CN104306370A - Medicine composition for treatment of liver protection and preparation method of medicine composition - Google Patents
Medicine composition for treatment of liver protection and preparation method of medicine composition Download PDFInfo
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- CN104306370A CN104306370A CN201410508802.3A CN201410508802A CN104306370A CN 104306370 A CN104306370 A CN 104306370A CN 201410508802 A CN201410508802 A CN 201410508802A CN 104306370 A CN104306370 A CN 104306370A
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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 invention provides a medicine composition for treating liver diseases, removing toxicity and protecting liver. The composition is prepared from glycine betaine and silymarin which serve as effective ingredients in a weight ratio of 200:(7-14), as well as a proper amount of auxiliaries. In the medicine composition, glycine betaine has the effects of resisting fatty liver, lowering blood pressure, resisting tumors and the like; and silymarin is capable of stabilizing liver cell membranes and maintaining integrity of liver cells, so that toxin cannot penetrate cell membranes to destroy liver, synthesis of DNA of liver cells can be accelerated, liver cirrhosis, fatty liver and other diseases can be prevented. Tests prove that the medicine composition which is a glycine betaine and silymarin combined preparation can be used for treating liver diseases, and has the effects of removing toxin and protecting liver. The effect of the medicine composition is better than that in the prior art.
Description
Technical field
The present invention relates to pharmaceutical composition preparation field, specifically, relate to a kind of pharmaceutical composition for liver protecting therapy and preparation method thereof.
Background technology
Betanin, molecular formula is C
5h
11nO
2, be a kind of alkaline matter, can extract from the root of natural plants, stem, leaf and fruit or adopt trimethylamine and monoxone to be raw material chemosynthesis.Betanin has maintenance Premeabilisation of cells pressure, antitumor, blood pressure lowering, anti-peptic ulcer and gastrointestinal dysfunction, the functions such as treatment hepatic disease.
Silymarin, molecular formula is C
25h
22o
10, be flavonoid association, extract from catananche's Herba Silybi mariani fruit and seed.Silymarin has the inhibitory action to lipoxidase, peroxidase.Clinically for liver poisoning, hepatic insufficiency is treated, radioprotective and effect for reducing blood fat.
Acute hepatitis is generally without antiviral therapy.Only advocate early stage application of interference element when acute hepatitis C and prevent chronicity, and chronic viral hepatitis needs antiviral therapy.Antiviral therapy medicine used comprises:
1. interferon: recombinant DNA LeIF (IFN-α) can suppress copying of HBV.Intramuscular injection every other day, continuous 6 months, only 30 ~ 50% patients obtained more lasting effect.The choice drug of hepatitis C is interferon, can apply with ribavirin combination.
2. lamivudine: the sweet class medicine of dideoxy cytosine core being a kind of synthesis, has the effect of Anti-HBV activity.Oral lamivudine, level of HBV-DNA in serum can obviously decline, and 12 weeks HBV-DNA negative conversion rates of taking medicine reach more than 90%.Long-term prescription can reduce ALT, improves inflammation, but HBeAg negative conversion rate only 16 ~ 18%, treat more than 6 months, HBV variation can occur, but still can continue 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, copying of HBV-DNA can be suppressed.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 comprises:
1. thymosin α1 (Zadaxin), has two-way immunoregulation effect, can rebuild former, the immunologic function of secondary immunodeficiency patient.
2. thymosin, participates in body cell generation immunoreation, the differentiation and maturation of inducer T lymphocyte, amplifier T cell to 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 mainly comprises:
1. hepatocyte growth-promoting factors, promotes liver cell regeneration, has protective effect to hepatocyte injury, and can conditioner body immunity function and anti-fibrosis effect.
3. diammonium glycyrrhizinate (diammonium glycyrrhizinate), has stronger antiinflammatory, Cell protection film and improve the effect of liver function, is applicable to the chronic persistent hepatitis that raises with glutamate pyruvate transaminase and chronic active hepatitis.
4. ademetionine (Transmetil), the ademetionine of supplemented with exogenous, has and promotes that jaundice disappears and the effect of liver function recovery.
Summary of the invention
The object of this invention is to provide and be a kind ofly used for the treatment of hepatopathy, detoxify pharmaceutical composition of protecting the liver and preparation method thereof, especially for pharmaceutical composition and preparation method thereof for the treatment of non-alcoholic fatty liver disease.
In order to realize the object of the invention, a kind of pharmaceutical composition for liver protecting therapy of the present invention, the effective ingredient of described compositions is betanin and silymarin, the two weight ratio is that (preferably the two weight ratio is 100:5-6 to 200:7-14, more preferably the two weight ratio is 20:1), and be aided with appropriate adjuvant.Described adjuvant includes but not limited to sucrose, micropowder silica gel, microcrystalline Cellulose, carboxymethyl starch sodium, hypromellose, jelly powder, citric acid, potassium sorbate, defatted milk powder, essence, pigment, Saccharum Sinensis Roxb. etc.
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: mixing after betanin, silymarin, sucrose and/or micropowder silica gel being pulverized, and granulates.
The preparation method of foregoing pharmaceutical compositions is: betanin, silymarin, microcrystalline Cellulose, carboxymethyl starch sodium and/or hypromellose are mixed, add suitable quantity of water, stirs, makes pill.
The preparation method of foregoing pharmaceutical compositions is: betanin, silymarin, Saccharum Sinensis Roxb. and jelly powder are mixed, make Icing Sugar, then in 50-60 DEG C of water, add Icing Sugar while stirring, be warming up to 85-95 DEG C, add the defatted milk powder that water in advance is dissolved, 5-10 minute after boiling, then add potassium sorbate, stop heating, treat that temperature is down to 60-75 DEG C, add the citric acid, pigment, the essence that have dissolved, filter with 100 mesh filter screens while hot, after cooling, obtain colloid agent.
Preferably, the preparation method of foregoing pharmaceutical compositions is: betanin, silymarin, Saccharum Sinensis Roxb. and jelly powder are mixed, make Icing Sugar, then in 60 DEG C of water, Icing Sugar is added while stirring, be warming up to 90 DEG C, add the defatted milk powder that water in advance is dissolved, seethe with excitement latter 10 minutes, add potassium sorbate again, stop heating, treat that temperature is down to 75 DEG C, add the citric acid, pigment, the essence that have dissolved, filter with 100 mesh filter screens while hot, after cooling, obtain colloid agent.
The present invention also provides the application of described pharmaceutical composition in preparation treatment hepatopathy, removing toxic substances hepatic.
The present invention has the following advantages:
The non-alcoholic fatty liver disease that betanin can prevent high fat diet from inducing effectively, improves liver function, and its mechanism may be relevant with suppression HMGB1/TLR4 signal transduction pathway.The clinical syndrome that non-alcohol fatty liver (non-alcoholic fatty liverdisease, NAFLD) is is pathological characters with hepatic cell fattydegeneration and lipopexia, clinically at present there is no fully effective Drug therapy.Betanin can promote the metabolism of sulfur-containing amino acid, can the liver protecting activity.By research betanin mechanism of action, find that it has the potentiality preventing alcoholic liver injury to be in progress and to treat.Experiment shows, by rat liquid ethanol feeding 6 weeks, raise serum triglycerides and TNF-alpha levels in rat body, glutamate pyruvate transaminase and glutamic oxaloacetic transaminase, GOT activeness, and liver lipids is piled up.The Scavenging activity of liver oxygen-derived free radicals reduces, and the mrna expression of CD14, TNF-α, COX-2 and iNOS is significantly induced.These changes caused by ethanol can be suppressed effectively by betanin.The level that ethanol feeds the liver S-adenosylmethionine of rat, cysteine and glutathion significantly reduces, and give betanin, these indexs significantly increase.Disclose the therapeutic value of its potential alcoholic liver disease.Betanin may be that anti-oxidation function by improving impaired Metabolism of Sulfur-Containing Amino Acids causes to the protective effect of alcoholic liver injury.
Silymarin is present in active component main in bitter Ji extract, comprise four kinds of isomerss such as silibinin (Silybin), Isosilybin (Isosilybin), Silychristin (Silychristin) and silidianin (Silydianin), wherein silibinin content is 50 ~ 70%.Silymarin enters by hindering harmful toxins, and helps remove these materials from hepatocyte thus the liver protecting cell, stablize liver plasma membrane, and has the function that wounded hepatocytes is regenerated.The same with other biological flavonoid, Herba Silybi mariani has powerful antioxidation, and hepatocyte can be protected to destroy from free radical, and its effect outclass vitamin E.In addition, silymarin can promote protein synthesis and anti-hepatic fibrosis.At present, effectively can treat with silymarin the hepatic fibrosis that ethanol causes in the world; Can 70% be reached to the curative effect of alcoholic fatty liver; To alcoholic cirrhosis complication with diabetes person, Herba Silybi mariani effectively can reverse insulin resistant; Add Herba Silybi mariani treatment hepatitis B with lamivudine, liver function recovery can be made at short notice normal, compensate for the deficiency of lamivudine.
Pharmaceutical composition of the present invention has protection liver plasma membrane, promotes the multiple pharmacological effect such as wounded hepatocytes synthetic DNA and structural protein, immunomodulating and anti-hepatic fibrosis, provides a kind of determined curative effect, safe ready, the pharmaceutical preparation that side effect is little.
In pharmaceutical composition of the present invention, betanin has the effects such as anti-fatty liver, blood pressure lowering, antitumor, silymarin can stablize liver plasma membrane, maintain hepatocellular integrity, make toxin cannot penetration cell film destroy liver, and the DNA synthesizing liver cell can be accelerated, the disease such as liver cirrhosis, fatty liver can be prevented.The present invention, by betanin and silymarin combination preparation, proves through test, can treat hepatopathy, have removing toxic substances hepatoprotective effect, and effect be better than prior art.
Detailed description of the invention
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.If do not specialize, the conventional means that technological means used in embodiment is well known to those skilled in the art, raw materials used medicine is commercial goods.
Embodiment 1 is for the pharmaceutical composition (powder) and preparation method thereof of liver protecting therapy
Take betanin 6kg, silymarin 210g, sucrose 650g, micropowder silica gel 140g, after pulverizing, mixing, is distributed into every bag of 7g.
Embodiment 2 is for the pharmaceutical composition (powder) and preparation method thereof of liver protecting therapy
Take betanin 6kg, silymarin 210g, sucrose 650g, micropowder silica gel 140g, mixing after pulverizing, granulates, subpackage after dry.
Embodiment 3 is for the pharmaceutical composition (powder) and preparation method thereof of liver protecting therapy
Take betanin 6kg, silymarin 210g, sucrose 790g, after pulverizing, mixing, is distributed into every packed 7g.
Embodiment 4 is for the pharmaceutical composition (powder) and preparation method thereof of liver protecting therapy
Take betanin 6kg, silymarin 210g, sucrose 790g, mixing after pulverizing, granulates, subpackage after dry.
Embodiment 5 is for the pharmaceutical composition (pill) and preparation method thereof of liver protecting therapy
Take betanin 6kg, silymarin 210g, add microcrystalline Cellulose 160g, carboxymethyl starch sodium 280g and hypromellose 350g, mixing, adds 20kg water, stirs, and refining medicine, makes ball, even up in pellet processing machine, dry, polishing, subpackage.
Embodiment 6 is for the pharmaceutical composition (pill) and preparation method thereof of liver protecting therapy
Take betanin 6kg, silymarin 420g, add microcrystalline Cellulose 160g, carboxymethyl starch sodium 280g and hypromellose 350g, mixing, adds 22kg water, stirs, and refining medicine, makes ball, even up in pellet processing machine, dry, polishing, subpackage.
Embodiment 7 is for the pharmaceutical composition (fruit jelly) and preparation method thereof of liver protecting therapy
The drug regimen composition formula of the present embodiment is: betanin 2kg, silymarin 100g, jelly powder 230g, water 10kg, sugared 2.25kg, potassium sorbate 6g, defatted milk powder 200g, citric acid 33g, essence 14.82g, pigment 37.05g.
Preparation method: 1, for subsequent use by making Icing Sugar after betanin, silymarin, Saccharum Sinensis Roxb. and jelly powder mix homogeneously.2, water is heated to 60 DEG C, adds Icing Sugar, Keep agitation.3,90 DEG C time add the defatted milk powder dissolved in advance, seethe with excitement latter 10 minutes, then add potassium sorbate, stop heating.4, when temperature is down to 75 DEG C, the citric acid, pigment, the essence that have dissolved is added.The impurity in not consoluet jelly powder and Saccharum Sinensis Roxb. is filtered out with 100 mesh filter screens when 5, taking the dish out of the pot.6, filling and sealing while hot.
Embodiment 8 is for the pharmaceutical composition (fruit jelly) and preparation method thereof of liver protecting therapy
The drug regimen composition formula of the present embodiment is: betanin 2kg, silymarin 120g, jelly powder 230g, water 10kg, sugared 2.25kg, potassium sorbate 6g, defatted milk powder 200g, citric acid 33g, essence 14.84g, pigment 37.1g.
Preparation method: 1, for subsequent use by making Icing Sugar after betanin, silymarin, Saccharum Sinensis Roxb. and jelly powder mix homogeneously.2, water is heated to 60 DEG C, adds Icing Sugar, Keep agitation.3,90 DEG C time add the defatted milk powder dissolved in advance, seethe with excitement latter 10 minutes, then add potassium sorbate, stop heating.4, when temperature is down to 75 DEG C, the citric acid, pigment, the essence that have dissolved is added.The impurity in not consoluet jelly powder and Saccharum Sinensis Roxb. is filtered out with 100 mesh filter screens when 5, taking the dish out of the pot.6, filling and sealing while hot.
Embodiment 9 is for the pharmaceutical composition (fruit jelly) and preparation method thereof of liver protecting therapy
The drug regimen composition formula of the present embodiment is: betanin 3kg, silymarin 120g, jelly powder 230g, water 12kg, sugared 2.25kg, potassium sorbate 6g, defatted milk powder 200g, citric acid 33g, essence 17.84g, pigment 44.60g.
Preparation method: 1, for subsequent use by making Icing Sugar after betanin, silymarin, Saccharum Sinensis Roxb. and jelly powder mix homogeneously.2, water is heated to 50 DEG C, adds Icing Sugar, Keep agitation.3,85 DEG C time add the defatted milk powder dissolved in advance, seethe with excitement latter 5 minutes, then add potassium sorbate, stop heating.4, when temperature is down to 60 DEG C, the citric acid, pigment, the essence that have dissolved is added.The impurity in not consoluet jelly powder and Saccharum Sinensis Roxb. is filtered out with 100 mesh filter screens when 5, taking the dish out of the pot.6, filling and sealing while hot.
Embodiment 10 is for the pharmaceutical composition (fruit jelly) and preparation method thereof of liver protecting therapy
The drug regimen composition formula of the present embodiment is: betanin 2.5kg, silymarin 160g, jelly powder 230g, water 10kg, sugared 2.25kg, potassium sorbate 6g, defatted milk powder 200g, citric acid 33g, essence 15.38g, pigment 38.45g.
Preparation method: 1, for subsequent use by making Icing Sugar after betanin, silymarin, Saccharum Sinensis Roxb. and jelly powder mix homogeneously.2, water is heated to 55 DEG C, adds Icing Sugar, Keep agitation.3,95 DEG C time add the defatted milk powder dissolved in advance, seethe with excitement latter 8 minutes, then add potassium sorbate, stop heating.4, when temperature is down to 70 DEG C, the citric acid, pigment, the essence that have dissolved is added.The impurity in not consoluet jelly powder and Saccharum Sinensis Roxb. is filtered out with 100 mesh filter screens when 5, taking the dish out of the pot.6, filling and sealing while hot.
Comparative example 1: with reference to CN101933900A, it discloses a kind of for compound preparation preventing and treating poultry liver diseases and preparation method thereof
Specific as follows:
The composition of compound preparation: silymarin 25% (W/V), betanin 1.6% (W/V), ethanol 3% (V/V), sodium laurylsulfate 0.06% (W/V), glycerol 10% (V/V), sodium citrate 2% (W/V), propylparaben 0.03% (W/V), purified water adds to 100%.
Method for making:
1, first sodium citrate is dissolved in 27ml purified water, then add silymarin, betanin, ethanol and sodium laurylsulfate, stir to obtain mixture A;
2, get 60ml purified water, add propylparaben, be placed to room temperature after adding dissolving, then add glycerol, stir to 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 silymarin-betanin suspension that particle diameter is 5-500nm after 2 circulation homogenizing.
Experimental example: on the impact of non-alcoholic fatty liver disease
The clinical syndrome that non-alcohol fatty liver (non-alcoholic fatty liverdisease, NAFLD) is is pathological characters with hepatic cell fattydegeneration and lipopexia, clinically at present there is no fully effective Drug therapy.The present invention has protection liver plasma membrane, promotes the multiple pharmacological effect such as wounded hepatocytes synthetic DNA and structural protein, immunomodulating and anti-hepatic fibrosis.This research adopts high fat diet to set up rat NAFLD model, verifies curative effect and the mechanism of action of its treatment NAFLD rat.
1 materials and methods
1.1 general materials: adult male SD rats 130, weight 180-220g, purchased from Beijing dimension tonneau China Experimental Animal Center, credit number: SCXK (capital) 2012-0001.Ursodeoxycholic Acid Tablets is provided by Shanghai Xinyi Pharmaceutical Co., Ltd.Glutamate pyruvate transaminase (GPT), glutamic oxaloacetic transaminase, GOT (GOT), triacylglycerol (TG) and T-CHOL (TC) test kit build up Bioengineering Research Institute purchased from Nanjing, and tumor necrosis factor (TNF-α) and interleukin 8 (IL-8) test kit are purchased from Senxiong Science & Technology Industry Co., Ltd., Shanghai.
1.2 method
1.2.1NAFLD the foundation of rat model: rat adaptability raises 3d, be divided into 13 groups at random: model group, positive controls, embodiment 1 group, embodiment 2 groups, embodiment 3 groups, embodiment 4 groups, embodiment 5, in group, embodiment 6 groups, embodiment 7 groups, embodiment 8 groups, embodiment 9 groups, embodiment 10 groups and comparative example 1 group, often organize 10.Wherein model group feed normal feedstuff, embodiment 1-10 group respectively gavage gives the pharmaceutical composition prepared according to embodiment of the present invention 1-10 method of 100mg/kg.Positive controls gastric infusion Bears phenylephrine acid 60mg/kg, comparative example 1 group of gastric infusion compound preparation 100mg/kg, model group gavage carboxymethyl cellulose suspension, 1 time/d.After last administration in 6th week, after water 1 evening is can't help in fasting, eye socket puts to death rat after getting blood, gets hepatic tissue and makes liver homogenate.
1.2.2 experimental index measures: illustrate by test kit and detect GPT, GOT, TG and TC in serum, by liver tissue homogenate's liquid of preparation, in 4 DEG C, centrifugal radius 8cm, the centrifugal 10min of 3500r/min, get supernatant centrifugal 10rain again, adopt TNF-α and IL-8 level in enzyme-linked immunosorbent assay liver homogenate.
1.3 statistical procedures: application SPSS11.5 software carries out statistical analysis, and measurement data represents with average ± standard deviation (x ± s), and adopt variance analysis, P<0.05 is significant difference, has statistical significance.
2 the results are shown in Table 1.
The comparison (x ± s) of table 1 13 groups of rat blood serum biochemical indicators
| 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,
aMP.AMp.Ampp<0.05.
Table 1 result show, 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 obviously can increase rat blood serum biochemical indicator (P<0.05).
13 groups of liver tissues of rats TNF-α and IL-8 level compare in table 2.
Table 2 13 groups of liver tissues of rats TNF-α 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,
aMP.AMp.Ampp<0.05.
Table 2 result show, compared with model group mice, each administration group in various degree add liver tissues of rats TNF-α and IL-8 level (P<0.01 or P<0.05); Respectively compared with comparative example 1, embodiment 1-10 group obviously can increase liver tissues of rats TNF-α and IL-8 level (P<0.05).
Above result shows, the pharmaceutical composition prepared in embodiment of the present invention 1-10 is used for the treatment of hepatopathy, and detoxifying, comparatively prior art is good for the effect protected the liver.
Herba Silybi mariani is catananche, and silibinin has bioactive main component in silymarin, and silibinin is natural anti-oxidation medicine, is used for the treatment of multiple hepatic disease for a long time, has good efficacy.The present embodiment is made up of silibinin and betanin, and silibinin is soluble in water, therefore it absorbs rapidly, has good biological availability.This result of study shows; after the treatment of application the present embodiment; each treatment group liver function, blood lipid level are clearly better, inflammation performance obviously alleviates; illustrate that pharmaceutical composition provided by the invention can improve NAFLD Liver Function and blood fat disorder; reduce inflammatory factor release, prompting this product may realize by suppressing the cytokines such as TNF-α and IL-8 the protective effect of NAFLD rat liver.
Although above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (10)
1. for the pharmaceutical composition of liver protecting therapy, it is characterized in that, the effective ingredient of described compositions is betanin and silymarin, and the two weight ratio is 200:7-14, and is aided with appropriate adjuvant.
2. pharmaceutical composition according to claim 1, is characterized in that, in described compositions, the weight ratio of betanin and silymarin is 100:5-6.
3. pharmaceutical composition according to claim 1, is characterized in that, in described compositions, the weight ratio of betanin and silymarin is 20:1.
4. the pharmaceutical composition according to any one of claim 1-3, it is characterized in that, described adjuvant includes but not limited to sucrose, micropowder silica gel, microcrystalline Cellulose, carboxymethyl starch sodium, hypromellose, jelly powder, citric acid, potassium sorbate, defatted milk powder, essence, pigment, Saccharum Sinensis Roxb..
5. the pharmaceutical composition according to any one of claim 1-3, is characterized in that, described compositions is powder, powder, pill or colloid agent.
6. the preparation method of pharmaceutical composition described in claim 5, is characterized in that, mixing after betanin, silymarin, sucrose and/or micropowder silica gel being pulverized, granulates.
7. the preparation method of pharmaceutical composition described in claim 5, is characterized in that, betanin, silymarin, microcrystalline Cellulose, carboxymethyl starch sodium and/or hypromellose is mixed, adds suitable quantity of water, stirs, makes pill.
8. the preparation method of pharmaceutical composition described in claim 5, is characterized in that, betanin, silymarin, Saccharum Sinensis Roxb. and jelly powder is mixed, make Icing Sugar, then in 50-60 DEG C of water, add Icing Sugar while stirring, be warming up to 85-95 DEG C, add the defatted milk powder that water in advance is dissolved, 5-10 minute after boiling, then add potassium sorbate, stop heating, treat that temperature is down to 60-75 DEG C, add the citric acid, pigment, the essence that have dissolved, filter with 100 mesh filter screens while hot, after cooling, obtain colloid agent.
9. preparation method according to claim 8, is characterized in that, betanin, silymarin, Saccharum Sinensis Roxb. and jelly powder is mixed, make Icing Sugar, then in 60 DEG C of water, add Icing Sugar while stirring, be warming up to 90 DEG C, add the defatted milk powder that water in advance is dissolved, seethe with excitement latter 10 minutes, then add potassium sorbate, stop heating, treat that temperature is down to 75 DEG C, add the citric acid, pigment, the essence that have dissolved, filter with 100 mesh filter screens while hot, after cooling, obtain colloid agent.
10. the application of pharmaceutical composition described in any one of claim 1-5 in preparation treatment hepatopathy, removing toxic substances hepatic.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105770188A (en) * | 2016-05-10 | 2016-07-20 | 李艳凤 | Traditional Chinese medicinal preparation for protecting liver and preparation method of traditional Chinese medicinal preparation |
| CN110354249A (en) * | 2019-07-26 | 2019-10-22 | 珠海宝德润生健康科技有限公司 | A kind of hepatoprotective composition and preparation method thereof |
| CN111450259A (en) * | 2020-03-31 | 2020-07-28 | 天津大学 | Synthesis method of mesoporous drug therapy system for treating hepatitis B |
| WO2020153909A1 (en) * | 2019-01-24 | 2020-07-30 | National University Of Singapore | Natural compound compositions for treating medical conditions |
Citations (1)
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| CN101933900A (en) * | 2009-07-02 | 2011-01-05 | 天津瑞普生物技术股份有限公司 | Compound preparation for preventing and treating poultry liver diseases and preparation method thereof |
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| CN101933900A (en) * | 2009-07-02 | 2011-01-05 | 天津瑞普生物技术股份有限公司 | Compound preparation for preventing and treating poultry liver diseases and preparation method thereof |
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| ASHWANI K. SINGAL等: "Antioxidants as Therapeutic Agents for Liver Disease", 《LIVER INT.》, vol. 31, no. 10, 30 November 2011 (2011-11-30), pages 1432 - 1448 * |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105770188A (en) * | 2016-05-10 | 2016-07-20 | 李艳凤 | Traditional Chinese medicinal preparation for protecting liver and preparation method of traditional Chinese medicinal preparation |
| CN105770188B (en) * | 2016-05-10 | 2019-12-06 | 李艳凤 | liver-protecting traditional Chinese medicine preparation and preparation method thereof |
| WO2020153909A1 (en) * | 2019-01-24 | 2020-07-30 | National University Of Singapore | Natural compound compositions for treating medical conditions |
| CN110354249A (en) * | 2019-07-26 | 2019-10-22 | 珠海宝德润生健康科技有限公司 | A kind of hepatoprotective composition and preparation method thereof |
| CN111450259A (en) * | 2020-03-31 | 2020-07-28 | 天津大学 | Synthesis method of mesoporous drug therapy system for treating hepatitis B |
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| CN104306370B (en) | 2016-11-23 |
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