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Ginkgol biloba extract delayed pulse capsule and quality control method thereof

A technology of Ginkgo biloba extract and delayed pulse is applied in the directions of medical raw materials, pharmaceutical formulations, and measuring devices derived from Ginkgo biloba. Good isolation, reducing the link of tableting, and controllable drug release behavior

Active Publication Date: 2014-01-29
ZHEJIANG UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, considering the complex composition of EGS, it is difficult to synchronize the slow-release behavior of each component in the commonly used sustained-release preparations, and it is difficult to in-depth research on the impact of slow release on drug efficacy.

Method used

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  • Ginkgol biloba extract delayed pulse capsule and quality control method thereof
  • Ginkgol biloba extract delayed pulse capsule and quality control method thereof
  • Ginkgol biloba extract delayed pulse capsule and quality control method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0040] A ginkgo extract delayed pulse capsule, comprising an insoluble capsule body, ginkgo extract immediate-release dripping pills placed in the insoluble capsule body, an isolation layer and a time-lag layer, and a soluble capsule cap, wherein the isolation layer is made of a water-soluble material, The time-lag layer is made of polymer swelling material, and the isolation layer is located between the ginkgo extract quick-release dropping pills and the time-lag layer;

[0041]Among them: the insoluble capsule body is 0# ethyl cellulose shell; the soluble capsule cap is 0# gelatin capsule shell; Ginkgo extract quick-release drop pills are made of 20% Ginkgo extract, 2% stearic acid, 2% Tween 80 , composed of 76% polyethylene glycol, Ginkgo biloba extract, stearic acid, Tween 80 and polyethylene glycol are mixed in proportion, heated and melted evenly, then dropped into immiscible condensing agent simethicone oil to shrink and condense, The ginkgo extract quick-release drop p...

Embodiment 2

[0047] A ginkgo extract delayed pulse capsule, comprising an insoluble capsule body, ginkgo extract immediate-release dripping pills placed in the insoluble capsule body, an isolation layer and a time-lag layer, and a soluble capsule cap, wherein the isolation layer is made of a water-soluble material, The time-lag layer is made of polymer swelling material, and the isolation layer is located between the ginkgo extract quick-release dripping pill and the time-lag layer;

[0048] Among them: the insoluble capsule body is cellulose acetate shell; the soluble capsule cap is 0# gelatin capsule shell; Ginkgo extract quick-release drop pills are made of 10% Ginkgo extract, 5% stearic acid, 10% Tween 80,75 % Polyethylene glycol composition, the Ginkgo biloba extract, stearic acid, Tween 80 and polyethylene glycol are mixed in proportion, heated and melted evenly, and then dropped into immiscible simethicone oil to shrink and condense to obtain the Ginkgo biloba Extract quick-release ...

Embodiment 3

[0050] A ginkgo extract delayed pulse capsule, comprising an insoluble capsule body, ginkgo extract immediate-release dripping pills placed in the insoluble capsule body, an isolation layer and a time-lag layer, and a soluble capsule cap, wherein the isolation layer is made of a water-soluble material, The time-lag layer is made of polymer swelling material, and the isolation layer is located between the ginkgo extract quick-release dripping pill and the time-lag layer;

[0051] Among them: the insoluble capsule body is cellulose acetate shell; the soluble capsule cap is 0# gelatin capsule shell; Ginkgo extract quick-release drop pills are made of 40% Ginkgo extract, 5% stearic acid, 10% Tween 80, 45% Composed of polyethylene glycol, Ginkgo biloba extract, stearic acid, Tween 80 and polyethylene glycol are mixed in proportion, heated and melted evenly, and then dropped into immiscible simethicone oil to shrink and condense to obtain the Ginkgo biloba extract quick-release drop...

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Abstract

The invention relates to a ginkgol biloba extract delayed pulse capsule and a quality control method thereof and belongs to the technical field of pharmaceutic preparations. The ginkgol biloba extract delayed pulse capsule comprises an insoluble capsule body, ginkgol biloba extract quick release dropping pills, an isolated layer and a time delay layer which are arranged in the insoluble capsule body as well as a soluble capsule cap, wherein the isolated layer is made by adopting a water-soluble material, the time delay layer is made by adopting a macromolecule swelling material, and the isolated layer is arranged between the ginkgol biloba extract quick release dropping pills and the time delay layer. The ginkgol biloba extract delayed pulse capsule has the beneficial effects that firstly pulsed release is controlled by water absorption swelling time of a high polymer material of the time delay layer and is not influenced by variation of pH value of gastrointestinal tract or evacuation speed of the gastrointestinal tract of a patient, a time delay regulating range is wide, reproducibility is good, and individual difference is small; secondly, a traditional Chinese medicine raw material controlling method in HPLC (high performance liquid chromatography) fingerprint spectrum control is used for reference in the preparation quality control field, and the problem that quality of the existing traditional Chinese medicine multi-ingredient sustained-release preparation can not be controlled is solved.

Description

technical field [0001] The invention relates to a ginkgo extract delayed pulse capsule and a quality control method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The pulse drug delivery system is a timed drug delivery system designed according to the principles of chronopharmacology and chronotherapy. In view of the fact that cardiovascular and cerebrovascular diseases often occur in the early morning, a preparation with a time lag of 5-6 hours can be designed: the patient takes the medicine before going to bed (9-10 p.m.), and the drug is released before the onset of the disease (3-4 a.m.). It can effectively prevent and treat diseases and reduce side effects. Ginkgo biloba extract (EGS) has a wide range of pharmacological activities. Its treatment of cardiovascular and cerebrovascular diseases has definite curative effect and good safety. Its immediate release preparation (injection, etc.) is the first-line drug fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K36/16A61P9/10A61P9/14A61P3/06G01N30/02
Inventor 单伟光杨燕张晨芳付晖
Owner ZHEJIANG UNIV OF TECH
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