Fingerprint atlas quality investigating method of ginkgo lactone material

A ginkgolide and fingerprint technology, applied in the field of injections containing ginkgolide, can solve the problem that there is no method for finding the content of active ingredients, affecting product stability and clinical efficacy, etc.

Inactive Publication Date: 2006-11-29
JIANGSU KANION PHARMA CO LTD
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  • Description
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Problems solved by technology

Although there have been many reports on the research on ginkgolides and their preparations in the prior art, the research on ginkgolides has not stopped, especially for the separation of ginkgolide monomers and research on derivatives thereof. There are literature reports
At present, the research on the effective monomers of ginkgolides has reported the structures of ginkgolides A, B, and C, and preparing ginkgolides into injections. A very important technical problem is the control of product quality. Up to now So far, no method has been found that can accurately control the content of active ingredients in ginkgolide injection products. Moreover, in the preparation process of ginkgolide injections, the selection of co-solvents is also very important, which directly affects the stability of the product and clinical efficacy. curative effect

Method used

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  • Fingerprint atlas quality investigating method of ginkgo lactone material
  • Fingerprint atlas quality investigating method of ginkgo lactone material
  • Fingerprint atlas quality investigating method of ginkgo lactone material

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Embodiment Construction

[0110] prescription:

[0111] Ginkgolide 5.0g

[0112] Meglumine 5.0g

[0113] NaCl 8.0g

[0114] 10% citric acid solution appropriate amount

[0115] Preparation method: Take meglumine and add 1000ml of fresh water for injection to dissolve, autoclave at 120°C for 30 minutes, take it out, heat it to 80°C in a 10,000-grade batching room, add ginkgolide (ginkgolide) that has been ground and passed through a 80-mesh sieve Conform to the quality standard described in the present invention), be heated to dissolve, adjust pH to 8.0 with 10% citric acid aqueous solution after cooling to room temperature, add NaCl 8.0g, needle-use activated carbon 2.0g, room temperature stirring adsorption 30min, filter carbon removal, Add fresh water for injection to a total of 1000ml, filter with a 0.22μm microporous membrane under a sterile filter plate in a 100-level aseptic workshop, pack in 10ml ampoules, melt seal, quality check, print, and pack.

[0116] This product is a sterile aqueous ...

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Abstract

The invention discloses a fingerprint pattern detection method for gingkgo inner ester raw material, where the fingerprint pattern of ginkgo inner ester raw material has four shared peaks, and area of nonshared peaks not more than 5%, and the ginkgo inner ester raw material which accords with the fingerprint pattern has controllable quality and good stability.

Description

[0001] This application is a divisional application of the 02128962.X application; the application date of the original application is August 23, 2002, the application number is 02128962.X, and the title of the invention is "preparation containing ginkgolide and its preparation process". technical field [0002] The invention relates to preparations of ginkgolides, in particular to injections containing ginkgolides. The injections are prepared from ginkgolides, which are extracts of ginkgo leaves from traditional Chinese medicines, and belong to the field of medicines. Background technique [0003] Ginkgolide is an effective substance extracted from the leaves of the Chinese herbal medicine Ginkgo biloba, which can be further subdivided into Ginkgolide A, B, C, and K structurally (Ginkgolide K is a Ginkgolide newly discovered by the inventor. ester monomer, another case application), etc., have had detailed bibliographical reports for the extraction method of ginkgolide, for ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/86G01N30/06A61K31/365A61P9/10
Inventor 楼凤昌萧伟戴翔翎王颖凌娅李明慧毕宇安
Owner JIANGSU KANION PHARMA CO LTD
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