CN1733105A

CN1733105A - Preparation for treating gynecological disease, its preparation process and quality control method

Info

Publication number: CN1733105A
Application number: CN 200510200479
Authority: CN
Inventors: 周霞
Original assignee: Yunyanxichuang Medicinal Science And Technology Development Co Ltd Guiyang C
Current assignee: Yunyanxichuang Medicinal Science And Technology Development Co Ltd Guiyang C
Priority date: 2005-08-18
Filing date: 2005-08-18
Publication date: 2006-02-15
Anticipated expiration: 2025-08-18
Also published as: CN1733105B

Abstract

Formulation for treating gynecological disease and its preparation process and quality control method, wherein the preparation is prepared from root of Fructus Rosae Laevigatae, spatholobus stem, Moghania philippinensis and mahonia stem, and the preparation has the dosage forms of mini-pills, dispersible tablets, soft capsules or dripping pills.

Description

Jinji preparation and the preparation method and the method for quality control of treatment gynaecopathia

Technical field: the present invention is a kind of Jinji preparation and preparation method and method of quality control of gynaecopathia, belongs to Chinese medicine

Technical field.

Technical background: gynaecopathia such as pelvic inflammatory disease, endometritis, cervicitis etc. all are to threaten the able-bodied common disease of women in the world today, brought great misery for numerous women, traditional Therapeutic Method mostly is antibiotic or physical therapy, the life-time service antibiotic, can make the patient that drug resistance takes place and easily cause double infection, physical therapy then makes most of patients not adhere to and therapy discontinued for a long time.Prevent and treat purpose in order to reach, a large amount of research has been done by many inventors and medicine enterprise, and the product of some treatments also is provided; As: JINJI JIAONANG, JINJI PIAN, these three kinds of products of JINJI KELI are this type of disease of treatment and develop, and still, technology preparation is unexposed in these three kinds of products, so can not be directly used in the guidance of production; And the extraction process of existing Jinji preparation and method of quality control simple coarse too, can not be active constituent-enriched to greatest extent, can not investigate comprehensively and control the quality of product; So in view of such circumstances, seek better preparation technology, more the stabilized quality control method still is that we are badly in need of the thing that solves at present.

Summary of the invention: the objective of the invention is to: a kind of Jinji preparation of gynaecopathia and the method for quality control of other preparation method and preparation are provided; The present invention is directed to the problem that prior art exists, a kind of good effect, adaptation is wide, preparation method is scientific and reasonable process and method of quality control are provided, can effectively control and improve the quality of products.

The present invention constitutes like this: calculate according to components by weight percent, it mainly is to be made by 9～20 parts of Radix Rosae Laevigataes, 18～40 parts of Caulis Spatholobis, 9～20 parts of Radix Flemingiae Philippinensiss, 9～20 parts of Caulis Mahoniaes, 4～8 parts of Radix Zanthoxylis, 3～7 parts of Herba Andrographis or their extract of corresponding weight portion; Described preparation comprises: injection: be directly used in drug administration by injection injection, need to be used for after the dilution concentrated solution for injection of intravenous drip, directly for the glucose intravenous infusion of intravenous drip and sodium chloride intravenous infusion and the injectable sterile powder and the aseptic block that make with freeze-drying or spray drying method; Oral formulations comprises: all acceptable dosage forms on tablet, dispersible tablet, effervescent tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, stomach or intestinal location delivery formulations, gel, suppository, oral liquid, soft extract, extractum and the membrane pharmaceutics.Say accurately: described preparation is micropill, tablet, dispersible tablet, capsule, soft capsule, granule, oral liquid or drop pill, Herba Andrographis in the prescription can also substitute with the andrographolide that the equivalent medicinal material extract obtains, and is used for the treatment of adnexitis, endometritis, gynecopathy such as pelvic inflammatory disease.

The preparation method of the Jinji preparation of treatment gynaecopathia of the present invention: get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, add water or ethanol extraction, extracting solution concentrates, carry out purification with one or more mixing uses in ethanol precipitation, organic solvent extractionprocess, the column chromatography, the extract that obtains adds different auxiliary material and makes corresponding preparations.

The preparation method of the Jinji preparation of treatment gynaecopathia of the present invention: get Herba Andrographis and be ground into coarse powder, add 5～15 times of amount 40～80% alcohol reflux 1～5 time, each 0.5～2.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste; All the other five tastes medical materials are put in the pot, add 5～15 times of decocting in water 1～4 time, the each decoction 0.5～2.5 hour, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 40～60% for the first time, make for the second time that to contain the alcohol amount be 70～90%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add different auxiliary material and make corresponding preparations.

Say accurately: get Herba Andrographis and be ground into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste; All the other five tastes medical materials are put in the pot, add the decocting in water secondary, add 6 times of decoctings boiled 2.5 hours at every turn, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, the-inferior and makes that to contain the alcohol amount be 50%, make for the second time that to contain the alcohol amount be 70%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add different auxiliary material and make corresponding preparations.

The preparation method of the Jinji preparation of treatment gynaecopathia of the present invention: get Herba Andrographis and be ground into coarse powder, added 10～30 times of amount 50～80% soak with ethanol 2～24 hours, percolation extracts then, and merge extractive liquid,, decompression recycling ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, add decocting in water 1～5 time, add 5～15 times of decoctings boiled 0.5～2.5 hour at every turn, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add 1～4 times of volume n-butanol extraction 1～6 time, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol, be concentrated into 60 ℃ of relative densities and be 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, adds different auxiliary material and make corresponding preparations.

Say accurately: get Herba Andrographis and be ground into coarse powder, added 20 times of amount 70% soak with ethanol 12 hours, percolation extracts then, and merge extractive liquid,, decompression recycling ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, added the decocting in water secondary, add 6 times of decoctings at every turn and boiled 2.5 hours, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add the equal-volume n-butanol extraction 4 times, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol, be concentrated into 60 ℃ of relative densities and be 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, adds different auxiliary material and make corresponding preparations.

The preparation method of the Jinji preparation of treatment gynaecopathia of the present invention: get Herba Andrographis and be ground into coarse powder, add 5～15 times of amount 40～80% alcohol reflux 1～5 time, each 0.5～2.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste, add 1～4 times of amount dissolve with ethanol, filter, filtrate is admixed macroporous resin, drying with water bath, resin column on the dry method is earlier with 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% ethanol elution, 1～10 times of resin volume 40～80% alcohol desorption of reuse, collect stripping liquid, it is 1.15～1.20 clear paste that decompression recycling ethanol is condensed into 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, add 5～15 times of decocting in water 1～4 time, the each decoction 0.5～2.5 hour, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 40～60% for the first time, make for the second time that to contain the alcohol amount be 70～90%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add different auxiliary material and make corresponding preparations.

Say accurately: get Herba Andrographis and be ground into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, decompression recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, add 2 times of amount dissolve with ethanols, filter, filtrate is admixed the D-101 macroporous resin, drying with water bath, resin column on the dry method, earlier with 6 times of resinite hydrops and 4 times of resin volume 10% ethanol elutions, 6 times of resin volume 50% alcohol desorptions of reuse are collected stripping liquid, and it is 1.15～1.20 clear paste that decompression recycling ethanol is condensed into 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, add the decocting in water secondary, add 6 times of decoctings boiled 2.5 hours at every turn, filter, merging filtrate, it is the clear paste of 1.15～1.20 () that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 50% for the first time, make for the second time that to contain the alcohol amount be 70%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are the clear paste of 1.15～1.20 (), add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add different auxiliary material and make corresponding preparations.

The preparation method of the Jinji preparation of treatment gynaecopathia of the present invention: Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, add 5～15 times of amount 40～80% alcohol reflux 1～5 time, each 0.5～2.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste, all the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials, add 5～15 times of decocting in water 1～4 time, decocted 0.5～2.5 hour at every turn, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 40～60% for the first time, make for the second time that to contain the alcohol amount be 70～90%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, vacuum drying, dried cream powder is broken into fine powder, adds different auxiliary material and make corresponding preparations.

Say accurately: Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, 70% ethanol of 8 times of amounts of adding, reflux, extract, three times, each 2 hours, filter, merging filtrate, recovery ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials add 8 times of water gagings, decoct secondary, each 2 hours, collecting decoction filtered, filtrate concentrates, and merges with above-mentioned concentrated solution, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 60%, make that to contain the alcohol amount be 80% for the second time, filter, filtrate recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, vacuum drying is broken into fine powder with dried cream powder, adds different auxiliary material and makes corresponding preparations.

The preparation method of the Jinji preparation of treatment gynaecopathia of the present invention can also be like this: the Herba Andrographis of getting prescription amount 15-25% is ground into fine powder.To remain Herba Andrographis and all the other five tastes medical materials are put in the pot, add the decocting in water secondary, add 6 times of decoctings at every turn and boiled 2.5 hours, filter collecting decoction, filtrate is condensed into the thick paste shape, add the punching Nelumbo nucifera Gaertn. Powder, mixing, vacuum drying (60-70 ℃ ,-0.08MPa), dried cream powder is broken into fine powder, adds an amount of different auxiliary material and make corresponding preparations.

The method of quality control of the Jinji preparation of the treatment gynaecopathia of being made by Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis of the present invention: this method comprises following all or part of content:

(1) the differential test method of all or part of composition in Radix Rosae Laevigatae medical material, Caulis Spatholobi medical material, Radix Flemingiae Philippinensis medical material, Caulis Mahoniae medical material, Radix Zanthoxyli medical material, Herba Andrographis medical material, formononetin, berberine hydrochloride, palmatine hydrochloride, Jatrorrhizine chloride, coptisine, nitidine, ethoxychelerythrine, Toddalolactone, andrographolide, the dehydrorographolide etc. in the Jinji preparation;

(2) content test method of all or part of composition in formononetin, berberine hydrochloride, palmatine hydrochloride, Jatrorrhizine chloride, coptisine, nitidine, ethoxychelerythrine, Toddalolactone, andrographolide, dehydrorographolide, total flavones, the total polysaccharides etc. in the Jinji preparation;

Say accurately: the discrimination method of described preparation is following all or part of content:

The thin layer chromatography discrimination method of Caulis Spatholobi medical material, formononetin in a, the Jinji preparation:

It is an amount of to get each preparation, add ethanol or methanol extraction, filter, filtrate volatilizes, residue is with methanol or dissolve with ethanol, admix silica gel, volatilize, put in the silicagel column, use petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃), chloroform or ethyl acetate or methanol or ethanol elution successively, eluent evaporate to dryness, residue add chloroform or ethyl acetate dissolving, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Caulis Spatholobi control medicinal material, shines medical material solution in pairs with legal system; Get the formononetin reference substance again, add methanol or ethanol and make the solution that every 1ml contains 1mg; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned four kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae is developing solvent with chloroform-methanol or ethanol 1～90: 0.2～10, launches, take out, dry, put under the ultra-violet lamp 254nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

The thin layer chromatography discrimination method of Caulis Mahoniae medical material, berberine hydrochloride, Jatrorrhizine chloride, palmatine hydrochloride, coptisine in b, the Jinji preparation:

It is an amount of to get each preparation, adds methanol or ethanol extraction, filters, and filtrate volatilizes, and residue is regulated pH value to 7～11 after adding dissolve with hydrochloric acid solution, and with chloroform or ethyl acetate extraction, extracting solution volatilizes, and residue is with methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Caulis Mahoniae control medicinal material, shines medical material solution in pairs with legal system; Get berberine hydrochloride, Jatrorrhizine chloride, palmatine hydrochloride, coptisine reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned seven kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄On the lamellae, with n-butyl alcohol-glacial acetic acid or formic acid-water 1～20: 0.1～5: 0.2～10 or benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 1～20: 0.5～10: 0.1～10: 0.1～10: 0.05～5 is developing solvent, launch, take out, dry, put inspect under the uviol lamp 365nm or the stifling rearmounted uviol lamp 365nm of ammonia under inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

The thin layer chromatography of Radix Rosae Laevigatae medical material is differentiated in c, the Jinji preparation:

It is an amount of to get each preparation, add ethanol or methanol extraction, filter, filtrate volatilizes, and residue hydro-oxidation sodium solution dissolving back discards ether or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃) liquid with ether or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃) extraction, water layer is with ethyl acetate or n-butanol extraction, ethyl acetate or n-butanol extracting liquid volatilize, and residue is with methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Radix Rosae Laevigatae control medicinal material, shines medical material solution in pairs with legal system; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae is developing solvent with chloroform-methanol or ethanol 1～90: 0.2～10, launches, and takes out, dry, spray is with 1～30% ethanol solution of sulfuric acid, and 90～150 ℃ to be heated to speckle colour developing clear, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, should show the same color speckle;

The thin layer chromatography of Radix Zanthoxyli medical material, nitidine, ethoxychelerythrine is differentiated in d, the Jinji preparation:

It is an amount of to get each preparation, adds ethanol or methanol extraction, filters, and filtrate is as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Radix Zanthoxyli control medicinal material, shines medical material solution in pairs with legal system; Get ethoxychelerythrine, nitidine chloride, Toddalolactone reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; With the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned six kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae, with benzene or toluene or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃)-ethyl acetate or chloroform-methanol or ethanol 0.5～60: 0.5～50: 0.02～10 or benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 5～40: 0.5～15: 0.2～10: 0.1～3: 0.02～3 is developing solvent, launch, take out, dry, put under the uviol lamp 365nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

The thin layer chromatography of Herba Andrographis medical material, andrographolide, dehydrorographolide is differentiated in e, the Jinji preparation:

It is an amount of to get each preparation, adds ethanol or methanol extraction, filters, and filtrate volatilizes, and residue adds methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Herba Andrographis control medicinal material, shines medical material solution in pairs with legal system; Get andrographolide, dehydrorographolide reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; With the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄On the lamellae, with chloroform-ethyl acetate-methanol or ethanol 0.5～15: 0.5～60: 0.5～50 or chloroform-methanol or ethanol 1～30: 0.05～5 is developing solvent, launch, take out, dry, put under the uviol lamp 254nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle, the spray with 0.2～10%3, the mixed in equal amounts solution of 5 dinitrobenzoic acid alcoholic solution-0.05～5mol/L potassium hydroxide or 0.05～5mol/L sodium hydroxide solution (face and use preceding mixing), in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle.

The liquid chromatograph of berberine hydrochloride is differentiated in f, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or hydrochloric acid-methanol (1: 100) and extracts, and shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the berberine hydrochloride reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, 0.005～0.2mol/L sodium dihydrogen phosphate or 0.005～0.2mol/L potassium dihydrogen phosphate or water-acetonitrile or methanol 10%～90%: 90%～10% are mobile phase, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless;

The liquid chromatograph of andrographolide, dehydrorographolide is differentiated in g, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with andrographolide, dehydrorographolide reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-0.2%～5% glacial acetic acid or 0.2%～5% formic acid or 0.02%～3% phosphate aqueous solution 10%～90%: 90%～10% are mobile phase, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless;

The liquid chromatograph of formononetin is differentiated in h, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the formononetin reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-water or 0.2%～5% glacial acetic acid or 0.2%～5% formic acid or 0.02%～3% phosphate aqueous solution are mobile phase, gradient elution, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless;

The method of testing of formulation content of the present invention is following all or part of content:

The assay of berberine hydrochloride in a, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or hydrochloric acid-methanol (1: 100) and extracts, and shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the berberine hydrochloride reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, 0.005～0.2mol/L sodium dihydrogen phosphate or 0.005～0.2mol/L potassium dihydrogen phosphate or water-acetonitrile or methanol 10%～90%: 90%～10% are mobile phase, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; Calculate with external standard method or standard curve method;

The assay of andrographolide, dehydrorographolide in b, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with andrographolide, dehydrorographolide reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-0.2%～5% glacial acetic acid or 0.2%～5% formic acid or 0.02%～3% phosphate aqueous solution 10%～90%: 90%～10% are mobile phase, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; Calculate with external standard method or standard curve method;

The assay of nitidine in c, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the nitidine chloride reference substance are contrast, with the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae, with benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 5～40: 0.5～15: 0.2～10: 0.1～3: 0.02～3 is developing solvent, launch, take out, dry, put under the uviol lamp 365nm and inspect, scan according to thin layer chromatography, wavelength: λ s=300nm, λ R=210nm calculates, promptly.

The assay of formononetin in d, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the formononetin reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-water or 0.2%～5% glacial acetic acid or 0.2%～5% formic acid or 0.02%～3% phosphate aqueous solution are mobile phase, gradient elution, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; Calculate with external standard method or standard curve method;

Among the present invention, Radix Rosae Laevigatae clearing away heat and eliminating dampness leukorrhagia stopping is a monarch drug, Radix Flemingiae Philippinensis clearing away heat-damp and promoting diuresis, detoxifcation, and the Caulis Spatholobi promoting the circulation of blood of enriching blood, the Caulis Mahoniae clearing away heat and cooling blood is monarch drug altogether; Herba Andrographis heat-clearing and toxic substances removing, Radix Zanthoxyli promoting blood circulation and detoxication, reducing swelling and alleviating pain are adjuvant drug altogether, and all medicines are harmonious, and play the effect of damp-clearing pain-relieving, menstruction regulating and pain relieving altogether.

Key of the present invention is: the applicant has carried out preparation technology and the method for quality control that pharmaceutical preparation provided by the invention is selected in a series of experiments; Guarantee its science, reasonable, feasible; The preparation that assurance obtains has effective therapeutic effect, and manufacturing enterprise can directly produce according to the present invention, prepare obvious results pharmaceutical preparation, and no longer needs to carry out new groping, study; In fact just be the selection of manufacturing condition for its key of preparation technique; If it is improper to select, or can not prepare effective product, sometimes even health risk, otherwise preparation variety with high costs, do not meet market demands again; Selection of the present invention solves these problems; Simultaneously, provide new kind again, made doctor and patient that more choice be arranged to market.The applicant has carried out a series of experiments, with the supplementary product kind of the preparation technology that selects pharmaceutical preparation provided by the invention, use and consumption, ratio etc.; Guarantee its science, reasonable, feasible; The preparation that obtains has effective therapeutic effect.

Experimental example: antiinflammatory action pharmacological research

Technology 1: get Folium Andrographis 160g and pulverize, cross 100 mesh sieves.To remain Herba Andrographis and put in the pot, add the decocting in water secondary, and add 6 times of decoctings at every turn and boiled 2 hours with all the other five tastes medical materials, collecting decoction filters, and being concentrated into relative density is the thick paste of 1.20 (80 ℃), vacuum drying (60～70 ℃ ,-0.08MPa), about 720～760g that gets dry extract is broken into fine powder with dried cream powder.

Technology 2: get Herba Andrographis and be ground into coarse powder, added 20 times of amount 70% soak with ethanol 12 hours, percolation extracts then, and merge extractive liquid,, decompression recycling ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, added the decocting in water secondary, add 6 times of decoctings at every turn and boiled 2.5 hours, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add the equal-volume n-butanol extraction 4 times, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol is concentrated into 60 ℃ of relative densities and is 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder.

Technology 3: get Herba Andrographis and be ground into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, decompression recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, add 2 times of amount dissolve with ethanols, filter, filtrate is admixed the D-101 macroporous resin, drying with water bath, resin column on the dry method, earlier with 6 times of resinite hydrops and 4 times of resin volume 10% ethanol elutions, 6 times of resin volume 50% alcohol desorptions of reuse are collected stripping liquid, and it is 1.15～1.20 clear paste that decompression recycling ethanol is condensed into 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, added the decocting in water secondary, add 6 times of decoctings at every turn and boiled 2.5 hours, filter, merging filtrate, it is the clear paste of 1.15～1.20 () that filtrate is condensed into 60 ℃ of relative densities, add ethanol precipitation twice, make that to contain the alcohol amount be 50% for the first time, make that to contain the alcohol amount be 70% for the second time, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder.

Technology 4: Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, 70% ethanol of 8 times of amounts of adding, reflux, extract, three times, each 2 hours, filter, merging filtrate, recovery ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials add 8 times of water gagings, decoct secondary, each 2 hours, collecting decoction filtered, filtrate concentrates, and merges with above-mentioned concentrated solution, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 60%, make for the second time that to contain the alcohol amount be 80%, filter, filtrate recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, vacuum drying is broken into fine powder with dried cream powder.

Technology 5: get Herba Andrographis and be ground into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste; All the other five tastes medical materials are put in the pot, added the decocting in water secondary, add 6 times of decoctings at every turn and boiled 2.5 hours, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add ethanol precipitation twice, make that to contain the alcohol amount be 50% for the first time, make that to contain the alcohol amount be 70% for the second time, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder.

1.1 the influence of xylol induced mice auricle edema

Experimental technique faces that to be mixed with the 0.10g/ml suspension with the preceding extract powder that each technology is made with 0.5% Carboxymethyl cellulose sodium (CMC-Na) standby, and animal is used healthy Kunming mouse, body weight 20 grams.With mice random packet (matched group normal saline), irritate the long-pending 20ml/kg of being of body of stomach, two weeks of continuous irrigation stomach, once a day, the last administration after 30 minutes with microsyringe only with 0.05ml/, dimethylbenzene is applied to mouse right ear, put to death mice after 15 minutes, cut two ears, dash with the 8mm diameter steel and lay round auricle in left and right sides auricle same area respectively along the auricle baseline, torsion balance claims two auricle weight in wet bases, with two auricle weight differences as the swelling level index.Inhibitory rate of intumesce equals the difference of average swelling degree of matched group and the average swelling degree of administration group and takes advantage of 100% again divided by the average swelling degree of matched group.

Average swelling degree (mg) suppression ratio (%) of group dosage (g/kg) animal (only)

Matched group 20ml/kg 8 24.21 ± 4.60

Hydrocortisone group 0.04 8 7.25 ± 2.03 69.10

Technology 1 group 2.0 8 16.16 ± 0.11 30.10

Technology 2 group 2.0 8 14.35 ± 2.23 34.11

Technology 3 group 2.0 8 14.56 ± 1.35 33.43

Technology 4 group 2.0 8 14.31 ± 4.24 32.29

Technology 5 group 2.0 8 14.37 ± 0.82 33.51

1.2 influence to the rat uterus inflammation

Experimental technique: animal is selected the female rat of SD kind for use, about 200 grams of body weight.The animal grouping, each treated animal under etherization, cut off the hypogastric region hair, long mouthful of 2cm is cut in the sterilization back in the abdomen center, expose the uterus, make a kerf in the place along 1cm on the left hand corner of uterus, one plastic hoop (caliber 12mm, long 0.5cm, alcohol disinfecting) is positioned over intrauterine, with the uterine incision sutured, postoperative beginning in 2 hours administration, once a day, the administration volume is the 20ml/kg body weight, put to death animal after 7 days, take out the uterus, both sides, remove fat, analytical balance is weighed, left side, every Mus uterus is inflammation swelling degree with the difference on right side, calculates the swelling rate and the suppression ratio of administration group.The swelling rate equals to cause scorching uterus average weight and not multiply by 100% with the difference that does not cause scorching uterus average weight divided by causing scorching uterus average weight, and the difference that suppression ratio equals average swelling rate in matched group uterus and the average swelling rate in administration group uterus multiply by 100% divided by the average swelling rate in matched group uterus.

Group dosage (g/kg) animal (only) swelling rate (%) suppression ratio (%)

Matched group 20ml/kg 10 210.40

Hydrocortisone group 0.04 10 6.72 96.57

1 group 2.0 10 17.89 91.21 of technology

2 group 2.0 10 15.23 92.34 of technology

3 group 2.0 10 15.41 92.15 of technology

4 group 2.0 10 15.56 92.13 of technology

5 group 2.0 10 15.39 92.39 of technology

The result shows that technology provided by the invention is rationally feasible, and curative effect is good.

Concrete embodiment: part is a weight portion, as: kilogram, gram etc.

Embodiments of the invention 1: 9 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 9 parts of Radix Flemingiae Philippinensiss, 9 parts of Caulis Mahoniaes, 4 parts of Radix Zanthoxylis, 3 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density are 1.15～1.20 clear paste; All the other five tastes medical materials are put in the pot, added the decocting in water secondary, add 6 times of decoctings at every turn and boiled 2.5 hours, filter, it is 1.15～1.20 clear paste that merging filtrate, filtrate are condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 50%, make for the second time that to contain the alcohol amount be 70%, filter, filtrate recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add soybean oil, pill promptly gets soft capsule, and is oral, 3 times on the one, one time 3

Embodiments of the invention 2: 20 parts of Radix Rosae Laevigataes, 40 parts of Caulis Spatholobis, 20 parts of Radix Flemingiae Philippinensiss, 20 parts of Caulis Mahoniaes, 8 parts of Radix Zanthoxylis, 7 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, add 15 times of amount 80% alcohol reflux 5 times, each 2.5 hours, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density are 1.15～1.20 clear paste; All the other five tastes medical materials are put in the pot, added 15 times of decocting in water 4 times, decocted 2.5 hours at every turn, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add ethanol precipitation twice, make that to contain the alcohol amount be 60% for the first time, make that to contain the alcohol amount be 90% for the second time, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, pill promptly gets pill.

Embodiments of the invention 3: 20 parts of Radix Rosae Laevigataes, 40 parts of Caulis Spatholobis, 20 parts of Radix Flemingiae Philippinensiss, 20 parts of Caulis Mahoniaes, 8 parts of Radix Zanthoxylis, 7 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, added 5 times of amount 40% alcohol reflux 0.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density are 1.15～1.20 clear paste; All the other five tastes medical materials are put in the pot, added 5 times of decocting in water 0.5 hour, filter, it is 1.15～1.20 clear paste that merging filtrate, filtrate are condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 40%, make that to contain the alcohol amount be 70% for the second time, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, extrudes-the spheronization pill, promptly get pellet.

Embodiments of the invention 4: 20 parts of Radix Rosae Laevigataes, 40 parts of Caulis Spatholobis, 20 parts of Radix Flemingiae Philippinensiss, 20 parts of Caulis Mahoniaes, 8 parts of Radix Zanthoxylis, 7 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, added 20 times of amount 70% soak with ethanol 12 hours, percolation extracts then, merge extractive liquid,, decompression recycling ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, added the decocting in water secondary, add 6 times of decoctings at every turn and boiled 2.5 hours, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add the equal-volume n-butanol extraction 4 times, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol, be concentrated into 60 ℃ of relative densities and be 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add carrageenan, cooling promptly gets gel.

Embodiments of the invention 5: 9 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 9 parts of Radix Flemingiae Philippinensiss, 9 parts of Caulis Mahoniaes, 4 parts of Radix Zanthoxylis, 3 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, added 10 times of amount 50% soak with ethanol 2 hours, percolation extracts then, merge extractive liquid,, decompression recycling ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, adding 5 times of decoctings boiled 0.5 hour, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add 1 times of volume n-butanol extraction 1 time, collect n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol is concentrated into 60 ℃ of relative densities and is 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃,-0.08MPa vacuum drying is broken into fine powder with dried cream powder, add 5% crospolyvinylpyrrolidone, 30% microcrystalline Cellulose, mixing, adding concentration is 50% ethanol, crosses 24 mesh sieves and granulates, 60 ℃ of dryings are crossed 24 mesh sieve granulate after 2 hours,,, get the tabletting material again with 0.3% magnesium stearate mixing, tabletting promptly gets dispersible tablet.

Embodiments of the invention 6: 20 parts of Radix Rosae Laevigataes, 40 parts of Caulis Spatholobis, 20 parts of Radix Flemingiae Philippinensiss, 20 parts of Caulis Mahoniaes, 8 parts of Radix Zanthoxylis, 7 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, added 30 times of amount 80% soak with ethanol 24 hours, percolation extracts then, merge extractive liquid,, decompression recycling ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, added decocting in water 5 times, add 15 times of decoctings at every turn and boiled 2.5 hours, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add 1～4 times of volume n-butanol extraction 6 times, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol, be concentrated into 60 ℃ of relative densities and be 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, splashes among the PEG4000, promptly get drop pill.

Embodiments of the invention 7: 20 parts of Radix Rosae Laevigataes, 40 parts of Caulis Spatholobis, 20 parts of Radix Flemingiae Philippinensiss, 20 parts of Caulis Mahoniaes, 8 parts of Radix Zanthoxylis, 7 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, decompression recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, add 2 times of amount dissolve with ethanols, filter, filtrate is admixed the D-101 macroporous resin, drying with water bath, resin column on the dry method is earlier with 6 times of resinite hydrops and 4 times of resin volume 10% ethanol elutions, 6 times of resin volume 50% alcohol desorptions of reuse, collect stripping liquid, it is 1.15～1.20 clear paste that decompression recycling ethanol is condensed into 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, add the decocting in water secondary, add 6 times of decoctings boiled 2.5 hours at every turn, filter, it is the clear paste of 1.15～1.20 () that merging filtrate, filtrate are condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 50%, make for the second time that to contain the alcohol amount be 70%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are the clear paste of 1.15～1.20 (), add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, granulate, promptly get granule.

Embodiments of the invention 8: 20 parts of Radix Rosae Laevigataes, 40 parts of Caulis Spatholobis, 20 parts of Radix Flemingiae Philippinensiss, 20 parts of Caulis Mahoniaes, 8 parts of Radix Zanthoxylis, 7 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, add 15 times of amount 80% alcohol reflux 5 times, each 2.5 hours, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste, add 4 times of amount dissolve with ethanols, filter, filtrate is admixed macroporous resin, drying with water bath, resin column on the dry method is earlier with 10 times of resinite hydrops and 6 times of resin volume 15% ethanol elutions, 10 times of resin volume 80% alcohol desorptions of reuse, collect stripping liquid, it is 1.15～1.20 clear paste that decompression recycling ethanol is condensed into 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, add 15 times of decocting in water 4 times, the each decoction 2.5 hours, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add ethanol precipitation twice, make for the first time that to contain the alcohol amount be 60%, make that to contain the alcohol amount be 90% for the second time, filter, filtrate recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, granulate, encapsulated, promptly get capsule.

Embodiments of the invention 9: 9 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 9 parts of Radix Flemingiae Philippinensiss, 9 parts of Caulis Mahoniaes, 4 parts of Radix Zanthoxylis, 3 parts of Herba Andrographis, get Herba Andrographis and be ground into coarse powder, added 5 times of amount 40% alcohol reflux 0.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste, add 1 times of amount dissolve with ethanol, filter, filtrate is admixed macroporous resin, drying with water bath, resin column on the dry method is earlier with 1 times of resinite hydrops and 1 times of resin volume 5% ethanol elution, 1 times of resin volume 40% alcohol desorption of reuse, collect stripping liquid, it is 1.15～1.20 clear paste that decompression recycling ethanol is condensed into 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, added 5 times of decoctings and boiled 0.5 hour, filter, it is 1.15～1.20 clear paste that merging filtrate, filtrate are condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 40%, make that to contain the alcohol amount be 70% for the second time, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, adds distilled water, promptly get oral liquid.

Embodiments of the invention 10: 9 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 9 parts of Radix Flemingiae Philippinensiss, 9 parts of Caulis Mahoniaes, 4 parts of Radix Zanthoxylis, 3 parts of Herba Andrographis, Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, 70% ethanol that adds 8 times of amounts, reflux, extract, three times, each 2 hours, filter, merging filtrate, recovery ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials add 8 times of water gagings, decoct secondary, each 2 hours, collecting decoction filtered, filtrate concentrates, and merges with above-mentioned concentrated solution, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 60%, make that to contain the alcohol amount be 80% for the second time, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, and vacuum drying is broken into fine powder with dried cream powder, add syrup, promptly get syrup.

Embodiments of the invention 11: 9 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 9 parts of Radix Flemingiae Philippinensiss, 9 parts of Caulis Mahoniaes, 4 parts of Radix Zanthoxylis, 3 parts of Herba Andrographis, Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, 70% ethanol that adds 8 times of amounts, reflux, extract, three times, each 2 hours, filter, merging filtrate, recovery ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials add 8 times of water gagings, decoct secondary, each 2 hours, collecting decoction filtered, filtrate concentrates, and merges with above-mentioned concentrated solution, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 60%, make that to contain the alcohol amount be 80% for the second time, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, and vacuum drying is broken into fine powder with dried cream powder, pill promptly gets pill.

Embodiments of the invention 12: 9 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 9 parts of Radix Flemingiae Philippinensiss, 9 parts of Caulis Mahoniaes, 4 parts of Radix Zanthoxylis, 3 parts of Herba Andrographis, Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, added 5 times of amount 40% alcohol reflux 0.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste, all the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials, add 5 times of decocting in water 0.5 hour, filter merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add ethanol precipitation twice, make that to contain the alcohol amount be 40% for the first time, make that to contain the alcohol amount be 70% for the second time, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, and vacuum drying is broken into fine powder with dried cream powder, granulate, promptly get granule.

Embodiments of the invention 13: 20 parts of Radix Rosae Laevigataes, 40 parts of Caulis Spatholobis, 20 parts of Radix Flemingiae Philippinensiss, 20 parts of Caulis Mahoniaes, 8 parts of Radix Zanthoxylis, 7 parts of Herba Andrographis, Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, add 15 times of amount 80% alcohol reflux 5 times, each 2.5 hours, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste, all the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials, add 15 times of decocting in water 4 times, decocted 2.5 hours at every turn, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 60% for the first time, make for the second time that to contain the alcohol amount be 90%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, vacuum drying, dried cream powder is broken into fine powder, granulate, encapsulated, promptly get capsule.

Embodiments of the invention 14: take by weighing 9～20 parts of Radix Rosae Laevigataes, 18～40 parts of Caulis Spatholobis, 9～20 parts of Radix Flemingiae Philippinensiss, 9～20 parts of Caulis Mahoniaes, 4～8 parts of Radix Zanthoxylis, 3～7 parts of Herba Andrographis; The Herba Andrographis of drawing the prescription amount 15-25% that decides scope is ground into fine powder, to remain Herba Andrographis and all the other five tastes medical materials are put in the pot, add the decocting in water secondary, and add 6 times of decoctings at every turn and boiled 2.5 hours, filter, collecting decoction, filtrate are condensed into the thick paste shape, add the punching Nelumbo nucifera Gaertn. Powder, mixing, 60-70 ℃ ,-condition of 0.08Mpa under vacuum drying, dried cream powder is broken into fine powder, add an amount of different adjuvant again and just can make the corresponding preparation dosage form.

In the above-described embodiments: Herba Andrographis can substitute with the andrographolide that the equivalent medicinal material extract obtains.

Embodiments of the invention 15: the discrimination method of described preparation is following all or part of content:

It is an amount of to get each preparation, add ethanol or methanol extraction, filter, filtrate volatilizes, residue is with methanol or dissolve with ethanol, admix silica gel, volatilize, put in the silicagel column, use petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃), chloroform or ethyl acetate or methanol or ethanol elution successively, eluent evaporate to dryness, residue add chloroform or ethyl acetate dissolving, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Caulis Spatholobi control medicinal material, shines medical material solution in pairs with legal system; Get the formononetin reference substance again, add methanol or ethanol and make the solution that every 1ml contains 1mg; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1 μ l of above-mentioned four kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae is developing solvent with chloroform-methanol or ethanol at 1: 0.2, launches, and takes out, and dries, put under the ultra-violet lamp 254nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, adds methanol or ethanol extraction, filters, and filtrate volatilizes, and residue is regulated pH value to 7～11 after adding dissolve with hydrochloric acid solution, and with chloroform or ethyl acetate extraction, extracting solution volatilizes, and residue is with methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Caulis Mahoniae control medicinal material, shines medical material solution in pairs with legal system; Get berberine hydrochloride, Jatrorrhizine chloride, palmatine hydrochloride, coptisine reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1 μ l of above-mentioned seven kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄On the lamellae, with n-butyl alcohol-glacial acetic acid or formic acid-water 1: 0.1: 0.2 or benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 1: 0.5: 0.1: be developing solvent at 0.1: 0.05, launch, take out, dry, put inspect under the uviol lamp 365nm or the stifling rearmounted uviol lamp 365nm of ammonia under inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, add ethanol or methanol extraction, filter, filtrate volatilizes, and residue hydro-oxidation sodium solution dissolving back discards ether or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃) liquid with ether or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃) extraction, water layer is with ethyl acetate or n-butanol extraction, ethyl acetate or n-butanol extracting liquid volatilize, and residue is with methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Radix Rosae Laevigatae control medicinal material, shines medical material solution in pairs with legal system; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae is developing solvent with chloroform-methanol or ethanol at 1: 0.2, launches, and takes out, dry, spray is with 1% ethanol solution of sulfuric acid, and 90～150 ℃ to be heated to speckle colour developing clear, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, adds ethanol or methanol extraction, filters, and filtrate is as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Radix Zanthoxyli control medicinal material, shines medical material solution in pairs with legal system; Get ethoxychelerythrine, nitidine chloride, Toddalolactone reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; With the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1 μ l of above-mentioned six kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae, with benzene or toluene or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃)-ethyl acetate or chloroform-methanol or ethanol 0.5: 0.5: 0.02 or benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 5: 0.5: 0.2: be developing solvent at 0.1: 0.02, launch, take out, dry, put under the uviol lamp 365nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, adds ethanol or methanol extraction, filters, and filtrate volatilizes, and residue adds methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Herba Andrographis control medicinal material, shines medical material solution in pairs with legal system; Get andrographolide, dehydrorographolide reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; With the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄On the lamellae, with chloroform-ethyl acetate-methanol or ethanol 0.5: 0.5: 0.5 or chloroform-methanol or ethanol is developing solvent at 1: 0.05, launch, take out, dry, put under the uviol lamp 254nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle, the spray with 0.2%3, the mixed in equal amounts solution of 5 dinitrobenzoic acids alcoholic solution-0.05mol/L potassium hydroxide or 0.05mol/L sodium hydroxide solution (face and use preceding mixing), in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or hydrochloric acid-methanol (1: 100) and extracts, and shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the berberine hydrochloride reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, 0.005mol/L sodium dihydrogen phosphate or 0.005mol/L potassium dihydrogen phosphate or water-acetonitrile or methanol are mobile phase at 10%: 90%, the detection wavelength is one or several among the 200nm, 20 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless;

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with andrographolide, dehydrorographolide reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-0.2% glacial acetic acid or 0.2% formic acid or 0.02% phosphate aqueous solution are mobile phase at 10%: 90%, the detection wavelength is one or several among the 200nm, 20 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless;

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the formononetin reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-water or 0.2% glacial acetic acid or 0.2% formic acid or 0.02% phosphate aqueous solution are mobile phase, gradient elution, the detection wavelength is one or several among the 200nm, 20 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless.

Embodiments of the invention 16: the method for testing of described formulation content is following all or part of content:

The assay of berberine hydrochloride in a, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or hydrochloric acid-methanol (1: 100) and extracts, and shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the berberine hydrochloride reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, 0.2mol/L sodium dihydrogen phosphate or 0.2mol/L potassium dihydrogen phosphate or water-acetonitrile or methanol are mobile phase at 90%: 910%, the detection wavelength is one or several among the 410nm, 50 ℃ of column temperatures; Calculate with external standard method or standard curve method;

The assay of andrographolide, dehydrorographolide in b, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with andrographolide, dehydrorographolide reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-0.2% glacial acetic acid or 0.2% formic acid or 0.02% phosphate aqueous solution are mobile phase at 10%: 90%, the detection wavelength is one or several among the 200nm, 20 ℃ of column temperatures; Calculate with external standard method or standard curve method;

The assay of nitidine in c, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the nitidine chloride reference substance are contrast, with the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae, with benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 5: 0.5: 0.2: be developing solvent at 0.1: 0.02, launch, take out, dry, put under the uviol lamp 365nm and inspect, scan according to thin layer chromatography, wavelength: λ s=300nm, λ R=210nm calculates, promptly;

The assay of formononetin in d, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the formononetin reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-water or 0.2% glacial acetic acid or 0.2% formic acid or 0.02% phosphate aqueous solution are mobile phase, gradient elution, the detection wavelength is one or several among the 200nm, 20 ℃ of column temperatures; Calculate with external standard method or standard curve method.

Embodiments of the invention 17: the discrimination method of described preparation is following all or part of content:

It is an amount of to get each preparation, add ethanol or methanol extraction, filter, filtrate volatilizes, residue is with methanol or dissolve with ethanol, admix silica gel, volatilize, put in the silicagel column, use petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃), chloroform or ethyl acetate or methanol or ethanol elution successively, eluent evaporate to dryness, residue add chloroform or ethyl acetate dissolving, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Caulis Spatholobi control medicinal material, shines medical material solution in pairs with legal system; Get the formononetin reference substance again, add methanol or ethanol and make the solution that every 1ml contains 1mg; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 30 μ l of above-mentioned four kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae is developing solvent with chloroform-methanol or ethanol at 90: 10, launches, and takes out, and dries, put under the ultra-violet lamp 254nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, adds methanol or ethanol extraction, filters, and filtrate volatilizes, and residue is regulated pH value to 7～11 after adding dissolve with hydrochloric acid solution, and with chloroform or ethyl acetate extraction, extracting solution volatilizes, and residue is with methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Caulis Mahoniae control medicinal material, shines medical material solution in pairs with legal system; Get berberine hydrochloride, Jatrorrhizine chloride, palmatine hydrochloride, coptisine reference substance again, add methanol or ethanol respectively and make the solution that every Iml contains 1mg; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 30 μ l of above-mentioned seven kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄On the lamellae, with n-butyl alcohol-glacial acetic acid or formic acid-water 20: 5: 10 or benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 20: 10: 10: be developing solvent at 10: 5, launch, take out, dry, put inspect under the uviol lamp 365nm or the stifling rearmounted uviol lamp 365nm of ammonia under inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, add ethanol or methanol extraction, filter, filtrate volatilizes, and residue hydro-oxidation sodium solution dissolving back discards ether or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃) liquid with ether or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃) extraction, water layer is with ethyl acetate or n-butanol extraction, ethyl acetate or n-butanol extracting liquid volatilize, and residue is with methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Radix Rosae Laevigatae control medicinal material, shines medical material solution in pairs with legal system; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 30 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae is developing solvent with chloroform-methanol or ethanol at 90: 10, launches, and takes out, dry, spray is with 30% ethanol solution of sulfuric acid, and 150 ℃ to be heated to speckle colour developing clear, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, adds ethanol or methanol extraction, filters, and filtrate is as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Radix Zanthoxyli control medicinal material, shines medical material solution in pairs with legal system; Get ethoxychelerythrine, nitidine chloride, Toddalolactone reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; With the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 30 μ l of above-mentioned six kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄Lamellae, with benzene or toluene or petroleum ether (60～90 ℃) or petroleum ether (30～60 ℃)-ethyl acetate or chloroform-methanol or ethanol 60: 50: 10 or benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 40: 15: 10: be developing solvent at 3: 3, launch, take out, dry, put under the uviol lamp 365nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, adds ethanol or methanol extraction, filters, and filtrate volatilizes, and residue adds methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Herba Andrographis control medicinal material, shines medical material solution in pairs with legal system; Get andrographolide, dehydrorographolide reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; With the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 30 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica gel G F ₂₅₄On the lamellae, with chloroform-ethyl acetate-methanol or ethanol 15: 60: 50 or chloroform-methanol or ethanol 1～30: 0.05～5 is developing solvent, launch, take out, dry, put under the uviol lamp 254nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle, the spray with 10%3, the mixed in equal amounts solution of 5 dinitrobenzoic acids alcoholic solution-5mol/L potassium hydroxide or 5mol/L sodium hydroxide solution (face and use preceding mixing), in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or hydrochloric acid-methanol (1: 100) and extracts, and shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the berberine hydrochloride reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, 0.2mol/L sodium dihydrogen phosphate or 0.2mol/L potassium dihydrogen phosphate or water-acetonitrile or methanol are mobile phase at 90%: 10%, the detection wavelength is one or several among the 410nm, 50 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless;

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with andrographolide, dehydrorographolide reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-5% glacial acetic acid or 5% formic acid or 3% phosphate aqueous solution are mobile phase at 90%: 10%, the detection wavelength is one or several among the 410nm, 50 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless;

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the formononetin reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-water or 5% glacial acetic acid or 5% formic acid or 3% phosphate aqueous solution are mobile phase, gradient elution, the detection wavelength is one or several among the 410nm, 50 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless.

Embodiments of the invention 18: the method for testing of described formulation content is following all or part of content:

The assay of berberine hydrochloride in a, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or hydrochloric acid-methanol (1: 100) and extracts, and shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the berberine hydrochloride reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, 0.2mol/L sodium dihydrogen phosphate or 0.2mol/L potassium dihydrogen phosphate or water-acetonitrile or methanol are mobile phase at 90%: 10%, the detection wavelength is one or several among the 410nm, 50 ℃ of column temperatures; Calculate with external standard method or standard curve method;

The assay of andrographolide, dehydrorographolide in b, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with andrographolide, dehydrorographolide reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-5% glacial acetic acid or 5% formic acid or 3% phosphate aqueous solution are mobile phase at 90%: 10%, the detection wavelength is one or several among the 410nm, 50 ℃ of column temperatures; Calculate with external standard method or standard curve method;

The assay of nitidine in c, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the nitidine chloride reference substance are contrast, with the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 30 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae, with benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 40: 15: 10: be developing solvent at 3: 3, launch, take out, dry, put under the uviol lamp 365nm and inspect, scan according to thin layer chromatography, wavelength: λ s=300nm, λ R=210nm calculates, promptly;

The assay of formononetin in d, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the formononetin reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-water or 5% glacial acetic acid or 5% formic acid or 3% phosphate aqueous solution are mobile phase, gradient elution, the detection wavelength is one or several among the 410nm, 50 ℃ of column temperatures; Calculate with external standard method or standard curve method.

Claims

1. Jinji preparation for the treatment of gynaecopathia, it is characterized in that: calculate according to components by weight percent, it mainly is to be made by 9～20 parts of Radix Rosae Laevigataes, 18～40 parts of Caulis Spatholobis, 9～20 parts of Radix Flemingiae Philippinensiss, 9～20 parts of Caulis Mahoniaes, 4～8 parts of Radix Zanthoxylis, 3～7 parts of Herba Andrographis or their extract of corresponding weight portion; Described preparation comprises: injection: be directly used in the injection of drug administration by injection, injectable sterile powder and the aseptic block that needs to be used for after the dilution concentrated solution for injection of intravenous drip, directly makes for the glucose intravenous infusion of intravenous drip and sodium chloride intravenous infusion, with freeze-drying or spray drying method; Oral formulations: all acceptable dosage forms on tablet, dispersible tablet, oral cavity disintegration tablet, effervescent tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, stomach or intestinal location delivery formulations, gel, suppository, oral liquid, soft extract, extractum and the membrane pharmaceutics.

2. according to the Jinji preparation of the described treatment gynaecopathia of claim 1, it is characterized in that: described preparation is micropill, tablet, dispersible tablet, capsule, soft capsule, granule, oral liquid or drop pill, and the Herba Andrographis in the prescription substitutes with the andrographolide that the equivalent medicinal material extract obtains.

3. the preparation method of the Jinji preparation of treatment gynaecopathia as claimed in claim 1 or 2, it is characterized in that: get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, add water or ethanol extraction, extracting solution concentrates, carry out purification with one or more mixing uses in ethanol precipitation, organic solvent extractionprocess, the column chromatography, the extract that obtains adds different auxiliary material and makes corresponding preparations.

4. the preparation method of the Jinji preparation of treatment gynaecopathia as claimed in claim 3, it is characterized in that: get Herba Andrographis and be ground into coarse powder, add 5～15 times of amount 40～80% alcohol reflux 1～5 time, each 0.5～2.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density are 1.15～1.20 clear paste; All the other five tastes medical materials are put in the pot, add 5～15 times of decocting in water 1～4 time, the each decoction 0.5～2.5 hour, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 40～60% for the first time, make for the second time that to contain the alcohol amount be 70～90%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add different auxiliary material and make corresponding preparations.

5. according to the preparation method of the Jinji preparation of the described treatment gynaecopathia of claim 4, it is characterized in that: get Herba Andrographis and be ground into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density are 1.15～1.20 clear paste; All the other five tastes medical materials are put in the pot, add the decocting in water secondary, add 6 times of decoctings boiled 2.5 hours at every turn, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 50% for the first time, make for the second time that to contain the alcohol amount be 70%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add different auxiliary material and make corresponding preparations.

6. according to the preparation method of the Jinji preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: get Herba Andrographis and be ground into coarse powder, added 10～30 times of amount 50～80% soak with ethanol 2～24 hours, percolation extracts then, merge extractive liquid,, decompression recycling ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, add decocting in water 1～5 time, add 5～15 times of decoctings boiled 0.5～2.5 hour at every turn, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add 1～4 times of volume n-butanol extraction 1～6 time, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol, be concentrated into 60 ℃ of relative densities and be 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, adds different auxiliary material and make corresponding preparations.

7. according to the preparation method of the Jinji preparation of the described treatment gynaecopathia of claim 6, it is characterized in that: get Herba Andrographis and be ground into coarse powder, added 20 times of amount 70% soak with ethanol 12 hours, percolation extracts then, merge extractive liquid,, decompression recycling ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, added the decocting in water secondary, add 6 times of decoctings at every turn and boiled 2.5 hours, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add the equal-volume n-butanol extraction 4 times, merge n-butyl alcohol liquid, the reclaim under reduced pressure n-butyl alcohol, be concentrated into 60 ℃ of relative densities and be 1.15～1.20 clear paste, add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, adds different auxiliary material and make corresponding preparations.

8. according to the preparation method of the Jinji preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: get Herba Andrographis and be ground into coarse powder, add 5～15 times of amount 40～80% alcohol reflux 1～5 time, each 0.5～2.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste, add 1～4 times of amount dissolve with ethanol, filter, filtrate is admixed macroporous resin, drying with water bath, resin column on the dry method, earlier with 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% ethanol elution, 1～10 times of resin volume 40～80% alcohol desorption of reuse are collected stripping liquid, and it is 1.15～1.20 clear paste that decompression recycling ethanol is condensed into 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, add 5～15 times of decocting in water 1～4 time, the each decoction 0.5～2.5 hour, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 40～60% for the first time, make for the second time that to contain the alcohol amount be 70～90%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are the clear paste of 1.15～1.20 (), add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add different auxiliary material and make corresponding preparations.

9. according to the preparation method of the Jinji preparation of the described treatment gynaecopathia of claim 8, it is characterized in that: get Herba Andrographis and be ground into coarse powder, add 10 times of amount 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, decompression recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, add 2 times of amount dissolve with ethanols, filter, filtrate is admixed the D-101 macroporous resin, drying with water bath, resin column on the dry method is earlier with 6 times of resinite hydrops and 4 times of resin volume 10% ethanol elutions, 6 times of resin volume 50% alcohol desorptions of reuse, collect stripping liquid, it is 1.15～1.20 clear paste that decompression recycling ethanol is condensed into 60 ℃ of relative densities; All the other five tastes medical materials are put in the pot, add the decocting in water secondary, add 6 times of decoctings boiled 2.5 hours at every turn, filter, merging filtrate, it is the clear paste of 1.15～1.20 () that filtrate is condensed into 60 ℃ of relative densities, adds ethanol precipitation twice, makes that to contain the alcohol amount be 50% for the first time, make for the second time that to contain the alcohol amount be 70%, filter, filtrate recycling ethanol to 60 ℃ of relative densities are the clear paste of 1.15～1.20 (), add the Herba Andrographis ointment, mixing, 60-70 ℃ ,-the 0.08MPa vacuum drying, dried cream powder is broken into fine powder, add different auxiliary material and make corresponding preparations.

10. according to the preparation method of the Jinji preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, add 5～15 times of amount 40～80% alcohol reflux 1～5 time, each 0.5～2.5 hour, merge extractive liquid,, decompression recycling ethanol to 60 ℃ relative density is 1.15～1.20 clear paste, all the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials, add 5～15 times of decocting in water 1～4 time, the each decoction 0.5～2.5 hour, filter, merging filtrate, it is 1.15～1.20 clear paste that filtrate is condensed into 60 ℃ of relative densities, add ethanol precipitation twice, make for the first time that to contain the alcohol amount be 40～60%, make that to contain the alcohol amount be 70～90% for the second time, filter, filtrate recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, vacuum drying is broken into fine powder with dried cream powder, adds different auxiliary material and makes corresponding preparations.

11. preparation method according to the Jinji preparation of the described treatment gynaecopathia of claim 10, it is characterized in that: Herba Andrographis, Caulis Spatholobi, Caulis Mahoniae, Radix Angelicae Sinensis and Radix Zanthoxyli, 70% ethanol that adds 8 times of amounts, reflux, extract, three times, each 2 hours, filter, merging filtrate, recovery ethanol are 1.15～1.20 clear paste to 60 ℃ of relative densities; All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis, Radix Codonopsis three flavor medical materials add 8 times of water gagings, decoct secondary, each 2 hours, collecting decoction filtered, filtrate concentrates, and merges with above-mentioned concentrated solution, adds ethanol precipitation twice, make for the first time that to contain the alcohol amount be 60%, make that to contain the alcohol amount be 80% for the second time, filter, filtrate recycling ethanol is 1.15～1.20 clear paste to 60 ℃ of relative densities, vacuum drying is broken into fine powder with dried cream powder, adds different auxiliary material and makes corresponding preparations.

12. preparation method according to the Jinji preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: the Herba Andrographis of getting prescription amount 15-25% is ground into fine powder, to remain Herba Andrographis and all the other five tastes medical materials are put in the pot, add the decocting in water secondary, add 6 times of decoctings boiled 2.5 hours at every turn, filter, collecting decoction, filtrate is condensed into the thick paste shape, add the punching Nelumbo nucifera Gaertn. Powder, mixing, 60-70 ℃ ,-condition of 0.08Mpa under vacuum drying, dried cream powder is broken into fine powder, adds an amount of different adjuvant and make corresponding preparation.

13. the method for quality control of the Jinji preparation of treatment gynaecopathia as claimed in claim 1 or 2 is characterized in that: this method comprises following all or part of content:

(1) the differential test method of Radix Rosae Laevigatae medical material, Caulis Spatholobi medical material, Radix Flemingiae Philippinensis medical material, Caulis Mahoniae medical material, Radix Zanthoxyli medical material, Herba Andrographis medical material, formononetin, berberine hydrochloride, palmatine hydrochloride, Jatrorrhizine chloride, coptisine, nitidine, ethoxychelerythrine, Toddalolactone, andrographolide or all or part of composition of dehydrorographolide in the preparation;

(2) content test method of formononetin, berberine hydrochloride, palmatine hydrochloride, Jatrorrhizine chloride, coptisine, nitidine, ethoxychelerythrine, Toddalolactone, andrographolide, dehydrorographolide, total flavones or all or part of composition of total polysaccharides in the preparation.

14. according to the method for quality control of the Jinji preparation of the described treatment gynaecopathia of claim 13, it is characterized in that: the discrimination method of described preparation is following all or part of content:

The thin layer chromatography discrimination method of Caulis Spatholobi medical material, formononetin in a, the preparation:

It is an amount of to get each preparation, add ethanol or methanol extraction, filter, filtrate volatilizes, residue is with methanol or dissolve with ethanol, admix silica gel, volatilize, put in the silicagel column, use 60～90 ℃ petroleum ether or 30～60 ℃ of petroleum ether, chloroform or ethyl acetates or methanol or ethanol elution successively, eluent evaporate to dryness, residue add chloroform or ethyl acetate dissolving, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Caulis Spatholobi control medicinal material, shines medical material solution in pairs with legal system; Get the formononetin reference substance again, add methanol or ethanol and make the solution that every 1ml contains 1mg; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned four kinds of solution, putting respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica GF254 lamellae, is developing solvent with chloroform-methanol or ethanol 1～90: 0.2～10, launches, take out, dry, put under the ultra-violet lamp 254nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

The thin layer chromatography discrimination method of Caulis Mahoniae medical material, berberine hydrochloride, Jatrorrhizine chloride, palmatine hydrochloride, coptisine in b, the preparation:

It is an amount of to get each preparation, adds methanol or ethanol extraction, filters, and filtrate volatilizes, and residue is regulated pH value to 7～11 after adding dissolve with hydrochloric acid solution, and with chloroform or ethyl acetate extraction, extracting solution volatilizes, and residue is with methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Caulis Mahoniae control medicinal material, shines medical material solution in pairs with legal system; Get berberine hydrochloride, Jatrorrhizine chloride, palmatine hydrochloride, coptisine reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned seven kinds of solution, put respectively on same silica gel g thin-layer plate or silica gel H lamellae or silica GF254 lamellae, with n-butyl alcohol-glacial acetic acid or formic acid-water 1～20: 0.1～5: 0.2～10 or benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 1～20: 0.5～10: 0.1～10: 0.1～10: 0.05～5 is developing solvent, launch, take out, dry, put inspect under the uviol lamp 365nm or the stifling rearmounted uviol lamp 365nm of ammonia under inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

The thin layer chromatography of Radix Rosae Laevigatae medical material is differentiated in c, the preparation:

It is an amount of to get each preparation, add ethanol or methanol extraction, filter, filtrate volatilizes, and residue hydro-oxidation sodium solution dissolving back discards ether or petroleum ether or petroleum ether liquid with ether or 60～90 ℃ petroleum ether or 30～60 ℃ Petroleum ether extraction, water layer is with ethyl acetate or n-butanol extraction, ethyl acetate or n-butanol extracting liquid volatilize, and residue is with methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Radix Rosae Laevigatae control medicinal material, shines medical material solution in pairs with legal system; Adopt the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, drawing each 1～30 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica GF254 lamellae, is developing solvent with chloroform-methanol or ethanol 1～90: 0.2～10, launch, take out, dry, spray is with 1～30% ethanol solution of sulfuric acid, 90～150 ℃ to be heated to speckle colour developing clear, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, adds ethanol or methanol extraction, filters, and filtrate is as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Radix Zanthoxyli control medicinal material, shines medical material solution in pairs with legal system; Get ethoxychelerythrine, nitidine chloride, Toddalolactone reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; With the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned six kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae or silica GF254 lamellae, with benzene or toluene or 60～90 ℃ petroleum ether or 30～60 ℃ petroleum ether-ethyl acetate or chloroform-methanol or ethanol 0.5～60: 0.5～50: 0.02～10 or benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 5～40: 0.5～15: 0.2～10: 0.1～3: 0.02～3 is developing solvent, launch, take out, dry, put under the uviol lamp 365nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, adds ethanol or methanol extraction, filters, and filtrate volatilizes, and residue adds methanol or dissolve with ethanol, as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Other gets the Herba Andrographis control medicinal material, shines medical material solution in pairs with legal system; Get andrographolide, dehydrorographolide reference substance again, add methanol or ethanol respectively and make the solution that every 1ml contains 1mg; With the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate or silica gel H lamellae or silica GF254 lamellae, with chloroform-ethyl acetate-methanol or ethanol 0.5～15: 0.5～60: 0.5～50 or chloroform-methanol or ethanol 1～30: 0.05～5 is developing solvent, launch, take out, dry, put under the uviol lamp 254nm and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle, spray is with 0.2～10%3, the mixed in equal amounts solution of 5 dinitrobenzoic acid alcoholic solution-0.05～5mol/L potassium hydroxide or 0.05～5mol/L sodium hydroxide solution is used preceding mixing facing, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, should show the same color speckle;

It is an amount of to get each preparation, puts in the measuring bottle, adds the hydrochloric acid-methanol extraction of methanol or 1: 100, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the berberine hydrochloride reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, 0.005～0.2mol/L sodium dihydrogen phosphate or 0.005～0.2mol/L potassium dihydrogen phosphate or water-acetonitrile or methanol 10%～90%: 90%～10% are mobile phase, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless;

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the formononetin reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-water or 0.2%～5% glacial acetic acid or 0.2%～5% formic acid or 0.02%～3% phosphate aqueous solution are mobile phase, gradient elution, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; In the test sample chromatograph, tool and the reference substance chromatograph consistent chromatographic peak of time of withing a hook at the end, negative noiseless.

15. according to the method for quality control of the Jinji preparation of the described treatment gynaecopathia of claim 13, it is characterized in that: the method for testing of described formulation content is following all or part of content:

The assay of berberine hydrochloride in a, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds the hydrochloric acid-methanol extraction of methanol or 1: 100, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the berberine hydrochloride reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, 0.005～0.2mol/L sodium dihydrogen phosphate or 0.005～0.2mol/L potassium dihydrogen phosphate or water-acetonitrile or methanol 10%～90%: 90%～10% are mobile phase, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; Calculate with external standard method or standard curve method;

The assay of andrographolide, dehydrorographolide in b, the Jinji preparation:

The assay of nitidine in c, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the nitidine chloride reference substance are contrast, with the disclosed thin layer chromatography test of Chinese Pharmacopoeia appendix, draw each 1～30 μ l of above-mentioned three kinds of solution, put respectively in same silica gel g thin-layer plate or silica gel H lamellae, with benzene or toluene-ethyl acetate or Ethyl formate-methanol or ethanol-isopropyl alcohol-strong ammonia solution 5～40: 0.5～15: 0.2～10: 0.1～3: 0.02～3 is developing solvent, launch, take out, dry, put under the uviol lamp 365nm and inspect, scan according to thin layer chromatography, wavelength: λ s=300nm, λ R=210nm calculates, promptly;

The assay of formononetin in d, the Jinji preparation:

It is an amount of to get each preparation, puts in the measuring bottle, adds methanol or ethanol extraction, shakes up, and filters with microporous filter membrane, gets subsequent filtrate as need testing solution; Take by weighing other flavour of a drug and adjuvant in the prescription ratio, make negative control solution with method; Methanol or alcoholic solution with the formononetin reference substance are contrast, adopt liquid chromatography, chromatographic column is a filler with octadecylsilane chemically bonded silica or eight alkyl silane bonded silica gels or dialkyl silane bonded silica gel, methanol or acetonitrile-water or 0.2%～5% glacial acetic acid or 0.2%～5% formic acid or 0.02%～3% phosphate aqueous solution are mobile phase, gradient elution, the detection wavelength is one or several among 200～410nm, 20～50 ℃ of column temperatures; Calculate with external standard method or standard curve method.

16. the application of the Jinji preparation of treatment gynaecopathia as claimed in claim 1 or 2 in preparation treatment adnexitis, endometritis, gynecopathy such as pelvic inflammatory disease medicine.