CN101700278B - Composition for treating liver injury - Google Patents

Composition for treating liver injury Download PDF

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CN101700278B
CN101700278B CN 200910216532 CN200910216532A CN101700278B CN 101700278 B CN101700278 B CN 101700278B CN 200910216532 CN200910216532 CN 200910216532 CN 200910216532 A CN200910216532 A CN 200910216532A CN 101700278 B CN101700278 B CN 101700278B
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fructus schisandrae
schisandrae chinensis
baicalin
liver injury
compositions
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CN101700278A (en
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易进海
谭正怀
刘云华
唐大轩
刘玉红
黄志芳
陈燕
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Sichuan Shanggong Technology Co ltd
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Sichuan Academy of Chinese Medicine Sciences SACMS
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Abstract

The invention relates to a composition for treating liver injury, which is prepared from scutellarin and shiandra lignan which are used as effective medicinal ingredients and are matched with auxiliary addition ingredients capable of being accepted medicinally, wherein in the effective medicinal ingredients, the ratio in parts by weight of the scutellarin to the shiandra lignan metered by the dosage of the crude medicinal material shiandra is 1/4-1/100. Experiments indicate that the combination of the two effective medicinal ingredients has obvious synergy effect on treating acute hepatitis, chronic hepatitis and liver injury, and the effect is obviously superior to the effect obtained by the single action of the effective ingredients and is also superior to effect obtained by the combination of scutelloside and shiandra lignan.

Description

The compositions that is used for treating liver injury
Technical field
The present invention relates to a kind ofly can be used for hepatic injury, particularly be applicable to the treatment of control acute, chronic hepatitis to have the Pharmaceutical composition of function for protecting liver and reducing enzyme activity.
Background technology
Comprise that hepatitis B virus carries, the hepatopathy of chronic hepatitis etc., be one of the most outstanding at present public health problem of China.The liver protecting and ALT lowering class medicines such as baicalin capsule, five-ester capsule, capsule of schisandra fruit are class important drugs that can be used for treating hepatopathy at present.
Baicalin (Baicalei) is dissolved in ethanol, methanol, ether, acetone, ethyl acetate and hot glacial acetic acid, is slightly soluble in chloroform and Nitrobenzol, and is water-soluble hardly.Glassy yellow acicular crystal, fusing point are 268~272 ℃ (methanol).Baicalin has main pharmacological such as antiinflammatory antiallergic action, antibiotic, function of gallbladder promoting, diuresis, cholesterol reducing.The baicalin capsule has been used for the treatment of acute infectious hepatitis, and the intramuscular injection of baicalin injection is used for the treatment of acute anicteric hepatitis.
Fructus Schisandrae Chinensis includes Radix Schisandrae Bicoloris and Fructus Schisandrae Sphenantherae.Practising the Radix Schisandrae Bicoloris that claims is the dry mature fruit of magnoliaceae schisandra Schisandra chinesis (Turcz.) Baill; Fructus Schisandrae Sphenantherae is the dry mature fruit of Magnoliacea plant schisandra chinensis Schisandra sphenanthera Rehd.et Wils..The two all records in current edition " Chinese pharmacopoeia, have identical functions with cure mainly, restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming, can be used for chronic cough dyspnea due to deficiency, spontaneous perspiration, night sweat, seminal emission, spermatorrhea, incessant chronic diarrhea, Tianjin wound thirsty, quench one's thirst, cardiopalmus, insomnia, dreaminess etc.Studies show that at present; two kinds of Fructus Schisandrae Chinensis contain same or analogous chemical constituent; as lignanoid, volatile oil, organic acid etc.; the energy function of gallbladder promoting, transaminase lowering has protective effect to hepatocyte; can increase cellular immune function; make brain, liver, the active obviously enhancing of spleen SOD, so have the immunity of raising, antioxidation, anti-aging effects.Therefore, generally no longer distinguish in the present invention and be referred to as Fructus Schisandrae Chinensis.Fructus Schisandrae Chinensis and kernel ethanol extraction thereof cause that to rabbit, rat and Mouse Liver infringement due to the carbon tetrachloride Glutamate pyruvate transaminase rises has tangible reduction effect.22 kinds of lignanoid that report obtains from Fructus Schisandrae Chinensis and derivants thereof are arranged, find that nearly all lignanoid is to CCl 4Reaching the galactosamine hepatic injury all has inhibitory action, and therefrom separating (Fructus Schisandrae Chinensis) ester first, ester second, ester third and the ester fourth that obtain all has effect of reducing enzyme levels.Fructus Schisandrae Chinensis preparation and schisandrin B, the schisandra chinensis ester is first-class can also alleviate or suppress CCl 4Or hepatic injury due to the thio-ethylamine.At present with schizandrol extractum (magnolia vine fruit kernel alcohol extract, this product contains schizandrol and calculates by schisandrin B, must not be lower than 9.0%) medicine made is capsule of schisandra fruit, function cures mainly and is nourishing the liver and kidney, is used for acute and chronic, chronic persistent hepatitis (GPT is higher) and the disease person of the tool hepatic and renal YIN deficiency; The medicine made from Fructus Schisandrae Sphenantherae ethanol extractum is the five-ester capsule, can reduce serum glutamic pyruvic transminase, can be used for chronic, chronic persistent hepatitis Glutamate pyruvate transaminase rises person.
Summary of the invention
At above-mentioned situation, the present invention will provide a kind of and confirm be used for the treatment of acute, chronic hepatitis through test, and the compositions that has positive and better effect aspect function for protecting liver and reducing enzyme activity.
The present invention treats the pharmaceutical composition of hepatic injury, is to be effective medicinal ingredient with baicalin and Fructus Schisandrae Chinensis lignanoid, forms jointly with the auxiliary adding ingredient of acceptable in the medicine.Wherein, the baicalin in said effective medicinal ingredient and be 1/4~1/100 in the weight portion ratio of the Fructus Schisandrae Chinensis lignanoid of crude drug raw material Fructus Schisandrae Chinensis amount, better ratio is 1/10~1/40, preferred ratio is 1/20.
Baicalin is the main medicinal ingredient in the baikal skullcap root effective ingredient noroxylin, and is now existing widely used a kind of active drug composition.Present its source and acquisition mode, can be by obtaining after with conventional method hydrolysis or enzymolysis from the baicalin of medicinal raw material Radix Scutellariae extract, also can obtain, or obtain through chemical improvement and/or after modifying by other related compound by full chemosynthesis mode.Wherein, the simplest usual way, be by natural medicinal raw material---can comprise the medicinal raw material Radix Scutellariae of general common direct employing, or equally also to contain other natural medicinal raw material of baicalin composition, as and the multiple natural medicinal raw materials such as leaf of the seed of the Ye Hegen of head grass, Bignoniaceae plant Semen Oroxyli and peel of stem, Plantaginaceae plant Big Semen Plantaginis, be hydrolyzed again after obtaining the baicalin extract and obtain baicalin through extracting with separating.
When adopting the baicalin composition that obtains with the raw extract mode by crude drug, except that can after further separation and purification, obtaining the baicalin of single respective pure form, can allow to use also contain simultaneously mainly be present in the extract as wogonin, oroxylin A, can add other flavone aglycone chemical compound composition such as baicalin, 7-methoxyl group baicalin, and can not have a negative impact and the mixture of other impurity component form of being difficult to avoid, but generally should not contain glycoside compositions such as baicalin to the effect of baicalin.Said scutellaria root flavone general aglycone extract, generally can by the Radix Scutellariae raw medicinal herbs behind self enzymolysis, alcohol extraction, recovery ethanol separate out the scutellaria root flavone general aglycone that precipitation obtains.Result of the test shows, in aforementioned pharmaceutical compositions of the present invention, adopts and replaces with the scutellaria root flavone general aglycone extract that contains said amount baicalin, generally can tangible influence or change not arranged to its function for protecting liver and reducing enzyme activity.Requirement and allowed band according to different preparations, and the chemical compound of single respective pure form is used in nonessential requirement and allow these impurity components to exist simultaneously with suitable form and/or ratio, can help simplifying greatly medicine production technical process of the present invention, reduce the cost of medicine.
Equally, the effective Fructus Schisandrae Chinensis lignanoid in the medicinal ingredient also allows to replace with the Fructus Schisandrae Chinensis extrat that contains said amount Fructus Schisandrae Chinensis lignanoid.Said Fructus Schisandrae Chinensis extrat can be for ethanol extraction currently reported and that use, as Fructus Schisandrae Sphenantherae ethanol extractum, magnolia vine fruit kernel alcohol extract etc.Research at present shows, Radix Schisandrae Bicoloris and Fructus Schisandrae Sphenantherae contain essentially identical chemical constituent and identical functions and cure mainly, so said in the present invention Fructus Schisandrae Chinensis extrat, can derive from Radix Schisandrae Bicoloris and/or Fructus Schisandrae Sphenantherae and need not differentiation, in the pharmaceutical composition that can realize the object of the invention, need not special differentiation at least.
Relevant results of pharmacodynamic test shows, in the aforementioned pharmaceutical compositions, said active drug composition baicalin replaces with the scutellaria root flavone general aglycone extract (not containing glycoside compositions such as baicalin) that contains said amount baicalin, and/or said active drug composition Fructus Schisandrae Chinensis lignanoid replaces with the Fructus Schisandrae Chinensis extrat that contains said amount Fructus Schisandrae Chinensis lignanoid, can the effect and the effect of said pharmaceutical composition do not had a negative impact.
Above-mentioned two effective medicinal ingredients or said its corresponding extract specifically all can be by the method preparations of at present existing bibliographical information.For example, Fructus Schisandrae Chinensis extrat can be got the crude drug Fructus Schisandrae Chinensis and decoct with water 1 hour by the mode in " Chinese traditional patent formulation preparation " the 11st, filter, discard filtrate, the medicinal residues oven dry is pulverized, with 70% alcohol reflux 2 times, each 1.5 hours, filter merging filtrate, be concentrated into thick paste, promptly get Fructus Schisandrae Chinensis extrat; Or its ethanol extract is concentrated into rare extractum (do not have alcohol flavor), water precipitating divides and takes off the oily precipitation that layer contains lignanoid's composition and be Fructus Schisandrae Chinensis extrat.Or according to the mode in " Chinese traditional patent formulation preparation " the 19th, get drying, the Fructus Schisandrae Chinensis after pulverizing, with 75% alcohol reflux three times, add for the first time 4 times of amount 75% ethanol, refluxed 3 hours, add 3 times of amount 75% ethanol for the second time, refluxed 2 hours, and added 3 times of amount 75% ethanol for the third time, refluxed 1 hour, merge extractive liquid, left standstill 48 hours, drew supernatant, decompression recycling ethanol adds 90% alcohol reflux 2 hours again, filters, collect filtrate, decompression recycling ethanol, promptly.
Scutellaria root flavone general aglycone extract can be with reference to the mode in this Chinese patent 2007100483153, get radix scutellariae medicinal materials, pulverize, add the water heat tracing, carry out enzyme digestion reaction, filter, discard filtrate, the medicinal residues alcohol reflux, extracting solution reclaims ethanol, separate out precipitation,, promptly get scutellaria root flavone general aglycone extract sedimentation and filtration, drying.Can also further obtain scutellaria root flavone general aglycone extract with ethanol purification.
The inventor's further investigation finds that two effective medicinal ingredients in the above-mentioned form compositions are being used for the treatment of acute, chronic hepatitis, and aspect such as function for protecting liver and reducing enzyme activity, can produce remarkable role in synergy.
According to actual needs, the above-mentioned compositions of the present invention can be by present usual manner, by the corresponding auxiliary adding ingredient of acceptable in said drug effect medicinal ingredient and the medicine, as disintegrating agent, excipient, lubricant, binding agent, filler etc., co-production becomes the operational oral type pharmaceutical preparation that comprises common formulations such as tablet, drop pill, capsule, micropill.
The specific embodiment by the following examples is described in further detail foregoing of the present invention again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.Do not breaking away under the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
The specific embodiment
Embodiment 1
Get Fructus Schisandrae Sphenantherae (or Radix Schisandrae Bicoloris) 15kg, decoct with water 1 hour, filter, discard filtrate, the medicinal residues oven dry is pulverized, with 70% alcohol reflux 2 times, each 1.5 hours, filter, merging filtrate, reclaim ethanol to there not being the alcohol flavor, it is an amount of to add water, fully stirs, standing over night, inclining supernatant, and lower floor's oily precipitation is separated through silica gel column chromatography, earlier with petroleum ether-ethyl acetate (10: 1) eluting remove impurity, reuse petroleum ether-ethyl acetate (10: 4) eluting, thin layer chromatography is checked, merges and contains lignanoid's part, removes solvent, get Fructus Schisandrae Chinensis lignanoid, wherein total lignans content 〉=95.0%.
Get pure product of baicalin (0.1kg, weight content 〉=98.0%) and above-mentioned Fructus Schisandrae Chinensis lignanoid (being equivalent to the 1kg Fructus Schisandrae Chinensis), add in the Polyethylene Glycol that dissolves, stir evenly, make drop pill, promptly get corresponding drop pills oral medicine.
Embodiment 2
Get Fructus Schisandrae Sphenantherae (or Radix Schisandrae Bicoloris) 10kg, decoct with water 1 hour, filter, discard filtrate, the medicinal residues oven dry is pulverized, with 70% alcohol reflux 2 times, each 1.5 hours, filter, merging filtrate, decompression recycling ethanol, it is an amount of to add water, stir, staticly settle, inclining supernatant, and lower floor's oily precipitation is Fructus Schisandrae Chinensis extrat.
Get pure product of baicalin (0.2kg, weight content 〉=98.0%) and above-mentioned Fructus Schisandrae Chinensis lignans extract (being equivalent to the 0.8kg Fructus Schisandrae Chinensis), add in the Polyethylene Glycol that dissolves, stir evenly, make drop pill, promptly get the drop pills oral medicine preparation.
Embodiment 3
Get Radix Scutellariae 10kg, pulverize, add water 4-10 doubly, in 40-70 ℃ of insulation 3-10 hour, carry out enzyme digestion reaction, filtering, is 50~95% alcohol reflux with medicinal residues concentration, extracting solution recovery ethanol, separate out precipitation, with sedimentation and filtration, drying, promptly get scutellaria root flavone general aglycone extract, baicalin weight content 〉=40%.
Get Radix Schisandrae Bicoloris (or Fructus Schisandrae Sphenantherae) 10kg, decoct with water 1 hour, filter, discard filtrate, the medicinal residues oven dry is pulverized, with 70% alcohol reflux 2 times, and each 1-2 hour, filter, merging filtrate, concentrated, promptly get Fructus Schisandrae Chinensis extrat.
Get the scutellaria root flavone general aglycone extract and the Fructus Schisandrae Chinensis extrat that is equivalent to the 2kg Fructus Schisandrae Chinensis of the above-mentioned 0.1kg of being equivalent to baicalin, adding starch is an amount of, and mix homogeneously is granulated, and incapsulates, and makes 1000, promptly gets described capsule oral drugs.
Embodiment 4
Get Radix Scutellariae 5kg, pulverize, add water 3-6 doubly, in 30-60 ℃ of insulation 3-8 hour, carry out enzyme digestion reaction, filtering, is 60~95% alcohol reflux with medicinal residues concentration, extracting solution recovery ethanol, separate out precipitation, with sedimentation and filtration, drying, promptly get scutellaria root flavone general aglycone extract, baicalin weight content 〉=40%.
Get Fructus Schisandrae Sphenantherae (or Radix Schisandrae Bicoloris) 5kg, decoct with water 1 time, filter, discard filtrate, the medicinal residues oven dry is pulverized, with 60-90% alcohol reflux 2 times, filter merging filtrate, decompression recycling ethanol, it is an amount of to add water, stirs, and staticly settles, inclining supernatant, and lower floor's oily precipitation is Fructus Schisandrae Chinensis extrat.
Get the scutellaria root flavone general aglycone extract and the Fructus Schisandrae Chinensis lignans extract that is equivalent to the 2kg Fructus Schisandrae Chinensis of the above-mentioned 0.1kg of being equivalent to baicalin, adding starch and Icing Sugar are an amount of, and mix homogeneously is granulated, and tabletting is made 2000, promptly gets described tablet oral drugs.
Embodiment 5
Get the pure product of baicalin (0.1kg, weight content 〉=98.0%) and, add right amount of auxiliary materials by the Fructus Schisandrae Chinensis extrat (being equivalent to the 4kg Fructus Schisandrae Chinensis) that the foregoing description 3 modes prepare, mix homogeneously, the extruding pill promptly gets described pill oral drugs.
Embodiment 6
Get Radix Scutellariae 10kg, pulverize, add water 4-10 doubly, in 40-70 ℃ of insulation 3-10 hour, carrying out enzyme digestion reaction, filter, is 50~95% alcohol reflux with medicinal residues concentration, extracting solution reclaims ethanol, separate out precipitation, filter reuse ethyl alcohol recrystallization purification, promptly get scutellaria root flavone general aglycone extract, baicalin weight content 〉=60%.
Get the scutellaria root flavone general aglycone extract of the above-mentioned 0.1kg of being equivalent to baicalin and the Fructus Schisandrae Chinensis lignanoid that is equivalent to the 10kg Fructus Schisandrae Chinensis that embodiment 1 mode prepares, mix, adding starch and Icing Sugar are an amount of, mix homogeneously is granulated tabletting, make 5000, promptly get described tablet oral drugs.
With baicalin and Fructus Schisandrae Chinensis lignanoid is that the pharmaceutical composition of the different proportion composition form of effective medicinal ingredient carries out following experimental study as trial drug.
1 material
1.1 experiment medicine
Baicalin: weight content 〉=98.0%, this test dose calculates with its weight (g).
Scutellaria root flavone general aglycone extract: this test dose calculates with the weight (g) that it contains baicalin.
Fructus Schisandrae Chinensis lignanoid (hereinafter to be referred as Fructus Schisandrae Chinensis): this test dose extracts with raw material crude drug Fructus Schisandrae Chinensis weight (g) with it and calculates.
Fructus Schisandrae Chinensis extrat: this test dose all extracts with raw material crude drug Fructus Schisandrae Chinensis weight (g) with it and calculates.
Con A:Sigma product faces the solution for standby that is made into desired concn with sterile saline with preceding.
Acetaminophen: chemical pure, to produce by Chemical Reagent Co., Ltd., Sinopharm Group, lot number is F20041216, faces the solution for standby that is made into desired concn with the warm distilled water of preceding usefulness.
CCl 4: face the solution for standby that is made into desired concn with olive oil with preceding.
Thioacetamide: analytical pure (AR), the 25g/ bottle, Tianjin Da Mao chemical reagent factory produces, and lot number is 2004,1,11, faces the solution for standby that is made into desired concn with sterile saline with preceding.
Glutamate pyruvate transaminase is measured test kit (ALT), glutamic oxaloacetic transaminase, GOT is measured test kit (AST), triglyceride (TG) is measured test kit, and T-CHOL (TC) is measured test kit (COD-CE-PAP method): lot number is 0805031, all available from Maike Tech Co., Ltd., Sichuan Prov..
1.2 laboratory animal
Mice: the ICR mice, male, the one-level animal, Jianyang branch of Chinese Academy of Medical Sciences Experimental Animal Center provides, and Kunming kind one-level mice is male, is provided by the Sichuan Provincial Academy of Traditional Chinese Medicine Experimental Animal Center.
2 methods and result
2.1 Con A is caused the influence of mouse liver injury model
Get the male ICR mouse that body weight is 22-24g, be divided into 10 groups at random, irritate stomach baicalin 0.1g/kg respectively, baicalin 0.5g/kg, Fructus Schisandrae Chinensis 0.4g/kg, Fructus Schisandrae Chinensis 2.0g/kg, baicalin 0.1g/kg+ Fructus Schisandrae Chinensis 0.4g/kg, baicalin 0.1g/kg+ Fructus Schisandrae Chinensis 2.0g/kg, baicalin 0.5g/kg+ Fructus Schisandrae Chinensis 0.4g/kg and baicalin 0.5g/kg+ Fructus Schisandrae Chinensis 2.0g/kg and equivalent 0.5%CMC, once a day, continuous 5 times, 40min is except that matched group after the last administration, the equal intravenous injection Con of all the other each treated animals A 25mg/kg, matched group is then given isopyknic normal saline, water 16h is can't help in the animal fasting then, gets hematometry its serum AST and ALT activity.
Table 1 baicalin, Fructus Schisandrae Chinensis different proportion cause the influence (x ± S) of mouse liver injury model to ConA
Figure G2009102165328D00061
Annotate: compare with model group: *P<0.05, * *P<0.001.
Table 2 pair AST index analysis of variance table
Figure G2009102165328D00071
Table 3 pair ALT index analysis of variance table
The result of table 1, table 2 and table 3 shows that all baicalin, Fructus Schisandrae Chinensis list are used or share all and can significantly reduce the activity of ConA mice serum AST and ALT, obviously strengthens but share the effect of single time spent of back, with model group significant difference is arranged relatively.As seen from Table 2, there are significant synergism in baicalin and Fructus Schisandrae Chinensis on reduction ConA mice serum AST activity; As seen from Table 3, there are significant synergism in baicalin and Fructus Schisandrae Chinensis on reduction Con A mice serum ALT activity.When the dosage of baicalin and Fructus Schisandrae Chinensis was heavy dose, the effect of its anti-acute liver damage effect and existing market anti-liver injury Western medicine new drug bicyclol was suitable.
2.2 to CCl 4Cause the influence of chmice acute liver injury model
Get the male ICR mouse that body weight is 22-24g, press table 6 gastric infusion, once a day, continuous 5 times, after the last administration 40min except that matched group, the equal lumbar injection CCl of all the other each treated animals 4(0.13ml/kg be diluted in the olive oil, the administration volume is 10ml/kg), matched group is then given isopyknic normal saline, and water 16h is can't help in the animal fasting then, gets hematometry its serum AST and ALT activity, the results are shown in Table 4.
Table 4 result shows, baicalin, Fructus Schisandrae Chinensis list with or unite with all can significantly reducing CCl 4The activity of mice serum AST and ALT relatively has significant difference with model group; Effect during use in conjunction significantly strengthens, the best results when its weight ratio is 0.25: 5.
2.3 to CCl 4Cause the influence of chmice acute liver injury model
Get the male ICR mouse that body weight is 22-24g, be divided into 8 groups of (I~VIII) at random, every group 10, irritate stomach baicalin 0.1g/kg+ Fructus Schisandrae Chinensis 2g/kg (III) respectively by the amount of table 5, baicalin 0.1g/kg+ Fructus Schisandrae Chinensis extrat (embodiment 2) 2g/kg (IV), baicalin 0.1g/kg+ Fructus Schisandrae Chinensis extrat (embodiment 3) 2g/kg (V), scutellaria root flavone general aglycone extract (embodiment 3) 0.1g/kg+ Fructus Schisandrae Chinensis 2g/kg (VI), scutellaria root flavone general aglycone extract 0.1g/kg+ Fructus Schisandrae Chinensis extrat (embodiment 2) 2g/kg (VII), scutellaria root flavone general aglycone extract 0.1g/kg+ Fructus Schisandrae Chinensis extrat (embodiment 3) 2g/kg (VIII) and equivalent 0.5%CMC, once a day, continuous 5 times
Table 4 baicalin, Fructus Schisandrae Chinensis different proportion are to CCl 4Cause the influence (x ± S) of mouse liver injury model
Figure G2009102165328D00081
Annotate: compare with model group: *P<0.05, * *P<0.001.
40min is except that matched group after the last administration, the equal lumbar injection CCl of all the other each treated animals 4(0.13ml/kg be diluted in the olive oil, the administration volume is 10ml/kg), matched group is then given isopyknic normal saline, and water 16h is can't help in the animal fasting then, gets hematometry its serum AST and ALT activity, the results are shown in Table 5.
Table 5 baicalin or its extract substitute and Fructus Schisandrae Chinensis or its extract substitute
To CCl 4Cause the influence (x ± S) of mouse liver injury model
Figure G2009102165328D00082
Annotate: compare with model group: *P<0.05, * *P<0.001.
The result of table 5 shows, no matter be that baicalin or scutellaria root flavone general aglycone extract all have similar function for protecting liver and reducing enzyme activity to Fructus Schisandrae Chinensis lignanoid or Fructus Schisandrae Chinensis extrat compatibility, with model group significant difference is arranged relatively, show in pharmaceutical composition of the present invention, baicalin in the active drug composition replaces with and contains said amount scutellaria root flavone general aglycone extract, and/or Fructus Schisandrae Chinensis lignanoid replaces with and contains said amount Fructus Schisandrae Chinensis extrat, the effect that can have basically identical can not have a negative impact to the effect and the effect of said pharmaceutical composition.
With pharmaceutical composition of the present invention (scutellaria root flavone general aglycone extract 2g crude drug/kg+ Fructus Schisandrae Chinensis extrat 2g crude drug/kg) further with carry out function for protecting liver and reducing enzyme activity by Radix Scutellariae extract (content of baicalin 〉=85%) the 2g pharmaceutical composition that crude drug/kg+ Fructus Schisandrae Chinensis extrat 2g crude drug/kg forms relatively, the results are shown in Table 6.
Table 6 Radix Scutellariae, Fructus Schisandrae Chinensis different proportion are to CCl 4Cause the influence (x ± S) of mouse liver injury model
Figure G2009102165328D00091
Annotate: compare with model group: P<0.05, * *P<0.001.
By table 6 as seen: be equivalent to the Radix Scutellariae extract that waits the scutellaria root flavone general aglycone extract of crude drug amount and be mainly baicalin respectively with the Fructus Schisandrae Chinensis extrat compatibility, the two all has function for protecting liver and reducing enzyme activity, with model group significant difference is arranged relatively, but the former obviously is better than the latter (P<0.05).
Above-mentioned experimental result is clear to be shown, by baicalin or Radix Scutellariae total glucosides unit's extract and Fructus Schisandrae Chinensis lignanoid or its extract is the pharmaceutical composition of the present invention of effective medicinal ingredient, comprehensive protecting the liver, can have remarkable role in synergy aspect the effect of reducing enzyme levels, its result obviously is better than wherein the effectively independent effect of medicinal ingredient baicalin and Fructus Schisandrae Chinensis lignanoid, thereby has gratifying DEVELOPMENT PROSPECT and value.

Claims (5)

1. the compositions that is used for treating liver injury, it is characterized in that with baicalin and Fructus Schisandrae Chinensis lignanoid be effective medicinal ingredient, form the baicalin in said effective medicinal ingredient and be 1/4~1/20 jointly in the weight portion ratio of the Fructus Schisandrae Chinensis lignanoid of crude drug raw material Fructus Schisandrae Chinensis amount with the auxiliary adding ingredient of acceptable in the medicine.
2. the compositions that is used for treating liver injury as claimed in claim 1 is characterized in that said baicalin and is 1/20 in the weight portion ratio of the Fructus Schisandrae Chinensis lignanoid of crude drug raw material Fructus Schisandrae Chinensis amount.
3. the compositions that is used for treating liver injury as claimed in claim 1 or 2 is characterized in that said effective medicinal ingredient baicalin replaces with the scutellaria root flavone general aglycone that contains said amount baicalin.
4. the compositions that is used for treating liver injury as claimed in claim 1 or 2 is characterized in that said effective medicinal ingredient Fructus Schisandrae Chinensis lignanoid replaces with the ethanol extraction of the Fructus Schisandrae Chinensis that contains said amount Fructus Schisandrae Chinensis lignanoid.
5. the compositions that is used for treating liver injury as claimed in claim 1 or 2 is characterized in that said compositions is oral type pharmaceutical preparation.
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