CN1588082A - Quality control method for Weinai-an capsule - Google Patents
Quality control method for Weinai-an capsule Download PDFInfo
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- CN1588082A CN1588082A CN 200410051242 CN200410051242A CN1588082A CN 1588082 A CN1588082 A CN 1588082A CN 200410051242 CN200410051242 CN 200410051242 CN 200410051242 A CN200410051242 A CN 200410051242A CN 1588082 A CN1588082 A CN 1588082A
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- relieving gastric
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Abstract
The invention discloses a quality control method for stomach calming capsule, it amends the original quality standard of stomach claming capsule, increases the thin layer chromatography incrimination method and pearl powder content detection method of astraglus root, notoginseng and manmade bezoar, upgrades the quality standard of stomach capsule product, and it can realize the effective control of quality of the product.
Description
Technical field
The present invention relates to a kind of method of quality control of capsule for relieving gastric trouble.
Background technology
Capsule for relieving gastric trouble is a kind of gastric and duodenal ulcer that is used for the treatment of; the Chinese medicine of chronic gastritis etc.; this product records in the 16 in ministerial standard Chinese traditional patent formulation preparation; by the Radix Astragali; pseudo-ginseng; the ginseng pulverate, five tastes medicinal materials such as nacreous layer powder and calculus bovis factitius are made, and the proper mass standard simply is not enough to control drug quality.
Summary of the invention
The objective of the invention is for a kind of method of quality control of the capsule for relieving gastric trouble that can control effectively to the quality of capsule for relieving gastric trouble finished product is provided.
Main technical schemes of the present invention is: the method for quality control of this capsule for relieving gastric trouble comprises following steps:
(1) get the capsule for relieving gastric trouble finished product, put microscopically and observe: irregular tiny fragment, translucent, tool rainbow sample gloss.The object line arcuation texture that the fragment surface has is met watery hydrochloric acid and is produced bubble rapidly.
(2) get capsule for relieving gastric trouble content 6g, the 50ml that adds diethyl ether, ultrasonic 15 minutes, put coldly, filter, wave most ether, residue adds methyl alcohol 60ml sonicated 30 minutes, filters filtrate and steams near dried, and it is an amount of to add zeyssatite, mix thoroughly, volatilize methyl alcohol, add water saturated normal butyl alcohol 30ml, sonicated 15 minutes, filter, filtrate adds 1% sodium hydroxide solution washes 3 times, and each 20ml discards alkali lye, with the saturated washing of normal butyl alcohol 3 times, each 20ml is neutral to n-butanol extracting liquid, evaporate to dryness, residue adds methyl alcohol 2ml makes dissolving, as need testing solution.Other gets pseudo-ginseng control medicinal material 0.4g, and Radix Astragali control medicinal material 4.0g shines medicinal material solution in pairs with legal system.Other gets the Astragaloside IV reference substance, adds methyl alcohol and makes 1ml and contain 1mg solution, in contrast product solution.Test according to thin-layered chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 2 μ l of above-mentioned four kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with the lower floor's solution after the placement of chloroform-methanol-water (13: 6: 2) refrigerator is developping agent, launch about 10cm, take out, dry, spray is with 10% ethanol solution of sulfuric acid, about 5 minutes of 105 ℃ of bakings; In the test sample chromatogram, with control medicinal material chromatogram and the corresponding position of reference substance chromatogram on, the spot of apparent same color under the daylight.Ultraviolet lamp (365nm) is the fluorescence spot of apparent same color down.
(3) get (2) item about 10ml of 1% sodium hydroxide solution washing lotion down, put on filter paper, dry back drips ninhydrin solution, heats 2 minutes at 100 ℃, and spot shows hyacinthine.
(4) get capsule for relieving gastric trouble content 0.3g, add methyl alcohol 20ml, sonicated 30 minutes is filtered, and filtrate evaporate to dryness, residue add methyl alcohol 2ml makes dissolving, as need testing solution.Other gets the cholic acid reference substance, adds methyl alcohol and makes the solution that 1ml contains 0.1mg, in contrast product solution.Test according to thin-layered chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 2 μ l of above-mentioned two kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with ethyl acetate-normal hexane-acetate-methyl alcohol (10: 8: 0.8: 1.2) be developping agent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, about 10 minutes of 110 ℃ of bakings.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, the spot of apparent same color under the daylight.Ultraviolet lamp (365nm) is the fluorescence spot of apparent same color down.
The method of quality control of this capsule for relieving gastric trouble, content to the capsule for relieving gastric trouble finished product is measured: in the assay of capsule for relieving gastric trouble finished product, it is tolerant to get capsule for relieving gastric trouble finished product 4 intragranulars, and it is fixed, slowly blazing to charing to put the interior accurate title of crucible, 700 ℃ of calcinations 1 hour, take out, put cold, dripping hydrochloric acid-water (1: 1) mixed solution 10ml, low-grade fever makes it dissolving, change over to after the cooling in the 250ml measuring bottle, add water to scale, shake up, the accurate 25ml that draws adds water 10ml in the 250ml conical flask, add each 5ml of 5% sodium potassium tartrate tetrahydrate and triethanolamine-water (1: 2) mixed liquor, shake up, add 20% sodium hydroxide solution 10ml, add the about 50mg of cupferron again, shake up, add the about 0.1g of chlorination Sodium carboxylic acid indicator (grinding at 100: 1), become pure blue by purple with diethylamine four acetic acid disodium vs (0.02mol/L) titration to solution; The percentage composition of calculation sample lime carbonate, promptly.Calculate according to the capsule for relieving gastric trouble finished product, the capsule for relieving gastric trouble finished product contains nacreous layer powder with lime carbonate (CaCO
3) meter, should be 24%～30%.
Above-mentioned steps need not carried out according to sequencing, and can also carry out conventional sense simultaneously, and this capsule for relieving gastric trouble finished product is a capsule, and content is brown powder; Gas perfume (or spice), mildly bitter flavor.This capsule for relieving gastric trouble finished product also should meet relevant every regulation under an appendix XII of Chinese Pharmacopoeia version in 2000 the A capsule item.
The capsule for relieving gastric trouble finished product that meets above condition is qualified.
The present invention has revised in improvement on the basis of quality standard of original capsule for relieving gastric trouble; revised and enlarged the Radix Astragali, pseudo-ginseng, the thin-layer chromatography of calculus bovis factitius is differentiated and the nacreous layer powder assay; improved the quality standard of capsule for relieving gastric trouble, helped realizing effective control the quality of capsule for relieving gastric trouble finished product.
Embodiment
The method of quality control of a kind of capsule for relieving gastric trouble of present embodiment comprises following steps:
(1) get the capsule for relieving gastric trouble finished product, put microscopically and observe: irregular tiny fragment, translucent, tool rainbow sample gloss.The object line arcuation texture that the fragment surface has is met watery hydrochloric acid and is produced bubble rapidly.
(2) get capsule for relieving gastric trouble content 6g, the 50ml that adds diethyl ether, ultrasonic 15 minutes, put coldly, filter, wave most ether, residue adds methyl alcohol 60ml sonicated 30 minutes, filters filtrate and steams near dried, and it is an amount of to add zeyssatite, mix thoroughly, volatilize methyl alcohol, add water saturated normal butyl alcohol 30ml, sonicated 15 minutes, filter, filtrate adds 1% sodium hydroxide solution washes 3 times, and each 20ml discards alkali lye, with the saturated washing of normal butyl alcohol 3 times, each 20ml is neutral to n-butanol extracting liquid, evaporate to dryness, residue adds methyl alcohol 2ml makes dissolving, as need testing solution.Other gets pseudo-ginseng control medicinal material 0.4g, and Radix Astragali control medicinal material 4.0g shines medicinal material solution in pairs with legal system.Other gets the Astragaloside IV reference substance, adds methyl alcohol and makes 1ml and contain 1mg solution, in contrast product solution.Test according to thin-layered chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 2 μ l of above-mentioned four kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with the lower floor's solution after the placement of chloroform-methanol-water (13: 6: 2) refrigerator is developping agent, launch about 10cm, take out, dry, spray is with 10% ethanol solution of sulfuric acid, about 5 minutes of 105 ℃ of bakings; In the test sample chromatogram, with control medicinal material chromatogram and the corresponding position of reference substance chromatogram on, the spot of apparent same color under the daylight.Ultraviolet lamp (365nm) is the fluorescence spot of apparent same color down.
(3) get (2) item about 10ml of 1% sodium hydroxide solution washing lotion down, put on filter paper, dry back drips ninhydrin solution, heats 2 minutes at 100 ℃, and spot shows hyacinthine.
(4) get capsule for relieving gastric trouble content 0.3g, add methyl alcohol 20ml, sonicated 30 minutes is filtered, and filtrate evaporate to dryness, residue add methyl alcohol 2ml makes dissolving, as need testing solution.Other gets the cholic acid reference substance, adds methyl alcohol and makes the solution that 1ml contains 0.1mg, in contrast product solution.Test according to thin-layered chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 2 μ l of above-mentioned two kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with ethyl acetate-normal hexane-acetate-methyl alcohol (10: 8: 0.8: 1.2) be developping agent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, about 10 minutes of 110 ℃ of bakings.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, the spot of apparent same color under the daylight.Ultraviolet lamp (365nm) is the fluorescence spot of apparent same color down.
The method of quality control of the capsule for relieving gastric trouble of present embodiment, content to the capsule for relieving gastric trouble finished product is measured: in the assay of capsule for relieving gastric trouble finished product, it is tolerant to get capsule for relieving gastric trouble finished product 4 intragranulars, it is fixed to put the interior accurate title of crucible, slowly blazing to charing, 700 ℃ of calcinations 1 hour, take out, put cold, dripping hydrochloric acid-water (1: 1) mixed solution 10ml, low-grade fever make it the dissolving, change over to after the cooling in the 250ml measuring bottle, add water to scale, shake up, the accurate 25ml that draws is in the 250ml conical flask, add water 10ml, add each 5ml of 5% sodium potassium tartrate tetrahydrate and triethanolamine-water (1: 2) mixed liquor, shake up, add 20% sodium hydroxide solution 10ml, add the about 50mg of cupferron again, shake up, add the about 0.1g of chlorination Sodium carboxylic acid indicator (grinding at 100: 1), become pure blue by purple with diethylamine four acetic acid disodium vs (0`02mol/L) titration to solution; The percentage composition of calculation sample lime carbonate, promptly.Calculate according to the capsule for relieving gastric trouble finished product, the capsule for relieving gastric trouble finished product contains nacreous layer powder with lime carbonate (CaCO
3) meter, it is qualified being no less than setting value.
Above-mentioned steps need not carried out according to sequencing, and can also carry out conventional sense simultaneously, and this capsule for relieving gastric trouble finished product is a capsule, and content is brown powder; Gas perfume (or spice), mildly bitter flavor.This capsule for relieving gastric trouble finished product also should meet relevant every regulation under an appendix XIIA of Chinese Pharmacopoeia version in 2000 the capsule item.
The capsule for relieving gastric trouble finished product that meets above condition is qualified.
The method of quality control of the capsule for relieving gastric trouble of present embodiment, capsule for relieving gastric trouble finished product contain nacreous layer powder with lime carbonate (CaCO
3) meter, it is qualified being no less than setting value.Setting value is 24%～30% in the present embodiment.
Claims (3)
1. the method for quality control of a capsule for relieving gastric trouble is characterized in that, comprises following steps:
(1) get the capsule for relieving gastric trouble finished product, put microscopically and observe: irregular tiny fragment, translucent, tool rainbow sample gloss; The object line arcuation texture that the fragment surface has is met watery hydrochloric acid and is produced bubble rapidly;
(2) get capsule for relieving gastric trouble content 6g, the 50ml that adds diethyl ether, ultrasonic 15 minutes, put coldly, filter, wave most ether, residue adds methyl alcohol 60ml sonicated 30 minutes, filters filtrate and steams near dried, and it is an amount of to add zeyssatite, mix thoroughly, volatilize methyl alcohol, add water saturated normal butyl alcohol 30ml, sonicated 15 minutes, filter, filtrate adds 1% sodium hydroxide solution washes 3 times, and each 20ml discards alkali lye, with the saturated washing of normal butyl alcohol 3 times, each 20ml is neutral to n-butanol extracting liquid, evaporate to dryness, residue adds methyl alcohol 2ml makes dissolving, as need testing solution; Other gets pseudo-ginseng control medicinal material 0.4g, and Radix Astragali control medicinal material 4.0g shines medicinal material solution in pairs with legal system; Other gets the Astragaloside IV reference substance, adds methyl alcohol and makes 1ml and contain 1mg solution, in contrast product solution; Test according to thin-layered chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 2 μ l of above-mentioned four kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with the lower floor's solution after the placement of chloroform-methanol-water (13: 6: 2) refrigerator is developping agent, launch about 10cm, take out, dry, spray is with 10% ethanol solution of sulfuric acid, about 5 minutes of 105 ℃ of bakings; In the test sample chromatogram, with control medicinal material chromatogram and the corresponding position of reference substance chromatogram on, the spot of apparent same color under the daylight; Ultraviolet lamp (365nm) is the fluorescence spot of apparent same color down;
(3) get (2) item about 10ml of 1% sodium hydroxide solution washing lotion down, put on filter paper, dry back drips ninhydrin solution, heats 2 minutes at 100 ℃, and spot shows hyacinthine;
(4) get capsule for relieving gastric trouble content 0.3g, add methyl alcohol 20ml, sonicated 30 minutes is filtered, and filtrate evaporate to dryness, residue add methyl alcohol 2ml makes dissolving, as need testing solution; Other gets the cholic acid reference substance, adds methyl alcohol and makes the solution that 1ml contains 0.1mg, in contrast product solution; Test according to thin-layered chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 2 μ l of above-mentioned two kinds of solution respectively, put respectively on same silica gel g thin-layer plate, with ethyl acetate-normal hexane-acetate-methyl alcohol (10: 8: 0.8: 1.2) be developping agent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, about 10 minutes of 110 ℃ of bakings; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, the spot of apparent same color under the daylight; Ultraviolet lamp (365nm) is the fluorescence spot of apparent same color down.
2. the method for quality control of a capsule for relieving gastric trouble, it is characterized in that: in the assay of capsule for relieving gastric trouble finished product, it is tolerant to get capsule for relieving gastric trouble finished product 4 intragranulars, and it is fixed, slowly blazing to charing to put the interior accurate title of crucible, 700 ℃ of calcinations 1 hour, take out, put cold, dripping hydrochloric acid-water (1: 1) mixed solution 10ml, low-grade fever makes it dissolving, change over to after the cooling in the 250ml measuring bottle, add water to scale, shake up, the accurate 25ml that draws adds water 10ml in the 250ml conical flask, add each 5ml of 5% sodium potassium tartrate tetrahydrate and triethanolamine-water (1: 2) mixed liquor, shake up, add 20% sodium hydroxide solution 10ml, add the about 50mg of cupferron again, shake up, add the about 0.1g of chlorination Sodium carboxylic acid indicator (grinding at 100: 1), become pure blue by purple with diethylamine four acetic acid disodium vs (0.02mol/L) titration to solution; The percentage composition of calculation sample lime carbonate, promptly; Calculate according to the capsule for relieving gastric trouble finished product, the capsule for relieving gastric trouble finished product contains nacreous layer powder with lime carbonate (CaCO
3) meter, it is qualified being no less than setting value.
3. the method for quality control of capsule for relieving gastric trouble according to claim 2, it is characterized in that: the capsule for relieving gastric trouble finished product contains nacreous layer powder with lime carbonate (CaCO
3) meter, setting value is 24%～30%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200410051242XA CN1295505C (en) | 2004-08-27 | 2004-08-27 | Quality control method for Weinai-an capsule |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200410051242XA CN1295505C (en) | 2004-08-27 | 2004-08-27 | Quality control method for Weinai-an capsule |
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| CN1588082A true CN1588082A (en) | 2005-03-02 |
| CN1295505C CN1295505C (en) | 2007-01-17 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB200410051242XA Active CN1295505C (en) | 2004-08-27 | 2004-08-27 | Quality control method for Weinai-an capsule |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101210915B (en) * | 2007-12-24 | 2011-05-11 | 王志敏 | Cabrite medicinal materials discrimination method |
| CN104165962A (en) * | 2013-05-15 | 2014-11-26 | 广州白云山中一药业有限公司 | Quality detection method for weinai'an tablet |
| CN105974025A (en) * | 2016-06-08 | 2016-09-28 | 健民药业集团股份有限公司 | Detection method of traditional Chinese preparation for treating stomach illness |
| CN110794080A (en) * | 2019-11-20 | 2020-02-14 | 刘圣梅 | Method for detecting quality of medicine for treating colitis |
| CN111329891A (en) * | 2020-02-28 | 2020-06-26 | 广州白云山中一药业有限公司 | Application of Weinaian in preparing medicine for preventing and treating cardiovascular and cerebrovascular diseases |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6081199A (en) * | 1983-10-11 | 1985-05-09 | Osaka Chem Lab | Novel saponin substance and method for isolating the same |
| CA2434050C (en) * | 2000-12-22 | 2014-09-16 | Tianjin Tasly Pharmaceutical Co., Ltd., China | Herbal composition for angina pectoris, method to prepare same and uses thereof |
| CN1361422A (en) * | 2000-12-26 | 2002-07-31 | 四川巴中普瑞制药有限公司 | Test method of angiocardiopathy treating medicine Baoxinning |
-
2004
- 2004-08-27 CN CNB200410051242XA patent/CN1295505C/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101210915B (en) * | 2007-12-24 | 2011-05-11 | 王志敏 | Cabrite medicinal materials discrimination method |
| CN104165962A (en) * | 2013-05-15 | 2014-11-26 | 广州白云山中一药业有限公司 | Quality detection method for weinai'an tablet |
| CN104165962B (en) * | 2013-05-15 | 2016-03-16 | 广州白云山中一药业有限公司 | The quality determining method of WEINAIAN sheet |
| CN105974025A (en) * | 2016-06-08 | 2016-09-28 | 健民药业集团股份有限公司 | Detection method of traditional Chinese preparation for treating stomach illness |
| CN110794080A (en) * | 2019-11-20 | 2020-02-14 | 刘圣梅 | Method for detecting quality of medicine for treating colitis |
| CN111329891A (en) * | 2020-02-28 | 2020-06-26 | 广州白云山中一药业有限公司 | Application of Weinaian in preparing medicine for preventing and treating cardiovascular and cerebrovascular diseases |
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| Publication number | Publication date |
|---|---|
| CN1295505C (en) | 2007-01-17 |
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Owner name: GUANGZHOU BAIYUNSHAN ZHONGYI PHARMACEUTICAL CO., L Free format text: FORMER NAME: GUANGZHOU ZHONGYI PHARMACEUTICAL CO., LTD. |
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Address after: 510530, No. 32, Po pan Road, Guangzhou, Guangdong, Luogang District Patentee after: Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., Ltd. Address before: 11, building 510620, west block, Times Square, 28 Tianhe North Road, Guangzhou, Guangdong Patentee before: Guangzhou Zhongyi Pharmaceutical Co., Ltd. |