CN103316074B - Medicine composite of halenia corni extract, astragalus extract and liquorice extract as well as preparation and application of medicine composite - Google Patents
Medicine composite of halenia corni extract, astragalus extract and liquorice extract as well as preparation and application of medicine composite Download PDFInfo
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Abstract
The invention relates to a composition method and a preparation method of a pharmaceutical preparation, and in particular relates to a medicine composite of a halenia corni extract, an astragalus extract and a liquorice extract as well as a preparation and an application of the medicine composite. The medicine composite consists of a halenia corni extract, an astragalus extract and a liquorice extract, wherein the weight ratio of the halenia corni extract to the astragalus extract to the liquorice extract is (6.4-12.8): (8.16-32.64): (1-4). The content of 1-hydroxy-3,4,5-trimethoxyxanthone in the halenia corni extract is not lower than 1.0%; in the astragalus extract, astragaloside IV accounts for not lower than 0.15% and calycosin glycoside accounts for not lower than 0.03%; and in the liquorice extract, glycyrrhizic acid accounts for not lower than 7.0% and liquiritin accounts for not lower than 0.5%; and the dosages of the 1-hydroxy-3,4,5-trimethoxyxanthone, the astragaloside IV, the calycosin glycoside, the glycyrrhizic acid and the liquiritin in each dosage unit of the medicine composite prepared from the halenia corni extract, the astragalus extract and the liquorice extract are respectively 2.72-5.44mg, 0.428-1.714mg, 0.122-0.49mg, 1.78-7.12mg and 0.285-1mg by weight.
Description
Technical field
The present invention relates to a kind of combined method and preparation method of pharmaceutical preparation, more particularly, relate to a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine and preparation thereof, application.
Background technology
China is high incidence of hepatitis b, can be rated as " hepatitis big country ".In Notifiable disease, its sickness rate is only second to infectious diarrhea and influenza and occupies the 3rd.The carrying rate of the hepatitis B surface antigen in population of China is up to more than 10%, and 1/4th in them finally will develop into chronic hepatitis, hepatitis interstitialis chronica or primary hepatocarcinoma.Hepatitis B not only has a strong impact on health, and causes heavy financial burden to family, society, China every year for the medical treatment of hepatitis and hepatopathy, health subsidies with up to more than 1,000 hundred million yuan.Hepatitis B has become one of great public health problem of China, and the hepatitis B medicine of efficient and cheap has huge economic benefit and social benefit.
Hepatitis B is strong to be recorded in " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Traditional Chinese medicine historical preparation the 12, and oral, A, B sheet share, once each 2 ~ 3,3 times on the one.
Major function is promoting the function of the gallbladder to alleviate jaundice, improves liver function, immunity moderation function.For acute or chronic hepatitis B and other hepatitis.
Herba Haleniae Corniculatae (Halenia elliptica D.Don) is that Gentianaceae Herba Haleniae Corniculatae belongs to annual herb plant, and be the one in " ZANGYINCHEN " class medicinal plants, main product is in Qinghai-Tibet Platean, be used as medicine with herb or aerial parts, bitter in the mouth, cold in nature, there is clearing heat and expelling damp, the effects such as depressed liver-energy dispersing and function of gallbladder promoting.Being used for the treatment of the diseases such as acute icterohepatitis, cholecystitis, dizzy headache, is one of Tibetan of China, the Qiang's conventional medical herbs among the people.Its main chemical compositions is mouth diphenylene ketone oxide and FMDV VP1 gene constituents, 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide, 1,7-dihydroxy-2,3,4,5-tetramethoxy mouth diphenylene ketone oxide, 1,5-dihydroxy-2,3,7-trimethoxy mouth diphenylene ketone oxide, 1,2-dihydroxy-3,4,5-trimethoxy mouth diphenylene ketone oxide etc.
The Radix Astragali is the dry root of leguminous plant Astragalus membranaceus (Fisch) Bge.Var.Monghoicus (Bge.) Hisao or film English Radix Astragali Astragalus membranaceus (Fisch) Bge..The Radix Astragali contains plurality of active ingredients, mainly contains Astragalus Saponin I, second, the third, flavonoid, astragalus polysaccharides A, B, C, D and amino acids etc., Radix Astragali total saponins has antiinflammatory, analgesia and immunoregulation effect, not only has immunological enhancement, also has immunoregulation effect; Have hypotensive effect, cardiotonic, protecting myocardial cell, the effect of raising heart preservation, to cerebrovascular protective effect, antibiooxidation effect, improves the ability etc. of resisting free radical and attacking simultaneously.The Radix Astragali can improve immunoglobulin, enhancing antibody produces, has obvious potentiation to bone-marrow-derived lymphocyte immunologic function, also has potentiation to T lymphocyte function.
Radix Glycyrrhizae is the dry root welding technology of glycyrrhizic legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflate Bat. or Glycyrrhiza glabra L. Glycyrrhiza glabra L..Nature and flavor are sweet, flat, have cough-relieving, relieving asthma, reduce phlegm and the effect of adrenocortical hormone sample, energy antiinflammatory, defying age, coordinating the actions of various ingredients in a prescription, and current 12 warps are one of widely used Chinese medicine.Principle active component is triterpenesization house thing (glycyrrhizin and glycyrrhetate, enoxolone etc.). the three major types compositions such as flavone compound (liquiritin, isoliquiritigenin, glycyrrhizin etc.) and Angelica Polysaccharide compounds.There is the infection such as immunomodulating, antiviral, antiinflammatory and anti-allergic effects.
Because the place of production of Chinese crude drug or harvest season etc. are comparatively large on quality of medicinal material impact, the Chinese crude drug that Chinese medicine finished product takes ormal weight in prescription ratio is produced, and causes the effect often criticizing product may be inconsistent, there is certain defect.Hepatitis B is good for sheet and is made up of Herba Haleniae Corniculatae, the Radix Astragali and Radix Glycyrrhizae three taste Chinese medicine, makes A, B two kinds of tablets altogether, needs two kinds and take simultaneously when taking, and adds production cost and reduces the compliance of patient.
Summary of the invention
The present invention seeks to provide a kind of corniculate spurgentian herb extract for above-mentioned weak point, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine and preparation thereof, application, it is medicine of a kind of hepatitis B diseases and preparation method thereof, application, by to Herba Haleniae Corniculatae, the Radix Astragali, effective site research in licorice medicinal materials, improve extraction process, extract for effective ingredient, formulate extract Testing index, and work out quality standard, finally by the optimal proportion (extract consumption is to take after the cubage of index components) determining each extract after the test of pesticide effectiveness, so both improve the curative effect of medicine, ensure again often to criticize the basically identical property of curative effect of finished product simultaneously.And A, B sheet is united two into one, reduce production cost, facilitate patient to take.Through pharmacodynamics orthogonal experiment, show that the drug effect of each prescription group amount that is main and corniculate spurgentian herb extract (that is to say 1-hydroxyl-3, 4, the amount of 5-trimethoxy mouth diphenylene ketone oxide) substantially become positive correlation, and Radix Astragali extract, the amount of Radix Glycyrrhizae extract is without obvious dependency, 1-hydroxyl-3 in the prescription that drug effect is obvious, 4, the content that the content of 5-trimethoxy mouth diphenylene ketone oxide is obviously good in sheet than hepatitis B is high, can find out, it is relatively on the low side that drugs compared hepatitis B is good for Herba Haleniae Corniculatae consumption in sheet, from effect experiment result, every minimum dose unit is containing 1-hydroxyl-3, 4, 5-trimethoxy mouth diphenylene ketone oxide content is between 2.72 ~ 5.44mg, curative effect is better, therefore exceeded hepatitis B by the preparation drug effect that the present invention makes and be good for sheet.
The composition of medicine of a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract takes following technical scheme to realize:
The composition of medicine of a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, it is characterized in that, it is made up of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, and wherein corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract weight proportion are 6.4 – 12.8:8.16 – 32.64:1 – 4.
Described a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine, is characterized in that, in corniculate spurgentian herb extract, 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide content is not less than 1.0%; Astragloside IV in Extraction of Radix Astragali content is not less than 0.15%, and calycosin glucoside content is not less than 0.03%; In Radix Glycyrrhizae extract, glycyrrhizic acid content is not less than 7.0%, and liquirtin content is not less than 0.5%.
The composition of medicine of described a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, it is characterized in that, 1-hydroxyl-3 is contained in each minimum dose unit (i.e. every a slice, grain, bag etc.) after corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract make composition of medicine, the amount of 4,5-trimethoxy mouth diphenylene ketone oxide, astragaloside, calycosin glucoside, glycyrrhizic acid, liquirtin is respectively following weight scope 2.72 – 5.44(mg), 0.428 – 1.714(mg), 0.122 – 0.49(mg), 1.78 – 7.12(mg), 0.285 – 1.14(mg).Instructions of taking is 3 times on the one, each 2 ~ 3 minimum dose units.
Described a kind of corniculate spurgentian herb extract, the composition of medicine of Radix Astragali extract and Radix Glycyrrhizae extract, it is characterized in that, corniculate spurgentian herb extract, 1-hydroxyl-3 is contained in each minimum dose unit after Radix Astragali extract and Radix Glycyrrhizae extract make composition of medicine, 4, 5-trimethoxy mouth diphenylene ketone oxide, astragaloside, calycosin glucoside, glycyrrhizic acid, liquirtin amount is respectively in following weight combination any one group: 2.72mg, 0.428 mg, 0.122 mg, 3.56 mg, 0.57 mg, 5.44 mg, 0.428 mg, 0.122 mg, 7.12 mg, 1.14 mg, 5.44 mg, 0.857 mg, 0.245 mg, 1.78 mg, 0.285 mg, 5.44 mg, 1.714 mg, 0.49 mg, 3.56 mg, 0.57 mg.Instructions of taking is 3 times on the one, each 2 ~ 3 minimum dose units.
The composition of medicine preparation method of described a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, is characterized in that,
(1) Herba Haleniae Corniculatae extracts by following technological process: the Herba Haleniae Corniculatae cutting after cleaning weighed, put in extraction pot, add 70% ethanol 10 times amount, 8 times amount respectively, reflux, extract, twice, 3 hours first times, second time 2 hours, filters, and releases backflow, merge secondary returning flow liquid, reclaim ethanol, be concentrated into thick paste, dry, be ground into fine powder and get final product.
(2) Radix Astragali extracts by following technological process: weighed by the Radix Astragali decoction pieces after cleaning, put in extraction pot, add decocting in water and carry twice, first time adds water 10 times, decoct 3 hours, second time adds water 8 times, decocts 2 hours, leaves standstill, filter, merge supernatant, be concentrated into thick paste, dry, be ground into fine powder and namely obtain extract.
(3) Radix Glycyrrhizae is extracted by following technological process: get the Radix Glycyrrhizae after cleaning, run through, and section, decocts with water twice.First time adds water 10 times, decocts 3 hours, and second time adds water 8 times, decocts 2 hours, collecting decoction, placing spends the night makes precipitation, gets supernatant concentration to paste, takes out appropriate, measure glycyrrhizic acid content, regulate and make to conform with the regulations, dry, be ground into fine powder and namely obtain extract.
(4) extract is after assay, takes extract respectively by weight ratio according to content data, makes preparation after adding suitable pharmaceutic adjuvant by preparation process.
The composition of medicine of described a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, is characterized in that its preparation is oral formulations.
The composition of medicine of described a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, is characterized in that the pharmaceutic adjuvant containing oral formulations.
The composition of medicine of described a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, is characterized in that oral formulations comprises hard capsule, soft capsule, tablet, granule.
The composition of medicine of described a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract is applied preparing to treat in acute or chronic hepatitis B and other hepatitis medicaments.Function cures mainly as promoting the function of the gallbladder to alleviate jaundice, improves liver function, immunity moderation function.Be used for the treatment of acute or chronic hepatitis B (hepatitis B) and other hepatitis.
The pharmaceutic adjuvant of described oral formulations selects microcrystalline Cellulose, carboxymethyl starch sodium, magnesium stearate, polyvidone
k30(PVP
k30), salad oil, Cera Flava, hydrogenated palm oil, soybean phospholipid, methyl-silicone oil, sucrose, starch, making beating starch, essence.
The present invention is a kind of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine and preparation thereof, application, by to the effective site research in Herba Haleniae Corniculatae, the Radix Astragali, licorice medicinal materials, improve extraction process, extract for effective ingredient, formulate extract Testing index, and work out quality standard, finally by the optimal proportion (extract consumption is to take after the cubage of index components) determining each extract after the test of pesticide effectiveness, so both improve the curative effect of medicine, ensure again often to criticize the basically identical property of curative effect of finished product simultaneously.And A, B sheet is united two into one, reduce production cost, facilitate patient to take.From the test of pesticide effectiveness, the preparation drug effect made with the present invention has exceeded hepatitis B and has been good for sheet.The amount of formulation effect relationship that the present invention makes is analysed clearly, definite ingredients, and the quality of the pharmaceutical preparations is stablized controlled, and curative effect is better, can meet clinical demand.
Detailed description of the invention
By the following examples, in conjunction with results of pharmacodynamic test, further illustrate the present invention, following embodiment does not only limit the present invention for illustration of the present invention.
A composition of medicine preparation method for corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, its method is as follows:
(1) Herba Haleniae Corniculatae extracts by following technological process: the Herba Haleniae Corniculatae cutting after cleaning weighed, put in extraction pot, add 70% ethanol 10 times amount, 8 times amount respectively, reflux, extract, twice, 3 hours first times, second time 2 hours, filters, release backflow, merge secondary returning flow liquid, reclaim ethanol, be concentrated into thick paste, dry, be ground into fine powder, obtain corniculate spurgentian herb extract;
(2) Radix Astragali extracts by following technological process: weighed by the Radix Astragali decoction pieces after cleaning, put in extraction pot, add decocting in water and carry twice, first time adds water 10 times, decoct 3 hours, second time adds water 8 times, decocts 2 hours, leave standstill, filter, merge supernatant, be concentrated into thick paste, dry, be ground into fine powder, obtain Radix Astragali extract;
(3) Radix Glycyrrhizae is extracted by following technological process: get the Radix Glycyrrhizae after cleaning, run through, and section, decocts with water twice.First time adds water 10 times, decocts 3 hours, and second time adds water 8 times, decocts 2 hours, collecting decoction, placing spends the night makes precipitation, gets supernatant concentration to paste, takes out appropriate, measure glycyrrhizic acid content, regulate and make to conform with the regulations, dry, be ground into fine powder, obtain Radix Glycyrrhizae extract;
(4) extract is after assay, takes extract respectively by weight ratio according to content data, makes preparation after adding pharmaceutic adjuvant by preparation process.
Embodiment 1
Prescription (prescription 4):
Corniculate spurgentian herb extract 160g
(containing 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide 2.72mg × 1000)
Radix Astragali extract 204g
(containing astragaloside 0.428 mg × 1000, calycosin glucoside 0.122 mg × 1000)
Radix Glycyrrhizae extract 50g
(containing glycyrrhizic acid 3.56 mg × 1000, liquirtin 0.57 mg × 1000)
Microcrystalline Cellulose 50 g
Carboxymethyl starch sodium 70g
Magnesium stearate 2g
Polyvidone
k30(PVP
k30) appropriate
Method for making: take corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract by prescription, adds microcrystalline Cellulose and carboxymethyl starch sodium, mix homogeneously.Add the PVP of 4%
k30liquid mixing kneading becomes soft material, crosses 20 mesh sieves, the wet grain of system.50 ~ 60 DEG C of dryings after 2 hours, with 18 mesh sieve granulate, add magnesium stearate, mix homogeneously, obtain 1000 with capsule fill.Usage and consumption: oral, one time 2 ~ 3,3 times on the one.
Embodiment 2
Prescription (prescription 4):
Corniculate spurgentian herb extract 160g
(containing 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide 2.72mg × 1000)
Radix Astragali extract 204g
(containing astragaloside 0.428 mg × 1000, calycosin glucoside 0.122 mg × 1000)
Radix Glycyrrhizae extract 50g
(containing glycyrrhizic acid 3.56 mg × 1000, liquirtin 0.57 mg × 1000)
Salad oil 500g
Cera Flava 40g
Hydrogenated palm oil 60g
Soybean phospholipid 50g
Methyl-silicone oil 3g
Method for making: get salad oil, adds Cera Flava, hydrogenated palm oil, and heating makes it dissolve, and lets cool, add soybean phospholipid, stir evenly, add corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, stir evenly, colloid mill grinds well, and adds methyl-silicone oil, and decompression degasification, medicinal liquid is pressed into soft capsule 1000.Usage and consumption: oral, one time 2 ~ 3,3 times on the one.
Embodiment 3
Prescription (prescription 4):
Corniculate spurgentian herb extract 160g
(containing 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide 2.72mg × 1000)
Radix Astragali extract 204g
(containing astragaloside 0.428 mg × 1000, calycosin glucoside 0.122 mg × 1000)
Radix Glycyrrhizae extract 50g
(containing glycyrrhizic acid 3.56 mg × 1000, liquirtin 0.57 mg × 1000)
Sucrose 700g
Starch 450g
Making beating starch 80g
Essence 3 ml
Method for making: take the corniculate spurgentian herb extract of recipe quantity, Radix Astragali extract, Radix Glycyrrhizae extract, sugarcane sugar and starch, pulverized 100 mesh sieves, and fully mixed half an hour; Making beating starch is washed into 10% starch slurry, lets cool for subsequent use.Starch slurry is joined in the material mixed under stirring, make soft material, cross 14 mesh sieves, the wet grain of system.Wet grain, in 50 ~ 60 DEG C of dryings 2 hours, sprays into essence after granulate, and place half an hour, subpackage obtains 1000 bags.Usage and consumption: oral, one time 2 ~ 3 bag, 3 times on the one.
Embodiment 4
Prescription (prescription 4):
Corniculate spurgentian herb extract 160g
(containing 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide 2.72mg × 1000)
Radix Astragali extract 204g
(containing astragaloside 0.428 mg × 1000, calycosin glucoside 0.122 mg × 1000)
Radix Glycyrrhizae extract 50g
(containing glycyrrhizic acid 3.56 mg × 1000, liquirtin 0.57 mg × 1000)
Microcrystalline Cellulose 50 g
Carboxymethyl starch sodium 70g
Magnesium stearate 1.5g
Polyvidone
k30(PVP
k30) appropriate
Method for making: take corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract by prescription, adds microcrystalline Cellulose and carboxymethyl starch sodium, mix homogeneously.Add the PVP of 4%
k30liquid mixing kneading becomes soft material, crosses 16 mesh sieves, the wet grain of system.50 ~ 60 DEG C of dryings after 2 hours, with 14 mesh sieve granulate, add magnesium stearate, mix homogeneously, tabletting, film coating, make 1000, obtain tablet.Usage and consumption: oral, one time 2 ~ 3,3 times on the one.
Embodiment 5
Prescription (prescription 7):
Corniculate spurgentian herb extract 320g
(containing 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide 5.44mg × 1000)
Radix Astragali extract 204g
(containing astragaloside 0.428 mg × 1000, calycosin glucoside 0.122 mg × 1000)
Radix Glycyrrhizae extract 100g
(containing glycyrrhizic acid 7.12 mg × 1000, liquirtin 1.14 mg × 1000)
Microcrystalline Cellulose 150 g
Carboxymethyl starch sodium 220g
Magnesium stearate 5g
Polyvidone
k30(PVP
k30) appropriate
Method for making: take corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract by prescription, adds microcrystalline Cellulose and carboxymethyl starch sodium, mix homogeneously.Add the PVP of 4%
k30liquid mixing kneading becomes soft material, crosses 16 mesh sieves, the wet grain of system.50 ~ 60 DEG C of dryings after 2 hours, with 14 mesh sieve granulate, add magnesium stearate, mix homogeneously, tabletting, film coating, make 1000, obtain tablet.Usage and consumption: oral, one time 2 ~ 3,3 times on the one.
Embodiment 6
Prescription (prescription 8):
Corniculate spurgentian herb extract 320g
(containing 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide 5.44mg × 1000)
Radix Astragali extract 408g
(containing astragaloside 0.857 mg × 1000, calycosin glucoside 0.245mg × 1000)
Radix Glycyrrhizae extract 25g
(containing glycyrrhizic acid 1.78 mg × 1000, liquirtin 0.285mg × 1000)
Microcrystalline Cellulose 100 g
Carboxymethyl starch sodium 160g
Magnesium stearate 4g
Polyvidone
k30(PVP
k30) appropriate
Method for making: take corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract by prescription, adds microcrystalline Cellulose and carboxymethyl starch sodium, mix homogeneously.Add the PVP of 4%
k30liquid mixing kneading becomes soft material, crosses 16 mesh sieves, the wet grain of system.50 ~ 60 DEG C of dryings after 2 hours, with 14 mesh sieve granulate, add magnesium stearate, mix homogeneously, tabletting, film coating, make 1000, obtain tablet.Usage and consumption: oral, one time 2 ~ 3,3 times on the one.
Embodiment 7
Prescription (prescription 9):
Corniculate spurgentian herb extract 320g
(containing 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide 5.44mg × 1000)
Radix Astragali extract 816g
(containing astragaloside 1.714 mg × 1000, calycosin glucoside 0.49 mg × 1000)
Radix Glycyrrhizae extract 50g
(containing glycyrrhizic acid 3.56 mg × 1000, liquirtin 0.57mg × 1000)
Microcrystalline Cellulose 150 g
Carboxymethyl starch sodium 220g
Magnesium stearate 5g
Polyvidone
k30(PVP
k30) appropriate
Method for making: take corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract by prescription, adds microcrystalline Cellulose and carboxymethyl starch sodium, mix homogeneously.Add the PVP of 4%
k30liquid mixing kneading becomes soft material, crosses 16 mesh sieves, the wet grain of system.50 ~ 60 DEG C of dryings after 2 hours, with 14 mesh sieve granulate, add magnesium stearate, mix homogeneously, tabletting, film coating, make 1000, obtain tablet.Usage and consumption: oral, one time 2 ~ 3,3 times on the one.
Corniculate spurgentian herb extract quality standard:
Differentiate: take this product and be about 0.15g, put in tool plug conical flask, add methanol 25ml supersound process 40 minutes, filter, filtrate volatilizes, and residue adds methanol 2ml makes dissolving, as need testing solution.Separately get Herba Haleniae Corniculatae contrast material 1g, be made in the same way of control medicinal material solution; Get 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide reference substance again, add methanol and make the solution of every 1ml containing 0.2mg, product solution in contrast.Test according to thin layer chromatography, draw each 2 μ l of above-mentioned three kinds of solution, put respectively on same silica GF254 lamellae, petroleum ether (60 ~ 90 DEG C)-acetone (7:3) is developing solvent, launches, and takes out, dry, inspect under putting ultra-violet lamp (254nm), in test sample chromatograph on the position corresponding to reference substance chromatograph, the fluorescence speckle of aobvious same color.
Moisture: get this product 2 ~ 5g, puts 100 ~ 105 DEG C and is dried to constant weight (double weight differential is no more than 5mg), should cross 10.0%.
Assay: chromatographic condition and system suitability take octadecylsilane chemically bonded silica as filler; With methanol-0.5% phosphoric acid solution (65:35) for mobile phase; Determined wavelength is 243nm.Number of theoretical plate is pressed 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide peak and is calculated and should be not less than 4000.
The preparation of reference substance solution: get 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide reference substance appropriate, accurately weighed, add methanol and make the solution of every l m l containing 0.08mg, to obtain final product.
The preparation of need testing solution: get this product about 0.3 g, accurately weighed, put in tool plug conical flask, precision adds methanol 50mL, close plug, weighed weight, supersound extraction 30 minutes, let cool. weighed weight again, supply less loss weight with methanol, shake up, filter, get subsequent filtrate, filter with microporous filter membrane (0.45 μm), to obtain final product.
Algoscopy: accurate absorption reference substance solution, each 10 μ l of need testing solution respectively, injection liquid chromatography, measures, and calculates, to obtain final product by external standard method.
This product presses dry product calculating must not be less than 1.0% containing 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide.
Radix Astragali extract quality standard
Differentiate: take this product powder 1.5g, add methanol 20ml, reflux 1 hour, filter, filtrate is added on neutral alumina column (100 ~ 120 orders, 5g, internal diameter 10 ~ 15mm), with 40% methanol 100ml eluting, collect eluent, evaporate to dryness, the residue 30ml that adds water makes dissolving, with water saturated n-butanol extraction 2 times, each 20ml, merges n-butyl alcohol liquid, wash 2 times with water, each 20ml, discard water liquid, n-butyl alcohol liquid evaporate to dryness, residue adds methanol 0.5ml makes dissolving, as need testing solution.Separately get astragaloside reference substance, add methanol and make the solution of every 1ml containing 1mg, product solution in contrast.Test according to thin layer chromatography, draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with lower floor's solution of chloroform-methanol-water (13:7:2) for developing solvent, launch, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to spot development at 105 DEG C clear.In test sample chromatograph, on the position corresponding to reference substance chromatograph, aobvious identical sepia speckle under daylight, aobvious identical orange-yellow fluorescence speckle under ultra-violet lamp (365nm).
Moisture: get this product 2 ~ 5g, puts 100 ~ 105 DEG C and is dried to constant weight (double weight differential is no more than 5mg), should cross 10.0%.
Assay: astragaloside
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With acetonitrile-water (32:68) for mobile phase; Evaporative light scattering detector detects.Number of theoretical plate calculates should be not less than 4000 by astragaloside peak.
The preparation of reference substance solution: get astragaloside reference substance appropriate, accurately weighed, add methanol and make the solution of every l m l containing 0.5mg, to obtain final product.
The preparation of need testing solution: get this product and be about 1.5g, accurately weighed, put Soxhlet to carry and attack in device, add methanol 40ml, merceration spends the night, add methanol more appropriate, reflux 4 hours, extracting solution recycling design is also concentrated into dry, residue adds water 10ml, slight fever makes dissolving, 4 times are extracted with water saturated n-butyl alcohol jolting, each 40ml, merge n-butyl alcohol liquid, 2 times are fully washed with ammonia solution, each 40m l, discard ammoniacal liquor, n-butyl alcohol liquid evaporate to dryness, the residue 5ml that adds water makes dissolving, let cool, by D101 type macroporous adsorptive resins, (internal diameter is 1.5cm, post height is 12cm), with water 50ml eluting, discard water liquid, use 40% ethanol 30mt eluting again, discard eluent, continue with 70% ethanol 80ml eluting, collect eluent, evaporate to dryness, residue adds dissolve with methanol, be transferred in 5ml measuring bottle, add methanol to scale, shake up, obtain.
Algoscopy: accurate absorption reference substance solution 10 μ l, 20 μ l, need testing solution 20 μ l respectively, injection liquid chromatography, measures, and calculates, to obtain final product with external standard two-point method logarithmic equation.
This product is pressed dry product and is calculated containing astragaloside (C
41h
68o
14) must not 0.15% be less than.
Calycosin glucoside
| Time (minute) | Mobile phase A (%) | Mobile phase B (%) |
| 0?20 | 20→40 | 80→60 |
| 20?30 | 40 | 60 |
Chromatographic condition and system suitability take octadecylsilane chemically bonded silica as filler; Take acetonitrile as mobility A, with 0.2% formic acid solution for Mobile phase B, the regulation according to the form below carries out gradient elution; Determined wavelength is 260nm.Number of theoretical plate calculates should be not less than 3000 by calycosin glucoside peak.
The preparation of reference substance solution: get calycosin glucoside reference substance appropriate, accurately weighed, add methanol and make the solution of every lml containing 50 μ g, to obtain final product.
The preparation of need testing solution: get this product powder and be about 0.6g, accurately weighed. put in round-bottomed flask, precision adds methanol 50ml, weighed weight, reflux 4 hours, lets cool, weighed weight again, supplies the weight of less loss, shakes up with methanol, filtering. precision measures subsequent filtrate 25ml, and recycling design is to dry, and residue adds dissolve with methanol, be transferred in 5ml measuring bottle, add methanol to scale, shake up, to obtain final product.
Algoscopy: accurate absorption reference substance solution and need testing solution each l0 μ l respectively, injection liquid chromatography, measures, to obtain final product.
This product is pressed dry product and is calculated, containing calycosin glucoside (C
22h
22o
10) must not 0.03% be less than.
Radix Glycyrrhizae extract quality standard
Differentiate: get this product lg, the 40ml that adds water dissolves, and extracts 3 times with n-butyl alcohol jolting, each 20ml (centrifugal if desired), merge n-butyl alcohol liquid, wash 3 times with water, each 20ml, n-butyl alcohol liquid evaporate to dryness, residue adds methanol 5ml makes dissolving, as need testing solution.Another extracting liquorice acid ammonium reference substance, add methanol and make the solution of every lml containing 2mg, product solution in contrast, test according to thin layer chromatography (annex VI B), draw each 5 μ l of above-mentioned two kinds of solution, put on the silica gel g thin-layer plate prepared in same use 1% sodium hydroxide solution respectively, with acetic ether-methanoic acid-glacial acetic acid-water (15:1:1:2) for developing solvent, launch, take out, dry, spray with 10% ethanol solution of sulfuric acid, be heated to spot development at 105 DEG C clear, inspect under putting ultra-violet lamp (365nm).In test sample chromatograph, on the position corresponding to reference substance chromatograph, aobvious identical orange-yellow fluorescence speckle.
Moisture: get this product 2 ~ 5g, puts 100 ~ 105 DEG C and is dried to constant weight (double weight differential is no more than 5mg), should cross 10.0%.
Assay: according to high effective liquid chromatography for measuring.
Chromatographic condition and system suitability, being filler with octadecylsilane chemically bonded silica, take acetonitrile as mobile phase A, and with 0.05 % phosphoric acid solution for Mobile phase B, the regulation according to the form below carries out gradient elution; Determined wavelength is 237nm.Number of theoretical plate calculates should be not less than 5000 by liquirtin peak.
The preparation of reference substance solution: extracting liquorice glycosides reference substance, ammonium glycyrrhizinate reference substance are appropriate, accurately weighed, add 70% ethanol and make the solution of every lml containing liquirtin 20 μ g, ammonium glycyrrhizinate 0.2mg respectively, obtain (glycyrrhizic acid weight=ammonium glycyrrhizinate weight/1. 0207).
The preparation of need testing solution: get this product fine powder and be about 0.2g, accurately weighed, put in tool plug conical flask, precision adds 70% ethanol 100ml, close plug, weighed weight, supersound process (power 250W, frequency 40kHz) 30 minutes, lets cool, weighed weight again, supply the weight of less loss with 70% ethanol, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l of need testing solution respectively, injection liquid chromatography, measures, to obtain final product.
This product by dry product, containing liquirtin (C
21h
22o
9) 0. 50% must not be less than, glycyrrhizic acid (C
42h
62o
16) must not 7.0% be less than.
Corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine are on the Fibrotic impact of hepatic injury regulating liver-QI
One, sketch
For CCl
4the proportioning of the good three kinds of extracts of the acute liver therapeutic effect caused is prescription 4,5,6,7,8,9.But more than tear Fang Junneng open and effectively reduce GPT and GOT(prescription 1,3 groups of P ≮ 0.05 that acute liver causes) release (P<0.05).
For CCl
4the proportioning of the good three kinds of extracts of rat chronic treating liver injury effect caused is prescription 4,5,6,7,8,9.Above prescription all effectively can reduce the release (P<0.05) of GPT and GOT that rat chronic hepatic injury causes.
Two, test objective
According to the requirement of new Western medicine preclinical study guideline, research affects hepatic injury regulating liver-QI is Fibrotic by reagent corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine, tentatively find out preferably dosage ratio, for research provides test basis further.
Three, experiment material
1, medicine and reagent
CCl
4: Nanjing Chemistry Reagent Co., Ltd., lot number: 10102511136
Glutamate pyruvate transaminase (GOT), glutamic oxaloacetic transaminase, GOT (GPT) test kit: biological engineering company limited is built up in Nanjing, lot number: 20130305
2, experimental animal
Cleaning grade mice, body weight 18-22g, Zhejiang Province's Experimental Animal Center provides, the animal productiong certification of fitness number: SCXK(Zhejiang) 2009-0033.
Male cleaning grade SD rat, body weight 180 ~ 220g, Zhejiang Province's Experimental Animal Center provides, the animal productiong certification of fitness number: SCXK(Zhejiang) 2009-0033.
Four, experimental technique
1, corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine cause the impact of acute liver to carbon tetrachloride
SPF level mice 96, male and female half and half, are divided into 12 groups at random, often organize 8, i.e. normal group, model group, and positive group hepatitis B is good for sheet 0.94g/kg, No. 1-No. 9 prescription groups.Each group every day gastric infusion, administration capacity is 0.2ml/10gd
-1, successive administration 10 days.Normal group and model group give 0.5%CMC-Na, and after last administration, water is can't help in fasting, and after 8 h, except normal group, all the other respectively organize equal lumbar injection (ip) 0.08%CCl
4peanut oil solution 0.1 ml/10g, after 12 h, eyeball gets blood, separation of serum (1).Glutamate pyruvate transaminase (GPT) in detection serum and the activity of glutamic oxaloacetic transaminase, GOT (GOT); Get liver, spleen weighs, calculate liver index, spleen index, fixed by liver 10% formalin, paraffin embedding, section, HE dyes, and observes hepatic tissue pathology and changes.
2, corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine cause the impact of rat chronic hepatic injury to carbon tetrachloride
SPF level SD rat 96, is divided into 12 groups at random, model group 8; Often organize 8, i.e. normal group, model group, positive group hepatitis B is good for sheet 0.47g/kg, No. 1-No. 9 prescription groups.After rat grouping, except Normal group, all the other animals give 40% CC1
42 times/week of oil solution subcutaneous injection, injection CC1
4time accurate Calculation dosage, subcutaneous injection amount is 0.8 ml/kg first, and later injection volume is 0.5 ml/kg.Test each group simultaneously and gavage respective medicine respectively, normal group and model group give 0.5%CMC-Na, and administration volume is 0.5mL/100g body weight, within every 3 days, adjust 1 time according to Mus body weight change and give CC1
4amount and gavage the dosage of medicine. vena ophthalmica blood sampling after 8wk, detect the activity (2) of glutamate pyruvate transaminase (GOT) in serum and glutamic oxaloacetic transaminase, GOT (GPT).Put to death animal afterwards, get liver, spleen weighs, calculate liver index, spleen index, fixed by liver 10% formalin, paraffin embedding, section, HE dyes, and observes liver tissue fibrosis pathological change degree.
Positive drug hepatitis B is good for sheet: people's consumption one time 6 (each 3 of A, B), 3 times on the one,
Orthogonal test, adopts Three factors-levels, and level adopts 50%, 100%, 200% of standard extract weight, need be formulated into 9 experiments.
The list of table 1 people consumption experimental program
The minimum dose unit of each prescription group and hepatitis B are good for corresponding each index components content in sheet
Illustrate during pharmacological testing: when prescription 1 is tested, take corniculate spurgentian herb extract 80mg, Radix Astragali extract 204mg, Radix Glycyrrhizae extract 25mg 309mg mixing altogether as carried out, be a minimum dose unit, be good for listing sample hepatitis B the effect that a slice A sheet adds a slice B sheet and contrast.Be one time 3 (i.e. people with once for 309*3mg) according to people's consumption again, 3 times on the one, be then converted to the consumption of Mouse and rat.
Animals administer dosage through overtreatment conversion is (3):
The list of table 2 rat consumption every day experimental program
| Factor | Corniculate spurgentian herb extract (mg/kg) | Radix Astragali extract (mg/kg) | Radix Glycyrrhizae extract (mg/kg) | Total amount (mg/kg) |
| Prescription 1 | 74 | 188.7 | 23.125 | 285.825 |
| Prescription 2 | 74 | 377.4 | 46.25 | 497.65 |
| Prescription 3 | 74 | 754.8 | 92.5 | 921.3 |
| Prescription 4 | 148 | 188.7 | 46.25 | 382.95 |
| Prescription 5 | 148 | 377.4 | 92.5 | 617.9 |
| Prescription 6 | 148 | 754.8 | 23.125 | 925.925 |
| Prescription 7 | 296 | 188.7 | 92.5 | 577.2 |
| Prescription 8 | 296 | 377.4 | 23.125 | 696.525 |
| Prescription 9 | 296 | 754.8 | 46.25 | 1097.05 |
The list of table 3 mice consumption experimental program
| Factor | Corniculate spurgentian herb extract (mg/kg) | Radix Astragali extract (mg/kg) | Radix Glycyrrhizae extract (mg/kg) | Total amount (mg/kg) |
| Prescription 1 | 148 | 377.4 | 46.25 | 571.65 |
| Prescription 2 | 148 | 754.8 | 92.5 | 995.3 |
| Prescription 3 | 148 | 1509.6 | 185 | 1842.6 |
| Prescription 4 | 296 | 377.4 | 92.5 | 765.9 |
| Prescription 5 | 296 | 754.8 | 185 | 1235.8 |
| Prescription 6 | 296 | 1509.6 | 46.25 | 1851.85 |
| Prescription 7 | 592 | 377.4 | 185 | 1154.4 |
| Prescription 8 | 592 | 754.8 | 46.25 | 1393.05 |
| Prescription 9 | 592 | 1509.6 | 92.5 | 2194.1 |
Five, experimental result
1. corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine cause the impact of acute liver to carbon tetrachloride
The different prescription of table 4 on mice CCl4 cause GOT and the GPT of acute liver damage impact (
± S, n=8)
Experimental data shows, GOT and GPT of model group is all obvious higher than Normal group, and hints model is successful (P<0.05).
Compare with model group, positive drug and each prescription group significantly can reduce the release (P<0.05, P<0.01) of GPT and GOT.Compared with positive drug, prescription 7,8, the reduction trend of the GOT of 9 is obvious, but without notable statistics difference.And each prescription all has the effect reducing GPT release, wherein reducing obvious prescription group is 7,8,9.
Each experimental group is for the improvement result of GOT above: Normal group > prescription 8> prescription 9> prescription 7> prescription 4> prescription 6> positive drug group > prescription 5> prescription 2> prescription 3> prescription 1> model group.
Each experimental group is for the improvement result of GPT above: Normal group > prescription 8> prescription 9> prescription 7> prescription 6> prescription 4> positive drug group > prescription 5> prescription 1> prescription 3> prescription 2 > model group.
2. corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract composition of medicine cause the impact of rat chronic hepatic injury to carbon tetrachloride
The different prescription of table 5 is to rat CCl
4cause GOT and the GPT of chronic hepatic injury impact (
± S, n=8)
Experimental data shows, GOT and GPT of model group is all obvious higher than Normal group, and hints model is successful (P<0.05).
Compare with model group, positive drug and each prescription group significantly can reduce GPT and GOT(prescription 1,3 groups of P ≮ 0.05) release (P<0.05).
Compare with positive drug, prescription 7,8, the release of the GOT of 9 is significantly lower than positive drug group (P<0.05).Though prescription 4 no difference of science of statistics simultaneously, reduces trend obvious.Prescription 7,8,9 compared with positive drug, significantly can improve the release (P<0.05) of GPT.
Each experimental group is for the improvement result of GOT above: Normal group > prescription 8> prescription 9> prescription 7> prescription 4> prescription 6> prescription 5> positive drug group > prescription 1> prescription 2 > prescription 3> model group
Each experimental group is for the improvement result of GPT above: Normal group > prescription 7> prescription 9> prescription 8> prescription 5> prescription 4> positive drug group > prescription 6> prescription 2> prescription 3> prescription 1> model group.
In general, prescription 4,7,8,9 groups has good drug effect, from the dose-effect relationship of effective ingredient, corniculate spurgentian herb extract measure Main Function, prompting prescription 4,7,8,9 class value obtains further developmental research.
3. rat liver specimens pathological checks
Normal group: liver organization structural integrity, hepatocyte is strand arrangement around central vein, and hepatocyte, without obvious degeneration, necrosis, has more glycogen storage, and endochylema loosens light dye, and sinus hepaticus is without dilatation and congestion, and interstitial is without cell infiltration.
Model group: liver organization structure is still complete, 4 routine hepatic portion hepatocyte see that fat in various degree becomes, and see that the fat differed in size drips cavity in endochylema, liver sinus hepaticus without dilatation and congestion, interstitial all without cell infiltration, a small amount of fibroplasia of 2 routine liver interstitial.
Positive drug group: liver organization structure is still complete, 3 routine liver small part liver cell fatty degenerations, see in endochylema that the fat differed in size drips cavity, liver sinus hepaticus is without dilatation and congestion, and interstitial is all without cell infiltration.
1-9 dosage group: liver organization structure is still complete, each group all has a few example to divide liver cell fatty degeneration in various degree, see in endochylema that the fat differed in size drips cavity, liver sinus hepaticus is without dilatation and congestion, 1-8 group liver interstitial is all without cell infiltration, 9 group of 4 routine liver interstitial is shown in inflammatory stove, and inflammatory cell is mainly mononuclear cell, the 5 group of 1 a small amount of fibroplasia of routine interstitial.
Compare with normal group, the routine liver liver cell fatty degeneration of model group 4, positive drug group and each treatment group are shown in identical pathological characters, and scoring is from high to low: model group > 9> positive drug group >7,8 > 4,5 >3 > 6>2 >1> normal group.
Six, discuss
The foundation of the proportioning conclusion of this experiment prescription is mainly carried out according to the result of enzyme activity.Although liver index and index and spleen index have certain meaning, the difference of animal two indexes is mainly due to difference that body weight produces in underfed situation due to the exception of liver function in modelling process.Therefore can only as auxiliary judging quota.The detection of enzyme activity directly can react the function situation of liver, therefore as the Main Basis carrying out experiment conclusion.
For further clear and definite corniculate spurgentian herb extract, Radix Astragali extract and the effect of Radix Glycyrrhizae extract in prescription, we adopt L
9(3
4) result of orthogonal test to effect experiment analyze, to detect the activity of glutamate pyruvate transaminase (GOT) in serum and glutamic oxaloacetic transaminase, GOT (GPT) for index, data statistics and interpretation of result as follows:
Table 6: factor level table
Different prescription sees the following form on the impact that mice CCl4 causes GOT and the GPT of acute liver damage
Different prescription is to rat CCl
4the impact causing GOT and the GPT of chronic hepatic injury sees the following form
Direct-vision method is adopted to align friendship interpretation of result:
Factor A(corniculate spurgentian herb extract)---factor A has appreciable impact to the glutamate pyruvate transaminase (GOT) in serum, appreciable impact is had on glutamic oxaloacetic transaminase, GOT (GPT), it is the principal element in three kinds of factors, it has been the main component of drug action, and its drug effect increases with extract and increases, the increase of corniculate spurgentian herb extract amount is described, may drug effect be improved.
Factor B(Radix Astragali extract)---obviously impact is not obvious on the glutamate pyruvate transaminase (GOT) in serum for factor B, affects not obvious on glutamic oxaloacetic transaminase, GOT (GPT).The amount of Radix Astragali extract is described, and drug effect does not have pronounced amount effect relationship, play the effect of auxiliary treatment.
Factor C(Radix Glycyrrhizae extract)---factor C affects not obvious on the glutamate pyruvate transaminase (GOT) in serum, affect not obvious on glutamic oxaloacetic transaminase, GOT (GPT), the amount of Radix Glycyrrhizae extract is described, and drug effect does not have pronounced amount effect relationship, play the effect of auxiliary treatment.
Seven, experiment conclusion
For CCl
4the proportioning of the good three kinds of extracts of the acute liver therapeutic effect caused is prescription 4,5,6,7,8,9.But more than tear Fang Junneng open and effectively reduce GPT and GOT(prescription 1,3 groups of P ≮ 0.05 that acute liver causes) release (P<0.05).
For CCl
4the proportioning of the good three kinds of extracts of rat chronic treating liver injury effect caused is prescription 4,5,6,7,8,9.Above prescription all effectively can reduce the release (P<0.05) of GPT and GOT that rat chronic hepatic injury causes.
Claims (7)
1. the composition of medicine of a corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, it is characterized in that, be made up of corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract, wherein corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract weight proportion are any a group below in weight proportion: 160:204:50,320:204:100,320:408:25,320:816:50;
The preparation method of the composition of medicine of described corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract comprises:
(1) Herba Haleniae Corniculatae extracts by following technological process: the Herba Haleniae Corniculatae cutting after cleaning weighed, put in extraction pot, add 70% ethanol 10 times amount, 8 times amount respectively, reflux, extract, twice, 3 hours first times, second time 2 hours, filters, release backflow, merge secondary returning flow liquid, reclaim ethanol, be concentrated into thick paste, dry, be ground into fine powder, obtain corniculate spurgentian herb extract;
(2) Radix Astragali extracts by following technological process: weighed by the Radix Astragali decoction pieces after cleaning, put in extraction pot, add decocting in water and carry twice, first time adds water 10 times, decoct 3 hours, second time adds water 8 times, decocts 2 hours, leave standstill, filter, merge supernatant, be concentrated into thick paste, dry, be ground into fine powder, obtain Radix Astragali extract;
(3) Radix Glycyrrhizae is extracted by following technological process: get the Radix Glycyrrhizae after cleaning, run through, and section, decocts with water twice;
First time adds water 10 times, decocts 3 hours, and second time adds water 8 times, decocts 2 hours, collecting decoction, placing spends the night makes precipitation, gets supernatant concentration to paste, takes out appropriate, measure glycyrrhizic acid content, regulate and make to conform with the regulations, dry, be ground into fine powder, obtain Radix Glycyrrhizae extract;
(4) extract is after assay, takes extract respectively by weight ratio according to content data, makes preparation after adding pharmaceutic adjuvant by preparation process;
In corniculate spurgentian herb extract, 1-hydroxyl-3,4,5-trimethoxy mouth diphenylene ketone oxide content is not less than 1.0%; Astragloside IV in Extraction of Radix Astragali content is not less than 0.15%, and calycosin glucoside content is not less than 0.03%; In Radix Glycyrrhizae extract, glycyrrhizic acid content is not less than 7.0%, and liquirtin content is not less than 0.5%.
2. the composition of medicine of a kind of corniculate spurgentian herb extract according to claim 1, Radix Astragali extract and Radix Glycyrrhizae extract, it is characterized in that: after corniculate spurgentian herb extract, Radix Astragali extract and Radix Glycyrrhizae extract make composition of medicine, in each dosage unit, contain 1-hydroxyl-3, the amount of 4,5-trimethoxy mouth diphenylene ketone oxide, astragaloside, calycosin glucoside, glycyrrhizic acid, liquirtin is respectively following weight scope 2.72 – 5.44mg, 0.428 – 1.714mg, 0.122 – 0.49mg, 1.78 – 7.12mg, 0.285 – 1.14mg.
3. a kind of corniculate spurgentian herb extract according to claim 1, the composition of medicine of Radix Astragali extract and Radix Glycyrrhizae extract, it is characterized in that: corniculate spurgentian herb extract, 1-hydroxyl-3 is contained in each dosage unit after Radix Astragali extract and Radix Glycyrrhizae extract make composition of medicine, 4, 5-trimethoxy mouth diphenylene ketone oxide, astragaloside, calycosin glucoside, glycyrrhizic acid, liquirtin amount is respectively in following weight combination any one group: 2.72mg, 0.428 mg, 0.122 mg, 3.56 mg, 0.57 mg, 5.44 mg, 0.428 mg, 0.122 mg, 7.12 mg, 1.14 mg, 5.44 mg, 0.857 mg, 0.245 mg, 1.78 mg, 0.285 mg, 5.44 mg, 1.714 mg, 0.49 mg, 3.56 mg, 0.57 mg.
4. the composition of medicine of a kind of corniculate spurgentian herb extract according to claim 1, Radix Astragali extract and Radix Glycyrrhizae extract, is characterized in that: its preparation is oral formulations.
5. the composition of medicine of a kind of corniculate spurgentian herb extract according to claim 4, Radix Astragali extract and Radix Glycyrrhizae extract, is characterized in that: the pharmaceutic adjuvant containing oral formulations.
6. the composition of medicine of a kind of corniculate spurgentian herb extract according to claim 5, Radix Astragali extract and Radix Glycyrrhizae extract, is characterized in that: oral formulations comprises hard capsule, soft capsule, tablet, granule.
7. the composition of medicine of a kind of corniculate spurgentian herb extract according to claim 1, Radix Astragali extract and Radix Glycyrrhizae extract is applied preparing to treat in acute or chronic hepatitis B and other hepatitis medicaments.
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