, drug withdrawal 1 all serum transaminases change situation:
Each experimental group glutamate pyruvate transaminase (ALT).Glutamic oxaloacetic transaminase, GOT (AST) value sees Table 3, and there was no significant difference on interior mutually for the moment ALT and the AST comparative statistics is arranged between each group.
Table 3 medication January, drug withdrawal 1 all Serum ALT AST change situation (enzyme activity unit X ± SD)
ALT AST group
The heavy dose of group 10.86 ± 3.98 17.82 ± 4.33 12.72 ± 2.87 22.80 ± 7.56 of dosage group 12.67 in medication drug withdrawal in January 1 all medication drug withdrawal in January 1 all virus control groups 12.33 ± 3.67 18.89 ± 3.18 10.00 ± 3.06 20.86 ± 6.91 positive drug control group 10.50 ± 3.34 19.09 ± 6.16 12.20 ± 1.99 22.89 ± 6.79 capsule small dose group 13.14 ± 4.60 24.60 ± 8.22 10.40 ± 3.10 28.33 ± 7.42 capsules ± 3.93 25.50 ± 7.63 12.67 ± 2.46 24.40 ± 5.95 capsules
In addition: we simultaneously control test 10 with the identical duck of each medication group normal not ALT, the AST of virus inoculation serum duck in age, be respectively ALT (28.00 ± 8.94,23.78 ± 6.59); AST (18.00 ± 5.29,19.00 ± 5.86).
, generally acknowledged by Chinese scholars with studying human hepatitis B pathogeny, virus replication for the hepatitis B animal model and screening effective medicine with the DHBV infected duck.1-3 age in days duckling infects DHBV and can keep long-term viremia and not have the tangible phenomenon of turning out cloudy naturally, therefore, we use 1 age in days duckling and set up the examination that the duck hepatitis-B animal model carries out medicine antivirus action of the present invention through the method for abdominal cavity infection DHBV, for the treatment hepatitis patient provides the preclinical study data.
Experimental result shows: with in dosage Drug therapy of the present invention January and heavy dose of 2 weeks of Drug therapy of the present invention, January serum DHBV DNA titre aggregate level is reduced, drug withdrawal 1 Zhou Houjun has DNA titre aggregate level rise phenomenon, illustrate that this medicine has certain antivirus action and relevant with dosage size, administration time length in vivo, also need prolong administration time if will reach the satisfied effect that suppresses virus long term.
Because the characteristics of duck hepatitis B animal model self.Promptly the interior duckling of 3 ages in days is because immune system is grown imperfection, after infecting DHBV, simple viral carrier state only appears, and the liver organization pathological changes is slight, the liver function Non Apparent Abnormality, we have experimental result to find that each experimental group ALT, AST do not have the difference on the statistics, though can not confirm medicine of the present invention the effect of improving liver function are arranged, and can illustrate that this medicine continuous use under these three kinds of dosage does not have tangible toxicity damage to hepatic tissue January.
Southern Blot checks prompting medication January, and medicine of the present invention has the effect of DBBV DNA in certain inhibition liver, but can not remove GCC DNA and RC DNA, and this also is the reason that serum DHBV DNA gos up after the drug withdrawal.
Embodiment
Radix Arnebiae (Radix Lithospermi) 10 gram Rhizoma Belamcandae 10 grams
Herba Taxilli 20 gram Radix Scutellariaes 10 grams
Radix Sanguisorbae 10 gram Spica Prunellaes 10 grams
Radix Gentianae 6 gram Radix Curcumaes 10 grams
Rhizoma Curcumae Longae 8 gram Radix Bupleuri 8 grams
Fructus Chebulae's 8 gram Cortex Moutans 8 grams
Semen Coicis 15 gram Fructus Crataegi (parched to brown)s 10 grams
The Radix Astragali 30 gram Cortex Phellodendris 8 grams
With Radix Curcumae, Rhizoma Curcumae Longae decoction pieces, collect volatile oil with steam distillation.Medicinal residues and all the other Chinese crude drugs of distillation back merge, and decocting method fries in shallow oil twice altogether routinely, adds water five times by the medicine total amount first, and decocting 1 hour is got steaming liquid.Medicinal residues were added the twice decocting 30 minutes again, discard medicinal residues, merge decocting liquid twice, impurity is removed in centrifugation.Plate-and-frame filtration is condensed into extract powder with filtrate, pulverizes, and volatile oil is evenly sprayed on extract powder, fully stirs, and granulates, and is encapsulated, and every capsules is adorned 0.3 gram medicated powder.
Claims (3)
1, a kind of pharmaceutical composition for the treatment of hepatitis is characterized in that it is made up of the component of following weight portion
Radix Arnebiae (Radix Lithospermi) 15-30 part Rhizoma Belamcandae 15-20 part
Herba Taxilli 30-50 part Radix Scutellariae 12-20 part
Radix Sanguisorbae 15-20 part Spica Prunellae 20-30 part
Radix Gentianae 8-12 part Radix Curcumae 15-20 part
Rhizoma Curcumae Longae 10-15 part Radix Bupleuri 10-14 part
Fructus Chebulae 8-12 part Cortex Moutan 12-15 part
Semen Coicis 20-40 part Fructus Crataegi (parched to brown) 15-30 part
Radix Astragali 30-90 part Cortex Phellodendri 10-20 part
2,, it is characterized in that the weight ratio of each component is according to the pharmaceutical composition of claim 1:
Radix Arnebiae (Radix Lithospermi) 10-15 part Rhizoma Belamcandae 10-15 part
Herba Taxilli 20-40 part Radix Scutellariae 10-15 part
Radix Sanguisorbae 10-15 part Spica Prunellae 10-20 part
Radix Gentianae 6-10 part Radix Curcumae 10-15 part
Rhizoma Curcumae Longae 8-12 part Radix Bupleuri 8-12 part
Fructus Chebulae 8-10 part Cortex Moutan 8-12 part
Semen Coicis 15-30 part Fructus Crataegi (parched to brown) 10-15 part
Radix Astragali 30-60 part Cortex Phellodendri 8-15 part
3, according to the method for the preparation of compositions capsule of claim 1 or 2, it is characterized in that this method comprises:
Earlier Radix Curcumae, Rhizoma Curcumae Longae are collected volatile oil with steam distillation, will distill back medicinal residues and all the other Chinese crude drugs then and merge, decoct with water twice, for the first time add water five times, fried in shallow oil 1 hour, add the water twice for the second time, fried in shallow oil 30 minutes, and merged decocting liquid twice, filter, remove impurity, clear liquor is condensed into dried cream, pulverizes, volatile oil is evenly sprayed on extract powder, fully stir, granulate.Encapsulated, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97120174A CN1051470C (en) | 1997-11-18 | 1997-11-18 | Medicine for curing viral hepatitis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97120174A CN1051470C (en) | 1997-11-18 | 1997-11-18 | Medicine for curing viral hepatitis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1182616A true CN1182616A (en) | 1998-05-27 |
| CN1051470C CN1051470C (en) | 2000-04-19 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN97120174A Expired - Fee Related CN1051470C (en) | 1997-11-18 | 1997-11-18 | Medicine for curing viral hepatitis |
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| Country | Link |
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| CN (1) | CN1051470C (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1679689B (en) * | 2005-02-02 | 2010-05-05 | 北京阜康仁生物制药科技有限公司 | Heat-clearing and toxicity-relieving Chinese medicine preparation and production thereof |
| CN103751577A (en) * | 2013-12-23 | 2014-04-30 | 孙丽 | Traditional Chinese medicine for treating liver phlegm stagnation type hepatopathy |
| CN106924339A (en) * | 2015-12-30 | 2017-07-07 | 姚萍 | It is a kind of to treat Chinese medicinal formulae of virus B hepatitis and preparation method thereof |
-
1997
- 1997-11-18 CN CN97120174A patent/CN1051470C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1679689B (en) * | 2005-02-02 | 2010-05-05 | 北京阜康仁生物制药科技有限公司 | Heat-clearing and toxicity-relieving Chinese medicine preparation and production thereof |
| CN103751577A (en) * | 2013-12-23 | 2014-04-30 | 孙丽 | Traditional Chinese medicine for treating liver phlegm stagnation type hepatopathy |
| CN106924339A (en) * | 2015-12-30 | 2017-07-07 | 姚萍 | It is a kind of to treat Chinese medicinal formulae of virus B hepatitis and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1051470C (en) | 2000-04-19 |
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