西替伪麻缓释片释放度测定方法研究

Study of cetirizine hydrochloride and pseudoephedrine hydrochloride sustained-release tablets in vitro release behavior

目的探讨西替伪麻缓释片的体外释放特性。方法以水为溶剂,采用《中国药典》2000年版二部溶出度测定第一法测定装置测定,定量测定采用高效液相法测定。对均一性、释放度曲线、不同溶剂介质的释放特点进行了考察。结果盐酸伪麻黄碱的释药曲线可用一级方程动力学拟合,证明国产西替伪麻缓释片具有较好的体外释放特性。结论该方法简便、宜行。

Aim To explore release characteristics in vitro of cetirizine/pseudoephedrine sustained release tablets. Methods The tablets＇ release was determined with water as the solvent using the first method of dissolution specified in the volume Ⅱ of ChP 2000 edition and quantitative assay was performed using HPLC. Their uniformity, release curve, and release characteristics in different solvents were examined. Results The release curve of pseudoephedrine hydrochloride can be fitted with the first-order equation dynamics. It indicates that home - made cetirizine/pseudoephedrine sustained release tablets have satisfactory release characteristics in vitro. Conclusion The method is simple and easy to perform.