CN101732684A - Method for quality detection of capsule for nourishing stomach - Google Patents
Method for quality detection of capsule for nourishing stomach Download PDFInfo
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- CN101732684A CN101732684A CN200910185367A CN200910185367A CN101732684A CN 101732684 A CN101732684 A CN 101732684A CN 200910185367 A CN200910185367 A CN 200910185367A CN 200910185367 A CN200910185367 A CN 200910185367A CN 101732684 A CN101732684 A CN 101732684A
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- yangweishu
- hesperidin
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Abstract
The invention discloses a method for the quality detection of a capsule for nourishing the stomach. The method comprises the steps of distinguishing the capsule for nourishing the stomach, measuring the content of hesperidin and the like. By the measurement of the method, the content of tangerine peel in each granule can not be less than 0.27mg, calculated by the hesperidin (C28H34O15). The method has advanced technology and simple and convenient operation and can effectively control the quality of product.
Description
Technical field
The present invention relates to a kind of quality determining method of Chinese patent medicine, particularly a kind of yangweishu capsules quality determining method.
Background technology
Yangweishu capsules is the capsules through being processed into such as Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Polygonati (steaming), Rhizoma Dioscoreae, Rhizoma Zingiberis, Semen Cuscutae, Pericarpium Citri Reticulatae, Radix Scrophulariae, Fructus Mume, Fructus Crataegi (stir-fry), Radix Glehniae, and QI invigorating consolidates, and tonifying-Yin and nourishing-stomach is transferred regulating the function of middle-JIAO, the circulation of qi promoting food stagnation removing.Be used for the scorching hot distending pain of gastral cavilty that deficiency of both QI and YIN causes, feverish sensation in the palms and soles, xerostomia, bitter taste, diseases such as poor appetite, and chronic atrophic gastritis, chronic gastritis have above-mentioned patient.Do not have assay item and thin layer to differentiate in existing yangweishu capsules quality determining method, the difficult quality of finished product is accomplished effective control, the quality neither one index of different batches product is weighed, and is very big to clinically therapeutical effect influence.Therefore, the detection method that need further improve the quality.
Summary of the invention
The object of the present invention is to provide a kind of stable, favorable reproducibility, specificity yangweishu capsules quality determining method strong and easy and simple to handle.
Its technical scheme is: a kind of yangweishu capsules quality determining method is characterized in that this method comprises
A, content of hesperidin are measured: get this product content, add the methanol solution that contains sodium hydroxide, and supersound extraction, the extracting solution standardize solution filters, and gets subsequent filtrate, as need testing solution; It is an amount of that other gets the Hesperidin reference substance, adds the dissolve with methanol solution that contains sodium hydroxide, in contrast product solution; According to high effective liquid chromatography for measuring, be filler with the octadecylsilane chemically bonded silica, acetonitrile-phosphoric acid solution is a mobile phase, the detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000, and accurate respectively reference substance solution and the need testing solution drawn injects chromatograph of liquid, measures, and every of yangweishu capsules contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, must not be less than 0.27mg.
B, Hesperidin are differentiated: get above-mentioned need testing solution 20ml, put and steam in the water-bath to about 5ml, thin up adds dilute hydrochloric acid and regulates pH value to 20ml, the reuse ethyl acetate extraction, and the extracting solution evaporate to dryness, residue adds N, and N '-dimethyl formamide dissolving is as need testing solution.Other gets the Hesperidin reference substance, adds N, N '-dimethyl formamide dissolving, product solution in contrast.According to the thin layer chromatography test, draw above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with ethyl acetate-methanol-water, launch, take out, to dry, spray is put under the ultra-violet lamp (365nm) and is inspected with 5% aluminum chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
The quality determining method of yangweishu capsules of the present invention, increased the Determination of Hesperidin Content of Pericarpium Citri Reticulatae medical material in the yangweishu capsules has been measured, and formulated rational limit, strengthened control dynamics to drug quality, the content assaying method that is adopted has that separating degree is good, precision is high, good reproducibility, characteristics easy and simple to handle, can carry out reliable quantified controlling to the quality of yangweishu capsules; Simultaneously, increased the qualitative identification to Hesperidin, made best test sample preparation method, found suitable thin layer chromatography condition, the foundation of this discrimination method can be played discriminating effect fast to the quality of product.Therefore, the quality determining method of yangweishu capsules of the present invention has further improved the quality standard of yangweishu capsules, has fully guaranteed the quality and the definite curative effect of product, and the foundation of science also is provided for the low-quality goods on the discriminating market.
The specific embodiment
Yangweishu capsules prescription composition: Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Polygonati (steaming), Rhizoma Dioscoreae, Rhizoma Zingiberis, Semen Cuscutae, Pericarpium Citri Reticulatae, Radix Scrophulariae, Fructus Mume, Fructus Crataegi (stir-fry), Radix Glehniae.
Preparation technology: get the recipe quantity medical material, decoct with water secondary (Semen Cuscutae is decocted a drug wrapped), 1.5 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate staticly settles, and gets supernatant, and being concentrated into relative density is the thick paste of 1.34～1.37 (20 ℃), add an amount of Pulvis Talci, starch and silicon dioxide, mixing, system granule, dry, incapsulate, make 1000, promptly.
Yangweishu capsules is differentiated:
Get the need testing solution 20ml under [assay] item, put and steam in the water-bath to about 5ml, thin up adds dilute hydrochloric acid and regulates pH value to 6 to 20ml, uses ethyl acetate extraction 3 times, each 20ml, combined ethyl acetate liquid, evaporate to dryness, residue adds N, N '-dimethyl formamide 1ml makes dissolving, as need testing solution.Other gets the Hesperidin reference substance, adds N, and N '-dimethyl formamide is made the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VI B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with ethyl acetate-methanol-water (110: 15: 10) is developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with 5% aluminum chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
The yangweishu capsules assay:
Get this product content, porphyrize is got 0.5g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 80% methanol solution 25ml that adds the 0.1mol/L sodium hydroxide, close plug claims to decide weight, supersound process (power 200W, frequency 40KHZ) 15 minutes, put coldly, claim to decide weight again, 80% methanol solution with the 0.1mol/L sodium hydroxide is supplied the weight that subtracts mistake, shakes up, centrifugal 5 minutes, get supernatant or filtration, get subsequent filtrate, as need testing solution; It is an amount of that other gets the Hesperidin reference substance, and accurate the title decides, and 80% methanol solution that adds the 0.1mol/L sodium hydroxide is made the solution that contains Hesperidin 30 μ g among every 1ml, in contrast product solution; According to high effective liquid chromatography for measuring, be filler with the octadecylsilane chemically bonded silica, acetonitrile-0.4% phosphoric acid solution (20: 80) is a mobile phase, the detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000, and accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing inject chromatograph of liquid, measure, and every of yangweishu capsules contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, must not be less than 0.27mg.
Claims (5)
1. the quality determining method of a yangweishu capsules is characterized in that this method comprises:
A, content of hesperidin are measured: get this product content, add the methanol solution that contains sodium hydroxide, and supersound extraction, the extracting solution standardize solution filters, and gets subsequent filtrate, as need testing solution; It is an amount of that other gets the Hesperidin reference substance, adds the dissolve with methanol solution that contains sodium hydroxide, in contrast product solution; According to high effective liquid chromatography for measuring, be filler with the octadecylsilane chemically bonded silica, acetonitrile-phosphoric acid solution is a mobile phase, the detection wavelength is 286nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 3000, and accurate respectively reference substance solution and the need testing solution drawn injects chromatograph of liquid, measures, and every of yangweishu capsules contains Pericarpium Citri Reticulatae in Hesperidin, must not be less than 0.27mg.
B, Hesperidin are differentiated: get above-mentioned need testing solution 20ml, put and steam in the water-bath to about 5ml, thin up adds dilute hydrochloric acid and regulates pH value to 20ml, the reuse ethyl acetate extraction, and the extracting solution evaporate to dryness, residue adds N, and N '-dimethyl formamide dissolving is as need testing solution.Other gets the Hesperidin reference substance, adds N, N '-dimethyl formamide dissolving, product solution in contrast.According to the thin layer chromatography test, draw above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with ethyl acetate-methanol-water, launch, take out, to dry, spray is put under the 365nm ultra-violet lamp and is inspected with 5% aluminum chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
2. a kind of yangweishu capsules quality determining method according to claim 1 is characterized in that: the described methanol solution that contains sodium hydroxide is: 80% methanol solution of 0.1mol/L sodium hydroxide.
3. a kind of yangweishu capsules quality determining method according to claim 1 is characterized in that: phosphoric acid solution is 0.4% phosphoric acid solution in described acetonitrile-phosphoric acid solution, and the volumetric ratio of acetonitrile-phosphoric acid solution is: 20: 80.
4. a kind of yangweishu capsules quality determining method according to claim 1 is characterized in that: adding dilute hydrochloric acid adjusting pH value is 6.
5. a kind of yangweishu capsules quality determining method according to claim 1 is characterized in that: the ratio of ethyl acetate-methanol-water developing solvent is 110: 15: 10.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009101853674A CN101732684B (en) | 2009-11-06 | 2009-11-06 | Method for quality detection of capsule for nourishing stomach |
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|---|---|---|---|
| CN2009101853674A CN101732684B (en) | 2009-11-06 | 2009-11-06 | Method for quality detection of capsule for nourishing stomach |
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|---|---|
| CN101732684A true CN101732684A (en) | 2010-06-16 |
| CN101732684B CN101732684B (en) | 2012-07-04 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103091437A (en) * | 2012-11-13 | 2013-05-08 | 江苏艾兰得营养品有限公司 | Determination method of hesperidin content |
-
2009
- 2009-11-06 CN CN2009101853674A patent/CN101732684B/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103091437A (en) * | 2012-11-13 | 2013-05-08 | 江苏艾兰得营养品有限公司 | Determination method of hesperidin content |
| CN103091437B (en) * | 2012-11-13 | 2014-12-24 | 江苏艾兰得营养品有限公司 | Determination method of hesperidin content |
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| Publication number | Publication date |
|---|---|
| CN101732684B (en) | 2012-07-04 |
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Owner name: HEFEI HUARUN SHENLU PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: HEFEI SHENLU SHUANGHE PHARMACEUTICAL INDUSTRY CO., LTD. |
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| CP03 | Change of name, title or address |
Address after: Peach Industrial Park, economic and Technological Development Zone 230051 Anhui city in Hefei Province, Hefei SHANGPAI Highway No. 12 Patentee after: Hefei shenlu Huarun Pharmaceutical Co. Ltd. Address before: 230051 Anhui city in Hefei Province, Hefei SHANGPAI Highway No. 12 Patentee before: Hefei Shenlu Shuanghe Pharmaceutical Industry Co., Ltd. |