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Composition of ginkgo leaf extract and dipyridamole, medicine containing same and preparing method thereof

A damole composition and composition technology, applied in pharmaceutical composition and its preparation, in the field of ginkgo damole composition, which can solve the problems of uncontrolled ginkgolide content, large toxic and side effects, and low content of active ingredients

Inactive Publication Date: 2010-09-22
厦门国宇知识产权研究有限公司
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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 the total flavonoids of Ginkgo biloba, does not control the content of ginkgolide wherein, especially does not control the ratio of bilobalide, ginkgolide A, B and C, and their ratio to the total The proportion of flavonol glycosides, so it is difficult to obtain satisfactory curative effect in the treatment of diseases
In addition, in recent years, compound preparations prepared from Ginkgo biloba extract and dipyridamole have been successively listed on the market. For example, CN1454596A discloses a compound intravenous infusion solution 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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The preparation method of embodiment 1 ginkgo damocomposition

[0049] Take 10 kg of dried ginkgo leaves, grind them into coarse powder with a pulverizer, add 6000 ml of 90% ethanol to reflux and extract for 6 hours, filter, extract the residue twice in the same way, filter, combine the filtrates, add aqueous sodium bicarbonate to adjust the pH to 10. Stand still for 6 hours, filter, add dilute hydrochloric acid to the filtrate to adjust the pH to 5, concentrate the filtrate, add 1500ml distilled water to the concentrate and heat to 75°C, keep at this temperature for 10 minutes while stirring, and refrigerate the water extract ( 0~4℃) overnight, filter, put the macroporous adsorption resin on the filtrate, control the flow rate until the water flows out, use 30~50% ethanol gradient elution until the effluent is colorless, and use 50% ethanol eluent with n-hexane : acetone (38: 1) mixed solvent extraction twice, separate the water layer and the organic layer, and recover...

Embodiment 2

[0051] The preparation of embodiment 2 ginkgo damocomposition

[0052] Take 10kg of fresh ginkgo leaves, crush them into a paste with a beater, add 5000ml of 75% ethanol to reflux and extract for 5 hours, filter, extract the residue 3 times in the same way, filter, combine the filtrates, add saturated lime water to adjust the pH to 9, Stand still for 6 hours, filter, add dilute hydrochloric acid to the filtrate to adjust the pH to 5.5, concentrate the filtrate, add water to the concentrate and heat to 70°C, keep at this temperature for 30 minutes while stirring, and refrigerate the water extract (0-4 ℃) overnight, filter, and the macroporous adsorption resin on the filtrate, after controlling the flow velocity to the water flow, use 30~50% ethanol gradient elution until the effluent is colorless, and the eluent of 50% ethanol is used with normal hexane: acetone ( 35:1) mixed solvent for extraction twice, separated the water layer and the organic layer, recovered the solvent fr...

Embodiment 3

[0054] The preparation of embodiment 3 ginkgo damocomposition

[0055] Ginkgo biloba extract (purchased from Hainan Zhicheng Pharmaceutical Trade Co., Ltd.) (containing 33% of total ginkgo flavonol glycosides and 11% of total ginkgo lactones) 900g, dipyridamole 100g.

[0056] Accurately weigh the above raw materials, pulverize, mix, add ethanol, evenly moisten, and then put it into a percolator, add ethanol until it is higher than the drug surface, and then percolate after standing for a period of time. Collect the percolation liquid, concentrate at low temperature and reduced pressure to a paste, and continue to concentrate to the required amount. Put the paste thick material into a drying oven to dry, dehydrate, put it into a light-shielding container and store it airtightly, and then the ginkgo damo composition is obtained.

[0057] After testing, the percentage by weight of each component in the Ginkgo-Damole composition prepared by the present embodiment is as follows: t...

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PUM

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Abstract

The present invention discloses a new ginkgodamole composition, medicine composition prepared hy using it, in particular, injection and their preparation method. Said ginkgodamole composition mainly contains the following components: (by wt%) 18-65% of ginkgo total flavone glycoside, 6-32% of dipyridamole, 4-25% of ginkgo total lactone and the heavy metal content is less than 9.4 ppm (weight), inwhich the ginkgo total lactone is formed from bilobalide, ginkgolide A, ginkgolide B and ginkgolide C according to the weight ratio of 4-40:7-40:3-30:3-40. Said medicine preparation, specially injection have obvious therapeutic effect for curing angiocardiopathy and cerebrovascular diseases.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a pharmaceutical composition containing total ginkgo flavonol glycosides, dipyridamole, and total ginkgo lactones (based on bilobalide, ginkgolide A, ginkgolide B, ginkgo The ginkgo damocomposition based on the total amount of lactone C), the preparation prepared from 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 ginkgolid...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7048A61K31/365A61K31/519A61P9/10A61P39/06A61P43/00
Inventor 郭东宇
Owner 厦门国宇知识产权研究有限公司
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