Bilobalide injection and content determination method

A technology of ginkgolide and determination method, which is applied in the field of detection method and content determination of ginkgolide injection, and can solve problems such as non-formation, inability to guarantee clinical efficacy and safety, uncertain composition ratio of ginkgolide, etc.

Active Publication Date: 2013-08-14
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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  • Bilobalide injection and content determination method

Examples

Experimental program
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Effect test

Embodiment 1

[0101] Ginkgo biloba coarse powder 50kg, add 65% ethanol and heat and reflux 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 and stir to dissolve, use citrate Adjust the pH value of the citric acid solution to 4-5, continue to concentrate, place at low temperature, and filter. First extract with an equal amount of n-hexane, then extract with an equal amount of ethyl acetate, and finally extract with a water-saturated sec-butanol-ethyl acetate mixed solvent, pass through a polyamide (30-60 mesh) resin column, first elute with water, and then use 30% ethanol was used for elution, and then 70% ethanol was used for elution, and the eluents were combined and concentrated under reduced pressure. Add 2 to 3 times the amount of boiling water, stir to dissolve, stand still, let cool, extract with ethyl acetate, concentrate under reduced pressure, add ethanol to heat and stir to ...

Embodiment 2

[0103] Ginkgo biloba coarse powder 200kg, add 6 times the amount of 80% ethanol and heat and reflux extract 3 times, each time for 1.5 hours, combine the extracts, filter, and recover the ethanol from the filtrate under reduced pressure until it has no alcohol smell, add 0.05% methionine and stir to dissolve, use cedar Adjust the pH value of the citric acid solution to 4-5, continue to concentrate, place at low temperature, and filter. First extract with n-hexane, then extract with ethyl acetate, and finally extract with water-saturated sec-butanol-ethyl acetate mixed solvent, pass through a polyamide (30-60 mesh) resin column, first elute with 30% ethanol, and then use 70 % ethanol was used for elution, and the eluents were combined and concentrated under reduced pressure. Add in 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, f...

Embodiment 3

[0105] Ginkgo biloba coarse powder 200kg, add 8 times the amount of 75% ethanol, heat and reflux extraction 3 times, each time for 1.5 hours, combine the extracts, filter, and recover the ethanol from the filtrate under reduced pressure until it has no alcohol smell, add 0.05% methionine and stir to dissolve, use citrate Adjust the pH value of the citric acid solution to 4-5, continue to concentrate, place at low temperature, and filter. First extract with n-hexane, then extract with ethyl acetate, and finally extract with water-saturated sec-butanol-ethyl acetate mixed solvent, pass through a polyamide (30-60 mesh) resin column, first elute with 30% ethanol, and then use 75 % ethanol was used for elution, and the eluents were combined and concentrated under reduced pressure. Add in 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,...

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Abstract

The invention relates to the field of plant extraction and in particular relates to a method for detecting bilobalide injection for treating cardiovascular and cerebrovascular diseases and a method for determining content of active ingredients. The content of ginkgo terpene lactone in every 1ml of the determined bilobalide injection is 1-10mg / ml based on the total amount of bilobalide (C15H18O8), ginkgolides A (C20H24O9), ginkgolides B (C20H24O10) and ginkgolides C (C20H24O11), and preferably 4.25-5.75mg.

Description

technical field [0001] The invention relates to the field of plant extraction, in particular to a detection method and content determination method of ginkgolide injection for treating cardiovascular and cerebrovascular diseases. Background technique [0002] Since the 1960s, many countries have used modern separation techniques to study the chemical components of Ginkgo biloba. Through 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 them. Dr.Willar Schwabe of Germany registered a simple extract of Ginkgo biloba for the first time, and applied for a patent in 1972 (W Schwabe DE176708 and DE2117429), named EGb761, for the treatment of cardiovascular and cerebrovascular diseases and nervous system diseases, with significant curative effect , and no toxic side effects, ginkgolides (ginkgolids) have strong platelet activating factor (PAF) ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61K9/08G01N30/36A61K127/00
Inventor 孙毅朱永红童正兵王婕
Owner CHENGDU BAIYU PHARMA CO LTD
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