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A kind of preparation method of metformin hydrochloride sustained release tablet

A technology for metformin hydrochloride and sustained-release tablets, which can be applied to pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as uneven drug release, large proportion, and unfavorable swallowing

Active Publication Date: 2020-11-13
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned patents (1), (3) mainly use the matrix slow-release preparations, which have the following problems: (1) The tablets are heavy, and the matrix slow-release materials account for a large proportion compared with other excipients, resulting in heavy tablets, which is not conducive to swallowing
(2) Uneven drug release, sudden release and persistent release
After the standards of the Pharmacopoeia were raised in 2015, metformin hydrochloride sustained-release tablets were prepared using the process disclosed in Patent 2, and the accelerated 6-month and long-term 24-month release of the product before the improvement was close to the standard limit, and there was a quality risk

Method used

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  • A kind of preparation method of metformin hydrochloride sustained release tablet
  • A kind of preparation method of metformin hydrochloride sustained release tablet
  • A kind of preparation method of metformin hydrochloride sustained release tablet

Examples

Experimental program
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Effect test

Embodiment 1

[0028] Embodiment 1: a kind of metformin hydrochloride slow-release tablet preparation method comprises the following steps:

[0029] S1: Weigh metformin hydrochloride, carmellose sodium, pregelatinized starch, and hypromellose according to the ratio, and set aside;

[0030] S2: Take the hypromellose weighed in S1 to prepare a binder solution, wherein the solvent is purified water, and the mass fraction of the binder is 4%;

[0031] S3: Weigh the ethyl cellulose and other components according to the ratio, and set aside. The other components are polyethylene glycol 6000 and cetyl alcohol. Under stirring, the weighed ethyl cellulose, polyethylene glycol Add alcohol 6000 and cetyl alcohol to 95% ethanol solution, continue to stir until completely dissolved, soak overnight, pass through a 125-mesh sieve, and set aside.

[0032] S4: Metformin hydrochloride, carmellose sodium and pregelatinized starch are uniformly pulverized through a 85-mesh sieve, stirred and mixed for 30 minut...

Embodiment 2

[0039] Embodiment 2: a kind of metformin hydrochloride slow-release tablet preparation method comprises the following steps:

[0040] S1: Weigh metformin hydrochloride, carmellose sodium, pregelatinized starch, and hypromellose according to the ratio, and set aside;

[0041] S2: Take the hypromellose weighed in S1 to prepare a binder solution, wherein the solvent is purified water, and the mass fraction of the binder is 4%;

[0042] S3: Weigh the ethyl cellulose and other components according to the ratio, and set aside. The other components are polyethylene glycol 6000 and cetyl alcohol. Under stirring, the weighed ethyl cellulose, polyethylene glycol Add alcohol 6000 and cetyl alcohol to 95% ethanol solution, continue to stir until completely dissolved, soak overnight, pass through a 125-mesh sieve, and set aside;

[0043] S4: Metformin hydrochloride, carmellose sodium and pregelatinized starch are uniformly pulverized through a 85-mesh sieve, stirred and mixed for 30 minutes...

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Abstract

Disclosed is a method for preparing metformin hydrochloride sustained-release tablets, capable of improving stability of the metformin hydrochloride sustained-release tablets. According to the method, the sustained-release rate of metformin hydrochloride is controlled by film coating, and hydroxypropyl methylcellulose is also used as a bonding agent. The metformin hydrochloride sustained-release tablets prepared by using this preparation process are low in weight, easy to swallow, and stable in release.

Description

technical field [0001] The invention relates to a method for preparing metformin hydrochloride sustained-release tablets. Background technique [0002] Metformin hydrochloride is very soluble in water, and the active ingredient in the tablet of metformin hydrochloride will be released suddenly, causing the blood concentration of metformin hydrochloride to be unstable. The adoption of metformin hydrochloride sustained-release tablet overcomes the defective of above-mentioned tablet. [0003] At present, metformin hydrochloride sustained-release tablet is a widely used hypoglycemic drug. This kind of sustained-release agent has already been marketed, and there are many patent applications for related sustained-release technologies. Such as (1) Patent No. CN200810140349.X discloses a sustained-release material of metformin hydrochloride sustained-release tablets of carmellose K100 and glyceryl behenate, and its technology is mainly metformin hydrochloride of prescription quant...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K47/38A61K31/155A61P3/10
CPCA61K9/0002A61K9/2054A61K9/2866A61K9/2893A61K31/155
Inventor 冉诗念陈用芳蒋其斌何伟叶兆敏
Owner CHONGQING CONQUER PHARML
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