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Freeze-dried ginkgolide powder injection and its preparing process

A technology for freeze-dried powder injection and ginkgolide, which is applied in the field of preparation of ginkgolide pharmaceutical preparations

Inactive Publication Date: 2003-01-15
OUHUA MEDICINE BIOTECH GUANGZHOU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the dosage form of ginkgolide is rarely reported at present, because ginkgolide itself is difficult to dissolve in water, so the use of freeze-dried powder injection as the form of administration has not yet been reported

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Get 55g of Ginkgo biloba lactone crude drug, place in 5000ml of solution made of 52g meglumine, then add 60g of mannitol, fully stir to make it dissolve, cool to room temperature, filter, aseptically subpackage in vials, After freeze-drying, press the plug and press the cap to obtain the ginkgolide freeze-dried powder injection of the present invention.

Embodiment 2

[0013] Get 45g of Ginkgo biloba lactone crude drug, place in 5000ml of solution made from 50g of meglumine, then add 50g of mannitol, fully stir to make it dissolve, cool to room temperature, filter, aseptically subpackage in vials, After freeze-drying, press the plug and press the cap to obtain the ginkgolide freeze-dried powder injection of the present invention. Pharmacodynamics test 1. Effects of ginkgolide lyophilized powder for injection iv on brain function, infarction rate and brain water content in rats with focal cerebral ischemia

[0014] Take 70 male SD rats, weighing 300-400g, and randomly divide them into 7 groups according to body weight, respectively high-dose 30.0mg / kg ginkgolide freeze-dried powder group, 15.0mg / kg middle-dose group, and 7.5mg low-dose group / kg, positive control Nimotong injection group 0.2mg / kg, positive control Jinnaduo injection group 1.0ml / kg, sham operation group and ischemia model control group (both give equal amount of normal saline ...

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PUM

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Abstract

A freeze dried ginkgolide powder as injection is prepared through dissolving the raw mixed ginkgolide in alkali solution, stirring thoroughly, dissolving mannitol in it, filtering, aseptic packing, and freeze drying. Its advantages are simple preparing process, high stability and high water solubility.

Description

Technical field [0001] The invention relates to a preparation method of a ginkgolide pharmaceutical preparation, more specifically, to a preparation method of a ginkgolide freeze-dried powder injection. Background technique [0002] There are many studies on Ginkgo biloba extract at home and abroad. Its production process, pharmacological research and clinical application are relatively mature, and there are many market products, such as Ginkgo biloba extract capsules and tablets successfully developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences. It is clinically used in cardiovascular and cerebrovascular diseases such as coronary heart disease, angina pectoris, cerebral arteriosclerosis, and cerebral arteriosclerosis and insufficient cerebral blood supply. The company's clinical trial of Ginkgo biloba extract for the prevention and treatment of Alzheimer's disease in the United States has also been successful. The side effects of the drug are minima...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/365A61P9/10
Inventor 张平
Owner OUHUA MEDICINE BIOTECH GUANGZHOU
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