Sustained-release pellet of ginkgo biloba extract and its preparation

A technology of sustained-release pellets and ginkgo leaves, applied in the preparation of drug sustained-release preparations, sustained-release pellets of ginkgo biloba extract and its preparation, can solve the problem of susceptibility to food and gastrointestinal emptying, slow-release Tablets are prone to problems such as sudden release and large fluctuations in blood drug concentration, achieving high yield and reproducibility, improving safety and effectiveness, and good fluidity

Inactive Publication Date: 2008-09-10
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It discloses that ordinary tablets and capsules of Ginkgo biloba extract are administered frequently, and the blood concentration fluctuates greatly. It also discloses that the sustained-release tablets still have the following defects: they are easily affected by operating conditions such as pressure in large-scale production, making it difficult to control the quality , easily affected by food and gastrointestinal emptying after oral administration, and most sustained-release tablets are prone to burst release, etc.

Method used

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  • Sustained-release pellet of ginkgo biloba extract and its preparation
  • Sustained-release pellet of ginkgo biloba extract and its preparation
  • Sustained-release pellet of ginkgo biloba extract and its preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1, prepare blank pellet

[0045] formula

[0046]

[0047] Mix the formula amount of lactose or microcrystalline cellulose and starch evenly, add the binder prepared by sucrose or hypromellose, use a granulator or a coating pan to get the mother and spheronize to the required mesh size of 15-30 mesh , add lubricant and glidant while rolling, dry, and sieve out 20-30 mesh blank pellets.

Embodiment 2

[0048] Embodiment 2, preparation quick-release pellet

[0049] formula

[0050]

[0051] Add the ginkgo biloba extract, hypromellose or polyvinylpyrrolidone in the prescribed amount into 70% or 80% ethanol respectively, and ultrasonicate for 15 minutes to form a uniform solution. In a fluidized bed or a coating pan, the temperature of the pellets is kept at 30° C., and the solution is evenly sprayed on the outer layer of the blank pellets obtained in Example 1 to prepare immediate-release pellets.

Embodiment 3

[0052] Embodiment 3, preparation sustained-release pellet

[0053] formula

[0054]

[0055] Preparation Process:

[0056] Put the quick-release pellets obtained in Example 2 into a fluidized bed or a coating pan, control the temperature of the pellets at 28°C, add triethyl citrate and talcum powder to the acrylic resin RS30D, stir evenly, and spray on The outer layer of the immediate-release pellets is made into sustained-release pellets; or,

[0057] Put the instant-release pellets obtained in Example 2 into a fluidized bed or a coating pan, keep the temperature of the pellets at 38°C, add PEG4000 to the ethylcellulose aqueous dispersion, stir evenly, and spray on the instant-release pellets. The outer layer of the pill is made into sustained-release pellets.

[0058] Determination of the release rate of sustained-release pellets

[0059] Release measurement conditions:

[0060] Instrument: ZRS-4 Drug Dissolution Apparatus

[0061] Solvent: pH6.8 phosphate buffer 90...

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PUM

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Abstract

The present invention belongs to the field of medical sustained-release preparation and relates to a ginkgo leaf extract sustained-release mini-pill and a preparation method thereof. The preparation consists of a hollow pill core, a quick-release layer and a release control layer to be filled into hard capsule. The preparation method is that a filling agent, a bond and a lubricant are uniformly mixed according to certain proportion to be made into the smooth round hollow pill core with 15 to 30 meshes. The ginkgo leaf extract and a macromolecular material bond are prepared into mixed liquid to be coated over the hollow pill core to be made into a quick-release mini-pill. A retarder, a pore-forming agent, a plasticizing agent or an antisticking agent are dissolved or dispersed by coating solvent to be sprayed over the outer layer of the quick-release mini-pill to be made into a sustained-release mini-pill, so as to ensure that the increasing weight of the sustained-release mini-pill is controlled within 5 percent to 30 percent. The sustained-release mini-pill can effectively control drug to be released slowly within 24 hours, the patient can take only once every day, which can ensures the medication compliance of the patient and especially aged patient and dementia patient and improves the safety and effectivity of medication.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to the preparation technology of sustained-release preparations of medicines, in particular to a sustained-release pellet of ginkgo biloba extract and a preparation method thereof. Background technique [0002] Ginkgo biloba L., also known as Gongsun tree, is one of the oldest plants and is known as the living fossil of gymnosperms. According to the records of Compendium of Materia Medica, ginkgo fruit has the functions of astringing the lungs, relieving asthma, stopping enuresis and leucorrhea. Modern pharmacological studies have shown that Ginkgo biloba extract has pharmacological effects such as inhibiting the production of oxygen free radicals, anti-platelet aggregation, improving myocardial tolerance to hypoxia, and improving blood supply in ischemic areas. The relevant Ginkgo biloba extract has been recorded in the Pharmacopoeia of the People's Republic of C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61K9/48A61K9/22A61K47/38A61P39/06A61P9/10A61P7/02
Inventor 裴元英王俊
Owner FUDAN UNIV
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