Tamsulosin Hydrochloride sustained-release preparation, preparation method and applications thereof

Abstract

The present invention relates to a tamsulosin hydrochloride sustained-release preparation, a preparation method and applications thereof. The preparation comprises, by weight, 5-95% of framework type medicine-containing sustained-release micro-pills, 1-20% of a film control type sustained-release coating film, and 1-10% of a medicine-containing rapid-release layer, wherein the framework type medicine-containing sustained-release micro-pills comprise 0.01-1% of tamsulosin hydrochloride, 5-50% of a sustained-release material, 1-10% of an adhesive, and 5-50% of a pore forming agent, the film control type sustained-release coating film comprises 1-40% of a sustained-release material, 1-5% of a plasticizer, 10-60% of a pore forming agent, and 1-5% of an anti-adhesion agent, and the medicine-containing rapid-release layer comprises 0.01-1% of tamsulosin hydrochloride, 1-95% of a rapid-release material, and 1-10% of an adhesive. The tamsulosin hydrochloride sustained-release preparation has advantages of fast, stable, sustained, and long-lasting effect, low side effect, controllable quality, suitability for mass production and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a tamsulosin hydrochloride sustained-release preparation, a preparation method thereof and an application thereof. Background technique [0002] Tamsulosin hydrochloride (structure shown in formula I, also known as tamsulosin hydrochloride) is a potent and highly selective α1-adrenergic receptor inhibitor (blocker), clinically used for the treatment of benign prostate Dysuria due to hyperplasia (BPH) and enlarged prostate. In vitro tests have shown that tamsulosin hydrochloride has a better curative effect than the similar drug terazosin hydrochloride. However, oral preparations of tamsulosin hydrochloride have rapid absorption and rapid onset of action, which may cause adverse reactions such as hypotension and dizziness, so tamsulosin hydrochloride sustained-release preparations are often used clinically. [0003] [0004] At present, tamsulo...

AI Technical Summary

Problems solved by technology

[0013] The tamsulosin hydrochloride matrix sustained-release preparation disclosed in the aforementioned literature is either a single release system or a membrane-controlled pellet release system, wherein the matrix granulation size, tabletting pressure fluctuation, and membrane-controlled pellet coating in the single release system Changes in the membrane and drug release pores will significantly affect the drug release behavior, which will lead to defects such as large drug release differences between batches and poor reproducibility in small-dose tamsulosin hydrochloride sustained-release preparations, while the release system of membrane-controlled pellets has initial defects. Defects such as insufficient drug release

Images