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Bilobalide injection and preparation method thereof

A technology of ginkgolide and injection, which is applied in the field of preparation of traditional Chinese medicine preparations, can solve the problems of not forming a drug quality control system, uncertain ratio of ginkgolide, and low content, so as to avoid unqualified clarity and insoluble particles, The effect of solving potential safety hazards and stabilizing the proportion of ingredients

Inactive Publication Date: 2012-08-08
CHENGDU BAIYU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These methods cannot effectively separate high-content ginkgolide compositions, and the composition ratio of ginkgolides is uncertain. Therefore, the drug effects are different in clinical use, and there is also a certain degree of safety due to its low content. risk, there is no complete pharmacology and toxicology and clinical trial data, therefore, the above-mentioned methods are all 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 the search of many official websites of ICH member states, 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 ginkgolide components. These methods can only measure the content of ginkgolide components. Due to the lack of strict control of harmful substances in their products , does not truly reflect the quality characteristics of the drug, and does not form a complete drug quality control system
[0013] In other invention patents, meglumine or sodium hydroxide is used as a co-solvent. Due to the unique five-membered ring structure of ginkgolide, it can lead to ring opening of the lactone under alkaline conditions and lose the efficacy of the drug. Medication poses a huge safety hazard

Method used

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  • Bilobalide injection and preparation method thereof
  • Bilobalide injection and preparation method thereof
  • Bilobalide injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0199] prescription:

[0200]

[0201] Take glycerin and 80% ethanol in total according to the prescription, mix well, add ginkgolide, stir to dissolve, add ethanol to the full amount, stir evenly, adjust the pH to 3.2-3.8 with 1-10% hydrochloric acid, after the intermediate is qualified, Filter until clear, potting and sterilizing.

Embodiment 2

[0203] prescription:

[0204]

[0205] Take glycerin and 80% ethanol according to the prescription, mix well, add ginkgolide, stir to dissolve, add ethanol to the full amount, stir evenly, adjust the pH to 3.2-3.8 with 5-10% citric acid, the intermediate is qualified Afterwards, filter until clear, potting and sterilizing.

Embodiment 3

[0207] prescription:

[0208]

[0209] Take glycerin and 80% ethanol according to the prescription, mix well, add ginkgolide, stir to dissolve, add ethanol to the full amount, stir evenly, adjust the pH to 3.2-3.8 with 5-10% citric acid, the intermediate is qualified Afterwards, filter until clear, potting and sterilizing.

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Abstract

The invention relates to a preparation method for a preparation of Chinese medicine, particularly relates to a bilobalide injection and a preparation method thereof and belongs to the field of medicine. The technical problem is solved by the invention by providing the bilobalide injection. The bilobalide injection has the advantages of clear components and fixed proportion; the bilobalide injection with high purity, clear component and fixed proportion is taken as an active ingredient; the content of the effective component is above 95%; and the bilobalide injection contains the following components.

Description

Technical field [0001] The invention relates to a preparation method of a traditional Chinese medicine preparation, in particular to ginkgolide injection and a preparation method thereof, and belongs to the field of medicine. 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 first registered a simple extract of ginkgo biloba, 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. Significant curative effect, and no toxic side effects, ginkgolids (ginkgolids) have strong platelet activating factor (PAF) antagonism. Ginkgo preparations ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/365A61K47/10A61P7/02A61P25/28A61P29/00A61P37/08A61P9/10
CPCA61K36/00A61K31/365A61K9/08A61K9/0019A61K47/10A61P7/02A61P9/10A61P25/28A61P29/00A61P37/08
Inventor 孙毅朱永红童正兵王婕
Owner CHENGDU BAIYU PHARMA CO LTD
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