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Quality control of Gongyanping preparation

A quality control method and preparation technology, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, unknown raw materials, etc., can solve problems such as the quality of difficult Gongyanping preparations, and achieve satisfactory reproducibility and strong specificity

Inactive Publication Date: 2005-12-28
叶耀良
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the Gongyanping standard in the seventeenth volume of "Prescriptions of Traditional Chinese Medicine", for the quality control of Gongyanping preparations, only the TLC identification of the medicinal materials of Diren and Liangmian. According to the requirements of modern pharmacy, this quality standard It is difficult to control the quality of Gongyanping preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] High performance liquid chromatography was used to determine the content of the main active ingredient of Liangmianzhen Chloride.

[0077] 1. Instruments and reagents

[0078] Instrument: agilent 1100 high performance liquid chromatography; diode array detector (MWD); chromatographic column is DIKMA Diamonsil (diamond) C18 (150mm×4.6mm, 5μm).

[0079] The reference substance of chlorinated ampoules was provided by China Institute for the Control of Pharmaceutical and Biological Products, batch number 0848-200001 (for content determination). Gong Yanping is trial produced by our company (batch numbers 04040121, 04040122, 04040123).

[0080] Water is pure water, methanol and acetonitrile are chromatographically pure, and other reagents are analytically pure.

[0081] 2. Chromatographic conditions

[0082] Chromatographic column DIKMA Diamondsil (Diamond) C18 (150mm×4.6mm, 5μm). Column temperature: 40°C. Mobile phase acetonitrile-methanol-3% acetic acid-triethylamine ...

Embodiment 2

[0110] Take 50 commercially available Gongyanping film-coated tablets (Guangdong Luofushan Pharmaceutical Co., Ltd. batch number: 0405101), and another medicinal material of Gongyanping’s prescription amount. The preparation of Gongyanping which is negative for lianmianzhen was prepared by law, and the content determination of lianjian chlorinated by high performance liquid phase, thin layer identification of chlorinated lianjian chlorinated, and contrast identification of lianmian zhen medicinal materials were carried out:

[0111] Results: Content determination: each capsule contains 0.30mg of chlorinated acantholine, the commercially available preparations are positive, and the negative preparations have no interference.

Embodiment 3

[0112] Example 3: Take 50 commercially available Gongyanping film-coated tablets, and take another medicinal material of Gongyanping prescription amount, default Angelica medicinal material, according to the preparation method recorded in the Gongyanping standard, make Angelica-negative Gongyanping in the same way Preparation, carry out the high-efficiency liquid phase content determination of ferulic acid, ferulic acid TLC identification:

[0113] Method: Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; acetonitrile-0.1% phosphoric acid solution (17:83) was used as mobile phase, and the detection wavelength was 324nm. Column temperature: 40°C. The number of theoretical plates should not be less than 3000 based on the ferulic acid peak.

[0114] Preparation of reference substance solution Accurately weigh an appropriate amount of ferulic acid reference substance, add methanol to make a solution containing 40μg per 1...

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Abstract

A quality control method for the Chinese medicine 'Gongyanping' prepared from 5 Chinese-medicinal materials including shing bugleweed herb, zanthoxylum nitidum, Chinese angelica root, etc features that the efficient liquid-phase method or quantitative thin-layer chromatography is used to measure the contents of one or more active components in it.

Description

Field of invention [0001] The present invention relates to a quality control method for traditional Chinese medicine preparations, and in particular to a quality control method for Gongyanping preparations made from five traditional Chinese medicines such as Dimin, Liangmianzhen, Angelica sinensis, Chuanpaoshi, and Wuzhi Maotao. Background technique: [0002] Chinese Patent No.: 00103132.5 "Gong Yanping Special-shaped Film Coated Tablets and Manufacturing Method" discloses a preparation method of Gong Yanping tablets. Over the years, with the in-depth research on Gong Yanping preparations, new dosage forms of Gong Yanping have been developed. The preparation method has attracted attention. For example, the patent application with application number 03118640.8 involves the preparation of a Gongyanping capsule. For example, the application with the application number 200410045022.6 involves the preparation of a Gongyanping dispersible tablet. For example, the application with t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
Inventor 叶耀良廖志钟
Owner 叶耀良
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