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Ginkgolide freezing-dried powder injection and preparation method thereof

A technology for freeze-dried powder injection and ginkgolide, which is applied in the field of ginkgolide pharmaceutical preparation and its preparation, and can solve the problems of powder injection being adjusted too high and unable to be completely reconstituted.

Inactive Publication Date: 2007-12-12
TIANJIN TASLY ZHIJIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when the powder injection is in use, it generally still needs to be fully dissolved with water for injection until it is clear before use, and the ginkgolide powder injection prepared by the prior art still cannot be completely redissolved after freeze-drying, because the final pH of the powder injection The value cannot be adjusted too high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Ginkgolide 50g, meglumine 60g, povidone K3090g.

[0031] Take the above-mentioned meglumine and povidone K30, add 4500ml of water for injection, heat and stir to dissolve, then add ginkgolide, keep stirring at 80°C until completely dissolved; cool to room temperature, adjust the pH to 8.0 with 10% citric acid, Adjust the volume to 5000ml, filter with a microporous membrane, fill the filtrate into a sterilized 7ml vial, freeze-dry, press the stopper and cap after the freeze-drying is completed, and obtain the product.

Embodiment 2

[0033] Ginkgolide 50g, Sodium Hydroxide 9g, Povidone K40 200g

[0034] Take the above sodium hydroxide and povidone K30, add 4500ml of water for injection, heat and stir to dissolve, then add ginkgolide, keep stirring at 80°C until completely dissolved; cool to room temperature, adjust pH to 8.0 with 10% acetic acid, adjust When the volume is up to 5000ml, filter with a microporous membrane, fill the filtrate into a sterilized 7ml vial, freeze-dry, press the stopper and cap after the freeze-drying is completed, and the product is obtained.

Embodiment 3

[0036] Ginkgolide 50g, Sodium Bicarbonate 30g, Povidone K15 150g

[0037] Take the above-mentioned sodium bicarbonate and povidone K15, add 4500ml of water for injection, heat and stir to dissolve, then add ginkgolide, keep stirring at 80°C until completely dissolved; cool to room temperature, adjust the pH to 8.0 with 10% citric acid, Adjust the volume to 5000ml, filter with a microporous membrane, fill the filtrate into a sterilized 7ml vial, freeze-dry, press the stopper and cap after the freeze-drying is completed, and obtain the product.

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PUM

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Abstract

The invention discloses a bilobalide pharmaceutical preparation and its preparation method, more specifically relates to a bilobalide freeze-dried injection and its preparation method. The bilobalide freeze-dried injection comprises bilobalide, metal alcali or meglumine, and povidone. The preparation method comprises the following steps weighing metal alcali or meglumine, manna sugar and povidone, adding water for injection, heating, stirring for dissolving, adding bilobalide, stirring until all the material is dissolved, cooling to room temperature, regulating pH to 7-10, filtering, and freeze drying. The invention solves the problem of redissolution of bilobalide freeze-dry powder in application.

Description

technical field [0001] The invention relates to a ginkgolide pharmaceutical preparation and a preparation method thereof, in particular to a ginkgolide freeze-dried powder injection and a preparation method thereof. Background technique [0002] There are many studies on Ginkgo biloba extract at home and abroad. Its production technology, pharmacological research and clinical application are relatively mature, and there are many market products. Ginkgo biloba extract mainly contains bioactive substances ginkgolides A and B, which are a type of strong platelet activating factor PAF antagonists, and these ingredients are only found in one plant of Ginkgo biloba. Due to the complex structure of the ingredients, It is also currently not possible to produce it by organic synthesis. Platelet activating factor is a mammalian endogenous physiologically active substance, which is mainly related to the pathogenesis of allergies, ulcers, asthma, thrombosis, certain inflammations, allo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/365A61K36/16A61K9/19A61K47/34A61P7/02A61P9/10A61P37/08A61P37/06A61P11/06A61P29/00A61K47/32
Inventor 叶正良郑永锋李旭周大铮
Owner TIANJIN TASLY ZHIJIAO PHARMA