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Metformin hydrochloride sustained-release tablet and method for preparing the same

A technology of metformin hydrochloride and sustained-release tablets, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, metabolic diseases, etc., can solve problems such as pain and inconvenience for patients, and achieve the advantages of simple process, reduced raw material cost, and reduced dosage. Effect

Active Publication Date: 2004-11-10
GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the effective dose of metformin hydrochloride sustained-release tablets is 500mg per tablet each time, it is necessary to swallow the whole tablet and not crush it when taking it. It is very inconvenient to have to swallow a tablet that is too heavy, and it is even more difficult for Chinese people. That’s right, and some patients need to take medicine for a long time. If they swallow large tablets for a long time, the patient will feel very painful.

Method used

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  • Metformin hydrochloride sustained-release tablet and method for preparing the same
  • Metformin hydrochloride sustained-release tablet and method for preparing the same
  • Metformin hydrochloride sustained-release tablet and method for preparing the same

Examples

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Comparison scheme
Effect test

Embodiment 1

[0049] Take by weighing metformin hydrochloride 500g, hypromellose (model 15KM) 105g; Micropowder ethyl cellulose 110g (model: 10FP, specification: viscosity is 9.0~11.0 centipoise, ethoxyl content is 48.0~49.5%, average The grain diameter is 3-15), ethyl cellulose (model: 10CP) 7g, talcum powder 5g, magnesium stearate 2g.

[0050] Preparation: 500 g of metformin hydrochloride (preliminarily crushed, passed through 100 mesh) and hydroxypropyl methylcellulose (HPMCK15M). Mix mechanically, add 10% ethyl cellulose (85% ethanol) to granulate during stirring, dry and granulate. After the above-mentioned sized dry granules, add micronized ethylcellulose dry powder, talcum powder and magnesium stearate, place in a granulator, and mix evenly. Tablet, get 1000 pieces. Each tablet contains 500mg of metformin hydrochloride, and the weight of the tablet is 729mg.

Embodiment 2

[0052] Take by weighing metformin hydrochloride 500g, hydroxypropyl methylcellulose (model 100KM) 150g; Micropowder ethylcellulose 110g (model: 7FP, specification: viscosity is 6.0~8.0 centipoise, and ethoxyl content is 48.0~49.5%, average The grain diameter is 5-15), ethyl cellulose (type: 10CP) 5g, lactose 30g, talc powder 1g, magnesium stearate 4g.

[0053] Operation method: powder metformin hydrochloride and lactose, pass through 100 mesh, hydroxypropyl methylcellulose pass through 80 mesh, mechanically mix, add 8% ethyl cellulose (70% ethanol) to granulate during stirring, dry, whole grain. After the above-mentioned sized dry granules, add micronized ethylcellulose dry powder, talcum powder and magnesium stearate, place in a granulator, and mix evenly. Tablet, get 1000 pieces. Each tablet contains 500mg of metformin hydrochloride, and the weight of the tablet is 811mg.

Embodiment 3

[0055] Weigh 500 g of metformin hydrochloride, 350 g of hydroxypropyl methylcellulose (model: 4KM); 125 g of micronized ethylcellulose (model: 7FP), 25 g of lactose, 4 g of talc, and 5 g of magnesium stearate.

[0056] Operation method: powder metformin hydrochloride and lactose, pass through 100 mesh, and pass through 100 mesh of hydroxypropyl methylcellulose. Mechanically mix, add 65% ethanol to granulate during stirring, dry and granulate. After the above-mentioned sized dry granules, add micronized ethylcellulose dry powder, talcum powder and magnesium stearate, place in a granulator, and mix evenly. Tablet, get 1000 pieces. Each tablet contains 500mg of metformin hydrochloride, and the weight of the tablet is 1000mg.

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Abstract

The invention provides a Metformin Hydrochloride slow release tablet and process for preparation, wherein the slow release tablet comprises metformin hydrochloride 46.5-70%, hydroxypropylcellulose 13.5-33.0%, micronization ethyl cellulose 10.0-14.0%, filling agent 1.3%-9.4%, and lubricating agent 1.2-1,5%. The preparation process comprises processing the prescribed raw material of metformin hydrochloride, cellulose glycollic ether, and the filling agent through the conventional tablet production process of granulation, drying, granulating, charging micronization ethyl cellulose, mixing homogenously with lubricant and tabletting.

Description

technical field [0001] The invention relates to a sustained-release agent for treating hyperglycemia and a preparation method thereof, in particular to metformin hydrochloride sustained-release tablets and a preparation method thereof. Background technique [0002] Metformin hydrochloride, as one of the commonly used drugs for the treatment of diabetes, is mainly used to control blood sugar levels in patients with type II diabetes. It mainly increases the anaerobic glycolysis of muscle tissue by strengthening the uptake and utilization of glucose by surrounding tissues, while aerobic metabolism remains unchanged. It concentrates on the intestinal wall, inhibits the absorption of glucose in the intestine, and inhibits gluconeogenesis. Inhibits the release of glucagon or inhibits the action of insulin antagonists, and increases insulin sensitivity. Metformin hydrochloride has a hypoglycemic effect on diabetics with normal or lost islet function, but has no hypoglycemic effect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/155A61P3/10
Inventor 张霖泽温新国陈卫谢锦桃
Owner GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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