Glimepiride dropping pill

A technology of urea dripping pills and Glimepiride, applied in the field of glimepiride dropping pills, can solve the problems of poor stability of glimepiride, high temperature, high humidity instability, and good stability, and achieve good drug stability and preparation The process is simple and the effect of reducing irritation

Active Publication Date: 2014-12-03
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main reason is that the solid dispersion has aging phenomenon, and the drug crystals will be precipitated from the carrier during storage, resulting in slower dissolution
[0010] Glimepiride has poor stability, is unstable to high temperature and high humidity, and is easy to degrade at room temperature for a long time to produce large impurities
The compatibility test of glimepiride with polyethylene glycol and poloxamer proves that glimepiride will be degraded during the storage process of the prepared dropping pills, resulting in the related substances exceeding the standard
[0011] The prior art fails to provide a glimepiride preparation with high dissolution rate and good stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030]

[0031] Preparation Process:

[0032] (1) Heat polyoxyethylene (40) stearate in a 60℃ water bath to melt;

[0033] (2) Crush the glimepiride, copovidone, and calcium ammonium alginate through a 120-mesh sieve, weigh them according to the prescription, mix them evenly, add them to the molten carrier material, stir evenly, keep warm at 60°C, and set aside;

[0034] (3) Drop the drug mixture solution prepared in (2) into dimethyl silicone oil below 10° C. to cool, filter, centrifuge to remove the oil, and package to get it.

Embodiment 2

[0036]

[0037]

[0038] Preparation Process:

[0039] (1) Heat polyoxyethylene (40) stearate in a 60℃ water bath to melt;

[0040] (2) Crush the glimepiride, copovidone, and calcium ammonium alginate through a 120-mesh sieve, weigh them according to the prescription, mix them evenly, add them to the molten carrier material, stir evenly, keep warm at 60°C, and set aside;

[0041] (3) Drop the drug mixture solution prepared in (2) into dimethyl silicone oil below 10° C. to cool, filter, centrifuge to remove the oil, and package to get it.

Embodiment 3

[0043]

[0044] Preparation Process:

[0045] (1) Heat polyoxyethylene (40) stearate in a 60℃ water bath to melt;

[0046] (2) Crush the glimepiride, copovidone, and calcium ammonium alginate through a 120-mesh sieve, weigh them according to the prescription, mix them evenly, add them to the molten carrier material, stir evenly, keep warm at 60°C, and set aside;

[0047] (3) Drop the drug mixture solution prepared in (2) into dimethyl silicone oil below 10° C. to cool, filter, centrifuge to remove the oil, and package to get it.

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PUM

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Abstract

The invention provides a glimepiride dropping pill which contains copovidone, calcium alginate ammonium and polyoxyethylene (40) stearate. The glimepiride dropping pill provided by the invention has the advantages of high dissolution rate, good stability, simple preparation process and small toxic and side effect.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a glimepiride dripping pill. Background technique [0002] Glimepiride (glimepiride) is a new sulfonylurea hypoglycemic agent, the chemical name is 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, molecular weight: 490.62, structural formula is as follows: [0003] [0004] Glimepiride was developed by the German company Hoechst Marion Roussel (HMR). It was first marketed in Sweden under the trade name Amaryl in September 1995. It was approved by the FDA to enter the US market in 1996. It is used to treat diets and exercises that are not controlled. Type 2 diabetes, it is the first sulfonylurea drug approved by the FDA that can be used simultaneously with insulin. Because the drug has a shorter action time with the receptor and shortens the secretion time of islet cor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/64A61K47/36A61K47/34A61K47/32A61P3/10
Inventor 赵志全陈小伟丁兵郑华
Owner SHANDONG NEWTIME PHARMA
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