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Preparation containing Gingkolactone and its producing process

A technology for ginkgolide and injections, which is applied in the field of injections containing ginkgolides, and can solve problems such as the method of not finding the content of active ingredients, affecting product stability and clinical efficacy, etc.

Inactive Publication Date: 2006-10-18
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • Preparation containing Gingkolactone and its producing process
  • Preparation containing Gingkolactone and its producing process
  • Preparation containing Gingkolactone and its producing process

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Embodiment Construction

[0111] prescription:

[0112] Ginkgolide 5.0g

[0113] Meglumine 5.0g

[0114] NaCl 8.0g

[0115] 10% citric acid solution appropriate amount

[0116] 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.

[0117] This product is a sterile aqueous ...

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Abstract

The invention discloses a ginkgolide injection. The injection contains ginkgolide and meglumine. The ginkgolides include ginkgolides A, B, and K. The ginkgolide injection product meets the requirements of fingerprints, and the product quality is It is controllable and stable, and when meglumine is added, it has a good solubilizing effect on ginkgolide. The invention also discloses a pharmaceutical composition containing ginkgolides A, B and K.

Description

technical field [0001] 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 [0002] 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 example, people such as Li Xingang have introduced the laboratory extraction method of ginkgolide (referring to Li Xingang etc., ginkgolide in ginkgo leaf Laboratory extraction method research, China Pharmaceutical Industry Journal, 1998 No. 1), Chinese patent document CN1195665A has intro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/365A61P9/10
Inventor 楼凤昌萧伟戴翔翎凌娅李明慧王颖毕宇安
Owner JIANGSU KANION PHARMA CO LTD
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