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Glimepiride dispersible tablet and preparation method thereof

A technology of glimepiride and dispersible tablets, applied in the field of medicine, can solve the problems of excessive particle size of raw materials, toxic and side effects, and high dosage of medicines

Inactive Publication Date: 2012-03-21
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent Nos. ZL200910023340.5 and ZL200810207446.6 also process the glimepiride raw material by sieving and then use it for tableting. The particle size of the raw material obtained by this method is too large, resulting in a low dissolution rate after tableting , drug absorption is not complete, and high doses will bring greater toxic and side effects

Method used

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  • Glimepiride dispersible tablet and preparation method thereof
  • Glimepiride dispersible tablet and preparation method thereof
  • Glimepiride dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1: Glimepiride dispersible tablets (specification: 1mg / tablet; based on 10,000 tablets)

[0045]

[0046]

[0047] The preparation method adopts the traditional preparation method, and the steps are as follows:

[0048] (1) Micronizing glimepiride to prepare bulk drugs with different particle size ranges for use;

[0049] (2) Take the prescription amount of Povidone K 30 Put in a beating bucket, add 40% ethanol to make 1% povidone K 30 Ethanol solution, stir to dissolve completely, set aside;

[0050] (3) The prepared raw materials are mixed with the prescription amount of lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and sodium starch glycolate in an equal volume addition method. After mixing uniformly, add adhesive to make soft material. The prepared soft material has suitable humidity and viscosity, and it is advisable to "knead it into a dough and disperse when touched";

[0051] (4) Granulate the soft material with a 12-mesh screen a...

Embodiment 2

[0060] Example 2: Glimepiride dispersible tablets (specification: 2mg / tablet; based on 10,000 tablets)

[0061]

[0062]

[0063] The internal addition and external addition of the above-mentioned components are based on the amount of internal and external auxiliary materials used in the "internal and external addition of auxiliary materials" method of the present invention. The preparation method is as follows:

[0064] (1) Micronizing glimepiride to prepare APIs with different particle size ranges for use;

[0065] (2) Take the prescription amount of Povidone K 29 / 32 Put it in a beating bucket and add purified water to make 10% povidone K 29 / 32 Aqueous solution, stir to dissolve completely, set aside;

[0066] (3) The spare raw materials are mixed with the prescribed amount of internal adjuvants lactose, sodium starch glycolate, and povidone in an equal incremental manner. After mixing uniformly, add adhesive to make soft material. The prepared soft material has suitable humidity a...

Embodiment 3

[0078] Example 3: Glimepiride dispersible tablets (specification: 1mg / tablet; based on 10,000 tablets)

[0079]

[0080] The preparation method is as follows:

[0081] (1) Micronize glimepiride to make D 90 Less than 3.6μm, D 50 Between 1.5μm~1μm, spare;

[0082] (2) Take the prescription amount of Povidone K 30 Put in a beating bucket, add 40% ethanol to make 1% povidone K 30 Ethanol solution, stir to dissolve completely, set aside;

[0083] (3) The prepared raw materials are mixed with the prescription amount of lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and croscarmellose sodium in an equal volume addition manner. After mixing uniformly, add adhesive to make soft material. The prepared soft material has suitable humidity and viscosity, and it is advisable to "knead it into a dough and disperse when touched";

[0084] (4) Granulate the soft material with a 12-mesh screen and dry at 40℃;

[0085] (5) Whole grain, the mesh number of the screen is 10 m...

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Abstract

The invention discloses a glimepiride dispersible tablet and a preparation method thereof. The dispersible table is prepared by micronizing the medicament glimepiride to control the grain diameter to be lower than 10 mu m, and adding auxiliary materials. According to the prepared dispersible tablet, the stability and absorption rate of the medicament are remarkably improved, and the bioavailability and curative effect are increased, so that the dose is reduced, toxic and side effects caused by the medicament are lightened, and the problems of low dissolution rate and the like of the conventional glimepiride tablets are solved. The method is suitable for the glimepiride dispersible tablet, which is mainly used for treating II-type diabetes mellitus which cannot be controlled in diet control and exercise.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and relates to a glimepiride preparation and a preparation method thereof, in particular to a glimepiride dispersible tablet and a preparation method thereof. technical background [0002] Glimepiride chemical name: 1-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)-ethyl]-benzenesulfonyl ]-3-(trans-4-methylcyclohexyl)-urea, molecular formula: C 24 H 34 N 4 O 5 S, has the following structure: [0003] [0004] Glimepiride is a new sulfonylurea hypoglycemic agent developed by Hoechst Marion Roussel (HMR) in Germany. It was first marketed in Sweden under the trade name Amaryl in September 1995 and was approved by the FDA to enter the US market in 1996. It is used to treat type II diabetes that is not controlled by diet and exercise. It is the first sulfonylurea drug approved by the FDA that can be used simultaneously with insulin. [0005] This product is a third-generation sulfonylurea long-acti...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/64A61P3/10
Inventor 汪玉梅张晓幸马慧丽王蓓王忠李冬梅杜淑朋董朝蓬朱亚芳
Owner 石药集团中诺药业(石家庄)有限公司
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