Oral solid drug composition of metformin hydrochloride repaglinide

A technology of metformin hydrochloride and its composition, which is applied in the field of oral solid pharmaceutical composition containing metformin hydrochloride repaglinide and its preparation, and can solve problems such as complex preparation process and difficulty in industrial production

Active Publication Date: 2010-06-30
万全万特制药(厦门)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above patents all use special auxiliary materials and complicated preparation processes. There are certain difficulties in realizing industrialized production when there are few types of auxiliary materials in China and the production equipment has not yet reached the advanced level.

Method used

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  • Oral solid drug composition of metformin hydrochloride repaglinide
  • Oral solid drug composition of metformin hydrochloride repaglinide
  • Oral solid drug composition of metformin hydrochloride repaglinide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018]

[0019] Preparation:

[0020] Mix the prescribed amount of metformin hydrochloride, precrossed starch, and PVP evenly, add the ethanol solution of repaglinide, stir evenly, add an appropriate amount of purified water to make a soft material, and granulate with 16 mesh; ventilate and dry at 60°C until the water content is 2-3 %, 24 mesh granules, add croscarmellose sodium and magnesium stearate, mix evenly, press into tablets to make plain tablets, make OPADRY II 85G into a 15% aqueous solution, and coat the weight gain to 3 %, that is.

Embodiment 2

[0022]

[0023] Preparation:

[0024] Weigh the prescribed amount of starch, prepare it into 10% starch slurry, and set aside; mix the prescribed amount of metformin hydrochloride and calcium hydrogen phosphate evenly, add the ethanol solution of repaglinide, stir evenly, add starch slurry to make soft material, 16 mesh granules; ventilated and dried at 60°C until the water content is 2-3%, granulated with 24 meshes, added with sorbitol, polacrilin potassium, and magnesium stearate, mixed evenly, pressed into tablets to obtain plain tablets, and OPADRY II 85G was formulated into 15 % aqueous solution, coating weight increase to 3%, that is.

Embodiment 3

[0026]

[0027] Preparation:

[0028] Weigh the prescription amount of HPMC, prepare it into a 2% solution, and set aside; mix the prescription amount of metformin hydrochloride, mannitol, and PVP evenly, add the ethanol solution of repaglinide, after stirring evenly, add the HPMC solution to make a soft material, 16 mesh Granules; ventilated and dried at 60°C until the water content is 2-3%, granulate with 24 mesh, add sodium carboxymethyl starch and magnesium stearate, mix well, press into tablets to obtain plain tablets, and make OPADRY II 85G into a 15% aqueous solution , the weight of the coating is increased to 3%, that is to say.

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Abstract

The invention discloses an oral solid drug composition containing metformin hydrochloride repaglinide, which contains pharmaceutically acceptable carriers. The preparation process is simple, the problem of chipping is effectively solved, and simultaneously, the repaglinide has good content uniformity and dissolution; and the oral solid drug composition is used for treating type II diabetes.

Description

technical field [0001] The invention relates to an oral solid pharmaceutical composition for treating type II diabetes, in particular to an oral solid pharmaceutical composition containing metformin hydrochloride repaglinide and a preparation method thereof. Background technique [0002] Non-insulin-dependent diabetes mellitus is a disease that seriously threatens human health. Its complications are diverse and complex, and the course of the disease eventually involves the kidneys, even life-threatening. In July 2008, the FDA approved the first compound preparation for the treatment of type II diabetes, a compound preparation of metformin hydrochloride and repaglinide. [0003] Both metformin hydrochloride and repaglinide are immediate-release ingredients, and the content of repaglinide is only a few tenths of a microgram to a few micrograms. The ratio of the two main ingredients is very different, and the crystal form of metformin hydrochloride is obvious, and its compressi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4402A61K31/155A61P3/10
Inventor 尚丽霞
Owner 万全万特制药(厦门)有限公司
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