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Metformin hydrochloride slowly released tablet and its preparation method

A technology of metformin hydrochloride and a preparation process, which is applied in metabolic diseases, pharmaceutical formulations, drug combinations and other directions, can solve the problems that ordinary metformin hydrochloride tablets cannot exert the hypoglycemic effect well and are inconvenient to take, and achieve the effect of inhibiting liver and kidney sugars. The effect of xenobiotic effect, reducing the frequency of taking, and simple production process

Inactive Publication Date: 2003-05-07
NANJING CHANGAO PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by the present invention is the problem that the existing metformin hydrochloride ordinary tablets cannot play a hypoglycemic effect well and are inconvenient to take

Method used

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  • Metformin hydrochloride slowly released tablet and its preparation method
  • Metformin hydrochloride slowly released tablet and its preparation method

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Experimental program
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Effect test

specific Embodiment approach 1

[0021] First, the raw materials and auxiliary materials were first dried at 50°C for 6 hours, all pulverized and passed through a 100-mesh sieve for later use; then, 500 g of metformin hydrochloride, hydroxypropyl methylcellulose HPMC (K 15M ) 450 grams, 20 grams of polyvinylpyrrolidone (PVP) are fully mixed by the method of increasing in equal amounts, then add an appropriate amount of 1% HPMC (K 15M ) 90% ethanol solution, made into soft material, granulated with 18 mesh sieve, dried at 50°C for 2 hours, taken out, granulated with 18 mesh sieve, added 30 grams of magnesium stearate and mixed evenly, and the main drug content in the measured granule was qualified Afterwards, it is pressed into tablets with a tablet machine, and finally 1,000 tablets of finished medicine can be made.

specific Embodiment approach 2

[0022] First, dry the raw materials and auxiliary materials at 60°C for 4 hours, crush them and pass through an 80-mesh sieve for later use; then, take 500 g of metformin hydrochloride, 440 g of sodium carboxymethyl cellulose, and 30 g of ethyl cellulose to fully After mixing, add an appropriate amount of 2% HPMC (K 100M ) 90% ethanol solution to make soft material, granulate with 18 mesh sieve, dry at 50°C for 2 hours, take out, granulate with 18 mesh sieve, add 30 grams of talcum powder and mix evenly, measure the main drug content in the granules after passing the test The tablet press is used to compress the tablets, and finally it can be made into 1000 tablets of finished medicine.

[0023] According to the relevant format and requirements of the 2000 edition of the Pharmacopoeia of the People's Republic of China, use 10% sodium nitroferricyanide solution-sodium ferricyanide test solution-10% sodium hydroxide solution, identification reaction of cyanide and ultraviolet sp...

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Abstract

A slowly-releasing mellitin tablet is prepared from fluamine, excipient, adhesive and lubricant through drying at 40-70 deg.C for 4-6 hrs, pulverizing, sieving by 80-120 meshes, proportionally mixing, mixing with alcohol solution, granularating by 18-mesh sieving, drying at 40-60 deg.C for 2-4 hrs, mixing with lubricant, and tabletting. Its advantages are long half-life (0.9-2.6 hr), low dosage and low by-effect.

Description

technical field [0001] The invention relates to a metformin hydrochloride sustained-release tablet and a preparation process thereof. Background technique [0002] At present, the commonly used diabetes treatment drugs in clinic include: sulfonylureas, biguanides, α-glucosidase inhibitors, insulin sensitizers and Chinese patent medicines. Among them, metformin hydrochloride is the most widely used biguanide drug in clinical practice. Compared with phenformin, it has less lactic acidosis effect and can be completely avoided. It has no hypoglycemic reaction and is effective for both obese and non-obese patients. For those who are ineffective in simple diet therapy, using this product alone can reduce their blood sugar concentration by about 20%. It is the first choice for overweight (obese) NIDDM. This product can be used alone for mild and moderate patients who are unsatisfied with simple diet control, and can also be used in combination with s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/155A61P3/10
Inventor 李战晁阳陈静
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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