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Ginkgolides B injection and preparation method thereof

A technology of ginkgolide and injection, which is applied in the field of mangolide B preparations, can solve problems such as potential safety hazards, achieve stable performance, meet safety and reliability, and solve solubility problems

Inactive Publication Date: 2017-04-26
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Preliminary tests have found that due to solubility limitations, the prepared injections are prone to safety hazards due to temperature changes and clinical dilution during use.

Method used

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  • Ginkgolides B injection and preparation method thereof
  • Ginkgolides B injection and preparation method thereof
  • Ginkgolides B injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] prescription:

[0074]

[0075] Prepare a mixed solvent of 1,2-propanediol, glycerol and ethanol in the above proportions. Weigh the ginkgolide B and put it in a container, add the mixed solvent, stir until dissolved, add the mixed solvent to the full amount, mix evenly, filter sterilization, potting, and sterilize to obtain the final product.

Embodiment 2

[0077] prescription:

[0078]

[0079] Prepare a mixed solvent of 1,2-propanediol, glycerol and ethanol in the above proportions. Weigh the ginkgolide B and put it in a container, add the mixed solvent, stir until dissolved, add the mixed solvent to the full amount, mix evenly, filter sterilization, potting, and sterilize to obtain the final product.

Embodiment 3

[0081] prescription:

[0082]

[0083] Prepare a mixed solvent of 1,2-propanediol, glycerol and ethanol in the above proportions. Weigh the ginkgolide B and put it in a container, add the mixed solvent, stir until dissolved, add the mixed solvent to the full amount, mix evenly, filter sterilization, potting, and sterilize to obtain the final product.

[0084] A quality control study was carried out to Example 1 and Example 2, and the results are as follows:

[0085] (1) Investigate the properties, insoluble particles and solution color of Example 1 and Example 2 respectively, and place the injection in

[0086] It was placed under the condition of 4°C for 2 months, and it was observed whether there was crystal precipitation under the condition of low temperature. The results are shown in Table 4. It shows that Example and Example 2 have better storage stability under low temperature conditions.

[0087] Table 4 Observation results of the characters of Example 1 and Examp...

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Abstract

The invention discloses a ginkgolides B injection and a preparation method thereof. The ginkgolides B injection comprises an effective treatment dose of ginkgolides B and an injection solvent, wherein the injection solvent is a mixture of 1,2-propanediol, glycerol and ethyl alcohol according to a volume ratio of (0.05 to 0.20):(0.25 to 0.55):(0.35 to 0.65). The ginkgolides B injection provided by the invention has the advantages that the solubility of the ginkgolides B can reach 10mg / ml; the ginkgolides B problem of the ginkgolides B can be effectively solved; the crystal separation problem of medicine in the storage and clinic dilution processes can be solved; various requirements of safety and reliability of clinic use can be met; the performance is stable; and the clinic application requirements can be met.

Description

technical field [0001] The present invention relates to an apricot lactone B preparation. Background technique [0002] Ginkgolide is currently considered to be the most promising natural PAF receptor antagonist, and Ginkgolide B has the strongest antagonistic effect on PAF. It is clinically used for the treatment of thrombosis, acute pancreatitis and cardiovascular diseases, and also for the treatment of metastatic cancer. [0003] The ginkgolide B raw material of the invention is a monomer extracted from Ginkgo biloba leaves, the purity is more than 98%, the unknown component is less than 0.5%, the component is single, and the safety is good. Ginkgolide B; Molecular formula: C 20 H 24 O 10 ; Molecular weight: 424.4; [0004] Ginkgolide B is very slightly soluble in water and slightly soluble in alcohol. The solubility in water, ethanol, 1,2-propanediol, and glycerol solvents are: 0.16, 6.88, 2.03, 0.98 mg / ml, respectively; under alkaline conditions, the lactone ring ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/365A61K47/10A61P7/02A61P1/18A61P9/00A61P35/04A61P25/00A61P39/06
Inventor 葛庆华李周丁存刚李丁刘斐肖志勇
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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