Ginkgo dipyridamole composition and preparation method of preparation thereof

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...

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.

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