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Ginkgo dipyridamole composition and preparation method of preparation thereof

A damocomposition and the technology of the composition are applied in the direction of drug combination, medical raw materials derived from Ginkgo biloba, and pharmaceutical formulations, etc., which can solve the problems of no control ratio, large toxic and side effects, and low content of active ingredients, and achieve stability and Improved safety, convenient clinical use, and definite curative effect

Active Publication Date: 2012-08-08
通化谷红制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And the ginkgo biloba injection in the prior art only controls the content of total flavonoids of ginkgo, does not control the content of ginkgolide wherein, especially does not control the ratio of bilobalide, ginkgolide A, B, C and M, and their The ratio to the total flavonol glycosides, so it is difficult to achieve satisfactory efficacy in the treatment of diseases
In addition, in recent years, compound preparations prepared from Ginkgo biloba extract and dipyridamole have also been listed on the market one after another. For example, CN1454596A discloses a compound intravenous drip of Ginkgo biloba extract and dipyridamole, wherein every 50 to 500 ml of intravenous infusion contains 4 to 30 mg of total ginkgo flavonoids and 1.5 to 15 mg of dipyridamole, because the content of ginkgolides and total flavonol glycosides in this intravenous infusion is not high, and ginkgolides are not controlled Therefore, the compound preparation is difficult to achieve satisfactory curative effect, and its clinical application value is not high.
The same problem also exists in the freeze-dried powder injection of Ginkgo biloba extract disclosed by CN1176656C and dipyridamole, because the active ingredient content is relatively low, it is also difficult to obtain satisfactory curative effect, and impurities (Ginkgo biloba) in this preparation acids, heavy metals, etc.) have not been effectively controlled, and the safety and stability of the resulting pharmaceutical preparations are poor. Due to the high content of impurities, the side effects are relatively large, and adverse reactions such as allergies and injection pains are prone to occur during injection.

Method used

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  • Ginkgo dipyridamole composition and preparation method of preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037]Embodiment 1: the preparation method of ginkgo damocomposition

[0038] Put 10 kg of ginkgo leaf thick shreds into an extraction tank, soak them in 70-80% ethanol for 1-2 hours with 10 times the amount and 8 times the amount, then heat and reflux for extraction for 2 hours and 1 hour respectively, and combine the extraction Liquid, filtered, ethanol was recovered from the filtrate, and an appropriate amount of purified water was added, and filtered with filter paper after standing for 12 hours in refrigeration. Washing with ethanol, collecting eluate of 60% ethanol, recovering ethanol from the eluent until it has no alcohol smell, and concentrating, drying, pulverizing and sieving the collected ointment.

[0039] A certain proportion of dipyridamole is added to the Ginkgo biloba extract prepared by the above method.

[0040] After testing, the percentage by weight of each component in the Ginkgo-Damole composition prepared by the present embodiment is as follows: total ...

Embodiment 2

[0041] Embodiment 2: the preparation method of ginkgo damole composition injection

[0042] Take an appropriate amount of the Ginkgo Damole composition of Example 1, put it into a blender, add water for injection, stir to dissolve, add water for injection to dilute to the configured amount, adjust the pH value to 5.0 with 10% sodium citrate solution, filter, pour Pack into ampoules and sterilize to obtain the ginkgo damole composition injection.

[0043] See Table 2 for the detection results of the contents of each component of the injection prepared in this example.

Embodiment 3

[0044] The preparation of embodiment 3 ginkgo damole composition injection

[0045] Take an appropriate amount of the Ginkgo Damole composition of Example 1, put it into a blender, add water for injection, stir to dissolve, add water for injection to dilute to the configured amount, adjust the pH value to 5.0 with 10% sodium citrate solution, filter, pour Pack into ampoules and sterilize to obtain the ginkgo damole composition injection.

[0046] See Table 2 for the detection results of the contents of each component of the injection prepared in this example.

[0047] The detection result of each component content of injection solution of the present invention of table 2

[0048]

[0049]

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PUM

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Abstract

The invention discloses a novel ginkgo dipyridamole composition and a preparation method of a preparation thereof. The ginkgo dipyridamole composition mainly comprises the following ingredients by weight: 25-35% of ginkgo total flavonoid glycol glycosides, 10-15% of dipyridamole and 10-18% of ginkgo total lactones, wherein the ginkgo total lactones are composed of bilobalide, ginkgolides A, ginkgolides B, ginkgolides C and ginkgolides M according to the weight ratio of 22-30: 15-18: 5-8: 8-22: 4-8. The ginkgo dipyridamole composition is high in active ingredient content and low in volume of contained impurities of ginkgo biloba phenolic substances (such as ginkgolic acid), proteins, tannins, pyrogen materials and the like. The pharmaceutic preparation, especially injection prepared by theginkgo dipyridamole composition is suitable for preventing and treating coronary diseases, thromboembolic diseases and the like, has obvious curative effects, and is safe in clinic use.

Description

technical field [0001] The present invention relates to a kind of preparation method of pharmaceutical composition and preparation thereof, particularly relate to a kind of glycosides containing ginkgo total flavonol glycosides, dipyridamole, total ginkgo lactone (by bilobalide, ginkgolide A, ginkgolide B , ginkgolide C, ginkgolide M total amount) ginkgo damo composition, the preparation prepared by the pharmaceutical composition and the preparation method thereof belong to the field of traditional Chinese medicine. Background technique [0002] Ginkgo biloba has the effects of improving cardiovascular and cerebrovascular circulation, providing memory, scavenging oxygen free radicals, and delaying aging. It has dual effects of treatment and health care. The injection prepared from Ginkgo biloba has been used clinically for many years and has achieved good results. Its main active ingredients are total flavonol glycosides of ginkgo biloba and total ginkgolides, and total gin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61P7/02A61P9/10A61K31/519
Inventor 郑建勇郑湘临
Owner 通化谷红制药有限公司
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