Dimethyl biguanide sustained release capsule and preparation method thereof

A technology of sustained-release capsules and metformin, which is applied in the field of metformin sustained-release capsules and its preparation, which can solve the problems of hospitalization and life-threatening problems, and achieve the effects of complete and uniform absorption, fewer times of taking, and stable blood drug concentration

Inactive Publication Date: 2005-01-26
范敏华
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Lactic acidosis is a relatively serious side effect. Although it occurs relatively rarely, once

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Embodiment 1: the preparation of metformin sustained-release capsules of the present invention:

[0013] 1. Preparation of drug-containing pellets:

[0014] Take 250 mg of metformin hydrochloride, 125 mg of microcrystalline cellulose blank core, 12.5 mg of povidone, and 1 ml of water, and load the aqueous solution of metformin hydrochloride and povidone on the blank core by fluidized bed technology to make drug-containing pellets.

[0015] 2. Preparation of slow-release microparticles

[0016] Take 33 mg of ethyl cellulose, 3.3 mg of diethyl phthalate, and 0.33 ml of ethanol to make a coating solution, and coat the drug-containing pellets with the coating solution to make sustained-release particles.

[0017] 3. Put the slow-release particles on the capsule shell

[0018] Sustained-release microparticles are filled into zero-size capsules to make sustained-release capsules.

Embodiment 2

[0019] Embodiment 2: the preparation of metformin sustained-release capsules of the present invention:

[0020] 1. Preparation of drug-containing pellets:

[0021] Take 250 mg of metformin hydrochloride, 100 mg of sodium carboxymethyl cellulose, 50 mg of hydroxypropyl methyl cellulose, 25 mg of microcrystalline cellulose, and an appropriate amount of water, mix them well, and place them in a spherical pellet granulator to make drug-containing pellets .

[0022] 2. Preparation of slow-release microparticles

[0023] Take 85mg of Eudragit RS100, 8.5mg of triethyl citrate, 1.7mg of polyethylene glycol 60000, and 0.85ml of ethanol to make a coating solution, and coat the drug-containing pellets with the coating solution to make sustained-release particles.

[0024] 3. Put the slow-release particles on the capsule shell

[0025] Sustained-release microparticles are filled into zero-size capsules to make sustained-release capsules.

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PUM

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Abstract

The invention discloses a dimethylbiguanide slow release capsule which includes capsule outer cover and slow release particles, wherein the slow release particles comprises dimethylbiguanide and hollow ball cores, retarding agent, slow release film forming material, bulking agent, plasticizing agent, adhesives and hole-forming agent.

Description

technical field [0001] The invention relates to a metformin capsule, in particular to a metformin sustained-release capsule and a preparation method thereof. Background technique [0002] Metformin is a biguanide antihyperglycemic agent used to treat non-insulin-dependent diabetes mellitus (NIDDM), and it is usually used clinically in the form of hydrochloride. Metformin, like other biguanide products, can cause lactic acidosis. Lactic acidosis is a relatively serious side effect. Although it occurs relatively rarely, once it occurs, 50% of the cases are very dangerous and must be hospitalized, or even life-threatening. Contents of the invention [0003] The object of the present invention is to provide a more safe and effective metformin hydrochloride sustained-release capsule for treating diabetes. [0004] Another object of the present invention is to provide a preparation method of metformin hydrochloride sustained-...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/155A61P3/10
Inventor 范敏华
Owner 范敏华
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