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Method for preparing tamsulosin hydrochloride sustained release preparation

A slow-release preparation, the technology of tamsulo hydrochloride, is applied in the directions of pharmaceutical formulations, drug combinations, active ingredients of amides, etc., to achieve the effects of simple process steps, single types of excipients, and uniform drug loading in pellets

Active Publication Date: 2012-12-19
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The inventor of this patent has developed a preparation method of tamsulosin hydrochloride sustained-release preparation through a large number of experiments, which effectively solves the problems existing in the preparation process of the existing preparation, such as content uniformity, reasonable and stable drug release, etc.

Method used

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  • Method for preparing tamsulosin hydrochloride sustained release preparation
  • Method for preparing tamsulosin hydrochloride sustained release preparation
  • Method for preparing tamsulosin hydrochloride sustained release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023]

[0024] Preparation:

[0025] (1) Add 2.0 g of tamsulosin hydrochloride to 100 ml of ethanol, heat to dissolve, mix evenly with 500 g of microcrystalline cellulose, dry in an oven at 60°C for 2 hours, pulverize, pass through a 100-mesh sieve, and then mix evenly with the remaining microcrystalline cellulose to obtain The drug-containing mixture is passed through a 100-mesh sieve and set aside.

[0026] (2) Get the drug-containing mixture obtained in (1) and place it in a centrifugal granulation pot, the aqueous solution of 2.5% hydroxypropyl methylcellulose is a binder, and the spraying speed is 25-75ml / min, and the medicinal powder forms spherical pellets , until the ball core grows to 40-50 mesh, discharge and dry at 60°C.

[0027] (3) Add 110g of talc powder to 500g of water, add 0.6g of simethicone and 1g of triethyl citrate, homogenize with a homogenizer to form a suspension, and add this suspension to Eudragit NE 30D 334g , stir evenly, slowly add Eudragit L...

Embodiment 2

[0030]

[0031] Preparation method is as embodiment 1

Embodiment 3

[0033]

[0034] Preparation method is as embodiment 1

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Abstract

The invention relates to a method for preparing a tamsulosin hydrochloride sustained release preparation. The method comprises the following steps of: dispersing components of a main medicament into a solvent, wherein the single excipient and the components of the main medicament are uniformly mixed in two steps; putting one part of the obtained mixture into a centrifugal granulator and preparingparent nucleuses; preparing medicament-containing pill cores by taking the residual mixture as supplied powder by a granulation method; and preparing coating fluid by a method of mixing two coating materials, and coating the medicament-containing pill cores. The method for preparing the tamsulosin hydrochloride sustained release preparation is simple and easy to operate, the problem that a trace amount of main medicament of the preparation and the excipient are difficult to fully and uniformly mix is solved, the release of the medicament is stable, and the requirements of quality standard aremet.

Description

technical field [0001] The invention relates to a preparation method of a sustained-release preparation, in particular to a preparation method of a long-acting α1 adrenergic receptor blocker tamsulosin hydrochloride sustained-release capsule. Background technique [0002] Tamsulosin hydrochloride, the chemical name is 5-[(2R)-2-[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide hydrochloride , the chemical structural formula is: [0003] [0004] Developed by Yamanouchi Pharmaceutical Co., Ltd., Japan, it is the first long-acting α1 adrenergic receptor blocker for benign prostatic hyperplasia, which can selectively block sympathetic α1 receptors, thus having high selectivity for urethra, bladder and prostate smooth muscle The ability to inhibit the rise of urethral pressure is 13 times the ability to inhibit the rise of vasodilation pressure, thereby reducing the urethral pressure of the prostate and significantly improving the urination disorder caused ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/18A61P13/08
Inventor 耿玉先黄河
Owner BEIJING WINSUNNY PHARMA CO LTD
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