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Pharmaceutical composition containing gliclazide

A Glichetide and composition technology, applied in the field of sustained-release pharmaceutical compositions, can solve problems such as poor water solubility and incomplete release of the main drug, and achieve the effect of increasing water solubility

Inactive Publication Date: 2009-07-01
北京德众万全医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the poor water solubility of Glichet, the sustained-release preparations prepared by the preparation methods provided by the above two patents have incomplete release of the main drug

Method used

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  • Pharmaceutical composition containing gliclazide
  • Pharmaceutical composition containing gliclazide
  • Pharmaceutical composition containing gliclazide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] This embodiment is made into a solid dispersion first and then into a sustained-release tablet

[0015]

[0016] Preparation process: weigh gliclazide and PEG6000 according to the prescription amount, use 95% ethanol solution as a binder, add hypromellose, and wet granulate with 60 mesh. Dried at 50°C, crushed and stirred with calcium hydrogen phosphate, sodium alginate, acesulfame potassium and colloidal silicon dioxide to dissolve, 30 mesh wet granulation, and dried at 60°C. Whole grains with 26 meshes, measure the water content, add magnesium stearate and acesulfame potassium, mix, and compress into tablets at 60-80N.

Embodiment 2

[0018] This embodiment is made into a solid dispersion first and then into a sustained-release tablet

[0019]

[0020] Preparation process: weigh gliclazide and PEG6000 according to the prescription amount, use 95% ethanol solution as a binder, add hypromellose, and wet granulate with 60 mesh. Dried at 50°C, crushed and stirred with calcium hydrogen phosphate, sodium alginate, acesulfame potassium and colloidal silicon dioxide to dissolve, 30 mesh wet granulation, and dried at 60°C. Whole grains with 26 meshes, measure the water content, add magnesium stearate and acesulfame potassium, mix, and compress into tablets at 60-80N.

Embodiment 3

[0022] This embodiment mode directly makes sustained-release tablet as

[0023]

[0024] Preparation process: Weigh gliclazide, calcium hydrogen phosphate and PEG6000 according to the prescription, use 95% ethanol solution as a binder, add acesulfame potassium and colloidal silicon dioxide and stir to dissolve them, 30 mesh wet granulation, Dry at 60°C. The granules are sized at 26 mesh, the water content is measured, magnesium stearate is added and mixed, and then pressed into tablets at 60-80N.

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Abstract

The invention relates to pharmaceutical composition with gliclazide and preparation method thereof. By producing solid dispersion, the invention improves the releasing rate of the medicament, so as to achieve better sustained-release purpose. The pharmaceutical composition applied to the treatment of diabetes, and reduces the frequency of injecting medicine and helps stabilize the blood concentration of the patients, meanwhile, the adaptability is increased too.

Description

technical field [0001] The invention relates to a sustained-release pharmaceutical composition for treating diabetes, in particular to a sustained-release pharmaceutical composition containing gliclazide solid dispersion. Background technique [0002] Gliclazide is a second-generation sulfonylurea hypoglycemic drug (also known as methylsulfonylurea), which is a commonly used hypoglycemic drug in clinical practice. Due to its definite curative effect, it is included in the National Essential Drug List and medical insurance drug. Currently, ordinary oral tablets containing 80 mg of gliclazide are used clinically. However, the short-term plasma concentration of its active ingredients reaches a peak in the patient's body, resulting in toxic and side effects. Sustained-release preparations can effectively solve this problem, making the blood drug concentration of active ingredients in the patient's body balanced and stable, and avoiding the occurrence of drug poisoning peaks. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/64A61K9/22A61K47/38A61P3/10
Inventor 蔡巍
Owner 北京德众万全医药科技有限公司
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