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Quality control of Chinese-medicine compound preparation

A quality control method and technology of compound preparations, applied in the direction of testing pharmaceutical preparations, pharmaceutical formulas, measuring devices, etc., can solve problems such as inability to fully reflect product quality, difficulty in implementation, and unreasonable quality

Inactive Publication Date: 2007-04-04
BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pharmaceutical preparations must be continuously updated and developed on the basis of ensuring stable, controllable and safe product quality. In order to better control the quality of the preparation, ensure the safety of medication, better guide production, and make process control more stringent Reasonable, so that consumers can fully understand the product texture, it is necessary to study and control the quality of the traditional Chinese medicine compound preparation; at present, in related pharmaceutical preparations, only astragaloside IV, total flavonol glycosides, and terpene lactones are generally used as detection indicators , but it cannot fully reflect the quality of the product at all, and it is not very reasonable to use it to control the quality of traditional Chinese medicine compound preparations; if other indicators are used for control, it is more difficult to implement because there are no ready-made detection schemes, detection conditions, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0400] Example 1: Using liquid chromatography to test the fingerprints based on the characteristics of astragalus flavonoids and ginkgo leaf flavonoids

[0401] (1) Preparation of the test solution: get 0.1g of the powder injection preparation of the present invention, add n-butanol to dissolve, filter, evaporate the filtrate to dryness, and dilute the residue to 5ml with methanol, as the test solution;

[0402] (2) Preparation of the reference substance solution: take formononetin, dissolve it with methanol and dilute it to an appropriate concentration, and use it as the reference substance solution;

[0403] (3) Chromatographic conditions: the chromatographic column adopts octadecylsilane bonded silica gel as a filler: the mobile phase is acetonitrile: water, gradient elution, the solvent ratio is from 0 minutes to 20 minutes, and the ratio of acetonitrile rises from 4% to 25%, from 20 minutes to 40 minutes, the proportion of acetonitrile rose from 25% to 45%, from 40 minute...

Embodiment 2

[0410] Example 2: Using liquid chromatography to test the fingerprints based on the characteristics of astragalus saponins and ginkgo biloba terpene lactones

[0411] (1) Preparation of the test solution: take 0.2g of the powder injection preparation of the present invention, add 40ml of water to dissolve, add 5 drops of 2% hydrochloric acid solution, extract 4 times 15ml, 10ml, 10ml, 10ml with ethyl acetate or shaking, combine The extract was washed with 20ml of 5% sodium acetate solution, and the sodium acetate solution was separated and washed with 10ml of ethyl acetate. Combine ethyl acetate or n-butanol extract and lotion, wash with water twice, 20ml each time, combine water lotion, wash with ethyl acetate 10ml, combine ethyl acetate solution, recover ethyl acetate until dry, add acetone to dissolve the residue to 5ml, that is;

[0412] (2) Preparation of the reference substance solution: take Ginkgolide A reference substance, dissolve it with methanol, and set the volum...

Embodiment 3

[0420] Example 3: Using liquid chromatography to test the fingerprints based on the characteristics of Astragalus flavonoids and Ginkgo biloba flavonoids

[0421] (1) Preparation of the test solution: take an appropriate amount of the small water injection preparation of the present invention, add ethanol to dissolve, filter, evaporate the filtrate to dryness, dissolve or dilute the residue with ethanol to a suitable concentration, and use it as the test solution;

[0422] (2) Preparation of the reference substance solution: take formononetin, dissolve it with ethanol, and set the volume to a suitable concentration as the reference substance solution;

[0423] (3) Chromatographic conditions: the chromatographic column uses octadecylsilane bonded silica gel as the filler: the mobile phase is methanol: 0.05% phosphoric acid solution, gradient elution, the flow rate is 0.5ml / min, the detection wavelength is 250 ± 5nm, and the column temperature is 20 ℃;

[0424] (4) Formulation ...

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PUM

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Abstract

A quality control method for the Chinese medicine prepared from astragalus root and gingko leaf or its extract includes fingerprint test method and / or differentiation test method and / or content measuring method.

Description

technical field [0001] The invention relates to a quality control method of a traditional Chinese medicine compound preparation, which belongs to the technical field of traditional Chinese medicine. Background technique [0002] Cardiovascular and cerebrovascular diseases such as coronary heart disease, cerebral thrombosis, senile dementia, etc. are one of the most common and harmful diseases in the world today, and have become one of the main causes of population death in many countries; according to surveys, the incidence rate in recent years There is an increasing trend year by year, and the number of middle-aged and young patients continues to increase. Cardiocerebral ischemic disease has become a common and frequently-occurring disease that endangers the health of our people; in order to achieve the purpose of prevention and treatment, many inventors and pharmaceutical companies have done a lot of research on it Work. Pharmaceutical preparations must be continuously up...

Claims

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Application Information

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IPC IPC(8): A61K36/481A61P9/10A61P7/02A61P25/28G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER