Ginkgolide osmotic pump tablet and preparation method thereof

A technology of ginkgolide and osmotic pump tablets is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and drug combinations, which can solve problems such as difficulty in ensuring the synchronization of traditional Chinese medicine ingredients, and achieve good in-vivo and in-vitro correlation. Solubility difference, effect of small individual differences

Inactive Publication Date: 2013-06-12
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Membrane control technology and skeleton technology commonly used at present are difficult to guarantee the synchronization of the in vivo release of different properties of traditional Chinese medicine ingredients

Method used

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  • Ginkgolide osmotic pump tablet and preparation method thereof
  • Ginkgolide osmotic pump tablet and preparation method thereof
  • Ginkgolide osmotic pump tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation process: add prescription amount of drug and polyvinylpyrrolidone into ethanol-dichloromethane (1:1) mixed solvent, and ultrasonically dissolve it completely. Rotary evaporation, water bath temperature 60 ° C, distilled off the organic solvent. Put it in a vacuum drying oven and continue drying for 24 hours to remove the residual solvent to obtain the ginkgolide solid dispersion. Pass the prescribed amount of ginkgolide solid dispersion, microcrystalline cellulose, and talcum powder through a 60-mesh sieve, and mix evenly to form the drug-containing layer; add the prescribed amount of lactose, polyoxyethylene PEO WSR303, polyoxyethylene PEO WSR N10 and talcum powder are all passed through a 60-mesh sieve, mixed evenly, which is the booster layer. A double-layer tablet press is used to compress into tablets to obtain tablet cores. Dissolve the prescribed amount of polyethylene glycol 4000 in acetone, and then dissolve the prescribed amount of ce...

Embodiment 2

[0029]

[0030]Preparation process: add the prescribed amount of drug and poloxamer into dichloromethane, and ultrasonically dissolve it completely. Rotary evaporation, water bath temperature 60 ° C, distilled off the organic solvent. Put it in a vacuum drying oven and continue drying for 30 hours to remove the residual solvent to obtain the ginkgolide solid dispersion. Pass the prescribed amount of ginkgolide solid dispersion, compressible starch, and talcum powder through a 100-mesh sieve, and mix evenly to form the drug-containing layer; pass the prescribed amount of sucrose, polyoxyethylene PEO WSR N10, and talc powder through a 100-mesh sieve. Mesh sieve, mix evenly, that is the booster layer. A double-layer tablet press is used to compress into tablets to obtain tablet cores. Dissolve the prescribed amount of polyethylene glycol 4000 in acetone, and then dissolve the prescribed amount of cellulose acetate in the solution to obtain the coating solution. The tablet c...

Embodiment 3

[0032]

[0033]

[0034] Preparation process: add the prescribed amount of medicine and polyethylene glycol 4000 into ethanol, and ultrasonically dissolve it completely. Rotary evaporation, water bath temperature 60 ° C, distilled off the organic solvent. Put it in a vacuum drying oven and continue drying for 12 hours to remove the residual solvent to obtain the ginkgolide solid dispersion. Pass the prescribed amount of ginkgolide solid dispersion, lactose, and talcum powder through a 80-mesh sieve, and mix evenly to form the drug-containing layer; pass the prescribed amount of glucose, polyoxyethylene PEO WSR303, and talc powder through a 80-mesh sieve, and mix Uniform, that is, the booster layer. A double-layer tablet press is used to compress into tablets to obtain tablet cores. Dissolve the prescribed amount of polyethylene glycol 4000 in acetone, and then dissolve the prescribed amount of cellulose acetate in the solution to obtain the coating solution. The table...

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Abstract

The invention provides a ginkgolide osmotic pump tablet and a preparation method thereof. The ginkgolide osmotic pump tablet provided by the invention is a double-layer tablet composed of a drug-containing layer and a push layer, and is coated, wherein the drug-containing layer comprises drug release holes. The ginkgolide osmotic pump tablet uses ginkgolide at effective positions of the ginkgo biloba extract as an active component, and a total amount of ginkgolide A, ginkgolide B, ginkgolide Cand bilobalide is not less than 70 %. According to the invention, by combining a solid dispersion solubilising technique and an osmotic pump tablets control-release technology, the ginkgolide is firstly prepared into the solid dispersion, and then further prepared into the ginkgolide osmotic pump tablet on a basis of improving solubility of poorly soluble components, thereby realizing synchronous slow release of complex components in the ginkgolide, reducing drug administration times and improving patient compliance.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a ginkgolide osmotic pump tablet and a preparation method thereof. Background technique [0002] Ginkgo biloba preparations are currently one of the most important drugs used for the treatment and prevention of cardiovascular and cerebrovascular diseases in the world and at home, and are also the herbal medicines with the largest sales volume and widest acceptance. my country's ginkgo resources account for more than 70% of the world's total resources. The annual output of ginkgo leaves is as high as 20,000 tons, and the annual output of ginkgo leaf standard extract (EGb761) is more than 100 tons. The raw materials are sufficient. The raw materials of foreign ginkgo products are also mainly from my country. The export value of Ginkgo biloba and Ginkgo biloba standard extracts ranks first in Chinese herbal medicines in my country. But the research ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/44A61K31/365A61P9/10A61P11/06A61P25/00
Inventor 韩丽妹王建新马琳怡张琴张林
Owner FUDAN UNIV
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