坦索罗辛缓释制剂释放度检测分析  

Analysis of the Release Degree of Tamsulosin Sustained-Release Preparation

作　　者：王卓琰 高莹莹[1] 商丽丽[1] WANG Zhuo-yan;GAO Ying-ying;SHANG Li-li(Baicheng Institute of Food and Drug Inspection)

机构地区：[1]白城市食品药品检验所

出　　处：《中国标准化》2023年第18期169-173,共5页China Standardization

摘　　要：盐酸坦索罗辛属是治疗良性前列腺增生症(BPH)的药物,为选择性α1肾上腺素受体阻断剂,用于治疗前列腺增生症引起的排尿障碍。口服本品常释制剂会出现血药浓度迅速升高,易引起血压下降,因此本品适宜制成缓释制剂。盐酸坦索罗辛吸收迅速(BCSI类),故稳定释放是保证本品安全性和有效性的重要条件。本文根据吉林省检验研究院关于《盐酸坦洛新(坦索罗辛)缓释制剂质量分析》,进一步进行关于坦索罗辛缓释制剂释放度检查分析。Tansulosin hydrochloride is used for the treatment of benign prostatic hyperplasia(BPH),which is a selectiveα1 adrenaline receptor blocking agent used for urination disorders caused by prostatic hyperplasia.The blood concentration of oral regular release preparation of this product increases rapidly,which is easy to decrease blood pressure,so this product is suitable for slow-release preparation.Tansorosin hydrochloride is absorbed quickly(BCS class I),so the stable release is an important condition to ensure the safety and effectiveness of this product.Based on the quality analysis of Tanluoxin(Tansorlosin)by Jilin Provincial Institute of Inspection,this paper carries out the inspection and analysis of the release degree of Tansorlosin preparations.

关 键 词：坦索罗辛 释放度 处方工艺 标准 分析 

分 类 号：R927.1[医药卫生—药学]