Quality control method for Kouyangqing granules and application thereof

A quality control method and stomatitis technology, which are applied to medical preparations containing active ingredients, measuring devices, pharmaceutical formulations, etc., can solve the problems of lack of quality control methods, imperfect quality standards of Kouyanqing granules, and easy to be imitated. , to achieve the effect of avoiding product forgery, advanced methods and stable quality

Active Publication Date: 2009-09-02
GUANGZHOU BAIYUSN HUTCHISON WHAMPOA CHINESE MEDICINE +1
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  • Abstract
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AI Technical Summary

Problems solved by technology

[0003] Kouyanqing granules have the effects of clearing away heat and nourishing yin, detoxifying and reducing swelling. It is used for oral ulcers caused by yin deficiency and hyperactivity of fire. It is a national protected variety of traditional Chinese medicine. The protected variety number is ZYB20720022230. Lack of comprehensive and effective quality control methods, easy to be imitated

Method used

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  • Quality control method for Kouyangqing granules and application thereof
  • Quality control method for Kouyangqing granules and application thereof
  • Quality control method for Kouyangqing granules and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1 Instruments and reagents

[0030] 1.1 Instrument: Dionex company high performance liquid chromatography (ASI-100 autosampler, ATH-585 column thermostat, P680 quaternary gradient pump, PDA-100 detector); chromatographic column: Dikma PLATISILODS (250mm×4.6 mm, 5 μm).

[0031] 1.2 Test drug: 10 batches of finished products and corresponding semi-finished products are provided by Guangzhou Baiyunshan Hutchison Whampoa Traditional Chinese Medicine Co., Ltd. The acetonitrile reagent used in the liquid chromatography in the experiment is chromatographically pure, the rest of the reagents used are analytically pure, and the water is ultrapure water.

[0032] 2. Methods and results

[0033] 2.1 Preparation of the test solution: Take 10 bags of this product, grind it finely, take about 10g, weigh it accurately, put it in a stoppered Erlenmeyer flask, add 50ml of methanol (or ethanol) precisely, seal it tightly, weigh it, Ultrasonic treatment (power 360W, frequency 35kHz) fo...

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Abstract

The invention discloses a quality control method for Kouyanqing granules, which comprises the following steps: preparing and mixing a reference substance solution; preparing a methanol solution of the Kouyanqing granules as a test solution; analyzing the reference substance solution and the test solution by a high performance liquid chromatography to obtain a high efficiency liquid chromatography finger print of the Kouyanqing granules; and comparing and monitoring the quality of the Kouyanqing granules according to a chromatogram map of the reference substance solution and a finger print of the test solution. The invention also discloses application of the quality control method in identifying the Kouyanqing granules. The quality control method adopts the high efficiency liquid chromatography to establish the finger print of the Kouyanqing granules, and can monitor the stability of technical processes for producing semi-finished products and finished products through the established standard finger print. The method effectively avoids counterfeiting of products, ensures normal production and circulation order of the products, and has outstanding practicability.

Description

technical field [0001] The invention relates to a quality control method and application of Kouyanqing granules, in particular to a quality control method and application of Kouyanqing granules by constructing fingerprints, and belongs to the technical field of drug analysis. Background technique [0002] The compound preparation, which is controlled and coordinated by "jun, minister, assistant, and envoy", emphasizes the overall effect, and most of it is not aimed at a certain target, nor is it a simple addition of several components. Only the detection of a single component reduces the The accuracy and specificity of identification cannot represent the overall efficacy of traditional Chinese medicine preparations, cannot reflect its inherent quality, and cannot solve problems such as adulteration of counterfeit products. Fingerprint of traditional Chinese medicine is a comprehensive and quantifiable chemical identification method, which can identify the authenticity and ev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8968A61P1/02G01N30/36G01N30/86
Inventor 苏薇薇李楚源关倩怡王德勤彭维林青王永刚黄琳梁峰肖晓丽
Owner GUANGZHOU BAIYUSN HUTCHISON WHAMPOA CHINESE MEDICINE
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