CN104306370B - Pharmaceutical composition for liver protecting therapy and preparation method thereof - Google Patents
Pharmaceutical composition for liver protecting therapy and preparation method thereof Download PDFInfo
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- CN104306370B CN104306370B CN201410508802.3A CN201410508802A CN104306370B CN 104306370 B CN104306370 B CN 104306370B CN 201410508802 A CN201410508802 A CN 201410508802A CN 104306370 B CN104306370 B CN 104306370B
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
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Abstract
The present invention provides a kind of pharmaceutical composition for treating hepatopathy, removing toxic substances protects the liver, and the effective ingredient of described compositions is glycine betaine and silymarin, and the two weight ratio is 200:7 14, and is aided with appropriate adjuvant.In the pharmaceutical composition of the present invention, glycine betaine has the effects such as anti-fatty liver, blood pressure lowering, antitumor, silymarin can stablize liver plasma membrane, maintain hepatocellular integrity, make toxin permeates cell membranes cannot destroy liver, and can accelerate to synthesize the DNA of liver cell, the disease such as liver cirrhosis, fatty liver can be prevented.The present invention, by glycine betaine and silymarin combination preparation, tests prove that, can treat hepatopathy, have removing toxic substances hepatoprotective effect, and effect is better than prior art.
Description
Technical field
The present invention relates to pharmaceutical composition preparation field, specifically, relate to a kind of drug regimen for liver protecting therapy
Thing and preparation method thereof.
Background technology
Glycine betaine, molecular formula is C5H11NO2, it is a kind of alkaline matter, can be from the root of natural plants, stem, leaf and fruit
Extracting or using trimethylamine and monoxone is raw material chemosynthesis.Glycine betaine has maintenance Premeabilisation of cells pressure, antitumor, drops blood
Pressure, anti-peptic ulcer and gastrointestinal dysfunction, treat the functions such as hepatic disease.
Silymarin, molecular formula is C25H22O10, for flavonoid association, from catananche's Herba Silybi mariani fruit and kind
Son extracts.Silymarin has lipoxidase, the inhibitory action of peroxidase.Clinically for liver poisoning, liver function
Treating dysfunction, radioprotective and effect for reducing blood fat.
Acute hepatitis is typically without antiviral therapy.Only advocate application interferon in early days to prevent slowly when acute hepatitis C
Property, and chronic viral hepatitis needs antiviral therapy.Used by antiviral therapy, medicine includes:
1. interferon: recombinant DNA LeIF (IFN-α) can suppress the duplication of HBV.Intramuscular injection every other day, continuous 6
Month, only 30～50% patient obtain more lasting effect.The choice drug of hepatitis C is interferon, can be with ribavirin combination
Application.
2. lamivudine: be the dideoxy cytosine core sweet class medicine of a kind of synthesis, there is the effect of Anti-HBV activity.It is administered orally and draws
Meter Fu Ding, level of HBV-DNA in serum can be decreased obviously, and 12 weeks HBV-DNA negative conversion rates of taking medicine reach more than 90%.Long-term prescription can drop
Low ALT, improves inflammation, but HBeAg negative conversion rate only 16～18%, treat more than 6 months, HBV can be occurred to make a variation, but still can
Continuing to take this medicine, side effect gently can continue to take 1～4 year.
3. famciclovir: be a kind of bird aminoglycoside, its long half time, high at IC, HBV-can be suppressed
The duplication of DNA.The side effect of this medicine is light, can share raising curative effect with lamivudine interferon etc..
4. other disease-resistant drug: as acyclovir, adefovirdipivoxil, foscarnet sodium etc. all have certain effect suppressing HBV.
Immunomodulator conventional in liver disease includes:
1. thymosin α1 (Zadaxin), has two-way immunoregulation effect, can rebuild primary, secondary immunodeficiency patient
Immunologic function.
2. thymosin, participates in body cell generation immunoreation, the differentiation and maturation of inducer T lymphocyte, amplifier T cell pair
The reaction of antigen, the balance of each subgroup of regulatory T-cell.
3. immune ribonucleic acid, in vivo can inducement interferon thus enhancing human body immunity function.
Common liver-protecting medicine specifically includes that
1. hepatocyte growth-promoting factors, promotes liver cell regeneration, effect protected to hepatocyte injury, and can regulate body and exempt from
Epidemic disease function and anti-fibrosis effect.
3. diammonium glycyrrhizinate (diammonium glycyrrhizinate), has stronger antiinflammatory, protects cell membrane and improves the effect of liver function, being suitable for
In the chronic persistent hepatitis raised with glutamate pyruvate transaminase and chronic active hepatitis.
4. ademetionine (Transmetil), the ademetionine of supplemented with exogenous, there is promotion jaundice and disappear and liver function
The effect recovered.
Summary of the invention
It is an object of the invention to provide a kind of for treating hepatopathy, the pharmaceutical composition that protects the liver of removing toxic substances and preparation method thereof,
Pharmaceutical composition especially for treatment non-alcoholic fatty liver disease and preparation method thereof.
In order to realize the object of the invention, a kind of pharmaceutical composition for liver protecting therapy of the present invention, described compositions
Effective ingredient is glycine betaine and silymarin, and the two weight ratio is that (preferably the two weight ratio is 100:5-6 to 200:7-14, more excellent
The two weight ratio of choosing is 20:1), and it is aided with appropriate adjuvant.Described adjuvant includes but not limited to sucrose, micropowder silica gel, crystallite fibre
Dimension element, carboxymethyl starch sodium, hypromellose, jelly powder, citric acid, potassium sorbate, defatted milk powder, essence, pigment, Saccharum Sinensis Roxb.
Deng.
The pharmaceutical composition of the present invention is the dosage forms such as powder, powder, pill or colloid agent.
The preparation method of foregoing pharmaceutical compositions is: after glycine betaine, silymarin, sucrose and/or micropowder silica gel being pulverized
Mixing, pelletizes.
The preparation method of foregoing pharmaceutical compositions is: by glycine betaine, silymarin, microcrystalline Cellulose, carboxymethyl starch sodium
And/or hypromellose mixing, add suitable quantity of water, stirring, make pill.
The preparation method of foregoing pharmaceutical compositions is: glycine betaine, silymarin, Saccharum Sinensis Roxb. and jelly powder is mixed, makes sugar
Powder, adds Icing Sugar the most while stirring in 50-60 DEG C of water, is warming up to 85-95 DEG C, adds the defatted milk that water in advance is dissolved
Powder, after boiling 5-10 minute, adds potassium sorbate, stops heating, treat that temperature is down to 60-75 DEG C, add the Fructus Citri Limoniae dissolved
Acid, pigment, essence, filter with 100 mesh filter screens while hot, obtains colloid agent after cooling.
Preferably, the preparation method of foregoing pharmaceutical compositions is: glycine betaine, silymarin, Saccharum Sinensis Roxb. and jelly powder are mixed,
Make Icing Sugar, in 60 DEG C of water, add Icing Sugar the most while stirring, be warming up to 90 DEG C, add the defatted milk that water in advance is dissolved
Powder, seethes with excitement latter 10 minutes, adds potassium sorbate, stops heating, treats that temperature is down to 75 DEG C, adds citric acid, the color dissolved
Element, essence, filter with 100 mesh filter screens while hot, obtains colloid agent after cooling.
The present invention also provides for the application in preparation treatment hepatopathy, removing toxic substances hepatic of the described pharmaceutical composition.
The invention have the advantages that
Glycine betaine can be effectively prevented the non-alcoholic fatty liver disease that high fat diet is induced, and improves liver function, its mechanism
May be relevant with suppression HMGB1/TLR4 signal transduction pathway.Non-alcohol fatty liver (non-alcoholic fatty
Liverdisease, NAFLD) it is the clinical syndrome as pathological characters with hepatic cell fattydegeneration and lipopexia, face at present
Bed there is no fully effective Drug therapy.Glycine betaine can promote the metabolism of sulfur-containing amino acid, can be with the liver protecting activity.By grinding
Study carefully glycine betaine mechanism of action, find that it has and prevent alcoholic liver injury progress and the potentiality for the treatment of.Experiment shows, is used by rat
Liquid ethanol feeding 6 weeks, raises serum triglycerides and TNF-α level in rat body, glutamate pyruvate transaminase and glutamic oxaloacetic transaminase, GOT and lives
Dynamic property, and liver lipids accumulation.The Scavenging activity of liver oxygen-derived free radicals reduces, CD14, TNF-α, the mRNA of COX-2 and iNOS
Express and significantly induced.These changes caused by ethanol can be suppressed effectively by glycine betaine.The liver S-of rat fed by ethanol
The level of S-adenosylmethionine, cysteine and glutathion substantially reduces, and gives glycine betaine, and these indexs dramatically increase.Take off
Show the therapeutic value of its potential alcoholic liver disease.Glycine betaine may be by improvement to the protective effect of alcoholic liver injury and is subject to
The anti-oxidation function of the Metabolism of Sulfur-Containing Amino Acids damaged causes.
Silymarin is present in active component main in bitter Ji extract, including silibinin (Silybin), different water
Fly four kinds of isomerisms such as Ji guest (Isosilybin), Silychristin (Silychristin) and silidianin (Silydianin)
Body, wherein silibinin content is 50～70%.Silymarin is by hindering harmful toxins to enter, and helps to remove from hepatocyte
These materials thus the liver protecting cell, stablize liver plasma membrane, and there is the function making wounded hepatocytes regenerate.With other biological
Flavonoid is the same, and Herba Silybi mariani has strength antioxidation, and hepatocyte can be protected to destroy from free radical, and its effect outclass dimension
Raw element E.It addition, silymarin can promote protein synthesis and anti-hepatic fibrosis.At present, in the world can be effective with silymarin
The hepatic fibrosis that treatment ethanol causes；To the curative effect of alcoholic fatty liver up to 70%；To alcoholic cirrhosis complication with diabetes
Person, Herba Silybi mariani can effectively reverse insulin resistant；Add Herba Silybi mariani treatment hepatitis B with lamivudine, liver function can be made at short notice
Recover normal, compensate for the deficiency of lamivudine.
The pharmaceutical composition of the present invention has protection liver plasma membrane, promotion wounded hepatocytes synthetic DNA and structural protein, exempts from
The multiple pharmacological effect such as epidemic disease regulation and anti-hepatic fibrosis, it is provided that a kind of determined curative effect, safe ready, the medicine system that side effect is little
Agent.
In the pharmaceutical composition of the present invention, glycine betaine has the effects such as anti-fatty liver, blood pressure lowering, antitumor, silymarin energy
Stablize liver plasma membrane, maintain hepatocellular integrity, make toxin permeates cell membranes cannot destroy liver, and can accelerate to synthesize liver
The DNA of cell, can prevent the disease such as liver cirrhosis, fatty liver.The present invention is by glycine betaine and silymarin combination preparation, through test card
Bright, hepatopathy can be treated, there is removing toxic substances hepatoprotective effect, and effect is better than prior art.
Detailed description of the invention
Following example are used for illustrating the present invention, but are not limited to the scope of the present invention.If not specializing, embodiment
The conventional means that technological means used by is well known to those skilled in the art, raw materials used medicine is commercial goods.
Embodiment 1 pharmaceutical composition (powder) being used for liver protecting therapy and preparation method thereof
Weigh glycine betaine 6kg, silymarin 210g, sucrose 650g, micropowder silica gel 140g, mix after pulverizing, be distributed into every
Bag 7g.
Embodiment 2 pharmaceutical composition (powder) being used for liver protecting therapy and preparation method thereof
Weigh glycine betaine 6kg, silymarin 210g, sucrose 650g, micropowder silica gel 140g, mix after pulverizing, pelletize, be dried
Rear subpackage.
Embodiment 3 pharmaceutical composition (powder) being used for liver protecting therapy and preparation method thereof
Weigh glycine betaine 6kg, silymarin 210g, sucrose 790g, mix after pulverizing, be distributed into every packed 7g.
Embodiment 4 pharmaceutical composition (powder) being used for liver protecting therapy and preparation method thereof
Weigh glycine betaine 6kg, silymarin 210g, sucrose 790g, mix after pulverizing, pelletize, dried subpackage.
Embodiment 5 pharmaceutical composition (pill) being used for liver protecting therapy and preparation method thereof
Weigh glycine betaine 6kg, silymarin 210g, add microcrystalline Cellulose 160g, carboxymethyl starch sodium 280g and hydroxypropyl
Methylcellulose 350g, mixing, add 20kg water, stirring, refine medicine, pellet processing machine is made ball, evens up, be dried, polishing, subpackage.
Embodiment 6 pharmaceutical composition (pill) being used for liver protecting therapy and preparation method thereof
Weigh glycine betaine 6kg, silymarin 420g, add microcrystalline Cellulose 160g, carboxymethyl starch sodium 280g and hydroxypropyl
Methylcellulose 350g, mixing, add 22kg water, stirring, refine medicine, pellet processing machine is made ball, evens up, be dried, polishing, subpackage.
Embodiment 7 pharmaceutical composition (fruit jelly) being used for liver protecting therapy and preparation method thereof
The drug regimen composition formula of the present embodiment is: glycine betaine 2kg, silymarin 100g, jelly powder 230g, water 10kg,
Sugar 2.25kg, potassium sorbate 6g, defatted milk powder 200g, citric acid 33g, essence 14.82g, pigment 37.05g.
Preparation method: 1, standby by making Icing Sugar after glycine betaine, silymarin, Saccharum Sinensis Roxb. and jelly powder mix homogeneously.2, water
It is heated to 60 DEG C, adds Icing Sugar, continuously stirred.3,90 DEG C time add the defatted milk powder that dissolves in advance, seethe with excitement latter 10 minutes, then add
Enter potassium sorbate, stop heating.4, when temperature is down to 75 DEG C, add dissolved citric acid, pigment, essence.Use when 5, taking the dish out of the pot
100 mesh filter screens filter out the impurity in the jelly powder and Saccharum Sinensis Roxb. not being completely dissolved.6, filling and sealing while hot.
Embodiment 8 pharmaceutical composition (fruit jelly) being used for liver protecting therapy and preparation method thereof
The drug regimen composition formula of the present embodiment is: glycine betaine 2kg, silymarin 120g, jelly powder 230g, water 10kg,
Sugar 2.25kg, potassium sorbate 6g, defatted milk powder 200g, citric acid 33g, essence 14.84g, pigment 37.1g.
Preparation method: 1, standby by making Icing Sugar after glycine betaine, silymarin, Saccharum Sinensis Roxb. and jelly powder mix homogeneously.2, water
It is heated to 60 DEG C, adds Icing Sugar, continuously stirred.3,90 DEG C time add the defatted milk powder that dissolves in advance, seethe with excitement latter 10 minutes, then add
Enter potassium sorbate, stop heating.4, when temperature is down to 75 DEG C, add dissolved citric acid, pigment, essence.Use when 5, taking the dish out of the pot
100 mesh filter screens filter out the impurity in the jelly powder and Saccharum Sinensis Roxb. not being completely dissolved.6, filling and sealing while hot.
Embodiment 9 pharmaceutical composition (fruit jelly) being used for liver protecting therapy and preparation method thereof
The drug regimen composition formula of the present embodiment is: glycine betaine 3kg, silymarin 120g, jelly powder 230g, water 12kg,
Sugar 2.25kg, potassium sorbate 6g, defatted milk powder 200g, citric acid 33g, essence 17.84g, pigment 44.60g.
Preparation method: 1, standby by making Icing Sugar after glycine betaine, silymarin, Saccharum Sinensis Roxb. and jelly powder mix homogeneously.2, water
It is heated to 50 DEG C, adds Icing Sugar, continuously stirred.3,85 DEG C time add the defatted milk powder that dissolves in advance, seethe with excitement latter 5 minutes, then add
Enter potassium sorbate, stop heating.4, when temperature is down to 60 DEG C, add dissolved citric acid, pigment, essence.Use when 5, taking the dish out of the pot
100 mesh filter screens filter out the impurity in the jelly powder and Saccharum Sinensis Roxb. not being completely dissolved.6, filling and sealing while hot.
Embodiment 10 pharmaceutical composition (fruit jelly) being used for liver protecting therapy and preparation method thereof
The drug regimen composition formula of the present embodiment is: glycine betaine 2.5kg, silymarin 160g, jelly powder 230g, water
10kg, sugar 2.25kg, potassium sorbate 6g, defatted milk powder 200g, citric acid 33g, essence 15.38g, pigment 38.45g.
Preparation method: 1, standby by making Icing Sugar after glycine betaine, silymarin, Saccharum Sinensis Roxb. and jelly powder mix homogeneously.2, water
It is heated to 55 DEG C, adds Icing Sugar, continuously stirred.3,95 DEG C time add the defatted milk powder that dissolves in advance, seethe with excitement latter 8 minutes, then add
Enter potassium sorbate, stop heating.4, when temperature is down to 70 DEG C, add dissolved citric acid, pigment, essence.Use when 5, taking the dish out of the pot
100 mesh filter screens filter out the impurity in the jelly powder and Saccharum Sinensis Roxb. not being completely dissolved.6, filling and sealing while hot.
Comparative example 1: with reference to CN101933900A, it discloses a kind of compound preparation for preventing and treating poultry liver diseases and system thereof
Preparation Method
Specific as follows:
The composition of compound preparation: silymarin 25% (W/V), glycine betaine 1.6% (W/V), ethanol 3% (V/V), lauryl alcohol
Sodium sulfate 0.06% (W/V), glycerol 10% (V/V), sodium citrate 2% (W/V), propylparaben 0.03% (W/V), purification
Water adds to 100%.
Preparation method:
1, first sodium citrate is dissolved in 27ml purified water, add silymarin, glycine betaine, ethanol and lauryl alcohol sulphuric acid
Sodium, stirs to obtain mixture A；
2, take 60ml purified water, add propylparaben, add and place to room temperature after dissolving, add glycerol, stirring
Obtain mixture B；
3, solution B is poured in solution A, after stirring and evenly mixing, be settled to 100ml by purified water, obtain mixture C；
4, mixture C is homogenized under 100MPa pressure by high pressure homogenizer, by obtaining after 2 circulation homogenizing
To the silymarin that particle diameter is 5-500nm-glycine betaine suspension.
Experimental example: the impact on non-alcoholic fatty liver disease
Non-alcohol fatty liver (non-alcoholic fatty liverdisease, NAFLD) is with hepatocyte
Steatosis and lipopexia are the clinical syndrome of pathological characters, and current clinic there is no fully effective Drug therapy.This
Bright have protection liver plasma membrane, promote wounded hepatocytes synthetic DNA and structural protein, immunomodulating and anti-hepatic fibrosis etc. multiple
Pharmacological action.This research uses high fat diet to set up rat NAFLD model, verifies curative effect and the effect of its treatment NAFLD rat
Mechanism.
1 materials and methods
1.1 general materials: adult male SD rats 130, weight 180-220g, dynamic purchased from the experiment of Beijing dimension tonneau China
Thing center, credit number: SCXK (capital) 2012-0001.Ursodeoxycholic Acid Tablets is provided by Shanghai Xinyi Pharmaceutical Co., Ltd.Paddy third
Transaminase (GPT), glutamic oxaloacetic transaminase, GOT (GOT), triacylglycerol (TG) and T-CHOL (TC) test kit build up biology purchased from Nanjing
Graduate School of Engineering, tumor necrosis factor (TNF-α) and interleukin 8 (IL-8) test kit are purchased from Shanghai gloomy male science and technology industry
Company limited.
1.2 method
1.2.1NAFLD the foundation of rat model: rat adaptability raises 3d, is randomly divided into 13 groups: model group, the positive are right
According to group, embodiment 1 group, embodiment 2 groups, embodiment 3 groups, embodiment 4 groups, embodiment 5 group, embodiment 6 groups, embodiment 7 groups,
Embodiment 8 groups, embodiment 9 groups, embodiment 10 groups and comparative example 1 group, often group 10.Wherein model group feed normal feedstuff, real
Execute example 1-10 group gavage respectively and give the pharmaceutical composition prepared according to embodiment of the present invention 1-10 method of 100mg/kg.Positive
Matched group gastric infusion Bears phenylephrine acid 60mg/kg, 1 group of gastric infusion compound preparation 100mg/kg of comparative example, model group gavage carboxylic
Methylcellulose suspension, 1 time/d.After 6th week last is administered, after water 1 evening is can't help in fasting, eye socket puts to death rat after taking blood, takes
Hepatic tissue makes liver homogenate.
1.2.2 experimental index measures: illustrate to detect GPT, GOT, TG and TC in serum by test kit, by the hepatic tissue of preparation
Homogenate, in 4 DEG C, centrifugal radius 8cm, 3500r/min is centrifuged 10min, takes supernatant and is centrifuged 10rain again, uses enzyme linked immunological
TNF-α and IL-8 level in determination of adsorption method liver homogenate.
1.3 statistical procedures: application SPSS11.5 software carries out statistical analysis, and measurement data is with average ± standard deviation (x
± s) represent, using variance analysis, P < 0.05 is significant difference, statistically significant.
2 the results are shown in Table 1.
The comparison (x ± s) of 1 13 groups of rat blood serum biochemical indicators of table
| Group | Number of elements | GPT(μ/L) | GOT(μ/L) | c(TG)(mmol/L) | c(TC)(mmol/L) |
| Model group group | 10 | 20.12±2.12 | 102.39±12.38 | 1.09±0.27 | 1.58±0.46 |
| Positive controls | 10 | 60.67±3.78** | 188.56±20.15** | 2.13±0.55** | 2.54±0.69** |
| Embodiment 1 group | 10 | 48.78±4.23**& | 147.96±18.88**& | 1.48±0.51*& | 2.24±0.56*& |
| Embodiment 2 groups | 10 | 45.98±3.3**& | 145.26±13.35**& | 1.46±0.44*& | 2.23±0.38*& |
| Embodiment 3 groups | 10 | 42.25±1.38**& | 143.32±10.21**& | 1.44±0.47*& | 2.22±0.34*& |
| Embodiment 4 groups | 10 | 40.98±1.34**& | 141.26±10.09**& | 1.42±0.21*& | 2.20±0.34*& |
| Embodiment 5 groups | 10 | 51.90±2.32**& | 150.67±11.21**& | 1.49±0.15*& | 2.26±0.26*& |
| Embodiment 6 groups | 10 | 52.01±1.23**& | 154.54±15.43**& | 1.50±0.42**& | 2.29±0.53*& |
| Embodiment 7 groups | 10 | 55.60±3.38**& | 160.25±6.87**& | 1.61±0.33**& | 2.38±0.21**& |
| Embodiment 8 groups | 10 | 54.32±3.12**& | 158.23±12.32**& | 1.58±0.36**& | 2.36±0.46**& |
| Embodiment 9 groups | 10 | 53.12±2.43**& | 156.64±11.98**& | 1.55±0.25**& | 2.33±0.37**& |
| Embodiment 10 groups | 10 | 52.35±1.98**& | 156.01±14.34**& | 1.52±0.52**& | 2.31±0.61**& |
| Comparative example 1 group | 10 | 30.24±3.24* | 120.32±5.61* | 1.21±0.24* | 2.01±0.41* |
Note: compared with model group, * P < 0.05, * * P < 0.01, compared with comparative example 1 group,&P<0.05。
Table 1 result shows, compared with model group mice, each administration group in various degree add rat blood serum biochemical indicator
(P < 0.01 or P < 0.05)；Respectively compared with comparative example 1 group, each group of embodiment 1-10 can substantially increase rat blood serum biochemical indicator
(P<0.05)。
13 groups of liver tissues of rats TNF-α and IL-8 level compare and are shown in Table 2.
2 13 groups of liver tissues of rats TNF-α of table and IL-8 level compare (x ± s, μ g/L)
| Group | Number of elements | TNF-α | IL-8 |
| Model group | 10 | 1.14±0.31 | 0.82±0.23 |
| Positive controls | 10 | 4.54±0.88** | 1.56±0.41** |
| Embodiment 1 group | 10 | 2.69±0.85*& | 1.25±0.26*& |
| Embodiment 2 groups | 10 | 2.66±1.12*& | 1.23±0.34*& |
| Embodiment 3 groups | 10 | 2.62±0.52*& | 1.22±0.12*& |
| Embodiment 4 groups | 10 | 2.59±0.91*& | 1.21±0.21*& |
| Embodiment 5 groups | 10 | 2.76±0.53**& | 1.26±0.16*& |
| Embodiment 6 groups | 10 | 2.80±0.46**& | 1.27±0.13*& |
| Embodiment 7 groups | 10 | 2.94±0.84**& | 1.35±0.07**& |
| Embodiment 8 groups | 10 | 2.90±0.61**& | 1.33±0.24**& |
| Embodiment 9 groups | 10 | 2.88±0.41**& | 1.30±0.27**& |
| Embodiment 10 groups | 10 | 2.85±0.56**& | 1.29±0.19**& |
| Comparative example 1 group | 10 | 1.48±1.03* | 1.12±0.12* |
Note: compared with model group, * P < 0.05, * * P < 0.01, compared with comparative example 1 group,&P<0.05。
Table 2 result shows, compared with model group mice, each administration group in various degree add liver tissues of rats TNF-α
With IL-8 level (P < 0.01 or P < 0.05)；Respectively compared with comparative example 1, embodiment 1-10 group can substantially increase liver tissues of rats
TNF-α and IL-8 level (P < 0.05).
Result above shows, in embodiment of the present invention 1-10, the pharmaceutical composition of preparation is used for treating hepatopathy, and removing toxic substances protects the liver
Effect good compared with prior art.
Herba Silybi mariani is catananche, and silibinin is to have bioactive main component in silymarin, and water flies
Ji guest is natural anti-oxidation medicine, is used for for a long time treating multiple hepatic disease, has good efficacy.The present embodiment by silibinin with
Glycine betaine forms, and silibinin is soluble in water, therefore it absorbs rapidly, has good biological availability.This result of study shows, should
After treating with the present embodiment, each treatment group liver function, blood lipid level are clearly better, inflammation performance substantially alleviates, and the present invention is described
The pharmaceutical composition provided can improve NAFLD Liver Function and blood fat disorder, reduces inflammatory factor release, points out this product pair
The protective effect of NAFLD rat liver may be by suppressing the cytokine such as TNF-α and IL-8 to realize.
Although, the present invention is described in detail the most with a general description of the specific embodiments, but
On the basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Cause
This, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to the scope of protection of present invention.
Claims (9)
1. for the pharmaceutical composition of liver protecting therapy, it is characterised in that the effective ingredient of described compositions is glycine betaine and water flies
Silibin, the two weight ratio is 200:7-14, and is aided with appropriate adjuvant.
Pharmaceutical composition the most according to claim 1, it is characterised in that glycine betaine and silymarin in described compositions
Weight ratio is 100:5-6.
Pharmaceutical composition the most according to claim 1, it is characterised in that glycine betaine and silymarin in described compositions
Weight ratio is 20:1.
4. according to the pharmaceutical composition described in any one of claim 1-3, it is characterised in that described adjuvant includes but not limited to sugarcane
Sugar, micropowder silica gel, microcrystalline Cellulose, carboxymethyl starch sodium, hypromellose, jelly powder, citric acid, potassium sorbate, defat
Milk powder, essence, pigment, Saccharum Sinensis Roxb..
5. according to the pharmaceutical composition described in any one of claim 1-3, it is characterised in that described compositions is powder, pill
Or colloid agent.
6. the preparation method of pharmaceutical composition described in claim 5, it is characterised in that by glycine betaine, silymarin, microcrystalline cellulose
Element, carboxymethyl starch sodium and/or hypromellose mixing, add suitable quantity of water, stirring, make pill.
7. the preparation method of pharmaceutical composition described in claim 5, it is characterised in that by glycine betaine, silymarin, Saccharum Sinensis Roxb. and fruit
Agar mixes, and makes Icing Sugar, adds Icing Sugar the most while stirring, be warming up to 85-95 DEG C, add and use in advance in 50-60 DEG C of water
Water-soluble defatted milk powder, after boiling 5-10 minute, adds potassium sorbate, stops heating, treat that temperature is down to 60-75 DEG C, add
Enter dissolved citric acid, pigment, essence, while hot with 100 mesh filter screens filter, after cooling colloid agent.
Preparation method the most according to claim 7, it is characterised in that glycine betaine, silymarin, Saccharum Sinensis Roxb. and jelly powder are mixed
Close, make Icing Sugar, in 60 DEG C of water, add Icing Sugar the most while stirring, be warming up to 90 DEG C, add the defat that water in advance is dissolved
Milk powder, seethes with excitement latter 10 minutes, adds potassium sorbate, stops heating, treats that temperature is down to 75 DEG C, add dissolved citric acid,
Pigment, essence, filter with 100 mesh filter screens while hot, obtains colloid agent after cooling.
9. the application in preparation treatment hepatopathy, removing toxic substances hepatic of the pharmaceutical composition described in any one of claim 1-5.
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