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Metformin hydrochloride enteric-coated sustained release tablet and preparation method thereof

A metformin hydrochloride enteric and metformin hydrochloride technology, which is applied in the field of metformin hydrochloride enteric-coated sustained-release tablets and the preparation thereof, and can solve the problems such as failure to conduct a metformin hydrochloride release test and unsatisfactory effect, etc.

Active Publication Date: 2010-07-28
贵州天安药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There are also metformin hydrochloride tablets with similar functions in the prior art. For example, the patent CN1561980A discloses a so-called metformin hydrochloride enteric-coated sustained-release tablet, and 9 groups of tests are disclosed in Table 2 of its specification sheet. The effects are not satisfactory. The above-mentioned Among the 9 groups of tests, in the 9th group of tests with the best effect, the release of metformin hydrochloride was too fast, and more importantly, the release test of metformin hydrochloride in acid solution was not carried out in this application. The medium release rate is not suitable, and the final release test is meaningless

Method used

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  • Metformin hydrochloride enteric-coated sustained release tablet and preparation method thereof
  • Metformin hydrochloride enteric-coated sustained release tablet and preparation method thereof
  • Metformin hydrochloride enteric-coated sustained release tablet and preparation method thereof

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Effect test

Embodiment 1

[0055] 1. Preparation prescription: Metformin hydrochloride 500g, sodium carboxymethylcellulose 40g, hypromellose 200g, polyvinylpyrrolidone K30 80g, 30% polyacrylic acid resin (No. IV ethanol solution 60-120ml, magnesium stearate 1% , enteric-coated powder (off-white, the enteric-coated agent of Huzhou Prospect Pharmaceutical Co., Ltd.) and an amount of ethanol, the enteric-coated sustained-release tablet of 500mg metformin hydrochloride / tablet is made.

[0056] 2. Preparation process

[0057] (1) Preparation of adhesive

[0058] Accurately weigh an appropriate amount of polyacrylic acid resin No. IV, and prepare a solution with a concentration of 30% with 95% ethanol for subsequent use.

[0059] (2) Preparation of tablet core

[0060] Take the main drug metformin hydrochloride and the auxiliary materials sodium carboxymethylcellulose, hypromellose, and polyvinylpyrrolidone K30, mix well and pass through a 60-mesh sieve, use 60-120ml of 30% polyacrylic acid resin IV ethanol s...

Embodiment 2

[0064] Preparation prescription: metformin hydrochloride 500g, sodium carboxymethylcellulose 30g, hypromellose 300g, polyvinylpyrrolidone K30 116g, 20% polyacrylic resin No. IV 60-120ml, magnesium stearate 1.0%, enteric coating powder (off-white, the enteric-coated coating agent of Huzhou Prospect Pharmaceutical Co., Ltd.) and ethanol are appropriate, make the enteric-coated slow-release tablet of 500mg metformin hydrochloride / tablet according to the method for embodiment 1

Embodiment 3

[0066] Preparation prescription: metformin hydrochloride 500g, sodium carboxymethylcellulose 30g, hypromellose 300g, polyvinylpyrrolidone K30 116g, 20% polyacrylic resin No. II 60-120ml, magnesium stearate 1.0%, enteric coating powder (off-white, the enteric-coated coating agent of Huzhou Prospect Pharmaceutical Co., Ltd.) and ethanol are appropriate, make the enteric-coated slow-release tablet of 500mg metformin hydrochloride / tablet according to the method for embodiment 1

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Abstract

The invention discloses a metformin hydrochloride enteric-coated sustained release tablet which is prepared by enteric coating the metformin hydrochloride sustained release tablet. Compared with the prior art, the sustained release tablet integrates with the enteric coating technology to prepare a new form of the metformin hydrochloride enteric-coated sustained release tablet. By using the enteric coating technology, the metformin hydrochloride does not disintegrate in the stomach or stimulate the gastric mucosa, and the adverse reaction of nausea, stomachache and diarrhea caused by medicine taking can be avoided; meanwhile, the metformin hydrochloride is prevented from being damaged by gastric juice, and the bioavailability is improved. The product is a sustained release preparation, the medicine can stably release in vivo, the effective blood concentration can be maintained for a long time, the toxic and side effects caused by over-high blood concentration in a short time are avoided, the medicine taking frequency is decreased, and the patient compliance is improved as well.

Description

technical field [0001] The invention relates to a metformin hydrochloride preparation, in particular to a metformin hydrochloride enteric-coated sustained-release tablet and a preparation method thereof. Background technique [0002] Metformin hydrochloride is the only oral antihyperglycemic drug widely used in developed countries in the world. It can improve the sugar tolerance of type 2 diabetic patients and reduce the basal and postprandial plasma glucose concentrations. The mechanism of action of this drug is different from that of sulfonylureas, and it does not produce hypoglycemia or hyperinsulinemia in normal people and patients with type 2 diabetes. The main mechanism of metformin hydrochloride for lowering blood sugar is to increase the sensitivity of peripheral tissues and liver to insulin, reduce insulin resistance, and reduce the absorption of glucose from the gastrointestinal tract. Because of its positive hypoglycemic effect, it is ineffective for people with ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/28A61K31/155A61K47/38A61K47/32A61P3/10
Inventor 张凡金联荪
Owner 贵州天安药业股份有限公司
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