Method for detecting ginkgolide effective parts

A technology of ginkgolide and effective parts is applied in the field of detection of effective parts of ginkgolide, which can solve the problems of non-formation, inability to guarantee clinical efficacy and safety, and indeterminate composition ratio of ginkgolide.

Active Publication Date: 2013-05-08
CHENGDU BAIYU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

None of these methods can effectively separate high-content ginkgolides, and the composition ratio of ginkgolides is uncertain. Therefore, the efficacy varies in clinical use. Due to its low content, there are also certain safety risks. There is no complete pharmacology, toxicology and clinical trial data. Therefore, the above methods are in the experimental stage and have not been implemented in the drug production process. Although there are related patents for ginkgolide injection in China, their composition is different from the present invention. According to ICH Searches on many official websites of member states have found that no other ginkgolide injection products have been listed so far
Currently, HPLC-UV, HPLC-MS and HPLC-ELSD methods are mostly used for the determination of ginkgolides. These methods can only measure the content of ginkgolides. Control does not truly reflect the quality characteristics of the drug, and does not form a complete drug quality control system. Although there are many invention patents for ginkgolide, because the control method is too simple and the composition ratio of ginkgolide is not fixed, it cannot be made into traditional Chinese medicine. Injection, the clinical efficacy and safety of application cannot be guaranteed
[0013] Although there are many patents and reports about ginkgolides in China, Germany and other countries, the technological process, quality control technology and clinical indications of the present invention are quite different from other invention patents, especially the different separation and purification processes to obtain The composition of the terpenoid lactones varies, so far, there is no report on the process of extracting the active part composition of ginkgolides with fixed ratios of 4 components (gingkolides A, B, C and bilobalide), and also There is no report on the fingerprint control technology of the four components in ginkgolides and the inspection methods for possible residual macromolecules and proteins

Method used

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  • Method for detecting ginkgolide effective parts
  • Method for detecting ginkgolide effective parts
  • Method for detecting ginkgolide effective parts

Examples

Experimental program
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Effect test

Embodiment 1

[0101] Ginkgo biloba coarse powder 50kg, add 65% ethanol and heat reflux to extract 3 times (10, 8, 6 times the amount), each time for 1.5 hours, combine the extracts, filter, concentrate under reduced pressure, add 0.05% methionine to stir to dissolve, use citric acid Adjust the pH value of the acid solution to 4 to 5, continue to concentrate, place at low temperature, and filter. First extract with the same amount of n-hexane, then with the same amount of ethyl acetate, and finally with water-saturated sec-butanol-ethyl acetate mixed solvent, pass through a polyamide (30-60 mesh) resin column, first eluted with water, and then used Elute with 30% ethanol and then with 70% ethanol. Combine the eluates and concentrate under reduced pressure. Add 2 to 3 times the amount of boiling water, stir to dissolve, let stand, let cool, extract with ethyl acetate, concentrate under reduced pressure, add ethanol to heat and stir to dissolve, filter, let cool, precipitate crystals, filter, a...

Embodiment 2

[0103] Ginkgo biloba coarse powder 200kg, add 6 times the amount of 80% ethanol to heat and reflux for 3 times, 1.5 hours each time, combine the extracts, filter, the filtrate is decompressed to recover ethanol until no alcohol taste, add 0.05% methionine to stir to dissolve, use citric acid Adjust the pH value of the acid solution to 4 to 5, continue to concentrate, place at low temperature, and filter. First extract with n-hexane, then with ethyl acetate, and finally with water saturated sec-butanol-ethyl acetate mixed solvent, pass through a polyamide (30-60 mesh) resin column, first eluted with 30% ethanol, followed by 70 Elute with% ethanol, combine the eluates and concentrate under reduced pressure. Add boiling water, stir to dissolve, let stand to cool, extract with ethyl acetate, concentrate under reduced pressure, add ethanol to heat and stir to dissolve, filter, let cool, precipitate crystals, filter, and dry to obtain crystals I (mainly bilobalide And ginkgolide B);...

Embodiment 3

[0105] Ginkgo biloba coarse powder 200kg, add 8 times the amount of 75% ethanol and heat reflux to extract 3 times, each 1.5 hours, combine the extracts, filter, the filtrate is decompressed to recover the ethanol until no alcohol taste, add 0.05% methionine to stir to dissolve, use citric acid Adjust the pH value of the acid solution to 4 to 5, continue to concentrate, place at low temperature, and filter. First extract with n-hexane, then with ethyl acetate, and finally with water saturated sec-butanol-ethyl acetate mixed solvent, pass through a polyamide (30-60 mesh) resin column, first eluted with 30% ethanol, then 75 Elute with% ethanol, combine the eluates and concentrate under reduced pressure. Add boiling water, stir to dissolve, let stand to cool, extract with ethyl acetate, concentrate under reduced pressure, add ethanol to heat and stir to dissolve, filter, let cool, precipitate crystals, filter, and dry to obtain crystals I (mainly bilobalide And ginkgolide B); the...

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Abstract

The invention provides a method for detecting ginkgolide effective parts, relates to the field of plant extraction, particularly relates to a method for extracting and separating ginkgolide, and based on the extraction and separation method, the ginkgolide with unchanged components is obtained. The ginkgolide with fixed components is obtained by the steps of extraction, leaching, column chromatographic separation, crystallization and crystal mixing and contains 25.0-50.0 percent of bilobalide (C15H18O8), 20.0-45.0 percent of ginkgolide A (C20H24O9), 10.0-30.0 percent of ginkgolide B (C20H24O10) and 5.0-15.0 percent of ginkgolide C (C20H24O11), and the total amount of the bilobalide, the ginkgolide A, the ginkgolide B and the ginkgolide C is more than 95 percent.

Description

Technical field [0001] The invention relates to the field of plant extraction, in particular to a method for detecting effective parts of ginkgolides. Background technique [0002] Since the 1960s, many countries have adopted modern separation techniques to study the chemical components of Ginkgo biloba. After pharmacological experiments and clinical verification, it has been found that the various biological activities of Ginkgo biloba are related to the specific chemical components contained in it. German Dr. Willar Schwabe registered a simple extract of Ginkgo biloba for the first time, and applied for a patent in 1972 (W Schwabe DE 176708 and DE 2117429), named EGb761, for the treatment of cardiovascular and cerebrovascular diseases and neurological diseases, with significant Efficacy, and no toxic side effects, ginkgolids (ginkgolids) have strong platelet activating factor (PAF) antagonism. Ginkgo preparations are listed as therapeutic drugs in Germany, France and China. Ot...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 孙毅朱永红童正兵王婕
Owner CHENGDU BAIYU PHARMA CO LTD
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