Preparation method of ginkgo leaf extract freeze dried powder injection

A technology for freeze-dried powder injection and extract, which is applied in the field of preparation of botanical medicinal preparations and can solve problems such as poor stability and the like

Inactive Publication Date: 2004-02-18
CHONGQING LUMMY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is in order to overcome the above-mentioned defect that the ginkgo leaf extract injection of current clinical application exists, the contriver has developed the freeze-dried powder injection of ginkgo through research, and this preparation has overcome the bad stability of ginkgo leaf extract injection Defects, good for storage and transportation, easy to use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] The preparation method of embodiment 1 Ginkgo biloba extract freeze-dried powder injection

[0011] (1) Take dried ginkgo leaves and pulverize them into coarse powder, place them in a multi-energy extraction tank and use 8 times the amount of 70% ethanol to reflux extract three times, each time for 3 hours, and combine the extracts to concentrate to a relative density of 1.2. Add 2 times the volume of distilled water, heat to 70°C and stir for 15 minutes, let stand for 24 hours in refrigeration, and centrifuge to separate the solution and the precipitate.

[0012] Add 10% silica gel to the solution, stir for 15 min, and filter. The filtrate was extracted with mixed solvent cyclohexane: acetone (40:1) for 4 times of ginkgolic acid. The aqueous layer and the organic layer were separated, the solvent was recovered from the organic layer, the aqueous layer was concentrated, and concentrated in vacuo to obtain a tan extract.

[0013] (2) Take 17.5g of ginkgo leaf extract (...

experiment example 1

[0014] Experimental example 1 long-term toxicity test

[0015] Ginkgo biloba extract freeze-dried powder for injection, intraperitoneal injection of 87.5, 43.75, 17.5 mg / kg (large, medium, small) in rats for 60 consecutive days is equivalent to three dose groups of 150, 75, and 30 times the clinical dose, respectively, The control group received ip saline solution. Results There was no obvious abnormality in the appearance signs and behavioral activities of the animals; the body weight increased rapidly, and there was no statistical difference between the groups (P>0.05); all the indexes of the peripheral blood examination fluctuated within the normal range, and there was no significant difference compared with the control group; The biochemical high-dose AST was statistically different from the control group (P0.05), and the anatomical observation of the animals in each group showed no abnormality in the arrangement, color, texture, etc. of the tissues and organs; Comparison...

experiment example 2

[0018] Experimental Example 2 Acute Toxicity Test

[0019] Dilute the lyophilized powder of Ginkgo biloba extract for injection with normal saline, prepare the highest concentration of 9%, and dilute it according to the 1:0.9 method of decreasing between groups. 70 mice were divided into 7 groups, and 0.2ml was injected into the tail vein according to the body weight of 10g. In the 1800mg / kg group, after i.v administration, the animals showed low reactivity, and the animals gradually died in about 1min. With the dose reduction, the death time of the animals was prolonged and the number decreased, and the undead animals returned to normal after 24 hours. Continue to observe for 8 days and calculate LD according to the improved Cole's method 50 It is 1397.66±188.16g / kg (1306.77~1494.86mg / kg).

[0020] Dilute the Ginkgo biloba extract freeze-dried powder for injection with physiological saline to concentrations of 14.0%, 12.6%, 11.34%, 10.21%, 9.19%, and 8.27%, respectively, and...

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Abstract

A freeze-dried powder injection of ginkgo leaf extract is prepared from the ginkgo leaf extract containing ginkgolide and ginkgetin through dissolving it in the water for injection, proportionally mixing with mannitol, filtering, superfiltering, freeze drying and sealing. It has high stability.

Description

technical field [0001] The invention relates to a preparation method of herbal medicinal preparations, in particular to a preparation method of ginkgo biloba extract freeze-dried powder injection. Background technique [0002] Ginkgo biloba has high medicinal value. In my country, Ginkgo biloba extract preparations have been used to treat diseases for more than 5,000 years. Since the 1960s, Ginkgo biloba extract has been used in many countries to treat cerebrovascular and peripheral vascular diseases, such as Germany, France, Japan, Korea and other countries, and Ginkgo biloba oral preparations and injections have been listed in Germany and France. There are dosage forms such as ginkgo biloba oral liquid and capsules on the market in China. The most commonly used Ginkgo biloba extract for therapeutic purposes currently contains 24% ginkgo flavonoids and 6% ginkgolides. The extraction, separation and purification method of Ginkgo biloba extract; has been disclosed in detail...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61P9/10
Inventor 安林邓渠清
Owner CHONGQING LUMMY PHARMA
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