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Qualitative quantitative determination method for liver-heat-clearing tablet

A quantitative detection method and liver-clearing technology, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as the inability to effectively control the quality of Qinggan tablets, affecting product production and quality assurance of clinical efficacy.

Active Publication Date: 2015-02-11
JIUZHITANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing quality standards cannot effectively control the quality of Qinggan Tablets, which will affect the production, quality assurance and clinical efficacy of the product

Method used

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  • Qualitative quantitative determination method for liver-heat-clearing tablet
  • Qualitative quantitative determination method for liver-heat-clearing tablet
  • Qualitative quantitative determination method for liver-heat-clearing tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0194] Qinggan Tablets: Batch No. 20120502

[0195] (1) Take 5 tablets of this product, remove the coating, grind finely, add 5ml of n-butanol saturated with water, let it stand for 0.5 hours, shake it from time to time, filter, put the filtrate on a water bath and evaporate to dryness, add 1ml of methanol to dissolve the residue, and serve as Test solution; take another 0.5 g of licorice reference medicinal material, and prepare the reference medicinal material solution in the same way; test according to thin-layer chromatography (Appendix VI B of the Chinese Pharmacopoeia 2010 edition), draw 15 μl of each of the above two solutions, and spot on the same silica gel respectively. On G thin-layer board, use n-butanol-ethanol-ammonia test solution = 4:1.5:0.5 as the developing agent, develop, take out, dry in the air, spray with 10% sulfuric acid ethanol solution, and heat at 105°C until the spots are clearly colored ;; In the chromatogram of the test product, on the position ...

Embodiment 2

[0211] Qinggan Tablets: Batch No. 20120608

[0212] (1) Take 10 tablets of this product, remove the coating, grind finely, add 10ml of n-butanol saturated with water, leave it for 1 hour, shake it from time to time, filter, put the filtrate on a water bath and evaporate to dryness, add 2ml of methanol to dissolve the residue, and use it as a Test solution; take another 0.3 g of licorice reference medicinal material, and prepare the reference medicinal material solution in the same way; test according to thin-layer chromatography (Appendix VI B of Chinese Pharmacopoeia 2010 edition), draw 10 μl of each of the above two solutions, and spot on the same silica gel respectively. On G thin-layer board, use n-butanol-ethanol-ammonia test solution = 5:2:1 as the developer, develop, take out, dry in the air, spray with 10% sulfuric acid ethanol solution, and heat at 105°C until the spots are clearly colored ;; In the chromatogram of the test product, on the position corresponding to ...

Embodiment 3

[0228] Qinggan Tablets: Batch No. 20120625

[0229] (1) Take 15 tablets of this product, remove the coating, grind finely, add 15ml of n-butanol saturated with water, let it stand for 1.5 hours, shake it from time to time, filter, put the filtrate on a water bath and evaporate to dryness, add 3ml of methanol to dissolve the residue, and serve as Test solution; take another 1 g of licorice reference medicinal material, and prepare the reference medicinal material solution in the same way; according to the thin-layer chromatography (Appendix VI B of the Chinese Pharmacopoeia 2010 edition), draw 5 μl of each of the above two solutions, and point them on the same silica gel G On a thin-layer board, use n-butanol-ethanol-ammonia test solution = 6: 2.5: 1.5 as a developing agent, develop, take out, dry in the air, spray with 10% sulfuric acid ethanol solution, and heat at 105°C until the spots are clearly colored; ; In the chromatogram of the test product, on the position correspo...

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Abstract

The invention discloses a qualitative quantitative determination method for a liver-heat-clearing tablet, and a conventional qualitative identification method for herba artemisiae scopariae in the liver-heat-clearing tablet is improved. The following steps are increased: (1) employing a microscopic identification process to identify radix isatidis in the liver-heat-clearing tablet; (2) employing thin-layer chromatography to identify radix isatidis in the liver-heat-clearing tablet by taking indirubin as a reference; and (3) employing high performance liquid chromatography to determine the content of chlorogenic acid in herba artemisiae scopariae and the content of glycyrrhizic acid in glycyrrhiza. Compared with the prior art, in the method, a qualitative discriminating method is added and also the content determination method for the effective compositions is added. The method is high in precision, good in reproducibility, high in recovery rate and accurate in determination result, and helps to improve the quality controllability and stability of the liver-heat-clearing tablet, and guarantee people drug use safety and validity. The qualitative quantitative determination method for the liver-heat-clearing tablet is capable of controlling the quality of the liver-heat-clearing tablet, also is capable of controlling the quality of other dosage forms of a same prescription, such as a capsule, a granule and the like.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a quality control method of Qinggan Tablets. Background technique [0002] Qinggan tablets are composed of Radix Radix, capillary root, and licorice. It has the effects of clearing heat and detoxifying, dehumidifying and promoting gallbladder. It can be used for cold and fever, sore throat, mumps, damp-heat jaundice and other diseases. The quality standard of this product is recorded in Volume 3 of Chinese Medicine Prescriptions in the "Drug Standards of the Ministry of Health of the People's Republic of China", the standard number is WS 3 -B-0626-91, in this standard, there are only qualitative identification methods for capillary and licorice, without any quantitative detection methods, which is not conducive to controlling the product quality of Qinggan Tablets. Qinggan Tablets are recorded in the liver and gallbladder sub-volume of the Natio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06
Inventor 郗瑞云谷陟欣张妮瑜欧金秀辛秀刘淑妦袁莉朱丽
Owner JIUZHITANG
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