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Method for preparing ginkgodipyidamolum injection

A technology of Damo injection and Ginkgo biloba, which is applied in the field of preparation of Ginkgo Damo injection, can solve problems such as medication safety risks and poor product quality stability, and achieve the goals of improving quality stability, improving drug effectiveness, and reducing safety risks Effect

Active Publication Date: 2011-01-19
SHANXI PUDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there are many domestic manufacturers producing Ginkgo biloba injection, but most of them are directly mixed with Ginkgo leaf extract and dipyridamole, which will be precipitated in Ginkgo biloba during storage, especially after freezing and thawing. Ineffective ingredients such as protein and tannin that are not removed during the preparation of leaf extracts have poor product quality and stability, and will also pose risks to the safety of human medicine

Method used

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  • Method for preparing ginkgodipyidamolum injection
  • Method for preparing ginkgodipyidamolum injection
  • Method for preparing ginkgodipyidamolum injection

Examples

Experimental program
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Effect test

Embodiment 1

[0028] 1. Extract Ginkgo biloba extract: Extract Ginkgo biloba with 6 times the weight of purified water, extract twice, reflux for 2 hours each time, filter, combine the filtrates and concentrate to 1 / 3 of the original volume; stir the concentrate Cool and let it stand, then take the supernatant, filter, absorb the filtrate through D101 macroporous resin, elute with ethanol, concentrate the eluate until it has no alcohol smell, then add purified water 2 times the weight of ginkgo leaves, stir and cool, then let it stand place, get the supernatant, filter, concentrate the filtrate to collect the paste, vacuum-dry until the water content is below 6% (weight), and pulverize;

[0029] 2. Refined ginkgo leaf extract: add 8 times the weight of 90% (volume) ethanol to the ginkgo leaf extract obtained in step 1, stir until dissolved, concentrate to no alcohol after centrifugation, then add 10 times concentrated medicine Liquid volume of purified water, stirred and cooled, left stands...

Embodiment 2

[0044] 1, extract Ginkgo biloba extract: same as Example 1;

[0045] 2. Refined Ginkgo biloba extract: Add 12 times the weight of 90% (volume) ethanol to the Ginkgo biloba extract obtained in step 1, stir until dissolved, concentrate to no alcohol after centrifugation, then add 10 times concentrated medicine Liquid volume of purified water, stirred and cooled, left standstill, the supernatant was taken, centrifuged and concentrated to collect the paste, dried in vacuum until the water content was below 6% (weight), and pulverized;

[0046] 3. Prepare ginkgo leaf extract: add purified water with 10 times the amount of the extract to the ginkgo leaf extract, heat to mix evenly, add dipyridamole at 0.5% by weight of the ginkgo leaf extract, adjust the pH value to 4.51, Continue heating to boiling, reflux for 1 hour, stop heating, cool to room temperature, and retest the pH to 4.46; then take the supernatant and filter it with a 0.22 μm filter membrane frame, and the filtrate is u...

Embodiment 3

[0053] 1, extract Ginkgo biloba extract: same as Example 1;

[0054] 2, refining Ginkgo biloba extract: use dehydrated alcohol, all the other steps are identical with embodiment 1;

[0055] 3. Preparation of ginkgo leaf extract: add purified water of 10 times the amount of the extract to the ginkgo leaf extract, heat to mix evenly, add dipyridamole of 2% by weight of the ginkgo leaf extract, adjust the pH value to 4.78, Continue heating to boiling, reflux for 0.5 hours, stop heating, cool to room temperature, and retest the pH to 4.65; then take the supernatant and filter it with a 0.22 μm filter membrane frame, and the filtrate is ultrafiltered with a 100,000 Dalton filter membrane, Pump the above-mentioned ultra-filtered liquid into a sterilization tank for heat sterilization. When the temperature rises to 115°C, start timing, and sterilize at 115±2°C for 40 minutes. After cooling, the ginkgo leaf extract is prepared for use;

[0056] 4. Preparation of ginkgo damole injecti...

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Abstract

The invention provides a method for preparing ginkgodipyidamolum injection. The method comprises the following steps of: 1) extracting a ginkgo leaf extract from ginkgo leaves; 2) extracting the ginkgo leaf extract once again with over 90 percent ethanol so as to refine the ginkgo leaf extract; 3) adding water into the refined ginkgo leaf extract and dipyridamole for inverse flow and filtering so as to obtain ginkgo leaf extracting solution; and 4) mixing the ginkgo leaf extracting solution, the dipyridamole and auxiliary materials so as to obtain the ginkgodipyidamolum injection, wherein in the ginkgodipyidamolum injection, the weight ratio of the ginkgo leaf extracting solution to the dipyridamole based on total ginkgo flavone-glycoides is 0.9-1.1:0.3-0.5. The method of the invention has the advantages of effectively removing various impurities, enhancing medicament effectiveness, improving the quality stability of the ginkgodipyidamolum injection and reducing safety risk.

Description

technical field [0001] The invention relates to a preparation method of an injection preparation, in particular to a preparation method of ginkgo damole injection. Background technique [0002] Ginkgo biloba, also known as ginkgo leaf, gongsun tree, duck palm tree, etc., is a gymnosperm and is one of the unique ancient tree species in my country. Ginkgo biloba contains a variety of nutrients, such as protein, vitamin C, carotene, vitamin E and mineral elements, such as calcium, iron, fluorine, copper, zinc, chromium, cobalt, boron, selenium, etc.; The leaves also contain dozens of active ingredients, the most important of which are flavonoids and terpene lactones. These ingredients have a very strong antioxidant effect, can remove excess free radicals in the organism, prevent lipid peroxidation in the body, Inhibit platelet activating factor, promote blood circulation and brain metabolism and other functions. Clinically, it can be used to treat various diseases such as cor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61K9/08A61P9/10A61P7/02A61K31/519
Inventor 胡成伟解晓荣李立忠李润宝王勇高文
Owner SHANXI PUDE PHARMA CO LTD
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