Summary of the invention
The present patent application people has obtained a kind of Pharmaceutical composition for the treatment of acute, chronic hepatitis, fatty liver through repeatedly studying, developing, thereby has finished the present invention on the basis of secret prescription handed down in the family from generation to generation.Said composition is made by Fructus Schisandrae Chinensis, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli, can effectively treat acute, chronic hepatitis, alleviate its related symptoms, blood lipid regulation, opposing infection, the liver protecting, and toxic and side effects is little, and is evident in efficacy.And it is simple to prepare the method technology that the present composition adopts, product quality be easy to control and cost lower.
The treatment that Fructus Schisandrae Chinensis is used for hepatitis has had application for a long time.Its main effective ingredient is a lignanoids aspect the hepatitis being used for, (γ-Schizandrin), schisandrin (Schizandrin), schisantherin B (Aomisin), schisandrin C (Pseudo-r-Schizandrin), schisantherin A (SchisantherinA) etc. also contain organic acid chemical compounds such as multiple volatile oil such as pinene and citric acid, malic acid, tartaric acid as deoxyschizandrin (Deoxyschizandrin), schisandrin B.Specific to effect be: have the effect that reduces glutamate pyruvate transaminase, can be used for treating various acute, chronic hepatitis, viral and chronic persistent hepatitis, can strengthen central nervous system's irritability, improve intellectual activity efficient, can also prevent the gastric mucosa injury that causes by ethanol, and vasodilator and certain cardiotonic are arranged.
Chrysomyiame gacephala (Fab.) is called maggot in spoken language, be the dry larva of Calliphoridae insecticide chrysomyia megacephala (big head golden fly) or other nearly edge insecticide, and its concrete effect is classified as the spleen invigorating removing food stagnancy in the traditional Chinese medical science, and heat clearing away removes infantile malnutrition.Specific to corresponding disease is infantile malnutrition heating, food stagnation dysentery, chancre, eye disorder due to malnutrition in children, acute gangrenous stomatitis.Say that on chemical composition analyzing the Chrysomyiame gacephala (Fab.) grind into powder as can be known, it contains alkaloid, oils and fats, protein and aminoacid.Concrete pharmacological action for relieving asthma, the ileum smooth muscle spasm all has and significantly strives the convulsion effect.
Oletum Trogopterori is the feces of Mammalia, flying squirrel section animal trogopterus xanthipes Milne-Edwards (cold number bird), flying squirrel or other nearly edge animal, and it is a lot of that function cures mainly project, promoting blood circulation to remove blood stasis, parch to black hemostasis.Be used for trusted subordinate's congestion and have a pain, dysmenorrhea, the blood stasis amenorrhea, puerperal abdominalgia with blood stasis; Traumatic injury is controlled in external, and Serpentis, insect bite are hindered.
Endothelium Corneum Gigeriae Galli is the dry gizzard tunica intima of Phasianidae animal man chicken.According to the viewpoint of the traditional Chinese medical science, gastric secretion, acidity and eupepsy are all seen and are increased behind the human oral Endothelium Corneum Gigeriae Galli, and wherein the increase of eupepsy occurs slowlyer, keeps also more of a specified duration.The back gastric motor function of taking medicine obviously strengthens, and shows stomach prolongation and the wriggling enhancing of moving period, strengthens because stomach moves, so gastric emptying rate is also accelerated greatly.Do not contain any digestive enzyme in the Endothelium Corneum Gigeriae Galli itself, it is not to produce immediately after taking medicine to the influence of stomachial secretion and motion, and must be through after a while, so its effect is caused by certain humoral factor that medicine is entered after digesting in the blood.
On the one hand, the invention provides a kind of compositions that is used for the treatment of acute, chronic hepatitis, fatty liver, it is made by Fructus Schisandrae Chinensis, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli.Wherein, the parts by weight of each composition are as follows: Fructus Schisandrae Chinensis 0.5-500; Chrysomyiame gacephala (Fab.) 20-500; Oletum Trogopterori 20-500; Endothelium Corneum Gigeriae Galli 20-500.Be preferably Fructus Schisandrae Chinensis 2-300; Chrysomyiame gacephala (Fab.) 50-300; Oletum Trogopterori 50-300; Endothelium Corneum Gigeriae Galli 50-300.Most preferably be Fructus Schisandrae Chinensis 10-200; Chrysomyiame gacephala (Fab.) 100-200; Oletum Trogopterori 100-200; Endothelium Corneum Gigeriae Galli 100-200.
In the compositions of the present invention's preparation, Fructus Schisandrae Chinensis can be the medicated powder after schisandra chinensis medicinal material is pulverized or Fructus Schisandrae Chinensis be extracted the back adopt its extract, can also adopt the known active component with the effect of treatment hepatopathy that extracts in the Fructus Schisandrae Chinensis, as in schizandrin, deoxyschizandrin, schisandrin B, Fructus Schisandrae Chinensis polysaccharide, schisandrin, schisantherin B, schisandrin C, the schisantherin A one or more.The preferred extract that adopts Fructus Schisandrae Chinensis more preferably adopts the water solublity and/or the liposoluble extract of Fructus Schisandrae Chinensis, especially preferably adopts the water solubility extract of Fructus Schisandrae Chinensis, and most preferred Fructus Schisandrae Chinensis extrat is that the alcohol of Fructus Schisandrae Chinensis is or/and water extract.The used Fructus Schisandrae Chinensis of the present invention is not subjected to the restriction of extraction process.
Preferred Fructus Schisandrae Chinensis extraction process can be: get schisandra raw material, and broken 40 mesh sieves of crossing, the alcohol heating reflux that adds 80% concentration then extracts, and extraction time is 1-5 time, and each extraction time is about 2-3 hour.Get final product Fructus Schisandrae Chinensis extrat.
In the compositions of the present invention's preparation, Chrysomyiame gacephala (Fab.) can be the Chrysomyiame gacephala (Fab.) powder through grinding, and can also be the commercially available medical material of Chrysomyiame gacephala (Fab.), or Chrysomyiame gacephala (Fab.) boils or the extract of Chrysomyiame gacephala (Fab.) after water and/or extraction through decocting.Chrysomyiame gacephala (Fab.) grounds travel (hereinafter to be referred as the Chrysomyiame gacephala (Fab.) powder) preferably.It obtains technology can be to get Chrysomyiame gacephala (Fab.), and the removing dirt carries out disinfection then, and sterilization is adopted and soaked ethanol 5-20 hour or individual hour method of radiation 1-20.Behind microwave drying, grind into powder.
In the compositions of the present invention preparation, Oletum Trogopterori can be that powder, the feces after trogopterus xanthipes Milne-Edwards (cold number bird), flying squirrel or other nearly edge animal wastes are smashed to pieces is smashed the back to pieces and sprayed yellow wine and fry powder to little the doing or feces and smash the back to pieces and spray vinegar and fry powder to little the doing, can also be that Oletum Trogopterori boils or the extract of Oletum Trogopterori after water and/or alcohol extraction through decocting.Be preferably the powder (abbreviating the Oletum Trogopterori powder as) after feces is smashed extremely little the doing of back sprinkling vinegar stir-fry to pieces.
In the compositions of the present invention's preparation, Endothelium Corneum Gigeriae Galli can be the powder that grinds to form after Endothelium Corneum Gigeriae Galli is concocted, and can also be that decocting boils or the extract of Endothelium Corneum Gigeriae Galli after water and/or alcohol extraction.The powder that grinds to form after preferably Endothelium Corneum Gigeriae Galli is concocted.Preparation technology pulverizes then according to Endothelium Corneum Gigeriae Galli process of preparing Chinese medicine scheme Endothelium Corneum Gigeriae Galli (parched), the vinegar Endothelium Corneum Gigeriae Galli of the 133rd page of record of one one of Chinese Pharmacopoeia (2005 editions).Most preferably be used as medicine (the abbreviating Endothelium Corneum Gigeriae Galli powder as) of pulverizing after the chicken inner wall of sandbag spray vinegar.What should be noted that is, according to the use of the existing traditional Chinese medical science to Endothelium Corneum Gigeriae Galli, Endothelium Corneum Gigeriae Galli can also be substituted by Endothelium corneum Anas domestica, Endothelium corneum Anseris domestica, and just effect is weaker a little, and this technical scheme change drops within the scope of the invention.
Compositions of the present invention can be by pressing field of Chinese medicines conventional method with above medicine materials in portions by weight, weighing, back mixed the getting of pulverizing, sieve.
Compositions of the present invention can also be mixed extract by after above medicine materials in portions by weight is extracted, and makes.
Compositions of the present invention can also get extract with the part medicinal material extract, and other pulverizing medicinal materials gets medicated powder, and extract and medicated powder are mixed, and makes.Preferably Fructus Schisandrae Chinensis is extracted, other pulverizing medicinal materials is mixed Fructus Schisandrae Chinensis extrat with other medical material, gets pharmaceutical composition of the present invention.Wherein, Fructus Schisandrae Chinensis extrat can be one or more in the water solublity of Fructus Schisandrae Chinensis and/or liposoluble extract or schizandrin, deoxyschizandrin, schisandrin B, Fructus Schisandrae Chinensis polysaccharide, schisandrin, schisantherin B, schisandrin C, the schisantherin A, especially preferably adopt the water solubility extract of Fructus Schisandrae Chinensis, most preferred Fructus Schisandrae Chinensis extrat is that the alcohol of Fructus Schisandrae Chinensis is or/and water extract.
Compositions of the present invention can also be by pressing field of Chinese medicines conventional method with above medicine materials in portions by weight, and weighing, decoction make.
Preferred manufacturing procedure is, takes by weighing medical material, with Fructus Schisandrae Chinensis extract extract, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli are pulverized, mix Fructus Schisandrae Chinensis extrat and Chrysomyiame gacephala (Fab.) powder, Oletum Trogopterori powder and Endothelium Corneum Gigeriae Galli powder.
Compositions of the present invention can directly be taken, also can mix with one or more pharmaceutically acceptable carriers, be made into required dosage form then, medicinal material extract can also be concentrated the back and mix, be made into required dosage form then with one or more pharmaceutically acceptable carriers.
Compositions of the present invention can be pharmaceutically acceptable any oral formulations form, and dosage form includes but not limited to hard capsule, soft capsule, tablet, granule, pill, suspensoid, powder, pill, oral liquid etc.
Can choose pharmaceutically acceptable carrier wantonly in during composite preparation of the present invention.For example capsule can contain for example mixture of crystallization and microcrystalline Cellulose, dextrin, gelatin, natural gum etc. of for example pharmaceutically acceptable starch of (one or more) reactive compound and inert filler and/or diluent (as corn, Rhizoma Solani tuber osi or tapioca), sugar, artificial sweetener, Powderd cellulose.Tablet can be according to the squeezing and pressing method of routine, wet granulation process or dry granulation method prepare, use acceptable diluents simultaneously, binding agent, lubricant, disintegrating agent, surfactant, suspending agent or stabilizing agent include but not limited to magnesium stearate, stearic acid, Talcum, sodium lauryl sulphate, microcrystalline Cellulose, carboxymethylcellulose calcium, polyvinyl pyrrolidone, gelatin, alginic acid, arabic gum, xanthan gum, sodium citrate, composition silicate, calcium carbonate, glycine, dextrin, sucrose, Sorbitol, dicalcium phosphate, calcium sulfate, lactose, Kaolin, mannitol, sodium chloride, Talcum, dry starch and Icing Sugar.Preferred surfactants comprises nonionic and anion surfactant.The representative example of surfactant includes but not limited to poloxamer 188, benzalkonium chloride, calcium stearate, cetostearyl alcohol, cetomacrogol emulsifying wax, sorbitan ester, silica sol, phosphate, sodium lauryl sulphate, aluminium-magnesium silicate and triethanolamine.Preparation of the present invention can adopt conventional delay to disengage or disengage preparation in limited time to change the absorbing state of reactive compound.
Compositions of the present invention, the amount that contains Fructus Schisandrae Chinensis, Chrysomyiame gacephala (Fab.), Oletum Trogopterori and Endothelium Corneum Gigeriae Galli crude drug in the unit formulation is Fructus Schisandrae Chinensis 0.001-2g, Chrysomyiame gacephala (Fab.) 0.04-2g, Oletum Trogopterori 0.04-2g, Endothelium Corneum Gigeriae Galli 0.04-2g, preferred Fructus Schisandrae Chinensis 0.004-1g, Chrysomyiame gacephala (Fab.) 0.1-1g, Oletum Trogopterori 0.1-1g, Endothelium Corneum Gigeriae Galli 0.1-1g, more preferably Fructus Schisandrae Chinensis 0.02-0.4g, Chrysomyiame gacephala (Fab.) 0.2-0.4g, Oletum Trogopterori 0.2-0.4g, Endothelium Corneum Gigeriae Galli 0.2-0.4g.。
In an embodiment preferred of the present invention, its preparation technology adds water 5-15 and doubly measures decoction 1-5 time for getting Fructus Schisandrae Chinensis, decocts 1-3 hour at every turn.Collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.20-2.00 (40 ℃), dry, pulverizing adds the Chrysomyiame gacephala (Fab.) powder, Oletum Trogopterori powder, the Endothelium Corneum Gigeriae Galli powder that have made and mixes, add adjuvant then and be prepared as pharmaceutically acceptable dosage form, as granule, tablet, pill, capsule.Drying means can be industrial suitable conventional drying method in this process, such as constant pressure and dry, drying under reduced pressure, spray drying, airpillow-dry, far-infrared ray drying, dielectric drying, microwave drying, lyophilization etc.Preferably decompression in the present invention.
In another embodiment preferred of the present invention, preparation technology adds 10 times of amounts of water and decocts 2 times for getting Fructus Schisandrae Chinensis, decocts 2 hours at every turn.Collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.30-1.50, drying under reduced pressure, pulverizing adds the Chrysomyiame gacephala (Fab.) powder, Oletum Trogopterori powder, the Endothelium Corneum Gigeriae Galli powder that have made and mixes, add adjuvant then and be prepared as pharmaceutically acceptable dosage form, as granule, tablet, pill, capsule, preferred for preparation is granule, capsule.
In an embodiment of the invention, contain Fructus Schisandrae Chinensis powder, Chrysomyiame gacephala (Fab.) powder, Oletum Trogopterori powder and Endothelium Corneum Gigeriae Galli powder in the medicine of the final preparation of the present invention.Wherein, the parts by weight of each composition are as follows: Fructus Schisandrae Chinensis powder 0.5-500; Chrysomyiame gacephala (Fab.) powder 20-500; Oletum Trogopterori powder 20-500; Endothelium Corneum Gigeriae Galli powder 20-500.Be preferably Fructus Schisandrae Chinensis powder 2-300; Chrysomyiame gacephala (Fab.) powder 50-300; Oletum Trogopterori powder 50-300; Endothelium Corneum Gigeriae Galli powder 50-300.Most preferably be Fructus Schisandrae Chinensis powder 10-200; Chrysomyiame gacephala (Fab.) powder 100-200; Oletum Trogopterori powder 100-200; Endothelium Corneum Gigeriae Galli powder 100-200.
Of the present invention another preferred embodiment in, contain Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.) powder, Oletum Trogopterori powder and Endothelium Corneum Gigeriae Galli powder in the medicine of the final preparation of the present invention.More than the weight range of each composition as follows: Fructus Schisandrae Chinensis extrat 0.5-500; Chrysomyiame gacephala (Fab.) powder 20-500; Oletum Trogopterori powder 20-500; Endothelium Corneum Gigeriae Galli powder 20-500.Be preferably Fructus Schisandrae Chinensis extrat 2-300; Chrysomyiame gacephala (Fab.) powder 50-300; Oletum Trogopterori powder 50-300; Endothelium Corneum Gigeriae Galli powder 50-300.Most preferably be Fructus Schisandrae Chinensis extrat 10-200; Chrysomyiame gacephala (Fab.) powder 100-200; Oletum Trogopterori powder 100-200; Endothelium Corneum Gigeriae Galli powder 100-200.Fructus Schisandrae Chinensis extrat wherein can be one or more in the water solublity of Fructus Schisandrae Chinensis and/or liposoluble extract or schizandrin, deoxyschizandrin, schisandrin B, Fructus Schisandrae Chinensis polysaccharide, schisandrin, schisantherin B, schisandrin C, the schisantherin A, especially preferably adopt the water solubility extract of Fructus Schisandrae Chinensis, most preferred Fructus Schisandrae Chinensis extrat is that the alcohol of Fructus Schisandrae Chinensis is or/and water extract.
In yet another embodiment of the present invention, contain Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.) extract, Oletum Trogopterori extract and Endothelium Corneum Gigeriae Galli extract in the medicine of the final preparation of the present invention.More than the weight range of each composition as follows: Fructus Schisandrae Chinensis extrat 0.5-500; Chrysomyiame gacephala (Fab.) extract 20-500; Oletum Trogopterori extract 20-500; Endothelium Corneum Gigeriae Galli extract 20-500.Be preferably Fructus Schisandrae Chinensis extrat 2-300; Chrysomyiame gacephala (Fab.) extract 50-300; Oletum Trogopterori extract 50-300; Endothelium Corneum Gigeriae Galli extract 50-300.Most preferably be Fructus Schisandrae Chinensis extrat 10-200; Chrysomyiame gacephala (Fab.) extract 100-200; Oletum Trogopterori extract 100-200; Endothelium Corneum Gigeriae Galli extract 100-200.Fructus Schisandrae Chinensis extrat wherein can be one or more in the water solublity of Fructus Schisandrae Chinensis and/or liposoluble extract or schizandrin, deoxyschizandrin, schisandrin B, Fructus Schisandrae Chinensis polysaccharide, schisandrin, schisantherin B, schisandrin C, the schisantherin A, especially preferably adopt the water solubility extract of Fructus Schisandrae Chinensis, most preferred Fructus Schisandrae Chinensis extrat is that the alcohol of Fructus Schisandrae Chinensis is or/and water extract.Chrysomyiame gacephala (Fab.) extract preferably Chrysomyiame gacephala (Fab.) boils or the extract of Chrysomyiame gacephala (Fab.) after water and/or extraction through decocting.Oletum Trogopterori extract preferably Oletum Trogopterori boils or the extract of Oletum Trogopterori after water and/or extraction through decocting.Endothelium Corneum Gigeriae Galli extract preferably Endothelium Corneum Gigeriae Galli boils or the extract of Endothelium Corneum Gigeriae Galli after water and/or extraction through decocting.
On the other hand, the present invention also provides the purposes of above compositions in preparation treatment acute, chronic hepatitis, fatty liver medicine.
The present composition is when being used for the patient, patient's dose is to take every day to be equivalent to Fructus Schisandrae Chinensis crude drug 1-200g, Chrysomyiame gacephala (Fab.) crude drug 1-200g, Oletum Trogopterori crude drug 1-200g, the medicine of Endothelium Corneum Gigeriae Galli crude drug 1-200g, preferably take and be equivalent to Fructus Schisandrae Chinensis crude drug 5-100g, Chrysomyiame gacephala (Fab.) crude drug 5-100g, Oletum Trogopterori crude drug 5-100g, Endothelium Corneum Gigeriae Galli crude drug 5-100g, more preferably Fructus Schisandrae Chinensis crude drug 20-50g, Chrysomyiame gacephala (Fab.) crude drug 20-50g, Oletum Trogopterori crude drug 20-50g, Endothelium Corneum Gigeriae Galli crude drug 20-50g, the mode of taking is every day 3 times, and each dose is present composition 0.5-10g.
Inventor's the effect that the invention provides combination treatment acute, chronic hepatitis, fatty liver that studies confirm that obviously improves, and good effect has good medical prospect.
The following specific embodiment only is to further specify for the present invention, and after understanding content of the present invention, those skilled in the art change the present invention without departing from the premise in the spirit of the present invention, and these changes all drop within protection scope of the present invention.
The specific embodiment
Embodiment 1
Fructus Schisandrae Chinensis 5g
Chrysomyiame gacephala (Fab.) 10g
Oletum Trogopterori 50g
Endothelium Corneum Gigeriae Galli 100g
Preparation method:
1. the preparation of Fructus Schisandrae Chinensis extrat: get Fructus Schisandrae Chinensis, add 10 times of amounts of water and decoct 3 times, decocted 2 hours at every turn.Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.40 (40 ℃), and drying is pulverized
2. the preparation of Chrysomyiame gacephala (Fab.) powder: get Chrysomyiame gacephala (Fab.), remove dirt and carry out disinfection then, sterilization is adopted and is soaked 5 hours method of ethanol.Behind microwave drying, grind into powder.
3. the preparation of Oletum Trogopterori powder: get flying squirrel feces and smash back sprinkling vinegar to pieces, the temperature fire is fried to little dried then, collects powder.
4. the preparation of Endothelium Corneum Gigeriae Galli powder: pulverize after the chicken inner wall of sandbag spray vinegar.
5. preparation of compositions:
(1) capsule: it is fixed according to aforementioned proportion Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, and drying is pulverized the adding adjuvant and made soft material, granulates, and drying adds magnesium stearate in the dried particles, incapsulates promptly.
(2) tablet: it is fixed according to aforementioned proportion Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, and grind into powder with auxiliary materials and mixing, is made tablet.
(3) granule: it is fixed according to aforementioned proportion Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, grinds to form fine powder, and other gets PEG400 heating melting, heats above-mentioned fine powder and stirs evenly, and pulverizes after the cooling to add auxiliary materials and mixing, makes granule.
(4) drop pill: it is fixed according to aforementioned proportion Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, and drying is pulverized, and splashes into and makes drop pill in the condensed fluid.
Embodiment 2
Fructus Schisandrae Chinensis 50g
Chrysomyiame gacephala (Fab.) 20g
Oletum Trogopterori 100g
Endothelium Corneum Gigeriae Galli 10g
Preparation method:
It is fixed to claim one by one according to the prescription ratio, pulverizes, and sieves mix homogeneously.The ratio that adds refined honey 140-160g in every 100g adds refined honey, makes big honeyed pills, the heavy 10g of every ball.
Embodiment 3
Fructus Schisandrae Chinensis 50g
Chrysomyiame gacephala (Fab.) 10g
Oletum Trogopterori 20g
Endothelium Corneum Gigeriae Galli 50g
Preparation method:
It is fixed according to aforementioned proportion Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, decoct half an hour in 3 times of medium and small fire of water gaging, the clear paste of gained decocting liquid simmer down to density 1.50, dry, pulverize the adding adjuvant and make soft material, granulate drying, magnesium stearate is added in the dried particles, incapsulate promptly.
Embodiment 4
Fructus Schisandrae Chinensis 50g
Chrysomyiame gacephala (Fab.) 25g
Oletum Trogopterori 20g
Endothelium Corneum Gigeriae Galli 10g
Preparation method:
It is fixed according to aforementioned proportion Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, and drying is pulverized the adding adjuvant and made soft material, granulates, and drying adds magnesium stearate in the dried particles, incapsulates promptly.
Embodiment 5
Deoxyschizandrin 3g
Chrysomyiame gacephala (Fab.) 25g
Oletum Trogopterori 20g
Endothelium Corneum Gigeriae Galli 10g
Preparation method:
It is fixed according to aforementioned proportion deoxyschizandrin, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, and drying is pulverized the adding adjuvant and made soft material, granulates, and drying adds magnesium stearate in the dried particles, incapsulates promptly.
Embodiment 6
Schisandrin B 2g
Chrysomyiame gacephala (Fab.) 25g
Oletum Trogopterori 20g
Endothelium Corneum Gigeriae Galli 10g
Preparation method:
It is fixed according to aforementioned proportion schisandrin B, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, and drying is pulverized the adding adjuvant and made soft material, granulates, and drying adds magnesium stearate in the dried particles, incapsulates promptly.
Embodiment 7
Schisandrin 2g
Chrysomyiame gacephala (Fab.) 25g
Oletum Trogopterori 20g
Endothelium Corneum Gigeriae Galli 10g
Preparation method:
It is fixed according to aforementioned proportion schisandrin, Chrysomyiame gacephala (Fab.), Oletum Trogopterori, Endothelium Corneum Gigeriae Galli to be claimed one by one, and drying is pulverized the adding adjuvant and made soft material, granulates, and drying adds magnesium stearate in the dried particles, incapsulates promptly.
Embodiment 8
Fructus Schisandrae Chinensis extrat 1g
Chrysomyiame gacephala (Fab.) extract 2g
Oletum Trogopterori extract 5g
Endothelium Corneum Gigeriae Galli extract 3g
Preparation method:
1. the preparation of Fructus Schisandrae Chinensis extrat: get Fructus Schisandrae Chinensis, add 10 times of amounts of water and decoct 3 times, decocted 2 hours at every turn.Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.40 (40 ℃), and drying is pulverized
2. the preparation of Chrysomyiame gacephala (Fab.) extract: get Chrysomyiame gacephala (Fab.), add 6 times of water gagings and decocted hour, filter then, filtrate is condensed into the clear paste of density 1.20, drying and crushing
3. the preparation of Oletum Trogopterori extract: get Oletum Trogopterori, add 3 times of water gagings and decoct 5 times, whenever next hour.Collecting decoction filters, and is concentrated into relative density and is 1.50 clear paste, drying and crushing.
4. the preparation of Endothelium Corneum Gigeriae Galli extract: get Endothelium Corneum Gigeriae Galli, add 5 times of water gagings and decoct 2 times, each 30min.Merging filtrate filters, and is concentrated into the clear paste of relative density 1.30, drying, and spray vinegar is pulverized.
It is fixed according to above-mentioned prescription ratio Fructus Schisandrae Chinensis extrat, Chrysomyiame gacephala (Fab.) extract, Oletum Trogopterori extract, Endothelium Corneum Gigeriae Galli extract to be claimed one by one, and drying is pulverized the adding adjuvant and made soft material, granulates, and drying adds magnesium stearate in the dried particles, incapsulates promptly.
Experimental example 1
Experimental raw: adopt the prescription and the preparation method of the embodiment of the invention 1, Fructus Schisandrae Chinensis extrat is mixed with the medical material of other pulverizing, must supply the reagent thing.Set three dosage groups (counting low dose group, middle dosage group, high dose group from low to high), wherein corresponding dosage is 0.5g/kg, 1g/kg, 2g/kg, is respectively 5,10,20 times of the clinical consumption of expection.The Fructus Schisandrae Chinensis extrat matched group is set in addition, blank group, model control group.The Fructus Schisandrae Chinensis extrat matched group is equivalent to the amount of Fructus Schisandrae Chinensis extrat in the present composition high dose group, and wherein the preparation method of Fructus Schisandrae Chinensis extrat is with the extracting method among the embodiment one.Model control group gives normal saline.
Experiment one: to the influence of acute, chronic hepatitis
With reference to the method for evaluation treatment acute, chronic hepatitis medicine commonly used now, make liver injury model with chemical substance, by medicine the significant degree of this medicine to acute, chronic hepatitis weighed in the influence of modeling.In this experiment, we adopt D-Gal structure acute liver damage mouse model.
Experimental technique: compositions for use of the present invention, Fructus Schisandrae Chinensis extrat all are dissolved in deionized water make suspension.Get the NIH mice, male and female half and half, body weight 18-22g.Random packet, gastric infusion.Irritate the stomach frequency for once a day, continuous six times, after the 5th administration one hour, except that the normal control group, all the other respectively organized equal lumbar injection D-Gal-N (D-Gal) 800mg/kg.Fasting 12 hours before experiment, last administration after 1 hour eyeground vein get blood test ALT AST, putting to death mice simultaneously, to get liver heavy, calculating liver coefficient.
Liver coefficient=liver weight (g)/mice body weight (10g).
The acute liver damage mice ALT AST liver coefficient influence that table 1 present composition causes the D aminogalactose
(compare * p<0.05 * * p<0.01 with model control group;
Compare △ p<0.05, △ △ p<0.01 with the Fructus Schisandrae Chinensis matched group).
Table 1 result shows that compare with matched group, each related data index of model group is significantly increased (p<0.01), proves the modeling success.Three dosage groups of the present composition have significantly reduced ALT AST (p<0.01), high dose group can significantly reduce liver coefficient (p<0.01). and the independent application of Fructus Schisandrae Chinensis extrat also can reduce relevant monitoring index, but the opinion with effect, present composition better effects if.Compare with the Fructus Schisandrae Chinensis group, the degree that the present composition improves acute liver damage significantly is better than the therapeutic effect of Fructus Schisandrae Chinensis.Be equal under the dosage, its effect significantly has been better than Fructus Schisandrae Chinensis group (p<0.05).On ALT AST index, highly significant be better than Fructus Schisandrae Chinensis group (p<0.01).
The acute liver damage mice pathological change influence that table 2 present composition causes the D aminogalactose
Illustrate: in degree of necrosis, 0 represents normally+represents a small amount of spotty necrosis (<10 point/visual field * 100)
++ expression most loose point, special mess necrosis (>10 point/visual field * 100)
+++expression most fragment sample necrosis or bridging necrosis
On steatosis, necrocytosis degree, 0 represents normal+expression scope<1/3
++ the expression scope is between 1/2~1/3
+++expression scope>1/2
Table 2 result shows the modeling success, and each dosage group of the present composition all can alleviate hepatic necrosis, steatosis, the cellular edema that D-Gal causes.Under the Isodose, aspect the effect that alleviates necrocytosis, cellular edema, steatosis, the present composition is better than Fructus Schisandrae Chinensis extrat.
Experiment two: to the influence of fatty liver
Experimental technique: get the SD rat, male and female half and half, body weight 200~250g.Random packet, gastric infusion.Irritate the stomach frequency for once a day, continuous seven times, after the 5th administration one hour, except that the normal control group, all the other each organize and gavage ethionine solution 250mg/kg.After the modeling 48 hours, put to death rat, get the liver precision and weigh, calculate liver coefficient (unit is the g/100g body weight), and carry out pathologic finding.Take by weighing 200mg liver tissue homogenate, measure TC TG (unit is heavy for the mmol/g liver).Because Fructus Schisandrae Chinensis is not used for the treatment of fatty liver separately, therefore in the fatty liver treatment, the Fructus Schisandrae Chinensis matched group is not set.This test has increased zhibituo and has organized in contrast.Zhibituo be in the market circulation bigger be used for the treatment of one of medicine of fatty liver.
The influence of the fatty liver that table 3 present composition causes the second Hydrogen thiocyanate
(compare * p<0.05 * * p<0.01 with model control group;
Compare △ p<0.05, △ △ p<0.01 with the zhibituo matched group).
As can be seen from Table 3, each dosage group of the present composition all can significantly reduce TG (p<0.01) in the rat liver, can significantly reduce TC and liver coefficient in the liver simultaneously under the high dose.With respect to zhibituo, the present composition significantly is better than zhibituo (p<0.05) to the effect of improving of fatty liver under the Isodose, and highly significant is better than zhibituo (p<0.01) on the index of TG TC.
Table 4 present composition is to the influence of rat fat liver degeneration
+ expression steatosis<1/3 lobule ++ steatosis 1/3~1/2 +++fatty liver>1/2 0 representatives are normal
The above results shows, normal group lobules of liver structural integrity, and changeable shape hepatocyte is radial arrangement around central vein, and header is distributed with artery and vein between lobule, lobule bile duct between lobule.Through modeling, the fat vacuole of a large amount of varying degree that distribute in the model control group.Each dosage group of the present composition has obviously reduced this fattyization degree, and effect is better than zhibituo under Isodose.
Above-mentioned experiment fully confirms; the present composition has therapeutical effect to hepatic injury: the present composition has protective effect to the chmice acute hepatic injury that D-GalN causes; can significantly reduce ALT AST and the liver coefficient of hepatic injury mice, alleviate pathology damage such as necrocytosis, cellular edema, steatosis.When being used for fatty liver, we have used ethionine to carry out modeling.Ethionine is by competing with methionine, and you provide ethyl substituent methyl, makes the synthetic obstacle that takes place of liver protein mapping, undertakes the carrier protein complex minimizing of triglyceride transhipment, thereby causes fatty liver.The present composition can significantly reduce liver TG TC and the liver coefficient of modeling rat, reduces pathological lesions such as steatosis, necrosis, thereby confirms that present composition team fatty liver has significant therapeutic effect.
Experimental example 2
Sufferer screening: select Patients with Viral Hepatitis 200 examples, screening conditions are the age: 18~55 years old, male or female, the ALT value is higher than normal 3-10, and doubly (normal reference value is a Serum ALT<40U/L), the total bilixanthin of serum is higher than 2~5 times of normal values, and (normal reference value is Bil<17.1umol/L), do not have other severe complication, get rid of gestation, breast-feeding female, selected sufferer is all taken other and is protected the liver and antiviral drugs in the first trimester of test.
Diagnostic criteria: the viral hepatitis treatment scheme of reference literature-Chinese Medical Association's infectious disease and parasitic disease credit meeting, hepatopathy credit meeting is published in Chinese hepatopathy magazine, 2000.8:324-329.
The sufferer grouping: be divided into two groups at random, 100 examples are organized in treatment, wherein male 80 examples, women 20 examples, 30 years old mean age.With liver disease types classification, acute hepatitis patient's 48 examples, chronic hepatitis patient 52 examples.Adopt the prescription and the preparation method of the embodiment of the invention 1, Fructus Schisandrae Chinensis extrat is mixed with the medical material of other pulverizing, must supply the reagent thing.The treatment group is taken above for the reagent thing, 10g/ every day 3 times.Matched group 100 examples, wherein male 76 examples, women 24 examples, 33 years old mean age.With liver disease types classification, acute hepatitis patient's 49 examples, chronic hepatitis patient 51 examples.Matched group is taken Fructus Schisandrae Chinensis extrat, and 10g/ every day 3 times, wherein the preparation method of Fructus Schisandrae Chinensis extrat is with the extracting method among the embodiment one.。
Efficacy determination rule: 1. produce effects: meet following arbitrary condition person: Serum ALT recovers normal, and it is normal that serum bilirubin recovers.2. effective: Serum ALT and serum bilirubin all recover normal.3. invalid: as not reach the produce effects standard.4. worsen: reach following arbitrary condition: Serum ALT obviously rises, and threshold values is 80U/L; Serum bilirubin obviously rises, and threshold values is 34.2umol/L.
Observation index: before the treatment, treatment two weeks, January, February detects sufferer liver function (Serum ALT, Bil), renal function, routine blood test, prothrombin time respectively.Treatment finishes the above-mentioned every data of back check.
Therapeutic scheme: oral, each 10g, every day three times.30 days courses of treatment, amount to two courses of treatment.
Therapeutic outcome: it is obviously uncomfortable that all sufferers are taken the back nothing, and the physical symptom improvement sees table
The health of table 5 therapeutic outcome improves situation
Serum ALT, Bil improvement see the following form
Table 6ALT, Bil improve the result
By above-mentioned data as seen, present composition clinical practice has obtained remarkable result, and therapeutic outcome has tangible statistical significance.Distinguishing feature is effectively to improve health body constitution, significantly improves liver function, and has no side effect.
The curative effect of experimental example 3 medicine composite for curing fatty livers of the present invention
Randomly draw 200 routine Patients with Fatty Liver in clinical, be divided into treatment and organize 100 examples, matched group 100 examples, wherein male 75 examples, women 25 examples are organized in treatment; Matched group man 72 examples, women 28 examples.48.6 years old treatment group mean age, 49.2 years old matched group mean age.Average ill 1.9 years of treatment group, average ill 1.83 of matched group.Two groups all are diagnosed as Patients with Fatty Liver, do not have other significant complications.
Adopt following Therapeutic Method:
1. adopt the prescription and the preparation method of the embodiment of the invention 1, Fructus Schisandrae Chinensis extrat is mixed with the medical material of other pulverizing, must supply the reagent thing.The treatment group is taken above for reagent thing, 10g/ time, every day 3 times.
2. matched group gives zhibituo, and 10g/ time, every day 3 times.
Above-mentioned treatment is carried out being one in 3 months and is treated the course of treatment.
Efficacy determination rule: 1. produce effects: meet following arbitrary condition person: TG and recover normal, it is normal that TC recovers.2. effective: TCTG all recovers normal.3. invalid: as not reach the produce effects standard.
Therapeutic outcome is as shown in the table:
Table 7 liang group clinical treatment result relatively
Compare with matched group, treatment group effective percentage reaches 93%, with matched group notable difference is arranged.
Experimental example 4
It below is the certain situation summary that the present composition is applied to Patients with Fatty Liver.
One female patient, Lee * *, the hepatic region continued to have a pain in nearly 2 years, and middle upper abdomen is then done to expand, and the performance of feed back is especially obvious.Dyspepsia often feels uncomfortable in chest weak, and body weight obviously increases.Patient's bodily form is more fat, height 165CM, body weight 68KG.On inspection, BP130/90mmHg, HR85 time/minute, abdominal part is swollen soft, and next refers to the liver rib.Further check and show, hematuria just Rt (-), ALT68U/L, BUN 12mmol/L, Cr 88umol/L, blood fat Cho 6.5mmol/L, TG 3.5mmol/L, the super demonstration of HDL 1.2mmol/L, LDL5.0mmol/L.B liver has stronger tiny luminous point, blood vessel structure is bad, liver deep tissue echo is weakened, and is diagnosed as hyperlipemia, fatty liver.Give the capsule that the embodiment of the invention 1 makes, every day three times, each 10g.Upper abdomen is done to expand and is alleviated in after two weeks; The showed increased of taking food after one month, health is weak, the limb weight condition obviously improves, and weight loss is 66KG, ALT58U/L, blood fat Cho 6.3mmol/L, TG 2.9mmol/L, LDL 4.3mmol/L, B ultrasonic changes not obvious.Take medicine continuously to ten weeks, the hepatic region abdomen aches transference cure, the weary transference cure that waits uncomfortable in chest no longer occurs.On inspection, ALT 38U/L, BUN9mmol/L, blood fat Cho 6.2mmol/L, TG 2.5mmol/L, LDL 4.2mmol/L, the B ultrasonic luminous point is even, and blood vessel structure recovers normal in the liver, and deep tissue echo is normal.
Confirm that thus the present composition has significant curative effect to fatty liver.
Experimental example 5
Patient Wang, male, 38 years old.B ultrasonic and CT detect and are shown as fatty liver, and gastroscopy is shown as chronic gastritis, and routine examination shows that triglyceride, cholesterol are obviously higher.Give the capsule that the embodiment of the invention 1 makes, every day three times, each 10g.Check behind the two weeks and show that ALT drops to normal level 55U/L by original 80U/L.When continuing to take to one month, triglyceride drops to normally from original 5.89mmol/L, and cholesterol is reduced to 5.25mmol/L from 6.92mmol/L.Check after two months and find the fatty liver transference cure.