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Rosiglitazone slow-release tablet and its preparation method

A technology for rosiglitazone and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., to improve effectiveness and adaptability, avoid peaks and valleys, reduce The effect of the frequency of use

Inactive Publication Date: 2006-09-27
GUANGDONG PHARMA UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The object of the present invention is to provide a rosiglitazone sustained-release tablet to solve the problem of rosiglitazone taking medicine multiple times a day

Method used

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  • Rosiglitazone slow-release tablet and its preparation method

Examples

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Effect test

Embodiment 1

[0016] Example 1 Preparation of Rosiglitazone Sustained-release Tablets

[0017] Preparation of solid dispersion: Take 3500 mg of polyethylene glycol 6000 and 500 mg of rosiglitazone, mix them, heat to melt and keep stirring. Pour the molten material on a watch glass, place it in the refrigerator to cool rapidly, freeze for 24 hours, take it out, grind it and pass it through an 80-mesh sieve to obtain the solid dispersion of rosiglitazone.

[0018] Preparation of tablet cores: Take 4000 mg of rosiglitazone solid dispersion that has passed through a 80-mesh sieve, 2250 mg of sodium alginate, 1750 mg of hydroxypropyl methylcellulose (E5), 100 mg of magnesium stearate, mix them, and pass through an 80-mesh sieve Twice, press a punch with a diameter of 5.8mm to obtain the tablet.

[0019] Sustained-release tablet preparation: take 300 mg of rosiglitazone, 1350 mg of sodium alginate, 5240 mg of microcrystalline cellulose (PH101), 1050 mg of hydroxypropyl methylcellulose (K15M), 60...

Embodiment 2

[0020] Example 2 Preparation of Rosiglitazone Sustained-release Tablets

[0021] Preparation of solid dispersion: Take 6000 mg of polyethylene glycol 6000 and 2000 mg of rosiglitazone, mix them, heat to melt and keep stirring. Pour the molten material on a watch glass, place it in the refrigerator to cool rapidly, freeze for 24 hours, take it out, grind it and pass it through an 80-mesh sieve to obtain the solid dispersion of rosiglitazone.

[0022] Preparation of tablet cores: take 2240 mg of rosiglitazone solid dispersion, 4500 mg of sodium alginate, 1160 mg of hydroxypropyl methylcellulose (E5), and 200 mg of magnesium stearate that have passed through an 80-mesh sieve, mix them, and pass through an 80-mesh sieve Twice, press a punch with a diameter of 5.8mm to obtain the tablet.

[0023] Sustained-release tablet preparation: Take 240 mg of rosiglitazone, 3200 mg of sodium alginate, 4000 mg of microcrystalline cellulose (PH101), 500 mg of hydroxypropyl methylcellulose (K15...

Embodiment 3

[0024] Example 3 Preparation of Rosiglitazone Sustained-release Tablets

[0025] Preparation of solid dispersion: Take 5000 mg of polyethylene glycol 6000 and 1000 mg of rosiglitazone, mix them, heat to melt and keep stirring. Pour the molten material on a watch glass, place it in the refrigerator to cool rapidly, freeze for 24 hours, take it out, grind it and pass it through an 80-mesh sieve to obtain the solid dispersion of rosiglitazone.

[0026] Preparation of tablet cores: Take 3600 mg of rosiglitazone solid dispersion, 1600 mg of sodium alginate, 2500 mg of hydroxypropyl methylcellulose (E5), 400 mg of magnesium stearate that have passed through a 80-mesh sieve, mix them, and pass through an 80-mesh sieve Twice, press a punch with a diameter of 5.8mm to obtain the tablet.

[0027] Sustained-release tablet preparation: Take 200 mg of rosiglitazone, 1,950 mg of sodium alginate, 1,500 mg of hydroxypropyl methylcellulose (K15M), 4,000 mg of microcrystalline cellulose (PH101...

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Abstract

The present invention relates to slow released medicine preparation, and is especially one kind of slow released rosiglitazone tablet and its preparation process. The slow released rosiglitazone tablet consists of core tablet and coating layer, the core tablet consists of solid rosiglitazone dispersion, sodium alginate, hypromellose and magnesium stearate, the coating layer consists of rosiglitazone, sodium alginate, microcrystalline cellulose, hypromellose and magnesium stearate, and the solid rosiglitazone dispersion consists of rosiglitazone and polyglycol-6000. The slow released rosiglitazone tablet has less medicine taking times, relatively long period of maintaining certain blood medicine concentration in human body, long period for body to maintain sensitivity on insulin, and raised medicine safety, effectiveness and adaptability.

Description

technical field [0001] The invention relates to the field of drug sustained-release preparations, in particular to a rosiglitazone sustained-release tablet and a preparation method thereof. Background technique [0002] At present, the incidence rate of diabetes is very high, and it has become the third largest disease after heart and cerebrovascular diseases and cancer. The incidence rate in developed countries has exceeded 2%, and the incidence rate in large cities in my country has exceeded 1%. It can be mainly divided into Insulin-dependent (type I, namely IDDM) and non-insulin-dependent (type II, namely NIDDM), of which type II accounts for more than 90%. Rosiglitazone is currently the only TZD prescription drug in clinical use, and its activity is 100 times higher than that of troglitazone. No hepatotoxicity has been found in clinical trials so far, and the market prospect is very broad. Because the treatment cycle of this drug is relatively long, generally speaking, i...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4436A61K47/38A61P3/10
Inventor 吕竹芬谢清春陈燕忠申楼张宇喆
Owner GUANGDONG PHARMA UNIV
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