Composition of long-acting oral pills of Yansuan Tanshuluoxin and its production

Abstract

An orally taken long-acting small pill of tamsulosin hydrochloride is proportionally composed of a core, a tamsulosin hydrochloride layer, a first release regulating layer chosen from Youteqi L30D55, Sulisi and kollicoat SR3D, a release assistant layer chosen from alginic acid, microcrystalline fiber and carboxymethyl cellulose sodium, and a second release regulating layer chosen from ethylcellulose, Youteqi L100 and Youteqi S100. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to an oral long-acting small pill composition of tamsulosin hydrochloride with uniform gastric dissolution rate and a manufacturing method thereof. Background technique [0002] The chemical name of tamsulosin hydrochloride is (R)(-)-5-[2-[[2-(o-ethoxyphenoxy)ethyl]amino]-2-methoxybenzenesulfonamide hydrochloride, Molecular formula is C 20 h 28 N 2 o 5 S. Tamsulosin has the effect of cutting off adrenal α1A receptors, especially its hydrochloride (Tansulosin hydrochloride) has the effect of cutting off α1 receptors in the urethra and prostate, so by reducing the pressure of the prostate in the urethral pressure curve, it can improve Difficulty urinating due to an enlarged prostate. [0003] Regarding the prior art of tamsulosin hydrochloride long-acting preparations, Korean Patent Publication No. 1993-0007245 describes adding a release modifier to a mixture of a physiologically active substance and a unit form and granulatin...

AI Technical Summary

Problems solved by technology

However, the method described in this patent is more difficult to adjust the desired ion size when granulating, so the obtained particles have a larger range of particle distribution from 0.1 to 1.5 mm as described in said patent

This uneven particle distribution reduces the utilization rate of raw materials because the gastric dissolution rate is not uniform or even only particles of a certain size are used.

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