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A kind of tamsulosin hydrochloride sustained-release pellet preparation

A technology of tamsulosin hydrochloride and slow-release pellets, which is applied in the direction of bulk transportation, urinary system diseases, active ingredients of amides, etc., can solve the problems of complex process, high production cost, poor production operability, etc., and achieve simple process and reduce Adverse reactions, stable and effective release effects

Active Publication Date: 2018-01-16
REGENEX PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The oral preparation includes at least two groups of pellets with different coating thicknesses, the process is complicated, the production cycle is long, the production operability is poor, and the production cost is high
[0007] At present, most conventional sustained-release preparations containing tamsulosin hydrochloride use enteric coating to control the drug release site. Luoxin is released at the same time, resulting in a burst release phenomenon within 2 to 4 hours of taking the drug, and its direct adverse reaction is to cause orthostatic hypotension

Method used

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  • A kind of tamsulosin hydrochloride sustained-release pellet preparation
  • A kind of tamsulosin hydrochloride sustained-release pellet preparation
  • A kind of tamsulosin hydrochloride sustained-release pellet preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Preparation of tamsulosin hydrochloride sustained-release capsules (based on 20,000 capsules, each capsule contains 0.2 mg tamsulosin hydrochloride)

[0031] Table 1 Example 1 Tamsulosin Hydrochloride Sustained Release Pill Core Formula Composition

[0032]

[0033] Embodiment 1 preparation method:

[0034] (1) Preparation of sustained-release pellet cores: Take tamsulosin hydrochloride, Eudragit® L100-55, microcrystalline cellulose, hypromellose E5 and Eudragit® NE30D according to the formula in the above table, and put them in a wet granulator Add water and mix evenly to make a soft material, add it to a multi-functional pellet coating machine, extrude, place it in a shot blasting pot, round it, and dry the material to make a drug-containing sustained-release pellet core;

[0035] (2) Apply the sustained-release coating layer: take 33.3g of Eudragit® NE30D, the coating material of the sustained-release coating layer, and make it into a 15-30% coating sol...

Embodiment 2

[0037] Example 2 Preparation of tamsulosin hydrochloride sustained-release capsules (based on 25,000 capsules, each capsule contains 0.2 mg tamsulosin hydrochloride)

[0038] Table 2 embodiment 2 tamsulosin hydrochloride sustained-release pellet core formula composition

[0039]

[0040] Embodiment 2 preparation method is the same as embodiment 1.

Embodiment 3

[0041] Example 3 Preparation of tamsulosin hydrochloride sustained-release capsules (based on 5000 capsules, each capsule contains 0.2 mg tamsulosin hydrochloride)

[0042] Table 3 Example 3 Tamsulosin hydrochloride sustained-release pellet core formula composition

[0043]

[0044] Embodiment 3 preparation method is the same as embodiment 1.

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Abstract

A tamsulosin hydrochloride sustained-release pellet preparation, the pellets include a tamsulosin hydrochloride sustained-release pellet core, a sustained-release coating layer and an enteric coating layer, which is a capsule. The tamsulosin hydrochloride sustained-release pellet preparation of the present invention adopts matrix sustained-release, membrane-controlled sustained-release, and enteric coating triple slow-release technology to control drug release, and the prepared tamsulosin hydrochloride sustained-release pellet capsules pass Control the release from the stomach to the intestines, and reduce the adverse reactions caused by the large amount of tamsulosin hydrochloride absorbed in a short period of time. The preparation method of the invention has simple process and can stably and effectively control the release of tamsulosin hydrochloride in vivo.

Description

technical field [0001] The invention relates to a slow-release pellet preparation, in particular to a slow-release pellet preparation of tamsulosin hydrochloride and a preparation method thereof. Background technique [0002] Tamsulosin hydrochloride, also known as tamsulosin hydrochloride, chemical name 5-[(2R)-2-[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxy Benzenesulfonamide hydrochloride. This product is used for the treatment of benign prostatic hyperplasia. It has a highly selective blocking effect on the urethra, bladder neck and prostatic smooth muscle. It is currently the most effective drug for treating benign prostatic hyperplasia with lower urinary tract symptoms. However, when it is administered with ordinary tablets or capsules, the rapid release in the body leads to a sudden increase in blood drug concentration, which is the main reason for its side effect of orthostatic hypotension. In order to avoid the above-mentioned side effects, researchers have ma...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/18A61K9/52A61P13/08A61P13/10A61P13/02
Inventor 邓子杰黄和意彭贵子陶艳王丽何清袁永玲左联卢智俊
Owner REGENEX PHARMA LTD
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