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Solid compound preparation containing metformin hydrochloride and glimepiride, preparation method and application thereof

A technology for metformin hydrochloride and compound preparations, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and pill delivery, etc. Can't reach etc.

Active Publication Date: 2014-01-15
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the applicant found in the research that the dissolution rate of glimepiride in the tablet prepared by the above-mentioned method is relatively slow, and it cannot reach the level of the common tablet of Amoli (product of Sanofi-Aventis Pharmaceuticals, France) imported from abroad. , the original manufacturer of glimepiride tablets) dissolution rate
In accordance with the technical requirements of the National Center for New Drug Evaluation, the quality standards of each main drug in the compound preparation are in accordance with the quality level requirements of a single preparation of a marketed product, and the dissolution rate of any main drug must not be lower than the quality standard of a marketed product before clinical research or approval is possible. The product is on the market, therefore, the preparation process cannot meet the relevant technical requirements

Method used

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  • Solid compound preparation containing metformin hydrochloride and glimepiride, preparation method and application thereof
  • Solid compound preparation containing metformin hydrochloride and glimepiride, preparation method and application thereof
  • Solid compound preparation containing metformin hydrochloride and glimepiride, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Take 1000.5g of metformin hydrochloride (particle size: 200 μ m), 20.2g of lactose, and 30.1g of mannitol, and use a high-speed stirring granulator to pre-mix for 3 minutes to make them uniform, and then add 91.4 g of povidone k30 aqueous solution (15%, w / w) , making soft materials, granulating with a swing granulator, and drying in a fluidized bed to obtain metformin hydrochloride granules with a moisture content of 0.75% by weight.

[0092] Take 40.0 g of glimepiride (particle size 2.5 μm), 200.8 g of lactose, 100 g of sucrose, and 18.0 g of croscarmellose sodium, and use a high-speed stirring granulator to pre-mix for 3 minutes to make them uniform, and then add povidone k25 aqueous solution (10%, w / w) 74.2 g of soft material, granulated by a swing granulator, and dried in a fluidized bed to obtain glimepiride granules.

[0093] According to the calculation results of the particle content, take 530.5 g of the above-mentioned metformin hydrochloride granules and 18.5 ...

Embodiment 2

[0095] Take 1000.5g of metformin hydrochloride (particle size 1000μm), 30.2g of maltodextrin, 58g of crospovidone, add 89.4g of povidone k30 aqueous solution (15%, w / w), and use a high-speed stirring granulator to pre-mix evenly , make soft material, shake granulator granulation, fluidized-bed drying obtains metformin hydrochloride granule, granule moisture 0.3% by weight, add croscarmellose sodium 1.8g, magnesium stearate 5.2g, micropowder silica gel 5.1g, Set the multi-directional mixer to mix for 5 minutes to make it uniform, and obtain the mixture containing metformin hydrochloride granules.

[0096] Take glimepiride 40.2g (particle size 20μm), lactose 1200.6g, glucose binder 1200g, xylitol 600.3g, crospovidone 50.1g, mix well, add povidone k25 aqueous solution (20%, w / w) 247.3g of soft material, granulated by a swing granulator, and dried in a fluidized bed to obtain glimepiride granules, adding 40.2g of sodium carboxymethyl starch, 5.3g of calcium stearate, 2.5g of talc...

Embodiment 3

[0099] Take 1000.3g of metformin hydrochloride (particle size 150μm), 401g of mannitol, 55.2g of dextrose, 45g of dextran, add 180.5g of povidone k25 aqueous solution (15%, w / w), and use a high-speed stirring granulator Mix uniformly in advance, make soft material, shake granulator granulation, fluidized bed drying obtains metformin hydrochloride granule, granule moisture 1.5% by weight, add sodium carboxymethyl starch 18.1g, zinc stearate 4.3g, talcum powder 2.2g, 2.0 g of micropowder silica gel was placed in a multidirectional mixer and mixed for 5 minutes to make it uniform to obtain a mixture containing metformin hydrochloride granules.

[0100] Take 40.2 g of glimepiride (particle size 1.0 μm), 300.3 g of lactose, 300 g of dextrose binder, and 30.1 g of croscarmellose sodium, mix well, add povidone k30 aqueous solution (10%, w / w ) 153.2g of soft material, granulated by a swing granulator, dried in a fluidized bed to obtain glimepiride granules, added 20.5g of croscarmello...

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Abstract

The invention provides a solid compound preparation containing metformin hydrochloride and glimepiride. The solid compound preparation is prepared from metformin hydrochloride granules and glimepiride granules. The metformin hydrochloride granules contain metformin hydrochloride and an adhesive, and the glimepiride granules contain glimepiride, a water soluble filler, a disintegrating agent and an adhesive. The solid compound preparation does not contain water insoluble filler. The invention also provides a preparation method and application of the solid compound preparation. Compared with common preparations and preparations adopting a water insoluble filler, the solid compound preparation provided by the invention can significantly improve the dissolution rate of glimepiride, and can effectively reduce interaction of the two main drugs, thereby reducing the increase of related impurities in a placement process. The product has stable quality and good uniformity, so that the effectiveness and safety of drug use by patients can be improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. Specifically, the invention relates to a solid compound preparation containing metformin hydrochloride and glimepiride, a preparation method and application thereof. Background technique [0002] Both metformin hydrochloride and glimepiride are drugs for the treatment of type Ⅱ diabetes, and their combined application has a synergistic effect, and is suitable for patients who cannot effectively control blood sugar with sulfonylureas alone or who have taken sulfonylureas and metformin at the same time for combined treatment of patients. [0003] The combined application of metformin hydrochloride and glimepiride has been applied and disclosed in domestic and foreign patents, such as the US patent US2003018028A1 applied by the American Wyeth Pharmaceutical Company, the world patent WO9903477A1 applied by the American Smith Kline Pharmaceuticals Company, etc. [0004] A large number of pr...

Claims

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Application Information

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IPC IPC(8): A61K31/64A61K31/155A61K47/32A61K9/16A61K9/24A61K9/28A61K9/20A61P3/10A61P3/04A61P3/06A61P9/10A61P9/12
Inventor 张俊伟宋丽明王杏林杨志强尹东东
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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