CN104000927B - A kind of pharmaceutical composition for treating hepatic encephalopathy and hepatitis B - Google Patents
A kind of pharmaceutical composition for treating hepatic encephalopathy and hepatitis B Download PDFInfo
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- CN104000927B CN104000927B CN201410276933.3A CN201410276933A CN104000927B CN 104000927 B CN104000927 B CN 104000927B CN 201410276933 A CN201410276933 A CN 201410276933A CN 104000927 B CN104000927 B CN 104000927B
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Abstract
The present invention provides a kind of more efficiently treatment hepatic encephalopathy and the pure Chinese medicine pharmaceutical composition of hepatitis B, the parts by weight composition of its raw material is:5~50 parts of rheum officinale, 10~60 parts of roxburgh rose root, 5~30 parts of black soya bean, 20~90 parts of serissa serissoide, 20~100 parts of sage, 30~150 parts of siphonstegia chinensis, 5~40 parts of ilex pubescens, 10~60 parts of radix glycyrrhizae, belong to Chinese medicinal formulae field.The present invention is based on the cause of disease and symptomatic treatment, by clearing heat and detoxicating, dampness removing, cooling blood and dissolving stasis, stop blooding, expel the heat-evil defaecation the effect of, so as to have the function that antiviral, cool blood, hemostasis, reduce blood ammonia, rush down stool, reduce intestinal endotoxin absorptions, protect liver brain, prevent hepatic encephalopathy and hepatitis B.
Description
Technical field
The present invention relates to a kind of pure Chinese medicine pharmaceutical composition, and in particular to a kind of pure Chinese medicine for treating hepatic encephalopathy and hepatitis B
Pharmaceutical composition, belongs to Chinese medicinal formulae field.
Background technology
Hepatitis B（Full name：Virus B hepatitis）It is by hepatitis type B virus（HBV）A kind of caused worldwide disease.Hair
National incidence is higher in exhibition, according to statistics, whole world Chronic asymptomatic carrier（HBsAg carrier）More than 2.8 hundred million,
China accounts for 1.3 hundred million.It is most asymptomatic, wherein 1/3 there is the clinical manifestation of hepatic lesion.There is hepatitis B patient 3000 in China at present
Ten thousand.Hepatitis B obstinate can also trigger the pathological change of patient's liver, cause degeneration of liver cells, necrosis, inflammatory cell infiltration, liver
Cytothesis, proliferation of fibrous tissue etc..
Hepatic encephalopathy（Hepatic encephalopathy, HE）It is with metabolic disorder caused by serious liver failure
For the central nervous system function imbalance syndrome of main feature, its pathogenesis is complicated and multifactor, is related to a variety of things
Matter metabolic disorder, wherein ammonia are in Central Position in HE pathogenesis.Clinically ammonia about in 80%HE patient's blood and cerebrospinal fluid
Level rise.When nearly all scholar has been found that serious liver failure, ammonia concentration is apparently higher than normal level.Based on blood ammonia
Rise plays an important role in HE, encephaledema, the elevated pathogenesis of intracranial pressure, clinically its primary treatment measure at present
Exactly reduce blood ammonia.
The medicine of clinical treatment hepatitis B is more at present, and compound Chinese medicinal preparation and chemical drug have, and chemical drug is mainly with interferon
Based on ucleotides compound, all there are the shortcomings of medication time is long, cure rate is not high.The medicine for treating hepatic encephalopathy is main
Based on being used cooperatively with a variety of chemical drugs, it is few to be used alone the medicine of a certain Traditional Chinese medicine historical preparation treatment hepatic encephalopathy, there is patent
A kind of pure Chinese medicine pharmaceutical composition for treating hepatic encephalopathy and hepatitis B, the pharmaceutical composition are disclosed in document CN102008588B
Include rheum officinale, roxburgh rose root, black soya bean, serissa serissoide, Salvia cavaleriei, siphonstegia chinensis, ilex pubescens and radix glycyrrhizae totally eight taste medicinal material.
The content of the invention
It is an object of the invention to provide the pure Chinese medicine drug regimen of a kind of more efficiently treatment hepatic encephalopathy and hepatitis B
Thing and preparation method thereof, the pharmaceutical composition is compared with the pharmaceutical composition disclosed in patent document CN102008588B, with more
Salvia cavaleriei is substituted for suitable and effective Chinese medicine sage, the complete all medicine phases in side are matched somebody with somebody, ventilation quality Zhi Qiben, clearing heat and detoxicating, sharp
Its mark is controlled in the humidifying stasis of blood, hemostasis, and giving consideration to both the incidental and fundamental, has receipts in rushing down, and is attacked heresy without hindering just, is opened and closed and protects its gas.So as to preferably reach
Antiviral, cool blood, hemostasis, reduce blood ammonia, rush down stool, reduce intestinal endotoxin absorptions, protect liver brain, prevent hepatic encephalopathy and hepatitis B
Effect.
For achieving the above object, the concrete technical scheme that uses of the present invention is：
A kind of pure Chinese medicine pharmaceutical composition of more efficiently treatment hepatic encephalopathy and hepatitis B, it is characterised in that the weight of raw material
Amount part, which forms, is:
5~50 parts of rheum officinale, 10~60 parts of roxburgh rose root, 5~30 parts of black soya bean, 20~90 parts of serissa serissoide, sage 20~100
Part, 30~150 parts of siphonstegia chinensis, 5~40 parts of ilex pubescens, 10~60 parts of radix glycyrrhizae.Wherein, preferable parts by weight composition is：
35 parts of rheum officinale, 13 parts of black soya bean, 85 parts of sage, 53 parts of roxburgh rose root, 26 parts of ilex pubescens, 130 parts of siphonstegia chinensis, serissa serissoide
78 parts, 40 parts of radix glycyrrhizae.
Pharmaceutical composition of the present invention can be made by the conventional fabrication process on galenic pharmacy the tablet of pro ore, capsule,
Granula or liquid preparation, and the liquid preparation of injection for intravenous or pulvis etc..
Also confirm patent described pharmaceutical composition of the present invention than in patent document CN102008588B by pharmacodynamics test
Disclosed pharmaceutical composition is more effective in terms for the treatment of hepatic encephalopathy and hepatitis B diseases, and now the pharmacological effect of the present invention is acted on
And caused technique effect is described as follows：
1st, pharmacodynamics test
1.1 material
1 age in days Guangxi sheldrake of animal, is provided by Guangxi herding seedling field.New zealand rabbit, 2.0~2.5kg of weight, male and female
It is unlimited, provided by farm of experimental animal special commission of Sichuan Province；
Drug test medicine：Embodiment 1（6g crude drugs/ml）, provided by Chengdu Lisite Pharmaceutical Co., Ltd..It is right
According to medicine：Reference examples 1（Prepared using preferred weight part composition in patent document CN102008588B）（6g crude drugs/ml）,
There is provided by Chengdu Lisite Pharmaceutical Co., Ltd..5% glucose injection, Kelun Pharm Ind Co., Ltd., Sichuan.Face use
Shi Junyong distilled water is made into required concentration；
Instrument and the automatic microplate reader of 450 types of reagent Model (Bio-Rad companies of the U.S.)；Nick translation medicine box, Pu Luo
Mai Ge companies；Virus：Duck hepatitis B virus, duck hepatitis B virus DNA (DHBV-DNA) strong positive serum, picks up from Shanghai fiber crops
Duck, -70 DEG C of preservations.Blood ammonia reagent dry plate（Johnson Co.'s auxiliary products）；Procaine hydrochloride injection（Shandong Fang Ming
Medicine company limited company, specification：40 mg·2 ml-1）；Ammonium chloride, sodium acid carbonate, sodium chloride are that analysis is pure.
Method
1.2.1 to the therapeutic effect of duck hepatitis B virus infection
1.2.1.1 test method
Duck hepatitis B virus infection:1 age in days Beijing duck is taken, it is positive through leg shin intravenous injection Shanghai sheldrake DHBV-DNA
Duck serum, every 0.2mL, after infection 7d take blood, separate serum, -70 DEG C of preservations.It is to be checked.After DHBV infection ducklings 7d, with
Machine is divided into 7 groups, and every group 10,2 times/d, successive administration 8 weeks is administered orally；Virus control group takes orally distilled water；Trial drug group
Taken orally with control drug group, two groups set respectively high dose group 115g (crude drug)/kg/d, middle dose group 76g (crude drug)/kg/d,
Low dose group 38g (crude drug)/kg/d, before 7d, that is, medication after infection (T0), medication the 14th day (T5), medication the 28th day (T10)
With the 14th day (P14) after drug withdrawal, from duck leg shin venous blood sampling, serum is separated.- 70 DEG C of preservations.It is to be checked.By duck serum to be checked,
Every batch of measures DHBV-DNA horizontal dynamics in duck serum with time point film.By nick translation kit specification method, use32P is marked
Remember DHBV-DNA probes, and do duck serum dot hybridization, autoradiograph diaphragm spot, OD values are measured with enzyme mark detector.
Sample DHBV-DNA level values are used as using hybridization spot OD values.Calculate different time (T14, T28) after every group of duck medication and stop
The inhibiting rate of medicine 14d (P3) serum DHBV-DNA.
Statistical method
Statistical procedures are carried out with NDST softwares.As a result represented with mean+SD (x ± s), group difference t
Examine.
Effect to rabbit hepatic encephalopathy model
1.2.2.1 the foundation of model
（1）64 new zealand rabbits are divided into 8 groups, i.e. blank control group, model group, trial drug by animal packet at random
The high, medium and low high, medium and low dosage group of dosage group and control drug, every group 8;
(2) modeling specific steps：（1）It will claim weight after 6 h of each group rabbit fasting, dorsal position is fixed on rabbit operating table
On, the hair near upper abdomen median line is cut off, in upper abdomen 1% procaine local infiltration anesthesia of center.（2）From breastbone
The notch of 6~8 cm is about under xiphoid-process along abdomen median line row, opens abdominal cavity, exposure liver, is pressed downward liver, cuts liver and diaphragm
Between falciform ligament, then lobe of the liver is turned over, blunt separation ligamentum hepatogastricum, makes lobe of the liver completely free, distinguish each leaf of liver.With
Bonnet cotton ligatures the root of left lateral lobe of liver, left middle lobe, right middle lobe and square leaf, and the lobe of the liver of ligation rapidly goes to crineous, from
Wiped out by leaf ligation top（Only leave right siphonal lobe and caudate lobe）.（3）Duodenum is found downwards along stomach pylorus, proposes abdomen
Chamber, an osculum is cut with eye scissors in intestinal wall, and thin catheter is inserted into about 4 cm of enteric cavity, makees purse string suture along around intubation, is received
The ligation of contracting pocket is fixed, and by intestinal tube Hui Na abdominal cavities, is checked in abdomen without bleeding, is closed abdominal cavity.（4）Injected into duodenal intubation
2.5% compound ammonium chloride solution（12.5 g of ammonium chloride and 7.5 g of sodium acid carbonate are dissolved in 500 mL, 5% glucose injections）,
2.5% compound ammonium chloride solution, 5 mL is injected into duodenal intubation every 5 min, causes ammonia generation in enteron aisle to increase and inhale
Take in blood, cause blood ammonia to raise rapidly, until trembling occurs in rabbit, whole body twitch, opisthotonos etc. similar to HE symptom, then
It is considered as and models successfully.The total amount of record compound ammonium chloride solution used, and the dosage per 1kg weights is calculated, record each group
Rabbit twitches incubation period（From be administered into occur whole body twitch time）, the twitch duration, twitch number and time-to-live
（The time survived after twitching）；
（3）After the 2nd time is injected 5 min of compound ammonium chloride solution, blood about 1 is taken by Rabbit central ear artery with blood sampling for administration
ML is in case measure the blood ammonia levels before administration.Then it is administered orally respectively, 2 times a day, successive administration 3d：Blank control group takes orally
Distilled water, trial drug group and control drug group difference high oral dose group 115g (crude drug)/kg/d, middle dose group 76g are (raw
Medicine)/kg/d, low dose group 38g (crude drug)/kg/d.Administration takes blood 1mL through arteria auricularis again after 3 days in case measure blood ammonia levels；
（4）The 205 Dry-type biochemical analyzers of measure application VITROS of blood ammonia, before being administered with detection of ALT with dry-chemical and give
Blood ammonia levels after medicine 3d；
（5）Statistical analysis experimental data is represented with mean ± standard deviation, as a result carries out Dan Yin with 3.1 softwares of PEMS
Plain variance analysis, is compared between group and is examined using SNK- q two-by-two between mean（Student- Newman- Keuls methods）.
As a result
1.3.1 therapeutic effect of this composition to duck hepatitis B virus the result shows that：Trial drug group and control drug
The high, medium and low dosage of group is notable to the inhibition of infected duck serum DHBV-DNA levels, has with model group comparing difference very aobvious
Work property meaning（P<0.01）, for each dosage group of trial drug compared with control drug accordingly each dosage group, difference has conspicuousness meaning
Justice（P<0.05）, the results are shown in Table 1:
Influence of 1 each group of table to the horizontal inhibiting rates of duck hepatitis B virus infection duck serum DHBV-DNA
Note：Compared with model group, * * P<0.01；
" trial drug group-high dose " compared with " control drug group-high dose ", #P<0.05；
" trial drug group-middle dosage " compared with " control drug group-middle dosage ", zero P<0.05；
" trial drug group-low dosage " compared with " control drug group-low dosage ", ◇ P<0.05；
1.3.2 this composition is to compound ammonium chloride solution dosage, twitch incubation period, twitch duration and time-to-live
Influence
As a result：Compared with blank control group, remaining 6 groups of rabbit compound ammonium chloride solution dosages increase, twitch prolongation of latency,
Twitch decreased duration, prolonged survival period（Equal P ＜ 0.05 or P ＜ 0.01）；Each dosage group of trial drug and control drug
Corresponding each dosage group compares, variant, and the increase of trial drug group compound ammonium chloride solution dosage, twitch prolongation of latency, take out
Jerk decreased duration, prolonged survival period, detailed results are shown in Table 2:
2 each group rabbit compound ammonium chloride solution dosage of table, twitch incubation period, twitch duration and time-to-live compare
（X ± s, n=7）
Note：Compared with blank control group：* P ＜ 0.05, * * P ＜ 0.01；
1.3.3 forward and backward blood ammonia change is administered
After 3d is administered, blank control group blood ammonia levels are without significant change, and model group blood ammonia levels are apparently higher than blank control
Group, illustrates modeling success.Compared with model group, trial drug group is substantially reduced with control drug group blood ammonia levels, is had extremely notable
Sex differernce（P ＜ 0.01）；Each dosage group of trial drug blood ammonia levels compared with control drug accordingly each dosage group reduce variant；
The results detailed in Table 3:
Blood ammonia change before the administration of 3 each group rabbit of table and after administration 3d（X ± s, n=7）
| Group | Blood ammonia levels/μm ol.L before modeling-1 | Blood ammonia levels/μm ol.L after administration-1 |
| Blank control 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：Compared with model group group：* P ＜ 0.01；
1.3 conclusion
The above results show that medicine water of the present invention takes orally after carrying, to hepatitis b virus infection duck serum DHBV-DNA water
Stabilize significant effect processed；Cause acute liver failure and the rapid elevation model of blood ammonia to rabbit lobe of the liver major part resection, can make
Blood ammonia reduces rapidly, and can extend twitch incubation period, shortens the twitch time, extends the time-to-live.Thus illustrate, medicine of the present invention
With intestine toxic material clearing, reduce blood ammonia, cooling blood and dissolving stasis, stop blooding, let out stool, reduce intestinal endotoxin, protect liver brain, have prevention hepatitis B, liver
The effect of property encephalopathic.And positive effect is better than the pharmaceutical composition disclosed in patent document CN102008588B.
Embodiment
Reference examples 1（Prepared using preferred weight part composition in patent document CN102008588B）
A kind of pure Chinese medicine pharmaceutical composition for treating hepatic encephalopathy and hepatitis B, it is characterised in that the parts by weight composition of raw material
For:35 parts of rheum officinale, 53 parts of roxburgh rose root, 13 parts of black soya bean, 78 parts of serissa serissoide, 85 parts of Salvia cavaleriei, 130 parts of siphonstegia chinensis, 26 parts of ilex pubescens,
40 parts of radix glycyrrhizae.
Embodiment 1
A kind of pure Chinese medicine pharmaceutical composition for treating hepatic encephalopathy and hepatitis B, it is characterised in that the parts by weight composition of raw material
For:35 parts of rheum officinale, 53 parts of roxburgh rose root, 13 parts of black soya bean, 78 parts of serissa serissoide, 85 parts of sage, 130 parts of siphonstegia chinensis, 26 parts of ilex pubescens,
40 parts of radix glycyrrhizae.
Embodiment 2
A kind of pure Chinese medicine pharmaceutical composition for treating hepatic encephalopathy and hepatitis B, it is characterised in that the parts by weight composition of raw material
For:20 parts of rheum officinale, 10 parts of roxburgh rose root, 30 parts of black soya bean, 50 parts of serissa serissoide, 80 parts of sage, 100 parts of siphonstegia chinensis, 40 parts of ilex pubescens,
10 parts of radix glycyrrhizae.
Embodiment 3
A kind of pure Chinese medicine pharmaceutical composition for treating hepatic encephalopathy and hepatitis B, it is characterised in that the parts by weight composition of raw material
For:50 parts of rheum officinale, 60 parts of roxburgh rose root, 20 parts of black soya bean, 80 parts of serissa serissoide, 100 parts of sage, 50 parts of siphonstegia chinensis, 30 parts of ilex pubescens,
60 parts of radix glycyrrhizae.
Embodiment 4
A kind of pure Chinese medicine pharmaceutical composition for treating hepatic encephalopathy and hepatitis B, it is characterised in that the parts by weight composition of raw material
For:It is 5 parts of rheum officinale, 30 parts of roxburgh rose root, 5 parts of black soya bean, 20 parts of serissa serissoide, 20 parts of sage, 30 parts of siphonstegia chinensis, 20 parts of ilex pubescens, sweet
40 parts of grass.
Embodiment 5
A kind of pure Chinese medicine pharmaceutical composition for treating hepatic encephalopathy and hepatitis B, it is characterised in that the parts by weight composition of raw material
For:30 parts of rheum officinale, 50 parts of roxburgh rose root, 10 parts of black soya bean, 90 parts of serissa serissoide, 50 parts of sage, 150 parts of siphonstegia chinensis, 5 parts of ilex pubescens,
30 parts of radix glycyrrhizae.
Claims (3)
1. a kind of pure Chinese medicine pharmaceutical composition for treating hepatic encephalopathy and hepatitis B, it is characterised in that the parts by weight of raw material, which form, is:
5~50 parts of rheum officinale, 10~60 parts of roxburgh rose root, 5~30 parts of black soya bean, 20~90 parts of serissa serissoide, 20~100 parts of sage, the moon
30~150 parts of row grass, 5~40 parts of ilex pubescens, 10~60 parts of radix glycyrrhizae.
2. the pure Chinese medicine pharmaceutical composition for the treatment of hepatic encephalopathy according to claim 1 and hepatitis B, it is characterised in that raw material
Parts by weight composition be：
35 parts of rheum officinale, 13 parts of black soya bean, 85 parts of sage, 53 parts of roxburgh rose root, 26 parts of ilex pubescens, 130 parts of siphonstegia chinensis, serissa serissoide 78
Part, 40 parts of radix glycyrrhizae.
3. the pure Chinese medicine pharmaceutical composition for the treatment of hepatic encephalopathy according to claim 1 or 2 and hepatitis B, it is characterised in that should
Tablet, capsule, granule or the liquid preparation of pro ore are made by the conventional fabrication process on galenic pharmacy for pharmaceutical composition.
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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 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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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| CN104000927B true CN104000927B (en) | 2018-04-27 |
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| 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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| 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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