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Metformin hydrochloride controlled-release tablet and preparation method thereof

A technology for metformin hydrochloride and sustained-release tablets, which is used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. and other problems, to achieve the effect of large production capacity, low production cost and small weight gain

Active Publication Date: 2009-11-18
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are the following problems in these preparations for sustained release through the matrix: ① uneven drug release, sudden release or no release; ② heavy tablets, in the above-mentioned patents, when the main component metformin hydrochloride is 500 mg, the tablet weight is generally 800 mg to 1000 mg

Method used

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  • Metformin hydrochloride controlled-release tablet and preparation method thereof
  • Metformin hydrochloride controlled-release tablet and preparation method thereof
  • Metformin hydrochloride controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0021] Embodiment: a kind of metformin hydrochloride sustained-release tablet, its preparation method is: at first metformin hydrochloride raw material and filler, binding agent are pulverized respectively, cross 120 mesh sieves; Add the agent into the wet granulator, stir evenly at a high speed, add the binder, continue to stir and mix, and make a soft material, then granulate, dry, granulate, add lubricant and press to get the plain tablet; the plain tablet is qualified Finally, pass the coating solution through a 100-200 mesh sieve, preheat the plain tablet to 40°C-50°C and start spraying, set the flow rate at 200-300ml / min, and control the speed at 4-6 rpm. The air temperature is 50°C-60°C, and the outlet air temperature is 40°C-50°C. Under the condition that the plain sheet does not stick to the pan, it is sprayed and dried to obtain the finished product.

example 1

[0022] Example 1: The weight ratio of each component is shown in Table 1:

[0023] Table 1

[0024]

[0025]Preparation steps: according to the above proportions: firstly crush metformin hydrochloride, compressible starch, and lactose respectively, pass through a 120 mesh sieve, weigh them according to the prescription amount, and set aside; take ethyl cellulose and appropriate amount of 95% ethanol (refrigerated overnight) Finally, make up 95% ethanol according to the above-mentioned proportion to make a 5% coating liquid, for subsequent use;

[0026] Take compressible starch, prepare 7% starch slurry, and set aside;

[0027] Take metformin hydrochloride and lactose powder, mix them uniformly according to the principle of equal amount addition, and make soft material with 7% starch slurry.

[0028] Granulate with a 14-mesh sieve, dry at 55-60°C, and control the water content to less than 3%.

[0029] After sizing with a 16-mesh sieve, add the prescribed amount of magnes...

example 2

[0034] Example 2: The weight ratio of each component is shown in Table 3:

[0035] table 3

[0036]

[0037] Preparation steps: according to the above ratio: first, crush metformin hydrochloride, compressible starch, and gelatin, pass through a 120-mesh sieve, weigh them according to the prescription amount, and set aside; take ethyl cellulose, and an appropriate amount of 95% ethanol (refrigerated overnight) Finally, make up 95% ethanol according to the above-mentioned proportion to make a 5% coating liquid, for subsequent use;

[0038] Take metformin hydrochloride, gelatin powder, compressible starch and mix uniformly according to the principle of increasing in equal amounts, and make a soft material with an appropriate amount of purified water.

[0039] Granulate with a 14-mesh sieve, dry at 55-60°C, and control the water content to less than 3%.

[0040] After sizing with a 16-mesh sieve, add the prescribed amount of talcum powder, mix evenly, and press into tablets w...

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Abstract

The invention provides a metformin hydrochloride controlled-release tablet, which comprises a metformin hydrochloride controlled-release tablet with effective dose and pharmaceutical accessories and is characterized in that the metformin hydrochloride controlled-release tablet uses the common tabletting, and the controlled-release effect is controlled by totally depending on the film coating technique. The coating adopted by the invention is a releasing system comprising the prescription which can cause the medicine to reach release degree standard in vitro. The preparation method in the invention is simple and convenient; the process conditions are easy to control and suitable for batch production, can use conventional production equipment in pharmaceutical industries for economically and conveniently producing the metformin hydrochloride controlled-release tablet on a large scale, can effectively and stably cause the release degree of the metformin hydrochloride controlled-release tablet in the second hour to be 10% to 35%, the release degree to be 40% to 70% in the sixth hour and the release degree to be more than 80% in the twelfth hour.

Description

technical field [0001] The invention relates to a metformin hydrochloride sustained-release tablet suitable for treating type II diabetes that cannot be effectively controlled by diet and exercise alone and a preparation method thereof. Background technique [0002] As a serious non-communicable chronic disease, diabetes has become the "third killer" that threatens human beings after tumors and cardiovascular and cerebrovascular diseases. No matter in developed or developing countries, its incidence rate is rising sharply. It is estimated that in 2007, about 246 million people worldwide suffered from diabetes, 46% of whom were in the labor force aged 40 to 59. If no measures are taken, it is estimated that by 2025, the number of diabetic patients in the world will increase to 380 million, of which 80% will be concentrated in China. low-income countries. At present, there are more than 20 million diabetic patients in my country, and there is a trend of increasing year by ye...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K9/22A61K31/155A61K47/38A61K47/40A61K47/42A61P3/10A61K47/10
Inventor 杨莉何远东
Owner CHONGQING CONQUER PHARML
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