Ginkgolide B powder injection and its preparation method

A technology of ginkgolide and powder injection, which is applied in the field of drug monomer ginkgolide B, and achieves the effects of low process cost, reduction of thrombus formation, and simple process

Inactive Publication Date: 2007-10-17
HAINAN SIHUAN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to provide a freeze-dried powder for injection containing ginkgolide B, which solves the problems of water solubility, molding, reconstitution clarity and long-term storage of ginkgolide B through reasonable selection of excipients stability issues

Method used

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  • Ginkgolide B powder injection and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Ginkgolide B 20.0g Meglumine 30.0g

[0019] EDTA-2Na 1.0g Dextran 40 200.0g

[0020] Add dextran 40 to 1500ml of water for injection according to the prescription ratio, heat to dissolve, let it cool to room temperature after the dissolution is complete, then add the prescription amount of ginkgolide B, meglumine, EDTA-2Na to the solution to dissolve, add Dilute the volume to 2000ml with water for injection, add 6.0g of activated carbon for decolorization and depyrogenation, and finally filter and sterilize with a 0.22μm filter membrane, pack in 1000 tubes, pre-freeze and dry, and crimp the cap to obtain the finished product of ginkgolide B for injection.

Embodiment 2

[0022] Ginkgolide B 20.0g Meglumine 60.0g

[0023] EDTA-CaNa 0.3g Dextran 40 30.0g

[0024] Add dextran 40 to 1500ml of water for injection according to the prescription ratio, heat to dissolve, let it cool to room temperature after the dissolution is complete, then add the prescription amount of ginkgolide B, meglumine, EDTA-CaNa to the solution to dissolve, add Dilute the volume to 2000ml with water for injection, add 6.0g of activated carbon for decolorization and depyrogenation, and finally filter and sterilize with a 0.22μm filter membrane, pack in 1000 tubes, pre-freeze and dry, and crimp the cap to obtain the finished product of ginkgolide B for injection.

Embodiment 3

[0026] Ginkgolide B 20.0g Meglumine 10.0g

[0027] EDTA-2Na 40.0g Mannitol 400.0g

[0028] Add mannitol into 1500ml of water for injection according to the prescription ratio to dissolve it. After the dissolution is complete, add the prescription amount of ginkgolide B, meglumine, and EDTA-2Na to the solution to dissolve it, and then add water for injection to a constant volume. 2000ml, add 6.0g of activated carbon for decolorization and depyrogenation, and finally filter and sterilize with a 0.22μm filter membrane, pack into 1000 tubes, pre-freeze and dry, and crimp the cap to obtain the finished product of ginkgolide B for injection.

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Abstract

The invention discloses a Ginkgolide B powder injection, which is characterized in that: it is a powder injection consisting of main medcine and pharmacological acceptable filter aid, excipient and stabilizer. Said main medicine is Ginkgolide B, and filter aid is meglumine, and excipient is mannitol or dextran 40, and stabilizer is EDTA-2Na or EDTA-CaNa. The weight ratio is: Ginkgolide B:EDTA-2Na or EDTA-CaNa:mannitol or dextran 40 = 1:0.5-3:0.01-2:1-20. The preparation solves the problems such as Ginkgolide B indissolvable problem, redissolve clarity and stability.

Description

technical field [0001] The invention relates to a drug monomer ginkgolide B obtained by extracting the leaves of the traditional Chinese medicine ginkgo biloba, as well as a ginkgolide B powder injection prepared from the drug and a preparation method thereof. Background technique [0002] Platelet activating factor (PAF) is an important inflammatory mediator and one of the mediators of various diseases. Pathological studies have shown that PAF plays an important role in processes such as allergy, ulcer, asthma, thrombosis, inflammation, organ transplant rejection, and shock caused by endotoxin. Total ginkgolides are a combination of ginkgolides A, B, C and bilobalide, the active ingredients extracted from ginkgo leaves, and are a strong antagonist of platelet activating factor from plant extracts. Studies have shown that among them, total ginkgolide B is the most active platelet activating factor antagonist. [0003] The structural formula of ginkgolide B is: [0004] ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/365A61K47/18A61K47/10A61P37/08A61P29/00A61P7/02A61P9/00
Inventor 夏中宁舒军
Owner HAINAN SIHUAN PHARMA
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