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Metformin hydrochloride tablet and preparation method thereof

A technology of metformin hydrochloride tablets and metformin hydrochloride, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as poor dissolution uniformity between batches, and achieve Good batch-to-batch reproducibility, high similarity, and low finished tablet weight

Active Publication Date: 2019-09-10
BEIJING ZHONGHUI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the problems of metformin hydrochloride tablets in the prior art, the uniformity of dissolution between batches and poor reproducibility between batches, the invention provides a metformin hydrochloride tablet

Method used

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  • Metformin hydrochloride tablet and preparation method thereof
  • Metformin hydrochloride tablet and preparation method thereof
  • Metformin hydrochloride tablet and preparation method thereof

Examples

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Effect test

Embodiment 1

[0031] The embodiment of the present invention provides a kind of metformin hydrochloride tablet, and composition comprises metformin hydrochloride, binder, skeleton membrane material and lubricant, binder is povidone K30, skeleton membrane material is magnesium stearate, lubricant is hard Magnesium fatty acid. Its preparation method is:

[0032] Add 40g of binder, 10g of skeleton membrane material and deionized water to make a suspension with a concentration of 20% by mass, and carry out one-step granulation of 925g of metformin hydrochloride with a particle size ≤ 2mm, and the air inlet temperature is 60-70°C , the air outlet temperature is 45-55°C, after the granulation is completed, dry until the water content is 0.5-2.5%, discharge, granulate with 16 mesh, add 5g of lubricant, mix well, compress into tablets, the tablet weight is 540mg.

Embodiment 2

[0034] The embodiment of the present invention provides a kind of metformin hydrochloride tablet, and composition comprises metformin hydrochloride, binder, skeleton membrane material and lubricant, binder is povidone K30, skeleton membrane material is sodium stearate, lubricant is hard Magnesium fatty acid. Its preparation method is:

[0035] Add 40g of binder, 10g of skeleton membrane material and deionized water to make a suspension with a concentration of 20% by mass, and carry out one-step granulation of 925g of metformin hydrochloride with a particle size ≤ 2mm, and the air inlet temperature is 60-70°C , the air outlet temperature is 45-55°C, after the granulation is completed, dry until the water content is 0.5-2.5%, discharge, granulate with 16 mesh, add 5g of lubricant, mix well, compress into tablets, the tablet weight is 540mg.

Embodiment 3

[0037] The embodiment of the present invention provides a metformin hydrochloride tablet, the composition includes metformin hydrochloride, a binder, a skeleton film material and a lubricant, the binder is povidone K30, the skeleton film material is stearic acid, and the lubricant is stearin Magnesium acid. Its preparation method is:

[0038] Add 40g of binder, 10g of skeleton membrane material and deionized water to make a suspension with a concentration of 15% by mass, and carry out one-step granulation of 925g of metformin hydrochloride with a particle size ≤ 2mm, and the air inlet temperature is 60-70°C , the air outlet temperature is 45-55°C, after the granulation is completed, dry until the water content is 0.5-2.5%, discharge, granulate with 16 mesh, add 5g of lubricant, mix well, compress into tablets, the tablet weight is 540mg.

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a metformin hydrochloride tablet and a preparation method thereof. The components of the metformin hydrochloride tablet comprise metformin hydrochloride, a binder, a framework film material and a lubricant, wherein the framework film material is selected from at least one of sodium stearate, magnesium stearate, stearic acid and the like. The preparation method of the tablet is a one-step granulation method. The in-vitro dissolution condition of the provided metformin hydrochloride tablet is highly similar to that of an original triturate, the tablet has excellent inter-batch stability, and the in-batch and inter-batch dissolution uniformity and inter-batch reproducibility of the tablet are superior to those of the original triturate.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a metformin hydrochloride tablet and a preparation method thereof. Background technique [0002] Metformin hydrochloride is a biguanide hypoglycemic drug used to treat non-insulin-dependent (type Ⅱ) diabetes. Especially for obese and hyperinsulinemia patients, this drug not only has hypoglycemic effect, but also reduces weight and Effects of hyperinsulinemia. Metformin hydrochloride can be used in combination with sulfonylureas, intestinal glycosidase inhibitors or thiazolidinediones to achieve better hypoglycemic effect. [0003] The commonly used dosage forms of metformin hydrochloride on the market mainly include ordinary tablets, sustained-release tablets, enteric-coated tablets and enteric-coated capsules. However, metformin hydrochloride is a water-soluble drug, and its common preparation is likely to cause digestive tract irritation symptoms due to ex...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/155A61K47/38A61K47/32A61K47/12A61P3/10
CPCA61K9/2013A61K9/2027A61K9/2054A61K9/2866A61K31/155A61P3/10
Inventor 曲永战李文博何希睿陈丙跃魏佳申云凤
Owner BEIJING ZHONGHUI PHARM CO LTD
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