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Medicine for treating cardiovascular and cerebrovascular diseases and quality detection method of medicine

A technology for cardiovascular and cerebrovascular diseases and drugs, which is applied in the field of preparation and dynamic quality control of ginkgolide solid dispersion based on component structure, and can solve unscientific problems

Inactive Publication Date: 2017-05-31
JIANGSU KANION PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is unscientific to only use single-component ginkgolide B as the raw material for the production of ginkgo preparations

Method used

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  • Medicine for treating cardiovascular and cerebrovascular diseases and quality detection method of medicine
  • Medicine for treating cardiovascular and cerebrovascular diseases and quality detection method of medicine
  • Medicine for treating cardiovascular and cerebrovascular diseases and quality detection method of medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] The determination of the equilibrium solubility of the ginkgolide composition of embodiment 1 in water and the PBS of different pHs:

[0081] Preparation of the test solution: prepare phosphate-buffered saline solutions with pHs of 2.0, 2.5, 5.0, 5.8, 6.5, 7.0, 7.4, 7.8-8.0, and take excess ginkgolide A: ginkgolide B weight ratio of 1: The ginkgolide composition of 2 is equally divided into 10 parts and placed in stoppered glass test tubes, and then water is added to one of the stoppered glass test tubes as a blank, and phosphates with different pH values ​​are added to the other stoppered glass test tubes. The buffered saline solution was sonicated until the drug was no longer dissolved to prepare a saturated solution of the ginkgolide composition, and then placed in a constant temperature oscillator to maintain the temperature at (37±1)°C and shaken for 24 hours. Filter the saturated solution with a 0.45 μm microporous membrane, discard the initial filtrate, and take ...

Embodiment 2

[0089] Embodiment 2 ginkgolide A: the determination of the ginkgolide composition oil-water partition coefficient that the weight ratio of ginkgolide B is 1:2

[0090] Take an appropriate amount of the ginkgolide composition and dissolve it in water-saturated n-octanol to make a n-octanol saturated solution of the ginkgolide composition, and precisely draw the solution into ten 10mL vials (2mL / bottle). , add 2ml of n-octanol-saturated water into one of the vials as a blank, add 2mL of phosphate buffer solution with different pH values ​​into the other vials, put them in an air shaker at 37°C, and shake for 24h until balanced. Take the lower layer of water phase, with 6000r·min -1 Centrifugal 10min, prepare reference substance solution according to the method for preparing reference substance solution described in Example 1 and chromatographic conditions and measure the concentration of ginkgolide composition C in n-octanol before distribution 0 and the concentration C of the ...

Embodiment 3

[0096] Embodiment 3 is based on the preparation of the ginkgolide solid dispersion of preferred composition

[0097] Method: Using solvent method to select chitosan as solid dispersion carrier, firstly prepare ginkgolide A: ginkgolide B weight ratio of 1:2 ginkgolide composition and 3000, 5000, 50000, 100000 and more than 100000 The chitosan ratio is 1:5, comparing the influence of different molecular weights on the solubility of the ginkgolide composition, the optimal molecular weight chitosan carrier is preferred. Further optimize the weight ratio (1:5, 1:10, 1:15) of the ginkgolide composition and the preferred chitosan carrier to prepare the ginkgolide solid dispersion, and take the dissolution rate as the investigation index to optimize the ginkgolide solid dispersion body prescription. see results Figure 3-5 .

[0098] Results: Compared with chitosan with other molecular weights, chitosan 3000 can improve the solubility of ginkgolide composition to the greatest exten...

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Abstract

The invention discloses a medicine for treating cardiovascular and cerebrovascular diseases and a quality detection method of the medicine. The medicine takes a ginkgolide composition as a main effective component, and the ginkgolide composition and pharmaceutically acceptable auxiliary materials or auxiliary components are prepared into a pharmaceutically acceptable preparation; the ginkgolide composition contains two active components including ginkgolide A (GA) and ginkgolide B (GB); the weight ratio of the ginkgolide A to the ginkgolide B is 1 to (2 to 9). According to the medicine disclosed by the invention, the ginkgolide A and the ginkgolide B have very high synergistic effect, and the medicine has remarkable application effect in treatment of the cardiovascular and cerebrovascular diseases. Simultaneous determination of content of components of a ginkgolide preparation is realized; a test shows that the detected separation degree of the GA and the GB is good, and the linear relation, the repeatability, the precision, the stability and the recovery rate are relatively good. According to the design of the preparation disclosed by the invention, the in-vivo bioavailability is improved and the pharmacological effect is improved.

Description

[0001] This application is a divisional application, and its parent case is an invention patent application with the invention name "a ginkgolide composition and its application", its application number is 201310126461.9, and its application date is April 11, 2013. technical field [0002] The invention relates to a ginkgolide composition and its application, in particular to the preparation of a ginkgolide solid dispersion based on component structure and its dynamic quality control method. Background technique [0003] Ginkgo biloba is one of the ancient tree species in my country, and Ginkgoaceae has been used as a traditional Chinese medicine in my country for thousands of years. With the development of modern Chinese medicine preparations, ginkgolides have become important raw materials for the preparation of ginkgo preparations. The main active ingredients in total ginkgolides include ginkgolide A (GA), ginkgolide B (GB), ginkgolide C (GC) and bilobalide (BB), among wh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/365A61K9/14A61P9/00A61P9/10G01N30/02G01N30/74
Inventor 萧伟贾晓斌刘丹
Owner JIANGSU KANION PHARMA CO LTD
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