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Metformin hydrochloride and glibenclamide composition and preparation method thereof

A technology for metformin gliclide and metformin hydrochloride, which is applied in the field of chemical medicine, can solve the problems of high automation, unfavorable scale and continuous production, and achieves the effect of uniform mixing

Active Publication Date: 2021-02-26
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are defects in the existing preparation technology, which is not conducive to large-scale and continuous production. The present invention provides a method for preparing metformin glibenclamide tablets by hot-melt extrusion granulation. The hot-melt extrusion granulation has the following advantages: mixing effect Good, no dead angle; less drug loss, high yield; integrating multiple processes such as mixing and granulation, continuous production can be realized; high automation, good process reproducibility; no solvent granulation, safe and environmentally friendly

Method used

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  • Metformin hydrochloride and glibenclamide composition and preparation method thereof

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Effect test

Embodiment 1

[0021] The metformin glibenclamide composition, calculated by weight, includes 1.25 mg of glibenclamide, 250 mg of metformin hydrochloride, 250 mg of hypromellose acetate succinate, 3 mg of sodium hydroxide, and 12.5 mg of low-substituted hydroxypropyl cellulose, 5 mg of Tween 80 was also included as an adjuvant.

Embodiment 2

[0023] The metformin glibenclamide composition, calculated by weight, includes polyethylene glycol as an auxiliary agent, which is 5-25 mg by weight. Preferably, 2.5 mg of glibenclamide, 250 mg of metformin hydrochloride, 250 mg of hypromellose acetate succinate, 5 mg of sodium hydroxide, 12.5 mg of low-substituted hydroxypropyl cellulose, and 5 mg of polyethylene glycol as an auxiliary agent .

Embodiment 3

[0025] Metformin glibenclamide composition, calculated in parts by weight, includes, auxiliary agents include 5-25 mg of sodium lauryl sulfate, 10-100 mg of lactose, 3-15 mg of croscarmellose sodium, 1-10 mg of magnesium stearate. Preferably, 2.5 mg of glibenclamide, 250 mg of metformin hydrochloride, 250 mg of hypromellose acetate succinate, 5 mg of sodium hydroxide, 12.5 mg of low-substituted hydroxypropyl cellulose; 5 mg of sodium lauryl sulfate, 10 mg of lactose, 3 mg of croscarmellose sodium, and 3 mg of magnesium stearate form adjuvants.

[0026] The preparation method of the metformin glibenclamide composition is used in Example 1, Example 2 and Example 3, and the steps are: S1, preparing metformin hydrochloride and hypromellose acetate succinate in a hot-melt manner Form metformin hydrochloride solid dispersion, cut and pass through 20 mesh sieves and sieve, obtain 20 mesh granules;

[0027] S2. Glibenclamide, sodium hydroxide, and low-substituted hydroxypropyl cellu...

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Abstract

The invention relates to a metformin hydrochloride and glibenclamide composition. The metformin hydrochloride and glibenclamide composition is prepared from, by weight, 1.25-2.5mg of glibenclamide, 250-500mg of metformin hydrochloride, 250-500mg of hydroxypropyl methylcellulose acetate succinate, 3-5mg of sodium hydroxide and 12.5-25mg of low-substituted hydroxypropyl cellulose. The metformin hydrochloride and glibenclamide composition further comprises an adjuvant. The invention further discloses a preparation method. The metformin hydrochloride and glibenclamide composition has the advantages of being high in dissolution rate, few in impurity and high in effective medicine content.

Description

technical field [0001] The invention relates to the field of chemical medicine, in particular to a metformin glibenclamide composition and a preparation method thereof. Background technique [0002] Diabetes is the chronic disease with the largest number of patients in my country, and it is tending to be younger. Diabetes is a group of clinical syndromes caused by the interaction of genetic and environmental factors. Absolute or relative insufficiency of insulin secretion and decreased sensitivity of target tissue cells to insulin lead to a series of metabolic disorders such as sugar, protein, fat, water and electrolytes. Clinically, hyperglycemia is the main sign, and prolonged illness can cause damage to multiple systems. Acute metabolic disorders such as ketoacidosis can occur in severe illness or stress. [0003] Metformin glibenclamide compound preparations have already been on the market in China, and there are two specifications: 250mg containing metformin hydrochl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/64A61K31/155A61K9/20A61K47/38A61K47/26A61K47/10A61K47/20A61P3/10
CPCA61K31/64A61K31/155A61K9/2095A61K9/2054A61K9/2018A61K9/2031A61K9/2013A61P3/10A61K2300/00
Inventor 沈桦朱德其马一明李雪梅冯璐魏文肖仕远刘辉韩朋芩张宇刘家俊
Owner CHENGDU HENGRUI PHARMA
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