CN1814126A

CN1814126A - Compound black-bone chicken soft capsule, its preparing method and quality control method

Info

Publication number: CN1814126A
Application number: CNA2005102007383A
Authority: CN
Inventors: 毛晓敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-11-25
Filing date: 2005-11-25
Publication date: 2006-08-09

Abstract

The invention relates to a Chinese medicine-compound black-bone chicken soft capsule having functions of tonifying Qi and blood and benefiting liver and kidney and the preparing and quality control methods thereof. It has many advantages of stability, convenient to take and carry, no sugar, no bad smell, etc, and the quality control method comprises identifying White Paeony Root, cortex moutan radicis, Milkvetch Root, Radix Codonopsis, Chinese Angelica Root and Rhizoma Chuanxiong in the soft capsule, making content determination on the active substance of White Paeony Root and cortex moutan radicis-paeoniflorin in the soft capsule and controlling total nitrogen content of the soft capsule.

Description

A kind of FUFANG WUJI RUANJIAONANG and preparation method thereof method of quality control

Technical field

The present invention relates to a kind of Chinese medicine preparation, particularly relate to FUFANG WUJI RUANJIAONANG, relate to the preparation method method of quality control of said preparation simultaneously.

Background technology

By the menoxenia of QI and blood deficiency or Liver and kidney two void, gynecological diseases such as insufficiency of the spleen or leukorrhagia due to deficiency of the kidney are common clinically multiple diseases, and adopt fills blood more on the tcm clinical practice, and methods such as liver and kidney tonifying are treated.Develop the Chinese medicine traditional advantage, stable, drug safety is made in exploitation, dosage is accurate, quality controllable, the reliable Chinese medicine preparation of curative effect is significant.

" FUFANG WUJI RUANJIAONANG " prescription is derived from ministerial standard " compound black-bone chicken oral liquid " [WS3-160 (Z-54)-94 (Z)].Former dosage form is an oral liquid, and clinical practice is extensive, records in national essential drugs (Chinese patent medicine), is national Class B OTC (over-the-counter).The granule that similar preparation also has the national drug standards to record.

The subject matter that prior art exists is: (1) oral liquid instability, and put easy generation precipitation for a long time, and carry transportation inconvenience; (2) granule is taken inconvenience, needs boiled water to take after mixing it with water, and supplementary product consumption is big; (3) all there is the sugar content height in existing dosage form, is unsuitable for the deficiency of diabetic to take; (4) carry out flavoring though existing dosage form has added correctivess such as sugar, Mel, mouthfeel still is not that the quality control standard of very desirable (5) existing preparation is lower.

Soft capsule dosage form external form slyness is attractive in appearance, it is easy to carry to take, and can cover bad smell, do not contain sugar, is suitable for diabetic to take.Because medicine is hidden within the rubber by complete sealed packet, it is stable to help medicine in addition.Because its plurality of advantages, soft capsule is popular in the world oral type dosage form, and the Chinese medicinal soft capsule preparation is also less in the market, far can not satisfy people's medication demand.So change the compound black-bone chicken oral solutions into soft capsule, medicine variety can not only be enriched, and the dosage form advantage can better be brought into play, have than the large market potentiality.

A kind of method of quality control of FUFANG WUJI RUANJIAONANG is provided simultaneously, can carry out thin layer to the Radix Paeoniae Alba in the FUFANG WUJI RUANJIAONANG, Cortex Moutan, Radix Codonopsis, the Radix Astragali, Radix Angelicae Sinensis and Rhizoma Chuanxiong with thin layer chromatography differentiates, can can measure the total nitrogen in the FUFANG WUJI RUANJIAONANG with the content of paeoniflorin in the high effective liquid chromatography for measuring FUFANG WUJI RUANJIAONANG.FUFANG WUJI RUANJIAONANG must be controlled product quality if can adopt above-mentioned discriminating and assay project to carry out Quality Control wholly or in part, guarantees the safe and effective of medication, improves the quality of product.

Summary of the invention

The present invention has overcome the deficiencies in the prior art, a kind of good effect, preparation stabilization is provided, has taken Chinese medicine easy to carry, as not contain sugar, no adverse drug abnormal smells from the patient and grab FUFANG WUJI RUANJIAONANG.The preparation method method of quality control of FUFANG WUJI RUANJIAONANG is provided simultaneously.

FUFANG WUJI RUANJIAONANG of the present invention is made up of capsule core material and softgel shell two parts.

A kind of capsule core material of FUFANG WUJI RUANJIAONANG comprises 12 flavor Chinese medicine extract and appropriate amount of auxiliary materials such as Gallus Domesticus, and softgel shell mainly is made up of sizing material and plasticizer, and can contain additives such as antiseptic, pigment, correctives, screening agent.

A kind of capsule core material of FUFANG WUJI RUANJIAONANG comprises 12 flavor Chinese medicine extract such as Gallus Domesticus, and 12 flavor Chinese medicines such as Gallus Domesticus are Gallus Domesticus, Radix Astragali Preparata, Rhizoma Dioscoreae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Rhizoma Chuanxiong, Poria, Radix Angelicae Sinensis, Radix Rehmanniae Preparata, the Radix Paeoniae Alba (wine stir-fry), Cortex Moutan, Fructus Schisandrae Chinensis (processed with wine).Its proportioning (weight ratio) is: Gallus Domesticus 750, Radix Astragali Preparata 280, Rhizoma Dioscoreae 560, Radix Codonopsis 280, the Rhizoma Atractylodis Macrocephalae 280, Rhizoma Chuanxiong 95, Poria 188, Radix Angelicae Sinensis 188, Radix Rehmanniae Preparata 375, the Radix Paeoniae Alba (wine stir-fry) 188, Cortex Moutan 188, Fructus Schisandrae Chinensis (processed with wine) 95.

Its capsule core material of a kind of FUFANG WUJI RUANJIAONANG contains following composition by weight percentage: 12 flavor Chinese medicine extract such as 10～70% Gallus Domesticuss, pharmaceutic adjuvant comprises 0～3% antioxidant, 0～20% stabilizing agent and proper amount of diluting.Its softgel shell contains 20～50% sizing material, 5～30% plasticizer, 0.01～0.3% antiseptic, 0～3% screening agent, 0～10% Polyethylene Glycol, 0～2% pigment, 0～1% correctives and an amount of water by raw material weight percentage ratio.

Above-mentioned diluent can be the material of one or more or other the conventional tool diluting effect in Oleum Arachidis hypogaeae semen, Oleum Glycines, safflower oil, Oleum Hippophae, Oleum Camelliae, salad oil, PEG400, the corn wet goods.

The aforementioned stable agent can be the material of one or more or other the conventional tool Stabilization in Cera Flava, Adeps caprae seu ovis, methylcellulose, ethyl cellulose, Polyethylene Glycol monostearate, tween 80, cetomacrogol 1000～6000, poloxamer 188～407, the glycerol.

Above-mentioned antioxidant can be the material of one or more or other the conventional tool antioxidation in vitamin E, tea polyphenols, tertiarybutylhydroquinone (TBHQ), Radix Glycyrrhizae antioxygen thing, Butylated hydroxyanisole (BHA), dibenzylatiooluene (BHT), the propyl gallate (PG).

Above-mentioned sizing material can be gelatin or other conventional material.

Above-mentioned plasticizer can be the material of one or more or other the conventional tool plasticization in glycerol, sorbitol, the sucrose.

Foregoing preservatives can be the material of the conventional tool antisepsis of one or more or other tool in methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the butyl p-hydroxybenzoate.

Above-mentioned screening agent can be the material of one or more or other tool bridging effect in titanium dioxide, barium sulfate, ferrum oxide, the precipitated calcium carbonate.

Above-mentioned pigment can be any in food coloring or the medicinal pigment.

Above-mentioned correctives can be the material of one or more or other the conventional tool flavored action in bourbonal,ethyl vanillin, essential oil, the Mentholum.

The preparation method of FUFANG WUJI RUANJIAONANG of the present invention is as follows:

1, capsule core material preparation:

(1) gets Gallus Domesticus 750 weight portions, Radix Astragali Preparata 280 weight portions, Rhizoma Dioscoreae 560 weight portions, Radix Codonopsis 280 weight portions, the Rhizoma Atractylodis Macrocephalae 280 weight portions, Rhizoma Chuanxiong 95 weight portions, Poria 188 weight portions, Radix Angelicae Sinensis 188 weight portions, Radix Rehmanniae Preparata 375 weight portions, the Radix Paeoniae Alba (wine stir-fry) 188 weight portions, Cortex Moutan 188 weight portions, Fructus Schisandrae Chinensis (processed with wine) 95 weight portions.

(2) extraction of Rhizoma Dioscoreae, the Radix Astragali, Radix Codonopsis, Poria: Rhizoma Dioscoreae, the Radix Astragali, Radix Codonopsis, Poria are cut into fragment, add the water of 7 times of amounts, heated and boiled 30 minutes, filter, collect filtrate, medicinal residues add the water of 5 times of amounts again, boiled 30 minutes, and filtered merging filtrate, concentrate, it is an amount of to add ethanol, standing over night, filter, filtrate recycling ethanol is condensed into thick paste or is dried to dried cream, be ground into fine powder, standby;

(3) extraction of Gallus Domesticus: after Gallus Domesticus is slaughtered, remove unhairing, pawl, intestinal etc., clean, be cut into fragment, it is an amount of to add dilute sulfuric acid, heating and refluxing extraction 3 hours filters, and filtrate is transferred pH value 5～6, and cold preservation is spent the night, defat, filter, filtrate is condensed into thick paste or is dried to dried cream, is ground into fine powder, and is standby;

(4) extraction of all the other seven flavor Chinese medicines such as Radix Rehmanniae Preparata: Radix Rehmanniae Preparata, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis and Fructus Schisandrae Chinensis powder are broken into coarse powder, with carrying out percolation after 70% the alcohol dipping, collect percolate, filter, decompression filtrate recycling ethanol, be condensed into thick paste or be dried to dried cream, be ground into fine powder, standby;

(5) with above-mentioned three groups of extract powder mix homogeneously or with above-mentioned three groups of thick extractum mix homogeneously or with above-mentioned three groups of thick extractum mix homogeneously, be dried to dried cream, be ground into fine powder, promptly make 12 flavor Chinese medicine extract such as Gallus Domesticus; In 12 flavor Chinese medicine extract such as Gallus Domesticus, add stabilizing agent, diluent, antioxidant, mix homogeneously is crossed colloid mill, and is standby;

2, softgel shell preparation: water, plasticizer, PEG400 (or not adding), the antiseptic of aequum added in the glue pot stir, the sizing material that adds aequum, stir, after treating that micelle expands, be heated to 50～80 ℃ and make micelle all melt and dissolved, add screening agent, the pigment of aequum, stir, filter, the filtrate insulation is left standstill or the degassing of reducing pressure stand-by;

3, preparation of soft capsule: capsule core material is wrapped in makes soft capsule in the softgel shell, can adopt dropping preparation method or pressing; Wash ball, drying then, be packaged to be FUFANG WUJI RUANJIAONANG.

A kind of method of quality control of FUFANG WUJI RUANJIAONANG, contain in following discriminating and the assay one or more:

1. differentiate

(1) with Radix Angelicae Sinensis and Rhizoma Chuanxiong in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

(2) with the peoniflorin in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

(3) with the Cortex Moutan in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

(4) with the Radix Codonopsis in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

(5) with the Radix Astragali in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

2. assay

(1) with the paeoniflorin content in the high effective liquid chromatography for measuring FUFANG WUJI RUANJIAONANG

(2) total nitrogen in the mensuration FUFANG WUJI RUANJIAONANG.

1. differentiate

It is an amount of to get this product content, after the defat, adds acetone or other The suitable solvent and extracts, and extracting solution is as need testing solution, or extracting solution steams/volatilize, and residue adds The suitable solvent makes dissolving, as need testing solution.Other gets Radix Angelicae Sinensis control medicinal material and Rhizoma Chuanxiong control medicinal material, and each is an amount of, makes control medicinal material solution after the extraction.Each is an amount of to draw above-mentioned three kinds of solution, puts respectively on same silica gel G or silica gel H lamellae, with normal hexane-ethyl acetate (3-30: 0.3-3) be developing solvent, launch, take out, dry, put under the ultra-violet lamp and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.

It is an amount of to get this product content, after the defat, is dissolved in water, extract with water saturated n-butyl alcohol jolting, and neutral alumina post on the extract, with ethyl acetate-methanol solution eluting, the eluent evaporate to dryness, the residue solubilizer makes dissolving, as need testing solution.Other gets the peoniflorin reference substance, and solubilizer is made reference substance solution in right amount.Draw above-mentioned need testing solution, each is an amount of for reference substance solution, put respectively on same silica gel G or silica gel H lamellae, with chloroform-ethyl acetate-methanol-formic acid (20-60: 2-8: 2-20: 0.05-0.5) be developing solvent,, launch, take out, dry, the spray developer makes colour developing, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.

It is an amount of to get this product content, after the defat, adds acetone or other The suitable solvent and extracts, and extracting solution is as need testing solution, or extracting solution steams/volatilize, and residue adds The suitable solvent makes dissolving, as need testing solution.Other gets the paeonol reference substance, and solubilizer is made reference substance solution in right amount.Draw above-mentioned need testing solution, each is an amount of for reference substance solution, put respectively on same silica gel G or silica gel H lamellae, with cyclohexane extraction-ethyl acetate (1-10: 0.3-3) be developing solvent, launch, take out, dry, the spray developer makes colour developing, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.

It is an amount of to get this product content, after the defat, adds ethanol extraction, the extracting solution evaporate to dryness, residue is dissolved in water, and adds water-saturated n-butanol and extracts, and n-butanol extracting liquid is as need testing solution, or n-butanol extracting liquid steams/volatilizes, and residue adds The suitable solvent makes dissolving, as need testing solution.It is an amount of that other gets the Radix Codonopsis control medicinal material, makes Radix Codonopsis control medicinal material solution after the extraction.Draw above-mentioned need testing solution, each is an amount of for control medicinal material solution, put respectively on same silica gel G or silica gel H lamellae, with n-butyl alcohol-glacial acetic acid-water (2-15: 0.5-5: 0.1-1) be developing solvent, launch, take out, dry, the spray developer is put under the ultra-violet lamp and is inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.

It is an amount of to get this product content, after the defat, add ethanol or other The suitable solvent and extract the extracting solution evaporate to dryness, residue adds the dissolving of 0.1-10% sodium hydroxide solution, filter, filtrate is regulated pH value to 3～8 with dilute hydrochloric acid, extracts with ethyl acetate or other The suitable solvent, extracting solution is as need testing solution, or extracting solution steams/volatilizes, and residue adds The suitable solvent makes dissolving, as need testing solution.It is an amount of that other gets Radix Astragali control medicinal material, makes Radix Astragali control medicinal material solution after the extraction.Each is an amount of to draw above-mentioned two kinds of solution, puts respectively on same silica gel G or silica gel H lamellae, with chloroform-methanol (5-20: 0.5～2) be developing solvent, launch, take out that dry, colour developing is put under the ultra-violet lamp and inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.

2. assay

Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels; Acetonitrile-potassium dihydrogen phosphate is a mobile phase; UV-detector or diode array detector; Theoretical cam curve is calculated by the peoniflorin peak should be not less than 2000.

It is an amount of that the preparation precision of reference substance solution takes by weighing the peoniflorin reference substance, adds water or other The suitable solvent and make the solution of determining concentration, product solution in contrast.

It is an amount of that the preparation precision of need testing solution takes by weighing the product content thing, after the defat, adds water or ethanol or other The suitable solvent and extract, as need testing solution.

Each is an amount of for accurate respectively absorption reference substance solution of algoscopy and need testing solution, injects chromatograph of liquid, measures, promptly.

(2) total nitrogen in the mensuration FUFANG WUJI RUANJIAONANG.

It is an amount of that precision takes by weighing the product content thing, after the defat, measures total nitrogen according to the meso method in the N2 method.

Described extraction can be adopted conventional methods such as supersound process, reflux, extract,, microwave extraction, vibration extraction;

The developing solvent that the thin layer chromatography of Radix Angelicae Sinensis and Rhizoma Chuanxiong is differentiated can also be petroleum ether-ethyl acetate (5-25: 0.5-5), cyclohexane extraction-ethyl acetate (5-25: 0.5-5), petroleum ether-chloroform-methanol (5-15: 1-5: 0.5-5) or other suitable developing solvent;

The developing solvent that the thin layer chromatography of peoniflorin is differentiated can also be chloroform-methanol-ethyl acetate (5-15: 1-10: 0.5-5) or other suitable developing solvent;

The developing solvent that the thin layer chromatography of Cortex Moutan is differentiated can also be cyclohexane extraction-chloroform-ethyl acetate (5-15: 1-10: 0.1-1) or other suitable developing solvent;

The developing solvent that the thin layer chromatography of Radix Codonopsis is differentiated can also be chloroform-methanol-water (5-15: 1-10: 0.5-5), n-butyl alcohol-ethyl acetate-water (2-8: 0.5-2: 1-10) or other suitable developing solvent;

The mobile phase that content of paeoniflorin is measured can also be acetonitrile-0.1% phosphoric acid solution (10-30: 90-70) or other suitable mobile phase.

1. differentiate

It is an amount of to get this product content, and it is an amount of to add kieselguhr, grinds well, and adds petroleum ether (30～60 ℃) 20ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, add acetone 20ml, supersound process 20 minutes filters, and filtrate is concentrated into 1ml, as need testing solution.Other gets Radix Angelicae Sinensis control medicinal material and each 0.5g of Rhizoma Chuanxiong control medicinal material, adds acetone 10ml respectively, jolting constantly, and merceration 1 hour filters, and filtrate is medical material solution in contrast.Draw each 5 μ l of above-mentioned three kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, be developing solvent with normal hexane-ethyl acetate (9: 1), launch, taking-up is dried, and puts under the ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.

It is an amount of to get this product content, and it is an amount of to add kieselguhr, grinds well, add kieselguhr 5g, grind well, add petroleum ether (30～60 ℃) 40ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, add water 40ml, heating makes dissolving, puts cold, extract 3 times with water saturated n-butyl alcohol jolting, each 25ml merges n-butyl alcohol liquid, wash with water 2 times, each 20ml discards water liquid, and n-butyl alcohol liquid is put water-bath and is concentrated into 1～2ml, adding an amount of neutral alumina mixes thoroughly, in water-bath, boil off n-butyl alcohol, be loaded on neutral alumina pillar (200 orders, 2g, internal diameter 1cm) on, with ethyl acetate-methanol (1: 1) 30ml eluting, collect eluent, evaporate to dryness, residue adds ethanol 1ml makes dissolving, as need testing solution.Other gets the peoniflorin reference substance, adds ethanol and makes the solution that contains 2mg among every 1ml, in contrast product solution.Draw above-mentioned need testing solution 10 μ l, reference substance solution 5 μ l, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, with chloroform-ethyl acetate-methanol-formic acid (40: 5: 10: 0.2) be developing solvent,, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.

It is an amount of to get this product content, and it is an amount of to add kieselguhr, grinds well, and adds petroleum ether (30～60 ℃) 20ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, add acetone 20ml, supersound process 20 minutes filters, and filtrate is concentrated into 1ml, as need testing solution.Other gets the paeonol reference substance, adds acetone and makes the solution that contains 2mg among every 1ml, in contrast product solution.Draw above-mentioned need testing solution 15 μ l, reference substance solution 4 μ l, putting in same sodium carboxymethyl cellulose with 0.3% respectively is on the silica gel g thin-layer plate of adhesive, is developing solvent with cyclohexane extraction-ethyl acetate (3: 1), launches, take out, dry, spray is with the acid 5% ferric chloride alcoholic solution of hydrochloric acid, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.

It is an amount of to get this product content, and it is an amount of to add kieselguhr, grinds well, add petroleum ether (30～60 ℃) 20ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, and residue adds ethanol 30ml, supersound process 30 minutes, filter, filtrate water bath method, residue add water 10ml makes dissolving, add water-saturated n-butanol extraction 2 times, each 10ml, combining extraction liquid is concentrated into 1ml, as need testing solution.Other gets Radix Codonopsis control medicinal material 3g, according to above-mentioned test sample preparation method, makes Radix Codonopsis control medicinal material solution from " residue adds ethanol 30ml " with method.Draw above-mentioned need testing solution 6 μ l, control medicinal material solution 2 μ l, putting in same sodium carboxymethyl cellulose with 0.3% respectively is on the silica gel g thin-layer plate of adhesive, with n-butyl alcohol-glacial acetic acid-water (7: 1: 0.5) is developing solvent, launches, and takes out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were heated 5 minutes, and put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color.

It is an amount of to get this product content, it is an amount of to add kieselguhr, grinds well, and adds petroleum ether (30～60 ℃) 40ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, and residue adds ethanol 50ml, reflux 20 minutes, filter, filtrate evaporate to dryness, residue add 0.3% sodium hydroxide solution 15ml makes dissolving, filter, filtrate is regulated pH value to 5～6 with dilute hydrochloric acid, uses ethyl acetate extraction 2 times, each 15ml, combined ethyl acetate liquid, evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Radix Astragali control medicinal material 2g, makes Radix Astragali control medicinal material solution from " residue adds ethanol 50ml " with method according to above-mentioned need testing solution preparation method.Draw each 10 μ l of above-mentioned two kinds of solution, putting in same sodium carboxymethyl cellulose with 0.3% respectively is on the silica gel g thin-layer plate of adhesive, is developing solvent with chloroform-methanol (10: 1), launch, take out, dry, put in the ammonia steam and smoke, inspect under the rearmounted ultra-violet lamp (365nm).In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color.

2. assay

Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05mol/l potassium dihydrogen phosphate (14: 86); Detect wavelength: 230nm; Theoretical cam curve is calculated by the peoniflorin peak should be not less than 3000.

It is an amount of that the preparation precision of reference substance solution takes by weighing the peoniflorin reference substance, adds water and make the solution that every 1ml contains 25 μ g, promptly.

It is an amount of that this product content got surely in the accurate title of the preparation of need testing solution, puts in the apparatus,Soxhlet's, and it is an amount of to add petroleum ether (30～60 ℃), and heating and refluxing extraction is to extracting liquid colourless, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, put in the tool plug conical flask, precision adds water 50ml, and close plug claims to decide weight, ultrasonic (power 250W, frequency 50kHz) handled 30 minutes, put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up, filter, get subsequent filtrate, promptly.

Accurate respectively reference substance solution and each the 20 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.

Contain the Radix Paeoniae Alba, Cortex Moutan in the dose with peoniflorin (C ₂₃H ₂₈O ₁₁) meter, must not be less than 2.4mg.

(2) total nitrogen in the mensuration FUFANG WUJI RUANJIAONANG.

It is an amount of that precision takes by weighing this product content, puts in the apparatus,Soxhlet's, and it is an amount of to add petroleum ether (30～60 ℃), and heating and refluxing extraction discards petroleum ether liquid to extracting liquid colourless, and medicinal residues are flung to petroleum ether, measures total nitrogen according to the meso method in the N2 method.

Nitrogenous (N) must not be less than 15mg in the dose.

The amount of described extraction sample or dissolving extract solvent for use, ultrasonic or time, standardize solution or dissolving back volume, point sample amount or the sample size of reflux, extract,, the concentration of reference substance can be that benchmark changes with described occurrence, or change in proportion.Described supersound process also can adopt conventional extracting method such as reflux, extract,, microwave extraction, vibration extraction; Described reflux, extract, also can adopt conventional extracting method such as supersound process, microwave extraction, vibration extraction.Described discrimination method Rf value is suitable, clear spot, and it is noiseless to lack flavor.Described content assaying method has all carried out the methodology checking, and it is noiseless to lack flavor, and linear relationship, the response rate etc. are good.Described content limit is to determine that according to the rate of transform of institute's pilot sample and the content limit in the related standards above-mentioned content limit is the minimum content limit, can improve content limit according to the concrete condition of producing.

The specific embodiment

Further specify the present invention by the following examples, but do not limit range of application of the present invention therefrom.

Embodiment 1: the extraction of Rhizoma Dioscoreae, the Radix Astragali, Radix Codonopsis, Poria

Rhizoma Dioscoreae, the Radix Astragali, Radix Codonopsis, Poria adopt aqueous extraction-alcohol precipitation technology to extract, and in effective component extracting, can reduce the rate of extract effectively, reduce the proposition of invalid components such as starch.

Influencing water puies forward the principal element of effect pulverizing medicinal materials degree, amount of water, decocting time, decoction number of times and soak time etc. is arranged.Medical material soaks into before decocting has certain influence to decocting effect, soak time before decocting should be soaked into degree of being with medical material, Poria, Rhizoma Dioscoreae are difficult for soaking in this four Chinese medicine, so with no hard-core degree of being, soak 0.5,1,2 hour observation after adding water with Poria, Rhizoma Dioscoreae fragment, Poria, the taking-up of Rhizoma Dioscoreae fragment smashed on time, hard-core was all arranged in as seen 0.5 hour, 1 hour, 2 hours no hard-cores, so soaked 2 hours after adding water, reheat decocts and is advisable.The principal element of precipitate with ethanol remove impurity is determining alcohol (reaches remove impurity and active ingredient loss few purpose), in concentrated solution (1: 1), adds ethanol usually, makes to contain the alcohol amount and reach 60%, 70%, 80%.Amount with yield of extract and n-butanol extract serves as to investigate index, and concentration of alcohol is investigated during to precipitate with ethanol, the results are shown in Table 1.As can be known from Table 1, it is better to add 2 times of amount ethanol during precipitate with ethanol.

Table 1: the comparison of alcohol precipitation process

Tested number	Medical material amount (g)	Concentrated solution: 95% ethanol (ml) (ml)	Extractum amount (g)	Yield of extract (%)	N-butanol extract yield (%)
Tested number	Medical material amount (g)	Concentrated solution: 95% ethanol (ml) (ml)	Extractum amount (g)	Yield of extract (%)	N-butanol extract yield (%)	1	436	450∶618	98.3	22.5	7.98
2	436	450∶618	100.6	23.1	7.81	1	436	450∶618	98.3	22.5	7.98
2	436	450∶618	100.6	23.1	7.81	3	436	450∶900	78.5	18.0	10.00
4	436	450∶900	76.8	17.6	10.22	3	436	450∶900	78.5	18.0	10.00
4	436	450∶900	76.8	17.6	10.22	5	436	450∶2400	56.1	12.9	13.99
6	436	450∶2400	55.3	12.7	14.19	5	436	450∶2400	56.1	12.9	13.99
6	436	450∶2400	55.3	12.7	14.19	7	436	450∶0	138.7	31.8	5.66
8	436	450∶0	141.5	32.5	5.54	7	436	450∶0	138.7	31.8	5.66

Embodiment 2: the extraction of Gallus Domesticus

Gallus Domesticus albumen can become easier polypeptide, aminoacid for the absorption of human body utilization through acid hydrolysis.Influencing acid-hydrolyzed principal element is sour kind, acid concentration and consumption, the concentration of heating hydrolysis and time.With Gallus Domesticus hydrolysis powder nitrogen content serves as to investigate index, determines that dilute sulfuric acid has consumption.The experiment and the results are shown in Table 2.As seen from Table 2, the ratio of Gallus Domesticus amount and dilute sulfuric acid be 1: 1.2 better.

Table 2: the comparison of dilute sulfuric acid consumption

Tested number	Gallus Domesticus (g): dilute sulfuric acid (ml)	Gallus Domesticus weight (g)	Dilute sulfuric acid (ml)	Gallus Domesticus hydrolysis powder (g)	Nitrogen content (%)	Total amount (g)
Tested number	Gallus Domesticus (g): dilute sulfuric acid (ml)	Gallus Domesticus weight (g)	Dilute sulfuric acid (ml)	Gallus Domesticus hydrolysis powder (g)	Nitrogen content (%)	Total amount (g)	1	1∶1.0	250	250	21.3	15.77	3.36
2	1∶1.0	250	250	22.5	15.91	3.58	1	1∶1.0	250	250	21.3	15.77	3.36
2	1∶1.0	250	250	22.5	15.91	3.58	3	1∶1.2	250	300	35.4	15.88	5.62
4	1∶1.2	250	300	34.8	16.03	5.58	3	1∶1.2	250	300	35.4	15.88	5.62
4	1∶1.2	250	300	34.8	16.03	5.58	5	1∶1.5	250	375	36.7	15.15	5.56
6	1∶1.5	250	375	35.1	15.98	5.61	5	1∶1.5	250	375	36.7	15.15	5.56

Embodiment 3: the extraction of seven flavor medicines such as all the other Radix Rehmanniae Preparata

Radix Rehmanniae Preparata,, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis and Fructus Schisandrae Chinensis seven flavors carry out percolation with the suitable ethanol when concentration, the principal element that influences percolation is the degree of grinding of medical material, concentration of alcohol and consumption, the speed of filtering.The speed of filtering rule of thumb can be fixed as 3-5ml/kgmin usually.Collection filter liquid measure with percolation to colourless be terminal point, percolation effect crux or determining alcohol, what serve as to investigate index with definite concentration of ethanol with the active component peoniflorin in yield of extract and the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba.The test and the results are shown in Table 3.As can be known from Table 3, concentration of alcohol 70% is better.

Table 3: the comparison of concentration of alcohol

Concentration of alcohol (%)	Medical material amount (g)	Extractum amount (g)	Yield of extract (%)	Paeoniflorin content (%)	The peoniflorin rate of transform (%)
Concentration of alcohol (%)	Medical material amount (g)	Extractum amount (g)	Yield of extract (%)	Paeoniflorin content (%)	The peoniflorin rate of transform (%)	80	469	93.8	20.0	1.58	90.5
80	469	91.2	19.4	1.62	91.2	80	469	93.8	20.0	1.58	90.5
80	469	91.2	19.4	1.62	91.2	70	469	126.6	27.0	1.19	91.2
70	469	128.1	27.3	1.21	91.3	70	469	126.6	27.0	1.19	91.2
70	469	128.1	27.3	1.21	91.3	60	469	132.3	28.2	1.14	89.7
60	469	133.8	28.5	1.15	90.4	60	469	132.3	28.2	1.14	89.7

Embodiment 4: make 3000 FUFANG WUJI RUANJIAONANG

Gallus Domesticus 750g Radix Astragali Preparata 280g Rhizoma Dioscoreae 560g

Radix Codonopsis 280g Rhizoma Atractylodis Macrocephalae 280g Rhizoma Chuanxiong 95g

Poria 188g Radix Angelicae Sinensis 188g Radix Rehmanniae Preparata 375g

The Radix Paeoniae Alba (wine stir-fry) 188g Cortex Moutan 188g Fructus Schisandrae Chinensis (processed with wine) 95g

More than 12 the flavor, Rhizoma Dioscoreae, the Radix Astragali, Radix Codonopsis, Poria are cut into fragment, add the water of 7 times of amounts, heated and boiled 30 minutes filters, and collects filtrate, medicinal residues add the water of 5 times of amounts again, boil 30 minutes, filter, merging filtrate concentrates, and adds 2 times of amount ethanol, standing over night, filter, filtrate recycling ethanol, being condensed into relative density is the clear paste of 1.1 (80 ℃); Other gets after Gallus Domesticus slaughters, and removes unhairing, pawl, intestinal etc., cleans, and is cut into fragment, and it is an amount of to add dilute sulfuric acid, and heating and refluxing extraction 3 hours filters, and filtrate is transferred pH value 5～6, and cold preservation is spent the night, and defat filters, and filtrate is condensed into the clear paste that relative density is 1.1 (80 ℃); All the other Radix Rehmanniae Preparata, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis and Fructus Schisandrae Chinensis powder are broken into coarse powder, with carrying out percolation after 70% the alcohol dipping, collect percolate, filter, and decompression filtrate recycling ethanol, being condensed into relative density is the clear paste of 1.1 (80 ℃); Three kinds of clear paste are mixed, and drying under reduced pressure is pulverized, and adds Oleum Camelliae 12429, Cera Flava 103.5g, and mixing is pressed into 3000 of soft capsules, promptly.

Embodiment 5: the discriminating of FUFANG WUJI RUANJIAONANG and assay (can comprise following all or part of, being three with dose of made soft capsule is example)

1. differentiate

(1) get 6 of this product, cut off, inclining content, adds kieselguhr 3g, grinds well, add petroleum ether (30～60 ℃) 20ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, add acetone 20ml, supersound process 20 minutes filters, and filtrate is concentrated into 1ml, as need testing solution.Other gets Radix Angelicae Sinensis control medicinal material and each 0.5g of Rhizoma Chuanxiong control medicinal material, adds acetone 10ml respectively, jolting constantly, and merceration 1 hour filters, and filtrate is medical material solution in contrast.Draw each 5 μ l of above-mentioned three kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, be developing solvent with normal hexane-ethyl acetate (9: 1), launch, taking-up is dried, and puts under the ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.

(2) get 12 of this product, cut off, inclining content, add kieselguhr 5g, grind well, add petroleum ether (30～60 ℃) 40ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, add water 40ml, heating makes dissolving, puts cold, extract 3 times with water saturated n-butyl alcohol jolting, each 25ml merges n-butyl alcohol liquid, wash with water 2 times, each 20ml discards water liquid, and n-butyl alcohol liquid is put water-bath and is concentrated into 1～2ml, adding an amount of neutral alumina mixes thoroughly, in water-bath, boil off n-butyl alcohol, be loaded on neutral alumina pillar (200 orders, 2g, internal diameter 1cm) on, with ethyl acetate-methanol (1: 1) 30ml eluting, collect eluent, evaporate to dryness, residue adds ethanol 1ml makes dissolving, as need testing solution.Other gets the peoniflorin reference substance, adds ethanol and makes the solution that contains 2mg among every 1ml, in contrast product solution.Draw above-mentioned need testing solution 10 μ l, reference substance solution 5 μ l, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, with chloroform-ethyl acetate-methanol-formic acid (40: 5: 10: 0.2) be developing solvent,, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.

(3) get need testing solution under the discriminating (1), as need testing solution.Other gets the paeonol reference substance, adds acetone and makes the solution that contains 2mg among every 1ml, in contrast product solution.Draw above-mentioned need testing solution 15 μ l, reference substance solution 4 μ l, putting in same sodium carboxymethyl cellulose with 0.3% respectively is on the silica gel g thin-layer plate of adhesive, is developing solvent with cyclohexane extraction-ethyl acetate (3: 1), launches, take out, dry, spray is with the acid 5% ferric chloride alcoholic solution of hydrochloric acid, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical blue brown speckle.

(4) get 10 of this product, cut off, inclining content, add kieselguhr 3g, grind well, add petroleum ether (30～60 ℃) 20ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, residue adds ethanol 30ml, and supersound process 30 minutes filters, filtrate water bath method, residue add water 10ml makes dissolving, adds water-saturated n-butanol extraction 2 times, each 10ml, combining extraction liquid is concentrated into 1ml, as need testing solution.Other gets Radix Codonopsis control medicinal material 3g, according to above-mentioned test sample preparation method, makes Radix Codonopsis control medicinal material solution from " residue adds ethanol 30ml " with method.Draw above-mentioned need testing solution 6 μ l, control medicinal material solution 2 μ l, putting in same sodium carboxymethyl cellulose with 0.3% respectively is on the silica gel g thin-layer plate of adhesive, with n-butyl alcohol-glacial acetic acid-water (7: 1: 0.5) is developing solvent, launches, and takes out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were heated 5 minutes, and put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color.

(5) get 15 of this product, cut off, inclining content, add kieselguhr 5g, grind well, add petroleum ether (30～60 ℃) 40ml supersound process 15 minutes, filter, discard petroleum ether liquid, medicinal residues are flung to petroleum ether, and residue adds ethanol 50ml, reflux 20 minutes, filter, filtrate evaporate to dryness, residue add 0.3% sodium hydroxide solution 15ml makes dissolving, filter, filtrate is regulated pH value to 5～6 with dilute hydrochloric acid, uses ethyl acetate extraction 2 times, each 15ml, combined ethyl acetate liquid, evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Radix Astragali control medicinal material 2g, makes Radix Astragali control medicinal material solution from " residue adds ethanol 50ml " with method according to above-mentioned need testing solution preparation method.Draw each 10 μ l of above-mentioned two kinds of solution, putting in same sodium carboxymethyl cellulose with 0.3% respectively is on the silica gel g thin-layer plate of adhesive, is developing solvent with chloroform-methanol (10: 1), launch, take out, dry, put in the ammonia steam and smoke, inspect under the rearmounted ultra-violet lamp (365nm).In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color.

2. assay

It is an amount of that the preparation precision of reference substance solution takes by weighing the peoniflorin reference substance, adds water and make the solution that every lml contains 25 μ g, promptly.

This product content is got in the preparation of need testing solution, and mixing is got about 0.6g, and accurate the title decides, put in the apparatus,Soxhlet's, it is an amount of to add petroleum ether (30～60 ℃), and heating and refluxing extraction discards petroleum ether liquid to extracting liquid colourless, medicinal residues are flung to petroleum ether, put in the tool plug conical flask, and precision adds water 50ml, close plug, claim to decide weight, ultrasonic (power 250W, frequency 50kHz) handled 30 minutes, put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up, filter, get subsequent filtrate, promptly.

Every of this product contains the Radix Paeoniae Alba, Cortex Moutan with peoniflorin (C ₂₃H ₂₈O ₁₁) meter, must not be less than 0.8mg.

(2) total nitrogen in the mensuration FUFANG WUJI RUANJIAONANG.

Get this product content, mixing is got about 0.2g, and accurate the title decides, put in the apparatus,Soxhlet's, it is an amount of to add petroleum ether (30～60 ℃), and heating and refluxing extraction discards petroleum ether liquid to extracting liquid colourless, medicinal residues are flung to petroleum ether, measure according to the meso method in the N2 method, promptly.

This product every nitrogenous (N) must not be less than 5.3mg.

Embodiment 6: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 35% gelatin, 18% glycerol, 0.08% the methyl parahydroxybenzoate and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract, 5% Cera Flava, 2% vitamin E and the safflower oils of surplus such as 10% Gallus Domesticus.

Embodiment 7: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 36% gelatin, 10% glycerol, 10% sorbitol, 0.1% the ethylparaben and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract, 5% Adeps caprae seu ovis, 3% Polyethylene Glycol, 3% glycerol, 1.5% tea polyphenols, 33% Oleum Hippophae and surplus Oleum Glycines such as 15% Gallus Domesticus.

Embodiment 8: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 37% gelatin, 22% sorbitol, 0.2% methyl parahydroxybenzoate, 0.35% lemon yellow, 0.07% ethyl vanillin, 1% the titanium dioxide and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract, 15% methylcellulose, 5% Polyethylene Glycol monostearate, 1% Butylated hydroxyanisole, 6% Oleum Camelliae and the salad oils of surplus such as 20% Gallus Domesticus.

Embodiment 9: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: the water of 35% gelatin, 15% glycerol, 0.07% nipalgin second vinegar, 0.2% cacao brown, 0.1% titanium dioxide and surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract such as 35% Gallus Domesticus, 61% Oleum Camelliae, 4% Cera Flava.

Embodiment 10: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: the water of 45% gelatin, 18% glycerol, 0.2% carmine and surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract, 1% ethyl cellulose, 2% tween 80,4% poloxamer and the Semen Maydis oil of surplus such as 40% Gallus Domesticus.

Embodiment 11: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 40% gelatin, 20% glycerol, 0.08% methyl parahydroxybenzoate, 0.02% propyl p-hydroxybenzoate, 0.2% greyish purple, 3% the calcium carbonate and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract, 5% glycerol and the Polyethylene Glycol of surplus such as 30% Gallus Domesticus.

Embodiment 12: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 42% gelatin, 21% glycerol, 0.08% methyl parahydroxybenzoate, 0.02% propyl p-hydroxybenzoate, 0.28% light green, 0.8% the titanium dioxide and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract such as 45% Gallus Domesticus, 3% ethyl cellulose, 5% Polyethylene Glycol, 2% glycerol, 1% vitamin E, 0.5% propyl gallate, 13.5% Oleum Glycines and the safflower oil of surplus.

Embodiment 13: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 43% gelatin, 20% glycerol, 0.1% ethylparaben, 0.2% light green, 0.75% the barium sulfate and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract, 5% ethyl cellulose, 8% Polyethylene Glycol, 1% Butylated hydroxyanisole, 1% propyl gallate and the Oleum Glycines of surplus such as 50% Gallus Domesticus.

Embodiment 14: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 44% gelatin, 22% glycerol, 0.08% butyl p-hydroxybenzoate, 0.18% white carbon black, 0.65% the titanium dioxide and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract such as 55% Gallus Domesticus, 5% Polyethylene Glycol, 4% poloxamer, 1% the Radix Glycyrrhizae polyphenoils and the Oleum Glycines of surplus.

Embodiment 15: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 45% gelatin, 18% glycerol, 0.1% the carmine and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 12 flavor Chinese medicine extract, 2.5% tween 80,5% glycerol and the Polyethylene Glycol of surplus such as 60% Gallus Domesticus.

Embodiment 16: the softgel shell of this FUFANG WUJI RUANJIAONANG contains by weight percentage: 41% gelatin, 19% glycerol, 0.1% ethylparaben, 0.24% cacao brown, 0.04% essential oil, 0.85% the titanium dioxide and the water of surplus; The capsule core material of this FUFANG WUJI RUANJIAONANG contains by weight percentage; The Polyethylene Glycol of 12 flavor Chinese medicine extract such as 65% Gallus Domesticus and surplus.

FUFANG WUJI RUANJIAONANG among the embodiment 6-embodiment 16 can obtain by following production method:

1, capsule core material preparation:

Claims

1. a FUFANG WUJI RUANJIAONANG Chinese medicine preparation is made up of capsule core material and softgel shell two parts, it is characterized in that, capsule core material comprises 12 flavor Chinese medicine extract and appropriate amount of auxiliary materials such as Gallus Domesticus; 12 flavor Chinese medicines such as Gallus Domesticus and weight proportion thereof are: Gallus Domesticus 750, Radix Astragali Preparata 280, Rhizoma Dioscoreae 560, Radix Codonopsis 280, the Rhizoma Atractylodis Macrocephalae 280, Rhizoma Chuanxiong 95, Poria 188, Radix Angelicae Sinensis 188, Radix Rehmanniae Preparata 375, the Radix Paeoniae Alba (wine stir-fry) 188, Cortex Moutan 188, Fructus Schisandrae Chinensis (processed with wine) 95, said ratio can change in proportion.

2. according to the FUFANG WUJI RUANJIAONANG of claim 1, it is characterized in that described adjuvant comprises stabilizing agent, antioxidant, diluent etc.; Stabilizing agent can be the material of one or more or other the conventional tool Stabilization in Cera Flava, Adeps caprae seu ovis, methylcellulose, ethyl cellulose, Polyethylene Glycol monostearate, tween 80, cetomacrogol 1000～6000, poloxamer 188～407, the glycerol; Antioxidant can be the material that one or more or other routine in vitamin E, tea polyphenols, tertiarybutylhydroquinone (TBHQ), Radix Glycyrrhizae antioxygen thing, Butylated hydroxyanisole (BHA), dibenzylatiooluene (BHT), the propyl gallate (PG) has antioxidation; Diluent can be the material of one or more or other the conventional tool diluting effect in Oleum Arachidis hypogaeae semen, Oleum Glycines, safflower oil, Oleum Hippophae, Oleum Camelliae, salad oil, PEG400, the corn wet goods.

3. according to the FUFANG WUJI RUANJIAONANG of claim 1, it is characterized in that described softgel shell mainly is made up of sizing material and plasticizer, and can contain additives such as antiseptic, pigment, correctives, screening agent; Sizing material can be gelatin or other conventional material; Plasticizer can be the material of one or more or other the conventional tool plasticization in glycerol, sorbitol, the sucrose; Anticorrosion chaste tree can be the material of one or more or other the conventional tool antisepsis in methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the butyl p-hydroxybenzoate; Pigment can be any in food coloring or the medicinal pigment; Correctives can be the material that one or more or other routine in bourbonal,ethyl vanillin, essential oil, the Mentholum has flavored action; Screening agent can be the material of one or more or other the conventional tool bridging effect in titanium dioxide, barium sulfate, ferrum oxide, the precipitated calcium carbonate.

4. according to the FUFANG WUJI RUANJIAONANG of claim 1, it is characterized in that the weight proportion of capsule core material component is:

The component percentage composition

12 flavor Chinese medicine extract 10～70% such as Gallus Domesticus

Stabilizing agent 0～20%

Antioxidant 0～3%

The diluent surplus

5. according to the FUFANG WUJI RUANJIAONANG of claim 1, it is characterized in that the weight proportion of softgel shell component is:

The component percentage composition

Sizing material 20～50%

Plasticizer 5～30%

Antiseptic 0.01～0.3%

Pigment 0～2%

Correctives 0～1%

Screening agent 0～3%

PEG400 0～10%

Water surplus

6. the preparation method of a FUFANG WUJI RUANJIAONANG is characterized in that, may further comprise the steps:

(1) extraction of Rhizoma Dioscoreae, the Radix Astragali, Radix Codonopsis, Poria: Rhizoma Dioscoreae, the Radix Astragali, Radix Codonopsis, Poria are cut into fragment, add the water of 7 times of amounts, heated and boiled 30 minutes, filter, collect filtrate, medicinal residues add the water of 5 times of amounts again, boiled 30 minutes, and filtered merging filtrate, concentrate, it is an amount of to add ethanol, standing over night, filter, filtrate recycling ethanol is condensed into thick paste or is dried to dried cream, be ground into fine powder, standby;

(2) extraction of Gallus Domesticus: after Gallus Domesticus is slaughtered, remove unhairing, pawl, intestinal etc., clean, be cut into fragment, it is an amount of to add dilute sulfuric acid, heating and refluxing extraction 3 hours filters, and filtrate is transferred pH value 5～6, and cold preservation is spent the night, defat, filter, filtrate is condensed into thick paste or is dried to dried cream, is ground into fine powder, and is standby;

(3) extraction of all the other seven flavor Chinese medicines such as Radix Rehmanniae Preparata: Radix Rehmanniae Preparata, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis and Fructus Schisandrae Chinensis powder are broken into coarse powder, with carrying out percolation after 70% the alcohol dipping, collect percolate, filter, decompression filtrate recycling ethanol, be condensed into thick paste or be dried to dried cream, be ground into fine powder, standby;

(4) capsule core material preparation: with above-mentioned three groups of extract powder mix homogeneously or with above-mentioned three groups of thick extractum mix homogeneously or with above-mentioned three groups of thick extractum mix homogeneously, be dried to dried cream, be ground into fine powder, promptly make 12 flavor Chinese medicine extract such as Gallus Domesticus; In 12 flavor Chinese medicine extract such as Gallus Domesticus, add stabilizing agent, diluent, antioxidant, mix homogeneously is crossed colloid mill, and is standby;

(5) softgel shell preparation: water, plasticizer, PEG400 (or not adding), the antiseptic of aequum added in the glue pot stir, the sizing material that adds aequum, stir, after treating that micelle expands, be heated to 50～80 ℃ and make micelle all melt and dissolved, add screening agent, the pigment of aequum, stir, filter, the filtrate insulation is left standstill or the degassing of reducing pressure stand-by;

(6) finished product prepares: capsule core material is wrapped in makes soft capsule in the softgel shell, can adopt dropping preparation method or pressing; Wash ball, drying then, be packaged to be FUFANG WUJI RUANJIAONANG.

7. the preparation method of a FUFANG WUJI RUANJIAONANG is characterized in that, the method for making of making 3000 soft capsules is as follows:

Gallus Domesticus 750g Radix Astragali Preparata 280g Rhizoma Dioscoreae 560g

Poria 188g Radix Angelicae Sinensis 188g Radix Rehmanniae Preparata 375g

More than 12 the flavor, Rhizoma Dioscoreae, the Radix Astragali, Radix Codonopsis, Poria are cut into fragment, add the water of 7 times of amounts, heated and boiled 30 minutes filters, and collects filtrate, medicinal residues add the water of 5 times of amounts again, boil 30 minutes, filter, merging filtrate concentrates, and adds 2 times of amount ethanol, standing over night, filter, filtrate recycling ethanol, being condensed into relative density is the clear paste of 1.1 (80 ℃); Other gets after Gallus Domesticus slaughters, and removes unhairing, pawl, intestinal etc., cleans, and is cut into fragment, and it is an amount of to add dilute sulfuric acid, and heating and refluxing extraction 3 hours filters, and filtrate is transferred pH value 5～6, and cold preservation is spent the night, and defat filters, and filtrate is condensed into the clear paste that relative density is 1.1 (80 ℃); All the other Radix Rehmanniae Preparata, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis and Fructus Schisandrae Chinensis powder are broken into coarse powder, with carrying out percolation after 70% the alcohol dipping, collect percolate, filter, and decompression filtrate recycling ethanol, being condensed into relative density is the clear paste of 1.1 (80 ℃); Three kinds of clear paste are mixed, and drying under reduced pressure is pulverized, and adds Oleum Camelliae 1242g, Cera Flava 103.5g, and mixing is pressed into 3000 of soft capsules, promptly.

8. the method for quality control of a FUFANG WUJI RUANJIAONANG is characterized in that, contains in following discriminating and the assay one or more:

(1) differentiates

A. with Radix Angelicae Sinensis and Rhizoma Chuanxiong in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

B. with the peoniflorin in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

C. with the Cortex Moutan in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

D. with the Radix Codonopsis in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

E. with the Radix Astragali in the thin layer chromatography discriminating FUFANG WUJI RUANJIAONANG

It is an amount of to get this product content, after the defat, add ethanol or other The suitable solvent and extract the extracting solution evaporate to dryness, residue adds the dissolving of 0.1-10% sodium hydroxide solution, filter, filtrate is regulated pH value to 3～8 with dilute hydrochloric acid, extracts with ethyl acetate or other The suitable solvent, extracting solution is as need testing solution, or extracting solution steams/volatilizes, and residue adds The suitable solvent makes dissolving, as need testing solution.It is an amount of that other gets Radix Astragali control medicinal material, makes Radix Astragali control medicinal material solution after the extraction.Each is an amount of to draw above-mentioned two kinds of solution, puts respectively on same silica gel G or silica gel H lamellae, with chloroform-methanol (5-20: 0.5-2) be developing solvent, launch, take out that dry, colour developing is put under the ultra-violet lamp and inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.

(2) assay

A. use the paeoniflorin content in the high effective liquid chromatography for measuring FUFANG WUJI RUANJIAONANG

B. measure the total nitrogen in the FUFANG WUJI RUANJIAONANG.

9. the method for quality control of FUFANG WUJI RUANJIAONANG according to Claim 8 is characterized in that:

(1) described extraction can be adopted conventional methods such as supersound process, reflux, extract,, microwave extraction, vibration extraction;

(2) developing solvent differentiated of the thin layer chromatography of Radix Angelicae Sinensis and Rhizoma Chuanxiong can also be petroleum ether-ethyl acetate (5-25: 0.5-5), cyclohexane extraction-ethyl acetate (5-25: 0.5-5), petroleum ether-chloroform-methanol (5-15: 1-5: 0.5-5) or other suitable developing solvent;

(3) developing solvent differentiated of the thin layer chromatography of peoniflorin can also be chloroform-methanol-ethyl acetate (5-15: 1-10: 0.5-5) or other suitable developing solvent;

(4) developing solvent differentiated of the thin layer chromatography of Cortex Moutan can also be cyclohexane extraction-chloroform-ethyl acetate (5-15: 1-10: 0.1-1) or other suitable developing solvent;

(5) developing solvent differentiated of the thin layer chromatography of Radix Codonopsis can also be chloroform-methanol-water (5-15: 1-10: 0.5-5), n-butyl alcohol-ethyl acetate-water (2-8: 0.5-2: 1-10) or other suitable developing solvent;

(6) mobile phase measured of content of paeoniflorin can also be acetonitrile-0.1% phosphoric acid solution (10-30: 90-70) or other suitable mobile phase.

10. the method for quality control of a FUFANG WUJI RUANJIAONANG is characterized in that, contains in following discriminating and the assay one or more,

(1) differentiates

(2) assay

Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05mol/1 potassium dihydrogen phosphate (14: 86); Detect wavelength: 230nm; Theoretical cam curve is calculated by the peoniflorin peak should be not less than 3000.

Contain the Radix Paeoniae Alba, Cortex Moutan in the dose in peoniflorin (C23H28O11), must not be less than 2.4mg.

B. measure the total nitrogen in the FUFANG WUJI RUANJIAONANG.

Nitrogenous (N) must not be less than 15mg in the dose.

The amount of described extraction sample or dissolving extract solvent for use, ultrasonic or time, standardize solution or dissolving back volume, point sample amount or the sample size of reflux, extract,, the concentration of reference substance can be that benchmark changes with described occurrence, or change in proportion; Described supersound process also can adopt conventional extracting method such as reflux, extract,, microwave extraction, vibration extraction, and described reflux, extract, also can adopt conventional extracting method such as supersound process, microwave extraction, vibration extraction; Described content limit is the minimum content limit, can improve content limit according to the concrete condition of producing.