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A kind of content determination method of ginkgo diterpene lactone for injection

A technology of ginkgolide and ginkgolide, which is applied in the field of content determination of traditional Chinese medicine injections, and can solve the problems of no ginkgolide content determination and the like

Active Publication Date: 2017-07-25
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the existing research, there is no method for simultaneous determination of ginkgolides A, B, C, and K

Method used

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  • A kind of content determination method of ginkgo diterpene lactone for injection
  • A kind of content determination method of ginkgo diterpene lactone for injection
  • A kind of content determination method of ginkgo diterpene lactone for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] (1) Preparation of mixed reference substance: accurately weigh the appropriate amount of ginkgolide A reference substance, ginkgolide B reference substance, ginkgolide C reference substance, and ginkgolide K reference substance, and add methanol to make each 1mL containing ginkgolide Mixed solution of A0.32mg, ginkgolide B0.52mg, ginkgolide C0.05mg, ginkgolide K0.04mg, ready to be obtained;

[0079] (2) Sample preparation: Take 5 bottles of 20121021 batches of ginkgo diterpene lactones for injection, add water to dissolve, quantitatively transfer to a 25mL volumetric flask, and set the volume to the mark. Accurately measure 2mL, put it in a 10mL measuring bottle, add 6moL·L -1 Hydrochloric acid 2mL, let stand for 3.5 hours, add methanol solution to dilute to the mark, shake well;

[0080] (3) Chromatographic conditions: adopt C 18 Chromatographic column, the mobile phase is tetrahydrofuran-water-methanol, gradient elution, the elution program is: 0-13min, tetrahydrofu...

Embodiment 2

[0083] (1) Preparation of mixed reference substance: prepare according to the preparation method of mixed reference substance in Example 1;

[0084] (2) Sample preparation: get 5 bottles of 20121018 batches of ginkgo diterpene lactones for injection, and prepare sample solution according to the method of step (2) in Example 1;

[0085] (3) Chromatographic conditions: adopt C 18 Chromatographic column, the mobile phase is tetrahydrofuran-water-methanol, gradient elution, the elution program is: 0-13min, tetrahydrofuran is 10%, water is 30%, methanol is 60%, 14-16min, tetrahydrofuran is 10%, water 60% for methanol, 30% for methanol; flow rate 1.0mL·min -1 , the column temperature is 30°C; the evaporative photodetector uses nitrogen as the carrier gas, and the flow rate is 3.0L min -1 , the drift tube temperature is 105°C;

[0086] (4) Determination of content: sample injection volume 10 μL reference substance solution, inject 5 μL and 15 μL respectively, measure according to ...

Embodiment 3

[0088] (1) Preparation of mixed reference substance: prepare according to the preparation method of mixed reference substance in Example 1;

[0089] (2) Sample preparation: get 5 bottles of 20121015 batches of ginkgo diterpene lactones for injection, and prepare sample solution according to the method of step (2) in Example 1;

[0090] (3) Chromatographic conditions: adopt C 18 Chromatographic column, the mobile phase is tetrahydrofuran-water-methanol, gradient elution, the elution program is: 0-13min, tetrahydrofuran is 10%, water is 30%, methanol is 60%, 14-16min, tetrahydrofuran is 10%, water 60% for methanol, 30% for methanol; flow rate 1.5mL min -1 , the column temperature is 20°C; the evaporative photodetector uses nitrogen as the carrier gas, and the flow rate is 5.0L min -1 , drift tube temperature 120°C;

[0091] (4) Determination of content: sample injection volume 10 μL reference substance solution, inject 5 μL and 15 μL respectively, measure according to the abo...

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Abstract

The invention relates to a content determination method of gingko diterpene lactone for injection, especially a method for simultaneous determination of the content of ginkgolide A, ginkgolide B, ginkgolide C and ginkgolide K in ginkgolide for injection by HPLC-ELSD technique. The method adopts a C18 chromatographic column, takes tetrahydrofuran-water-methanol (n-propanol) as the mobile phase, and determines the lactone content by means of gradient elution. The technology provided by the invention is simple, fast and accurate, and provides certain scientific basis for quality control of the gingko diterpene lactone for injection.

Description

[0001] This application claims the priority of the Chinese patent application submitted to the China Patent Office on March 16, 2014, the application number is 201410104189.9, and the title of the invention is "a method for determining the content of ginkgo diterpene lactone for injection", the entire content of which Incorporated in this application by reference. technical field [0002] The invention relates to the field of traditional Chinese medicines, in particular to a content determination method of traditional Chinese medicine injections. Background technique [0003] Ginkgo diterpene lactone for injection is made from ginkgo diterpene lactone meglumine injection produced by Jiangsu Kangyuan Pharmaceutical Co., Ltd., which has better stability, easy storage and transportation, and provides convenience for clinical application. . The main components of ginkgo diterpene lactone raw materials for injection are ginkgo diterpene lactones A, B, C, and K. Studies have sho...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 萧伟王振中毕宇安孙永成万琴伍清龙章晨峰于丹
Owner JIANGSU KANION PHARMA CO LTD
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