CN1069542C - Medicine for treating chronic hepatism and its preparing process - Google Patents
Medicine for treating chronic hepatism and its preparing process Download PDFInfo
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- CN1069542C CN1069542C CN99113887A CN99113887A CN1069542C CN 1069542 C CN1069542 C CN 1069542C CN 99113887 A CN99113887 A CN 99113887A CN 99113887 A CN99113887 A CN 99113887A CN 1069542 C CN1069542 C CN 1069542C
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Abstract
The present invention relates to a medicine for treating chronic hepatopathy and a preparation method thereof. The medicine is prepared into a medicine preparation with the raw materials of peach seed, red sage root, fiveleaf gynostemma herb, fermented Chinese caterpillar fungus powder, pine pollen, schisandra fruit and an amount of starch. The medicine has good effect on relieving the clinical symptoms of patients with chronic hepatitis B, inhibiting and reversing hepatic fibrosis progression and the comprehensive therapy of posthepatitic cirrhosis. The medicine has great significance and application value for the prevention and the reversion of hepatic fibrosis progression, the inhibition or the postponement of the formation of hepatic cirrhosis and the therapy of hepatic cirrhosis.
Description
The present invention relates to a kind of medicine for the treatment of chronic hepatopathy.Be to be Chinese patent medicine of feedstock production and preparation method thereof with the Chinese herbal medicine specifically.
China chronic HBV infection person accounts for 10% of total population, and wherein chronic hepatitis B patient has 1.5 thousand ten thousand people approximately, has the chronic hepatitis patient more than 30% to develop into liver cirrhosis, and mostly is middle age.Promptly for the HbsAg carrier of China, die from hepatopathy and (be mainly liver cirrhosis and hepatocarcinoma, the latter more than 60% by liver cirrhosis development) the risk male be 50%, the women is 14%, wherein the formation of hepatic fibrosis and development are to influence its prognosis, one of crucial pathological change that lapses to also is the most thorny knotty problem in the clinical chronic hepatopathy treatment.And up to now, many, generally acknowledged especially mostly curative effects are arranged though be used for the treatment of this sick medicament categories both at home and abroad, treat the back state of an illness easily repeatedly, and cost an arm and a leg.
The object of the present invention is to provide a kind of have clinical symptoms, inhibition and the reverse hepatic fibrosis progress of improving chronic hepatitis B patient and the chronic hepatopathy treatment capsule preparations that the posthepatitic cirrhosis Comprehensive Treatment is played good action and preparation method thereof.
The present invention is on China's theory of Chinese medical science and clinical practice basis, " blood stasis ", " weakened body resistance " pathogenesis in conjunction with chronic hepatopathy, hepatic fibrosis and Chinese medicine have the common recognition that is closely connected, adopt the supporting vital QI and dispersing blood stasis Therapeutic Principle, get Radix Salviae Miltiorrhizae (Rhizoma Curcumae, rhizoma sparganic) blood circulation promoting and blood stasis dispelling, get Cordyceps mycelium (Radix Astragali, Radix Ginseng, Rhizoma Polygonati) and set upright tonify deficiency, get Semen Persicae and help the Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, get loose Huang and help Cordyceps to set upright tonify deficiency.
The present invention adopts the quality of pharmaceutical raw material medicine (medical material) to meet the Chinese Pharmacopoeia pertinent regulations.
1. Semen Persicae
This product is the dry mature seed of rosaceous plant [Prunus Persica (L.) Batsch] or mountain peach [Prunusdavidiana (Carr.) Franch].The main place of production: Sichuan, Yunnan, Shaanxi, Shandong.
2. fermented Cordyceps powder
This strain is produced Cordyceps one peacilomyce hepiahi element [Paccilomyces hepiali Chen] C separating obtained the fresh Cordyceps [Cordyceps Sinensis (Berk Sacc)] from Qinghai
s-4 through the submerged fermentation cultivation, and the tunning filtration drying is made, and being produced by Jiangxi Traditional Chinese Medicine Factory provides.
3. Radix Salviae Miltiorrhizae
This product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae [Salvia miltiorrhiza Bge.].The main place of production: Anhui, Shandong, Hebei.
4. Fructus Schisandrae Chinensis
This product is the dry mature fruit of Magnoliacea plant [Scnisandra chinensis (Turcz.) Baill] or schisandra chinensis [Schisandra Sphenanthera Rehd.et Wits].The main place of production: Liaoning, Jilin, Heilungkiang, Hebei, Sichuan, Hubei, Shaanxi, Shanxi, Yunnan.
5. Herb Gynostemmae Pentaphylli
This product is the dry aerial parts of cucurbitaceous plant [Gynostemma Pentaphyllam (Thunb) mak.].The main place of production: Zhejiang, Guangxi.
6. Pollen Pini (pine yellow)
This product is the dry pollen that pinaceae plant Pinus massoniana Lamb [Pinus massoniana Lamb.] Pinus tabuliformis [Pinustabulaeformis Carr] belongs to several plants together.The main place of production: Zhejiang, Jiangsu.
Medicament capsule preparation of the present invention is made (consumption is a weight portion, and per 1000 capsules include) by following component
Semen Persicae 50-250 Radix Salviae Miltiorrhizae 300-700 Herb Gynostemmae Pentaphylli 200-600 fermented Cordyceps powder 150-450 Pollen Pini 50-250 Fructus Schisandrae Chinensis 50-250
Starch is an amount of
Formula optimization weight (part) ratio range of preparation medicine of the present invention is:
Semen Persicae 100-200 Radix Salviae Miltiorrhizae 500-600 Herb Gynostemmae Pentaphylli 300-500 fermented Cordyceps powder 200-300 Pollen Pini 100-200 Fructus Schisandrae Chinensis 100-200
Starch is an amount of
The optimum weight of medicine of the present invention (part) proportioning is:
Semen Persicae 130 Radix Salviae Miltiorrhizaes 530 Herb Gynostemmae Pentaphyllis 400 fermented Cordyceps powder 260 Pollen Pinis 130 Fructus Schisandrae Chinensis 130
Starch is an amount of.
The production method that above-mentioned each component is made medicament capsule preparation of the present invention is:
Take by weighing Radix Salviae Miltiorrhizae, Semen Persicae, Herb Gynostemmae Pentaphylli and decoct with water, collecting decoction is got supernatant, is condensed into extractum, and cooling adds ethanol, and precipitation filters; Other takes by weighing fermented Cordyceps powder, and Fructus Schisandrae Chinensis adds alcohol heat reflux, and cooling merges ethanol liquid, filters the filtrate concentrate drying; Other takes by weighing Pollen Pini and adds the ethanol warm macerating, merges leachate, and concentrate drying becomes dried cream, gets above-mentioned three kinds of dried cream, mixes and pulverizes, and it is an amount of to add starch, mixing, and the fill capsule, promptly.
Quality standard of the present invention is as follows:
Character: this product content is a chocolate brown powder.
Differentiate: fermented Cordyceps powder, Radix Salviae Miltiorrhizae, with thin layer chromatography (57 pages of appendix of Chinese Pharmacopoeia nineteen ninety version).
Check: meet relevant every regulation (the 16th page of appendix of Chinese Pharmacopoeia nineteen ninety version) under the capsule item.
Specification: every heavy 0.3 gram.
The present invention shows through animal test results: can prevent CCl effectively
4The formation of inductive rat liver fibrosis can significantly promote respectively by CCl again
4Reverse with the inductive rat liver fibrosis of N-nitrosodimethylamine; With colchicine, Radix Et Rhizoma Rhei worm ball relatively, no matter be to suppress Fibrotic progress, still promote Fibrotic reverse, or protection, recover the liver function aspect all have than remarkable advantages; To CCl
4The rat acute hepatic injury has good antagonism, not only can significantly reduce serum ALT activities, and the serum AST activity that increases is also had significant inhibition effect, significantly is better than the positive control drug bifendate; Active sharply rising of rat blood serum AST that D-galactosamine is caused has significant inhibition effect; To diethylnitrosamine bring out rat liver cancer precancer the liver cell proliferation kitchen range and index of correlation remarkable inhibitory action is arranged, to luring cancer 24 week back canceration degree certain resistance inhibitor action is arranged also.
Table 1 is respectively organized the variation (X ± SD) of hepatic tissue albumen, Hyp content for rat
Annotate: compare * * P＜0.01 with model control group; * * P＜0.001
| Group | n | Orgotein (mg/g liver) | Liver Hyp (mg/g albumen) |
| Of the present invention group of normal control group model matched group colchicine group | 8 12 12 9 | 242.8±32.1** 182.6±46.2 240.7±22.6*** 243.2±26.7*** | 0.46±0.16*** 1.28±0.42 0.57±0.18*** 0.59±0.07*** |
Table 2 is the variation of the time respectively organizing the positive kitchen range of CGT in the liver tissues of rats in 14 weeks and 24 weeks (X ± SD)
| Group n | Average diameter (mm) | Average area mm 2/) | Average external volume (mm 3/) | Area density (mm 2/cm 2) | Bulk density (mm 3/cm 3) |
| 14 all 24 all 11 of the present invention groups 14 11 24 weeks 13 of week of 11 matched groups of model | 0.36±0.08 1.10±0.58 0.26±0.04** 0.37±0.11*** | 0.14±0.07 2.48±3.09 0.07±0.02** 0.32±0.43* | 0.007±0.006 0.352±0.340 0.002±0.001* 0.014±0.008* | 19.63±18.71 83.24±17.56 3.47±1.88** 22.48±13.28*** | 24.14±28.51 417.75±320.60 2.52±1.74* 61.48±100.10 |
Annotate: with the model group comparison same period, * P＜0.05; * P＜0.01; * * P＜0.001
Table 3 is CCl
4Rat model is respectively organized pathology hepatic tissue Hyp, MDA content and S0D activity change (X ± SD)
Annotate: compare * P＜0.05, * * P＜0.01 with model control group; * * P＜0.001.Of the present invention group of SOD activity is in the normal group level.
| Group n | Steatosis | Collagen fiber | MDA (nM/g liver) | S0D (NU/1% liver homogenate) |
| 11 of the present invention groups 12 of model group 12 colchicine groups | 2.58±0.79 1.64±0.67** 1.60±0.70** | 2.42±0.90 1.55±0.93* 1.40±0.70*** | 329.2±67.9 312.6±109.6 273.8±48.2* | 837.6±209.2 917.0±208.3 1105.8±142.0** |
Extract powder of the present invention carries out the oral medication test in duck hepatitis B virus infection duck body, 3 batches of experiments were all infected with 75 intravenous injection DHBs of Beijing 1 age in days duckling in 7 days.The oral 100mg/kg of positive drug acyclovir 1 day 2 times, had highly significant to suppress (P＜0.01) in 3 days after 10 days and the drug withdrawal significant curative effect has been described.The each 1.36g/kg of the pure extract powder of effective dose, a twice-daily.
Table 4 is that drug oral of the present invention is to duck hepatitis-B infected duck serum-virus DNA suppression ratio
Annotate: drug treatment group different time DHBV-DNA suppression ratio of identical with the virus control group respectively time of suppression ratio is * P＜0.05 relatively; * P＜0.01
| The medicine name | Dosage (g/kg) | The experiment lot number | Duck number (only) | The clear DHBV-DNA suppression ratio of Sanguis Anas domestica % | ||
| T 5 | T 10 | P 3 | ||||
| Extract powder of the present invention | Thick pure 2.0 1.36 Bid * 10po. | Ⅰ Ⅱ Ⅲ | 6 6 6 | 50.01** 42.97* 42.68* | 71.97** 47.77* 53.00** | 27.71 36.67 30.94 |
| Acycloguanosine | 0.1g/kg Bid×10po. | Ⅲ | 6 | 17.01 | 60.72** | 30.70 |
Through being that the treatment that 95 routine patients of chronic hepatitis B carry out is observed to clinical diagnosis, with traditional Radix Et Rhizoma Rhei worm ball in contrast with supporting vital QI and dispersing blood stasis effect, observe the present invention to the hepatic tissue pathology morphological change and to fibrosis serological index-S-MAO activity, the metalloprotease tissue inhibitive factor, type, hyaluronic acid, the influence of laminin content and twenty-four-hour urine hydroxyproline output, the result proves that medicine of the present invention reaches 58.3% to the fibrosis reversion rate on the liver histological, and reduce serum ALT activities and the serum total bilirubin content that significantly increases effectively, improve serum albumin levels and white/globulin ratio; 6 fibrosis serological index all have improvement in various degree, and wherein the drop-out value of serum MAO activity and LN content is significantly greater than matched group, and the excretion of treatment back urine Hyp significantly increases before the treatment simultaneously.Show that medicine of the present invention not only can promote the liver function recovery of chronic hepatitis B patient effectively, its all index of fibrosis serology that significantly increase is presented the tangible effect of improving, its resultant effect obviously is better than Radix Et Rhizoma Rhei worm ball.
It is synthetic hyperfunction unusually that medicine of the present invention both can suppress the interior connective tissue of chronic hepatitis B liver, can promote the catabolism of connective tissue in the liver again, to stoping, reverse the progress of hepatic fibrosis, suppress or delay the formation of liver cirrhosis and the treatment of liver cirrhosis has great importance and using value.Variation before and after relevant fibrosis serological index of table 5 chronic hepatitis patient and the treatment (X ± SD)
Annotate: compare △ P＜0.001, △ △ P＜0.01 with the normal person; With * P＜0.05 of making comparisons before the treatment, * * P＜0.01, * * * P＜0.001; With difference comparison ▲ P＜0.05 before and after the treatment of control group; Interior is case load.
| Project | The normal person | Chb | Observation group | Matched group | ||||
| Before the treatment | After the treatment | After controlling preceding-Zhi | Before the treatment | After the treatment | After controlling preceding-Zhi | |||
| MAO(u) | 28±13 (20) | 63±29△ (37) | 64±30 | 28±16** | 36±27▲ (30) | 60±30 | 47±33 | 13±14 (7) |
| TIMP | 164±20 (60) | 192±39△△ (42) | 184±58 | 153±54** | 31±44▲ (24) | 204±59 | 39±39*** | 65±47 (18) |
| P-Ⅲ-P | 0.31±0.12 (15) | 1.41±2.19△ (34) | 1.81±3.90 | 0.80±1.69* | 1.01±2.08 (20) | 1.57±1.46 | 1.71±3.14 | -0.14±2.51 (14) |
| Ⅳ-C | 99±23 (60) | 494±300△ (46) | 547±345 | 386±212** | 161±262 (29) | 404±179 | 333±150* | 72±121 (17) |
| HA | 38±36 (60) | 371±295△ (61) | 377±293 | 208±85*** | 167±199 (44) | 356±313 | 220±218* | 136±251 (17) |
| LN (ng/ml) | 234±69 (60) | 373±71△ (61) | 369±73 | 210±241*** | 161±116▲ (42) | 382±68 | 282±103*** | 99±92 (18) |
| Urine Hyp (mg/24h) | 33.7±21.9 (18) | 21.4±8.4△△ | 21.6±8.9 | 24.5±7.8* | 3.2±7.5 (29) | 20.7±7.3 | 22.6±5.6 | 2.0±6.5 (11) |
Drug therapy posthepatitic cirrhosis of the present invention is studied observation through 80 routine patients and is shown: 1. significantly improves patients serum's albumin, reduces gamma globulin content.2. adjust the unusual of patient's blood plasma branched-chain amino acid/aromatic amino acid ratio.3. reduce serum LM and HA content that the patient increases significantly.4. improve CD
3 +, CD
4 +, CD
4 +/ CD
8 +Ratio, NK cytoactive and complement C
3Content, reduction is serum IgG and the IgM content that significantly increases.ANOMALOUS VARIATIONS that simultaneously can also the endocrine regulation hormone.Posthepatitic cirrhosis is had good combined therapy effect, aspect the generation of prevention hepatic encephalopathy certain practical significance is being arranged also.Treatment back BCAA/AAA (1.676 ± 0.324) is preceding (1.410 ± 0.385) rebound significantly of treatment; Matched group (1.278 ± 0.506) treatment preceding (1.620 ± 0.443) descends; 6 examples rise in observation group's 7 examples, and 1 example is slight to descend; Matched group is that 1 example rises, and 1 example is constant, and 5 examples descend.With difference before and after the treatment relatively, there were significant differences (P＜0.05) between two groups.
Table 6 is the variation (X ± S) of hormone metabolisms before and after two groups of patient treatments
Annotate: compare * P＜0.05, * * P＜0.001 with the normal person; Relatively preceding with treatment, △ P＜0.05; In () is case load.
| Project | The normal person | Liver cirrhosis patient | Observation group's matched group | |||
| Before the treatment | After the treatment | Before the treatment | After the treatment | |||
| T (pmol/L) E2/T urinates 17-KS (mg/24h) | 180±58 (28) 0.80±0.25 (28) 9.24±2.08 (12) | 130±55** (40) 1.50±1.02** (40) 5.68±2.72* (40) | 133±61 (12) 1.44±1.11 (12) 5.48±2.99 (16) | 188±78△ (12) 0.89±1.08△ (12) 7.56±4.79 (16) | 12 7±58** (10) 1.43±0.97** (10) 6.01±2.57* (12) | 113±54 (10) 1.65±1.04 (10) 4.91±0.53 (12) |
Table 7 is to change serum HA before and after two groups of patient treatments, LM content and urine Hyp output comparison (X ± S)
Annotate: compare * P＜0.001 with the normal person; Relatively preceding with treatment, △ P＜0.05; In () is case load
| The observation project | The normal person | Observation group's matched group | |||
| Before the treatment | After the treatment | Before the treatment | After the treatment | ||
| HA (μ g/L) LM (ng/L) urinates Hyp (mg/24h) | 30±48 (30) 354±193 (37) 33.7±21.9 (18) | 570±273* (19) 504±163* (13) 25.3±14.7 (16) | 490±224△ (19) 429±113△ (13) 27.1±19.8 (16) | 648±348* (18) 538±149* (15) 31.1±9.6 (13) | 712±316 (18) 547±158 (15) 31.9±13.5 (13) |
Embodiment:
Take by weighing raw material (gram) by following proportioning
Semen Persicae 140 Radix Salviae Miltiorrhizaes 550 Herb Gynostemmae Pentaphyllis 450 fermented Cordyceps powder 230 Pollen Pinis 150 Fructus Schisandrae Chinensis 150 starch are an amount of
Preparation as follows:
The Radix Salviae Miltiorrhizae, Semen Persicae, the Herb Gynostemmae Pentaphylli that take by weighing are decocted with water, and collecting decoction leaves standstill 24hr, gets supernatant, is condensed into extractum, and cooling adds ethanol, and precipitation filters; Other takes by weighing fermented Cordyceps powder, and Fructus Schisandrae Chinensis adds alcohol heat reflux, and cooling merges ethanol liquid, filters the filtrate concentrate drying; Other takes by weighing Pollen Pini and adds the ethanol warm macerating, merges leachate, and concentrate drying becomes dried cream, gets above-mentioned three kinds of dried cream, mixes and pulverizes, and it is an amount of to add starch, mixing, and the fill capsule, promptly.
Claims (5)
1. medicine that is used for the treatment of chronic hepatopathy is characterized in that adopting the following weight proportion raw material to make medicament:
Semen Persicae 50-250 Radix Salviae Miltiorrhizae 300-700 Herb Gynostemmae Pentaphylli 200-600 fermented Cordyceps powder 150-450 Pollen Pini 50-250 Fructus Schisandrae Chinensis 50-250
Starch is an amount of
2. by the described medicine that is used for the treatment of chronic hepatopathy of claim 1, it is characterized in that wherein the weight proportion of each raw material is:
Semen Persicae 100-200 Radix Salviae Miltiorrhizae 500-600 Herb Gynostemmae Pentaphylli 300-500 fermented Cordyceps powder 200-300 Pollen Pini 100-200 Fructus Schisandrae Chinensis 100-200
Starch is an amount of
3. by the described medicine that is used for the treatment of chronic hepatopathy of claim 1, it is characterized in that wherein the weight proportion of each raw material is:
Semen Persicae 130 Radix Salviae Miltiorrhizaes 530 Herb Gynostemmae Pentaphyllis 400 fermented Cordyceps powder 260 Pollen Pinis 130 Fructus Schisandrae Chinensis 130
Starch is an amount of.
4. by claim 1, the 2 or 3 described medicines that are used for the treatment of chronic hepatopathy, it is characterized in that described medicament is a capsule.
5. by the described preparation method that is used for the treatment of the medicine of chronic hepatopathy of claim 4, it is characterized in that production method is: the Radix Salviae Miltiorrhizae that will take by weighing by weight ratio, Semen Persicae, Herb Gynostemmae Pentaphylli decoct with water, collecting decoction, get supernatant, be condensed into extractum, cooling, add ethanol, precipitation filters; Other takes by weighing fermented Cordyceps powder, and Fructus Schisandrae Chinensis adds alcohol heat reflux, and cooling merges ethanol liquid, filters the filtrate concentrate drying; Other takes by weighing Pollen Pini and adds the ethanol warm macerating, merges leachate, and concentrate drying becomes dried cream, gets above-mentioned three kinds of dried cream, mixes and pulverizes, and it is an amount of to add starch, mixing, and the fill capsule, promptly.
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| CN1127917C (en) * | 2000-10-09 | 2003-11-19 | 北京长寿保健品有限公司 | Nutrient health-care food with function of slowdown senility |
| CN100394946C (en) * | 2004-12-17 | 2008-06-18 | 上海中医药大学 | Traditional Chinese medicine formulation for improving pulmonary fibrosis |
| CN1839996A (en) * | 2006-01-12 | 2006-10-04 | 上海现代中医药技术发展有限公司 | Chinese traditional medicine compound preparation for treating chronic hepatiosis and preparation method thereof |
| CN1899415B (en) * | 2006-01-12 | 2010-05-12 | 上海现代中医药技术发展有限公司 | Chinese medicine compound preparation for treating chronic hepatic disease and its preparing method |
| JP2008201749A (en) * | 2007-02-21 | 2008-09-04 | Okayama Univ | Inducer of hepatocyte growth factor production and pharmaceutical composition thereof |
| CN101078712A (en) | 2007-04-27 | 2007-11-28 | 上海现代中医药技术发展有限公司 | Method for determining plasma tanshinol and salvianolic acid B for strengthening body resistance and eliminating stasis |
| CN101042380A (en) | 2007-04-27 | 2007-09-26 | 上海现代中医药技术发展有限公司 | Method for measuring strengthen the body resistance and absorbing clots plant medicine plasma gamma-schizandrin |
| CN101334386B (en) | 2007-04-27 | 2012-07-11 | 上海现代中医药股份有限公司 | Determination method for plant medicine blood plasma amygdalin for strengthening the body resistance |
| CN101045092A (en) * | 2007-04-29 | 2007-10-03 | 上海现代中医药技术发展有限公司 | Application of plant medicine composition for strengthening the body resistance and resolving stagnate |
| CN103550547B (en) * | 2013-10-25 | 2015-06-10 | 孙振玲 | Traditional Chinese medicine for treating posthepatitic syndrome |
| CN109248229B (en) * | 2018-10-16 | 2021-12-24 | 大连润生康泰医学检验实验室有限公司 | Pharmaceutical composition for preventing and treating immunological liver injury and drug-induced liver injury, and preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1056423A (en) * | 1990-05-11 | 1991-11-27 | 陈江辉 | Qingganbao oral liquid compounding method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1056423A (en) * | 1990-05-11 | 1991-11-27 | 陈江辉 | Qingganbao oral liquid compounding method |
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