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A kind of ginkgolide double-layer controlled-release tablet and preparation method thereof

A technology of ginkgolide and controlled-release tablets, which is applied in the field of pharmaceuticals, can solve the problems of short drug action time and short elimination half-life, and achieve the effects of preventing and treating cardiovascular and cerebrovascular diseases, avoiding peak and valley phenomena, and less adverse reactions

Active Publication Date: 2021-03-16
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Ginkgolide preparations are considered to be the latest generation of Ginkgo biloba preparations, but the elimination half-life of ginkgolides in the human body is short, 1-3h, and the drug effect time is short

Method used

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  • A kind of ginkgolide double-layer controlled-release tablet and preparation method thereof
  • A kind of ginkgolide double-layer controlled-release tablet and preparation method thereof
  • A kind of ginkgolide double-layer controlled-release tablet and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0036] A kind of ginkgolide double-layer controlled-release tablet, the raw material ratio of every 1000 tablets is as shown in the following table:

[0037]

[0038]

[0039] The preparation method of described ginkgolide bilayer controlled-release tablet, comprises the steps:

[0040] S1. Dissolve povidone K30 in 50% ethanol solution to obtain adhesive solution A; put the ginkgo biloba extract and lactose in the prescribed amount in a grinder and grind for 3.5 hours, transfer them to a wet granulator, and add hydroxyl Promellose K4M, mixed evenly, added binder solution A, granulated, dried, granulated, then added magnesium stearate, silicon dioxide and mixed evenly to obtain drug-containing layer granules;

[0041] S2, dissolving povidone K30 in 50% ethanol solution to obtain binder solution B; placing the prescribed amount of glyceryl behenate, lactose, hypromellose E5, and iron oxide yellow in a wet granulator , mix evenly, add binder solution B, granulate, dry, gra...

Embodiment 2

[0045] A kind of ginkgolide double-layer controlled-release tablet, the raw material ratio of every 1000 tablets is as shown in the following table:

[0046]

[0047] The preparation method of described ginkgolide bilayer controlled-release tablet, comprises the steps:

[0048] S1. Dissolve povidone K30 in 50% ethanol solution to obtain adhesive solution A; put the ginkgo biloba extract and lactose in a grinder to grind for 3 hours, transfer to a wet granulator, and add hydroxypropyl Methocel K4M, mixed evenly, added binder solution A, granulated, dried, granulated, then added magnesium stearate, silicon dioxide and mixed evenly to obtain drug-containing layer granules;

[0049] S2, dissolving povidone K30 in 50% ethanol solution to obtain binder solution B; placing the prescribed amount of glyceryl behenate, hypromellose E5, and iron oxide yellow in a wet granulator, and mixing Uniformly, add binder solution B, granulate, dry, granulate, then add magnesium stearate and si...

Embodiment 3

[0053] A kind of ginkgolide double-layer controlled-release tablet, the raw material ratio of every 1000 tablets is as shown in the following table:

[0054]

[0055] The preparation method of described ginkgolide bilayer controlled-release tablet, comprises the steps:

[0056] S1. Dissolve povidone K30 in 50% ethanol solution to obtain binder solution A; place the prescribed amount of ginkgo leaf extract and lactose in a grinder and grind for 3 hours, transfer them to a wet granulator, and add polyoxygen Ethylene N10, mix evenly, add binder solution A, granulate, dry, granulate, then add magnesium stearate and silicon dioxide and mix evenly to obtain drug-containing layer granules;

[0057] S2, dissolving povidone K30 in 50% ethanol solution to obtain binder solution B; placing the prescribed amount of glyceryl behenate, lactose, hypromellose E5, and iron oxide yellow in a wet granulator , mix evenly, add binder solution B, granulate, dry, granulate, then add magnesium stea...

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Abstract

The invention discloses a ginkgolide two-layer controlled release tablet. The ginkgolide two-layer controlled release tablet comprises a drug-containing layer and a platform layer, wherein the drug-containing layer comprises a ginkgo leaf extract, a hydrogel polymer, a hydrophilic agent, a binder, a glidant and a lubricant; the platform layer comprises a hydrophobic agent, a hydrogel polymer, a hydrophilic agent, a binder, a coloring agent, a glidant and a lubricant; and the ginkgo leaf extract is an effective part of ginkgolide, and the total amount of ginkgolide A and ginkgolide B in the ginkgolide is not less than 70%. The invention also discloses a preparation method of the ginkgolide double-layer controlled release tablet. The ginkgolide double-layer controlled release tablet providedby the invention is clinically used for improving microcirculation and preventing and treating cardiovascular and cerebrovascular diseases. The ginkgolide double-layer controlled release tablet provided by the invention is a controlled release preparation, which has excellent drug release performance and can realize synchronous and slow release of complex components in ginkgolide, thereby reducing the times of drug administration and improving the compliance of patients. Experiments prove that the release rate of the ginkgolide double-layer controlled release tablet provided by the inventionis stable in the first 10 hours, and the cumulative release rate is as high as 96% within 20 hours, so that the ginkgolide double-layer controlled release tablet has very good release property.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a ginkgolide double-layer controlled-release tablet and a preparation method thereof. Background technique [0002] Ginkgo biloba is the dried leaf of Ginkgo biloba plant. It is sweet, bitter, astringent and flat in nature and taste, and it has the effects of astringing the lungs, relieving asthma, promoting blood circulation and removing blood stasis, and relieving pain. It is used clinically to improve microcirculation, prevent and treat Cardiovascular and cerebrovascular diseases, etc. [0003] With the development of Ginkgo biloba research, it has been proved that the active ingredients of Ginkgo biloba are mainly flavonoids and lactones. Among them, ginkgolides are important components with a special structure and significant pharmacological activity that are only found in Ginkgo biloba, and have not been found in any other plants so far. More importantly, they have uniq...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/24A61K36/16A61K47/26A61P9/14A61P9/00A61K127/00A61K31/365
CPCA61K9/2018A61K9/2086A61K31/365A61K36/16A61K2300/00
Inventor 杨贤龙何勇吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH