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Quality control method of ginkgolide injection

A quality control method and ginkgolide technology, which are used in the quality control of ginkgolide injection and the quality control of traditional Chinese medicine preparations

Active Publication Date: 2010-02-17
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no quality control method for simultaneously measuring ginkgolide A, ginkgolide B, and ginkgolide K in ginkgolide injection, and the present invention proposes a method that can effectively control the quality of ginkgolide injection, including After adjusting the pH of the injection to be acidic and acidified so that the lactones are all converted into lactones, the method of simultaneously measuring the contents of ginkgolide A, ginkgolide B and ginkgolide K is also proposed to directly test the free ginkgolide without acidification. A, ginkgolide B, ginkgolide K carry out the method for limited inspection and the method for fingerprint chromatogram determination, the method provided by the invention can reach the purpose of more comprehensively and effectively controlling the quality of ginkgolide injection preparations

Method used

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  • Quality control method of ginkgolide injection
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  • Quality control method of ginkgolide injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0159] Embodiment 1: a kind of quality control method of ginkgolide injection, the method comprises the steps:

[0160] High performance liquid chromatography content determination:

[0161] Determination according to high performance liquid chromatography (Appendix VI D of Chinese Pharmacopoeia 2005 edition).

[0162] Chromatographic conditions and system suitability test: filler: silica gel bonded with octadecylsilane; mobile phase: isopropanol: methanol: water = 6:20:70; detection wavelength: 220nm; number of theoretical plates: according to ginkgo biloba Lactone B meter should not be less than 6000.

[0163] Preparation of reference substance solution: Take appropriate amount of reference substances of ginkgolide A, ginkgolide B, and ginkgolide K, weigh them accurately, add 50% acetone and dissolve them to make solutions containing 0.5mg, 0.5mg, and 0.1mg per 1 mL , that is.

[0164] The source of the test product: Ginkgolide Injection, batch number: 070104

[0165] Pr...

Embodiment 2

[0168] Embodiment 2: a kind of quality control method of ginkgolide injection, the method comprises the steps:

[0169] High performance liquid chromatography content determination:

[0170] Determination according to high performance liquid chromatography (Appendix VID of Chinese Pharmacopoeia 2005 edition).

[0171] Chromatographic conditions and system suitability test: filler: octadecylsilane bonded silica gel; mobile phase: isopropanol: methanol: water = 7:21:72; detection wavelength: 220nm; number of theoretical plates: according to Ginkgo Ester B meter should not be less than 7000.

[0172] Preparation of reference substance solution: Take appropriate amount of reference substances of ginkgolide A, ginkgolide B, and ginkgolide K, weigh them accurately, add 50% acetone and dissolve them to make solutions containing 0.5mg, 0.5mg, and 0.1mg per 1 mL , that is.

[0173] The source of the test product: Ginkgolide Injection, batch number: 070107

[0174] Preparation of th...

Embodiment 3

[0177] Embodiment 3: a kind of quality control method of ginkgolide injection, the method comprises the steps:

[0178] High performance liquid chromatography content determination:

[0179] Determination according to high performance liquid chromatography (Appendix VID of Chinese Pharmacopoeia 2005 edition).

[0180] Chromatographic conditions and system suitability test: filler: octadecylsilane bonded silica gel; mobile phase: isopropanol: methanol: water = 9:25:75; detection wavelength: 220nm; number of theoretical plates: according to Ginkgo biloba Ester B meter should not be less than 7000.

[0181] Preparation of reference substance solution: Take appropriate amount of reference substances of ginkgolide A, ginkgolide B, and ginkgolide K, weigh them accurately, add 50% acetone and dissolve them to make solutions containing 0.5mg, 0.5mg, and 0.1mg per 1 mL , that is.

[0182] The source of the test product: ginkgolide injection, batch number: 070108

[0183] Preparation ...

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Abstract

The invention relates to a quality control method of injection, in particular to a quality control method of ginkgolide injection. The invention provides a method for controlling the quality of the ginkgolide injection by adopting high performance liquid chromatography. The method can control the quality of the ginkgolide injection by adopting one or more of a content determination method, a limittest method of dissociation ginkgolide and a chromatographic fingerprint method. The quality control method provided by the invention has the advantages of having high precision, stability and repeatability, and achieving the aim of effectively controlling the quality of the ginkgolide injection in an all-round way.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine analysis, and relates to a quality control method of traditional Chinese medicine preparations, in particular to a quality control method of ginkgolide injection. The quality control method includes a content determination method, a limit inspection method and a fingerprint spectrum determination method. technical background [0002] Ginkgolides are a group of terpenoids with strong biological activity contained in Ginkgo Leaf. The isolated ones include ginkgolides A, B, C, J, M, K, L and Bilobalides have been found to be strong antagonists of the vascular activating factor (PAF) and have good application prospects. BN52063 (Ginkgolide Mixture) and BN52021 (Ginkgolide B) have entered the clinical trial stage abroad. [0003] Ginkgolide injection is an injection made from total ginkgolides, the main component of which is ginkgolide A (C 20 h 24 o 9 ), ginkgolide B (C 20 h 24 o 10 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16G01N30/36G01N30/86A61P9/10
Inventor 肖伟戴翔翎凌娅王振中毕宇安尚强邹艳萍章晨峰
Owner JIANGSU KANION PHARMA CO LTD
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