CN104000927A - Medicine composition for treating hepatic encephalopathy and hepatitis B - Google Patents
Medicine composition for treating hepatic encephalopathy and hepatitis B Download PDFInfo
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Abstract
The invention provides a more effective pure traditional Chinese medicine composition for treating hepatic encephalopathy and hepatitis B and belongs to the field of Chinese medicinal formulae. The medicine composition comprises raw materials, by weight, 5 to 50 parts of rheum officinale, 10 to 60 parts of roxburgh rose roots, 5 to 30 parts of black beans, 20 to 90 parts of serissa japonica, 20 to 100 parts of salvia prionitis hance, 30 to 15 parts of siphonostegia chinensis, 5 to 40 parts of pubescent holly roots, 10 to 60 parts of liquorice. The medicine composition mainly accords with pathogenesis and symptomatic treatment, the effects of clearing away heat and toxic materials, promoting diuresis, cooling the blood, removing stasis, stopping bleeding, removing heat and facilitating excrement excretion are achieved, so that the functions of resisting viruses, cooling the blood, stopping bleeding, reducing blood ammonia, facilitating excrement excretion, reducing toxin absorption in the intestines, protecting the livers and the brain and preventing and treating hepatic encephalopathy and hepatitis B are achieved.
Description
Technical field
The present invention relates to a kind of pure Traditional Chinese medicine composition, be specifically related to a kind of pure Traditional Chinese medicine composition for the treatment of hepatic encephalopathy and hepatitis B, belong to Chinese medicinal formulae field.
Background technology
Hepatitis B (full name: hepatitis B) be a kind of worldwide disease being caused by hepatitis B virus (HBV).Developing country's sickness rate is higher, and according to statistics, whole world Chronic asymptomatic carrier (HBsAg carrier) surpasses 2.8 hundred million, and China accounts for 1.3 hundred million.Most asymptomatic, wherein 1/3 clinical manifestation that occurs hepatic injury.There is hepatitis B patient 3,000 ten thousand in China at present.Hepatitis B obstinate also can cause the pathological change of patient's liver, causes hepatocellular degeneration, necrosis, inflammatory cell infiltration, liver cell regeneration, proliferation of fibrous tissue etc.
Hepatic encephalopathy (Hepatic encephalopathy, HE) be the central nervous system function imbalance syndrome that metabolism disorder is principal character of take due to serious liver failure, its pathogenesis is complicated and multifactorial, relate to many kinds of substance Developmental and Metabolic Disorder, wherein ammonia in HE pathogenesis in Central Position.In about 80%HE patient's blood and cerebrospinal fluid, ammonia level raises clinically.When nearly all scholar finds serious liver failure, ammonia concentration is apparently higher than normal level.Based on blood ammonia, raise and play an important role in the pathogenesis of HE, cerebral edema, intracranial pressure rising, its primary treatment measure reduces blood ammonia exactly clinically at present.
The medicine for the treatment of clinically at present hepatitis B is more, and compound Chinese medicinal preparation and chemical medicine all have, and chemical medicine mainly be take interferon and ucleotides compound as main, all has long, the shortcoming such as cure rate is not high medicine time.The drug main for the treatment of hepatic encephalopathy will be take multiple chemical medicine and is used in conjunction with as main, use separately the medicine of a certain Traditional Chinese medicine historical preparation treatment hepatic encephalopathy few, have in patent documentation CN102008588B and disclose a kind of pure Traditional Chinese medicine composition for the treatment of hepatic encephalopathy and hepatitis B, this pharmaceutical composition comprises Radix Et Rhizoma Rhei, Radix Rosae Normalis, Semen sojae atricolor, Serissa foetida, Salvia cavaleriei, Herba Siphonostegiae, Radix Ilicis Pubescentis and Radix Glycyrrhizae totally eight taste medical materials.
Summary of the invention
The object of the present invention is to provide pure Traditional Chinese medicine composition of a kind of more efficiently treatment hepatic encephalopathy and hepatitis B and preparation method thereof, this pharmaceutical composition is compared with disclosed pharmaceutical composition in patent documentation CN102008588B, with more suitable and effective Chinese crude drug Arisaema balansae Engl. grass, substitute Salvia cavaleriei, the all medicines in full side match, purging FU-organs the turbid descending Zhi Qiben, and its mark is controlled in heat-clearing and toxic substances removing, dampness removing blood stasis dispelling, hemostasis, giving consideration to both the incidental and fundamental, in rushing down, there are receipts, attack heresy and just do not hinder, open and close and protect its gas.Thereby reach better antiviral, removing heat from blood, stop blooding, fall blood ammonia, rush down stool, reduce intestinal endotoxin absorption, hepatoprotective brain, prevent and treat the effect of hepatic encephalopathy and hepatitis B.
For achieving the above object, the concrete technical scheme that the present invention adopts is:
A pure Traditional Chinese medicine composition for more efficiently treatment hepatic encephalopathy and hepatitis B, is characterized in that the weight portion of raw material consists of:
5～50 parts of Radix Et Rhizoma Rhei, 10～60 parts of Radix Rosae Normaliss, 5～30 parts, Semen sojae atricolor, 20～90 parts of Serissa foetida, 20～100 parts of Arisaema balansae Engl. grasss, 30～150 parts of Herba Siphonostegiae, 5～40 parts of Radix Ilicis Pubescentiss, 10～60 parts, Radix Glycyrrhizae.Wherein, preferred weight portion consists of:
35 parts of Radix Et Rhizoma Rhei, 13 parts, Semen sojae atricolor, 85 parts of Arisaema balansae Engl. grasss, 53 parts of Radix Rosae Normaliss, 26 parts of Radix Ilicis Pubescentiss, 130 parts of Herba Siphonostegiae, 78 parts of Serissa foetida, 40 parts, Radix Glycyrrhizae.
Pharmaceutical composition of the present invention can be made by the conventional preparation technology on galenic pharmacy tablet, capsule, granule or the liquid preparation of pro ore, and the liquid preparation used of injection for intravenous or powder etc.
By pharmacodynamics test also described in proved patent of invention pharmaceutical composition than disclosed pharmaceutical composition in patent documentation CN102008588B more effective aspect treatment hepatic encephalopathy and hepatitis B diseases, existing pharmacological effect effect of the present invention and the technique effect that produces are described as follows:
1, pharmacodynamics test
1.1 material
animal1 age in days Guangxi sheldrake, is provided by herding seedling field, Guangxi.New zealand rabbit, body weight 2.0～2.5kg, male and female are not limit, and by Sichuan Province plant of laboratory animal special commission, are provided;
medicinetrial drug: embodiment 1(6g crude drug/ml), provided by Chengdu Lisite Pharmaceutical Co., Ltd..Control drug: reference examples 1(adopts prepare preferred weight part composition in patent documentation CN102008588B) (6g crude drug/ml), by Chengdu Lisite Pharmaceutical Co., Ltd., provided.5% glucose injection, Kelun Pharm Ind Co., Ltd., Sichuan.Facing the used time is all made into desired concn with distilled water;
instrument and reagentthe automatic microplate reader of Model 450 type (U.S. Bio-Rad company); Nick translation medicine box, Pu Luo Mai Ge company; Virus: DHB, DHB DNA (DHBV-DNA) strong positive serum, picks up from Shanghai sheldrake ,-70 ℃ of preservations.Blood ammonia reagent dry tablet (Johnson Co.'s auxiliary products); Procaine hydrochloride injection (Shandong Fang Ming Pharmaceutical limited company, specification: 40 mg2 ml
-1); Ammonium chloride, sodium bicarbonate, sodium chloride are analytical pure.
method
1.2.1 the therapeutical effect to duck hepatitis B virus infection
1.2.1.1 test method
Duck hepatitis B virus infection: get 1 age in days Beijing duck, clear through the positive Sanguis Anas domestica of lower limb shin intravenous injection Shanghai sheldrake DHBV-DNA, every 0.2mL, after infection, 7d gets blood, separation of serum ,-70 ℃ of preservations.To be checked.DHBV infects after duckling 7d, is divided at random 7 groups, and 10 every group, 2 times/d of oral administration, successive administration 8 weeks; The oral distilled water of virus control group; Trial drug group and control drug group are oral, two groups high dose group 115g (crude drug)/kg/d, middle dosage group 76g (crude drug)/kg/d, low dose group 38g (crude drug)/kg/d is set respectively, before after infecting, 7d is medication (T0), medication the 14th day (T5), after medication the 28th day (T10) and drug withdrawal the 14th day (P14), from duck lower limb shin venous blood sampling, separation of serum.-70 ℃ of preservations.To be checked.Sanguis Anas domestica to be checked is clear, and every batch with time point film, measure Sanguis Anas domestica clear in DHBV-DNA horizontal dynamic.Press nick translation test kit description method, use
32p labelling DHBV-DNA probe, and do the clear dot blot hybridization of Sanguis Anas domestica, autoradiography diaphragm speckle, measures OD value with enzyme mark detector.Using hybridization spot OD value as specimen DHBV-DNA level value.Calculate the suppression ratio of different time (T14, T28) and drug withdrawal 14d (P3) serum DHBV-DNA after every group of duck medication.
statistical method
With NDST software, carry out statistical procedures.Mean+SD for result (x ± s) expression, group difference is checked with t.
effect to Rabbit Liver encephalopathy (HIE) model
1.2.2.1 the foundation of model
(1) animal grouping64 new zealand rabbits are divided into 8 groups at random, i.e. blank group, model group, the high, medium and low dosage group of trial drug and the high, medium and low dosage group of control drug, 8 every group
;
(2) modelingconcrete steps: (1) will claim weight after each group rabbit fasting 6 h, and dorsal position is fixed on rabbit operating-table, cuts off near the hair of epigastrium median line, in upper abdomen 1% procaine local infiltration anesthesia for center.(2) from ensiform process of sternum along the capable otch that is about 6～8 cm of abdomen median line, open abdominal cavity, expose liver, to pressing down liver, cut off the falciform ligament between liver and diaphragm, then will on lobe of the liver, turn over, blunt separation hepatogastric ligament, makes lobe of the liver completely free, distinguishes each leaf of liver.With the root of bonnet cotton ligation left lateral lobe of liver, left middle lobe, right middle lobe and square leaf, the lobe of the liver of ligation becomes rapidly crineous, from ligation top, by leaf, wipes out (only leaving right outside leaf and caudate lobe).(3) along stomach pylorus, find duodenum downwards, propose abdominal cavity, with eye scissors, on intestinal wall, cut an osculum, thin catheter is inserted to enteric cavity approximately 4 cm, along intubate, make purse string suture around, shrink pocket ligation and fix, by intestinal tube Hui Na abdominal cavity, check that abdomen is interior without hemorrhage, close abdominal cavity.(4) in duodenal intubation, inject 2.5% compound recipe ammonium chloride solution (ammonium chloride 12.5 g and sodium bicarbonate 7.5 g are dissolved in 500 mL 5% glucose injections), every 5 min, in duodenal intubation, inject 2.5% compound recipe ammonium chloride solution 5 mL, cause ammonia in intestinal to generate increase absorbed into serum, cause that blood ammonia raises rapidly, until the symptom of the similar HE such as trembling appears in rabbit, whole body tic, opisthotonus is considered as modeling success.Record the total amount of compound recipe ammonium chloride solution used, and calculating the consumption of every 1kg weight, rabbit twitch incubation period (from being administered into the time that occurs that whole body is twitched), twitch persistent period, tic number of times and time-to-live (occur survive twitching time) respectively organized in record;
(3) administration and blood samplingafter the 2nd injection compound recipe ammonium chloride solution 5 min, by Rabbit central ear artery, get blood approximately 1 mL in order to measuring the blood ammonia levels before administration.Then distinguish oral administration, every day 2 times, successive administration 3d: the oral distilled water of blank group, trial drug group and control drug group be oral high dose group 115g (crude drug)/kg/d, middle dosage group 76g (crude drug)/kg/d, low dose group 38g (crude drug)/kg/d respectively.Administration is got blood 1mL in order to measuring blood ammonia levels through arteria auricularis after 3 days again;
(4) mensuration of blood ammoniaapplication VITROS 205 dry type biochemistry analyzer, with blood ammonia levels before detection of ALT with dry-chemical administration and after administration 3d;
(5) statistical analysisexperimental data represents by mean ± standard deviation, and result is carried out one factor analysis of variance with PEMS 3.1 softwares, relatively adopts between two SNK-q check (Student-Newman-Keuls method) between group between mean.
result
1.3.1 the therapeutical effect of this compositions to DHBresult shows: trial drug group and the high, medium and low dosage of control drug group are remarkable to the inhibition of infected duck serum DHBV-DNA level, be very significant (P<0.01) with model group comparing difference, each dosage group of trial drug each dosage group corresponding to control drug compared, difference has significant (P<0.05), the results are shown in Table 1:
The impact of each group of table 1 on the horizontal suppression ratio of the clear DHBV-DNA of duck hepatitis B virus infection Sanguis Anas domestica
Note: with model group comparison, * * P<0.01;
" trial drug group-high dose " compares with " control drug group-high dose ", #P<0.05;
" trial drug group-middle dosage " compares with " control drug group-middle dosage ", zero P<0.05;
" trial drug group-low dosage " compares with " control drug group-low dosage ", ◇ P<0.05;
1.3.2 the impact of this compositions on compound recipe ammonium chloride solution consumption, the incubation period of twitching, twitch persistent period and time-to-live
Result: with the comparison of blank group, all the other 6 groups of rabbit compound recipe ammonium chloride solution consumption increases, tic prolongation of latency, the persistent period shortening of twitching, prolonged survival period (all P < 0.05 or P < 0.01); Each dosage group of trial drug each dosage group corresponding to control drug compared, variant, the increase of trial drug group compound recipe ammonium chloride solution consumption, tic prolongation of latency, twitch persistent period shortening, prolonged survival period, and detailed results is in Table 2:
Table 2 is respectively organized rabbit compound recipe ammonium chloride solution consumption, twitch incubation period, tic persistent period and time-to-live comparison (x ± s, n=7)
Note: with blank group comparison: * P < 0.05, * * P < 0.01;
1.3.3 the forward and backward blood ammonia of administration changes
After administration 3d, blank group blood ammonia levels is without significant change, and model group blood ammonia levels, apparently higher than blank group, illustrates modeling success.Compare with model group, trial drug group and control drug group blood ammonia levels obviously reduce, and have utmost point significant difference (P < 0.01); Each dosage group of trial drug each dosage group corresponding to control drug compared blood ammonia levels and reduced variant; The results detailed in Table 3:
Blood ammonia before table 3 is respectively organized rabbit administration and after administration 3d changes (x ± s, n=7)
| Group | Blood ammonia levels/μ mol.L before modeling -1 | Blood ammonia levels/μ mol.L after administration -1 |
| Blank group | 81.58±18.67 | 82.17±16.06 |
| Model group | 80.15±17.68 | 252.43±46.12 |
| Control drug group-high dose | 79.55±19.07 | 97.66±21.45＊＊ |
| Control drug group-middle dosage | 82.15±19.88 | 109.48±23.86＊＊ |
| Control drug group-low dosage | 80.66±17.98 | 122.04±29.48＊＊ |
| Trial drug group-high dose | 81.04±19.33 | 94.32±22.65＊＊ |
| Trial drug group-middle dosage | 81.45±18.92 | 105.80±24.26＊＊ |
| Trial drug group-low dosage | 79.87±20.03 | 117.94±27.98＊＊ |
Note: with model group group comparison: * * P < 0.01;
1.3 conclusion
The above results shows, oral after medicine water extraction of the present invention, remarkable to the horizontal inhibition of the clear DHBV-DNA of hepatitis b virus infection Sanguis Anas domestica; The most of excision of Hepar Leporis seu Oryctolagi leaf is caused to acute hepatic failure the rapid elevation model of blood ammonia, can make blood ammonia reduce rapidly, and can extend the incubation period of twitching, shorten the tic time, extend the time-to-live.Explanation thus, medicine of the present invention has intestine toxic material clearing, falls blood ammonia, cooling blood and dissolving stasis, stop blooding, let out stool, reduce intestinal endotoxin, hepatoprotective brain, has the effect of the hepatitis B of preventing and treating, hepatic encephalopathy.And successful is better than disclosed pharmaceutical composition in patent documentation CN102008588B.
The specific embodiment
reference examples 1(adopting prepare preferred weight part composition in patent documentation CN102008588B)
Treat a pure Traditional Chinese medicine composition for hepatic encephalopathy and hepatitis B, it is characterized in that the weight portion of raw material consists of: 35 parts of Radix Et Rhizoma Rhei, 53 parts of Radix Rosae Normaliss, 13 parts, Semen sojae atricolor, 78 parts of Serissa foetida, 85 parts of Salvia cavalerieis, 130 parts of Herba Siphonostegiae, 26 parts of Radix Ilicis Pubescentiss, 40 parts, Radix Glycyrrhizae.
embodiment 1
Treat a pure Traditional Chinese medicine composition for hepatic encephalopathy and hepatitis B, it is characterized in that the weight portion of raw material consists of: 35 parts of Radix Et Rhizoma Rhei, 53 parts of Radix Rosae Normaliss, 13 parts, Semen sojae atricolor, 78 parts of Serissa foetida, 85 parts of Arisaema balansae Engl. grasss, 130 parts of Herba Siphonostegiae, 26 parts of Radix Ilicis Pubescentiss, 40 parts, Radix Glycyrrhizae.
embodiment 2
Treat a pure Traditional Chinese medicine composition for hepatic encephalopathy and hepatitis B, it is characterized in that the weight portion of raw material consists of: 20 parts of Radix Et Rhizoma Rhei, 10 parts of Radix Rosae Normaliss, 30 parts, Semen sojae atricolor, 50 parts of Serissa foetida, 80 parts of Arisaema balansae Engl. grasss, 100 parts of Herba Siphonostegiae, 40 parts of Radix Ilicis Pubescentiss, 10 parts, Radix Glycyrrhizae.
embodiment 3
Treat a pure Traditional Chinese medicine composition for hepatic encephalopathy and hepatitis B, it is characterized in that the weight portion of raw material consists of: 50 parts of Radix Et Rhizoma Rhei, 60 parts of Radix Rosae Normaliss, 20 parts, Semen sojae atricolor, 80 parts of Serissa foetida, 100 parts of Arisaema balansae Engl. grasss, 50 parts of Herba Siphonostegiae, 30 parts of Radix Ilicis Pubescentiss, 60 parts, Radix Glycyrrhizae.
embodiment 4
Treat a pure Traditional Chinese medicine composition for hepatic encephalopathy and hepatitis B, it is characterized in that the weight portion of raw material consists of: 5 parts of Radix Et Rhizoma Rhei, 30 parts of Radix Rosae Normaliss, 5 parts, Semen sojae atricolor, 20 parts of Serissa foetida, 20 parts of Arisaema balansae Engl. grasss, 30 parts of Herba Siphonostegiae, 20 parts of Radix Ilicis Pubescentiss, 40 parts, Radix Glycyrrhizae.
embodiment 5
Treat a pure Traditional Chinese medicine composition for hepatic encephalopathy and hepatitis B, it is characterized in that the weight portion of raw material consists of: 30 parts of Radix Et Rhizoma Rhei, 50 parts of Radix Rosae Normaliss, 10 parts, Semen sojae atricolor, 90 parts of Serissa foetida, 50 parts of Arisaema balansae Engl. grasss, 150 parts of Herba Siphonostegiae, 5 parts of Radix Ilicis Pubescentiss, 30 parts, Radix Glycyrrhizae.
Claims (3)
1. a pure Traditional Chinese medicine composition for more efficiently treatment hepatic encephalopathy and hepatitis B, is characterized in that the weight portion of raw material consists of:
5～50 parts of Radix Et Rhizoma Rhei, 10～60 parts of Radix Rosae Normaliss, 5～30 parts, Semen sojae atricolor, 20～90 parts of Serissa foetida, 20～100 parts of Arisaema balansae Engl. grasss, 30～150 parts of Herba Siphonostegiae, 5～40 parts of Radix Ilicis Pubescentiss, 10～60 parts, Radix Glycyrrhizae.
2. the pure Traditional Chinese medicine composition for the treatment of hepatic encephalopathy according to claim 1 and hepatitis B, is characterized in that the weight portion of raw material consists of:
35 parts of Radix Et Rhizoma Rhei, 13 parts, Semen sojae atricolor, 85 parts of Arisaema balansae Engl. grasss, 53 parts of Radix Rosae Normaliss, 26 parts of Radix Ilicis Pubescentiss, 130 parts of Herba Siphonostegiae, 78 parts of Serissa foetida, 40 parts, Radix Glycyrrhizae.
3. the pure Traditional Chinese medicine composition for the treatment of hepatic encephalopathy according to claim 1 and 2 and hepatitis B, is characterized in that this pharmaceutical composition makes tablet, capsule, granule or the liquid preparation of pro ore by the conventional preparation technology on galenic pharmacy
.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410276933.3A CN104000927B (en) | 2014-06-20 | 2014-06-20 | A kind of pharmaceutical composition for treating hepatic encephalopathy and hepatitis B |
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| CN201410276933.3A CN104000927B (en) | 2014-06-20 | 2014-06-20 | A kind of pharmaceutical composition for treating hepatic encephalopathy and hepatitis B |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109550020A (en) * | 2019-02-14 | 2019-04-02 | 任连智 | A kind of pharmaceutical preparation that treating hepatitis B big and small three Yang and preparation method |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008588A (en) * | 2010-12-16 | 2011-04-13 | 张蕊 | Medicine composition for curing hepatic encephalopathy and hepatitis B |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008588A (en) * | 2010-12-16 | 2011-04-13 | 张蕊 | Medicine composition for curing hepatic encephalopathy and hepatitis B |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109550020A (en) * | 2019-02-14 | 2019-04-02 | 任连智 | A kind of pharmaceutical preparation that treating hepatitis B big and small three Yang and preparation method |
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| CN104000927B (en) | 2018-04-27 |
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