软胶囊溶出度试验方法研究策略

Research Strategy of Dissolution Test of Soft Capsules

目的针对软胶囊剂型特点和处方组成,探讨软胶囊溶出度试验方法的适用性,为建立软胶囊质量控制方法提供参考。方法通过分析各国药典关于软胶囊溶出特性试验的要求,结合近年来国内外相关实验研究进展,对比各国药典软胶囊典型品种的溶出方法的异同。结果软胶囊溶出特性试验较一般固体口服制剂要复杂,且各国药典对软胶囊溶出特性要求不尽相同,其内容物的处方组成和亲水亲脂性、囊壳的破裂和交联作用、溶出装置等对其溶出特性均有影响。结论建立软胶囊溶出度试验方法可从溶出装置的选择、溶出介质的选择、破裂试验和体内外相关性等方面进行分析研究。

OBJECTIVE To provide references for effective quality control of soft capsules and discuss the applicability of meth- od for dissolution test of soft capsules. METHODS Based on analyzing dissolution requirements of soft capsules, we were compared the differences of methods for dissolution test in the pharmacopoeias of several countries with current correlative research from home and abord. RESULTS The dissolution characteristics of soft capsules are more complex than common oral solid dosage forms, and the requirments are different in the pharmacopoeias of several countries. The formula of contents, hydrophilicity, rupture test and crosslik- ing have impacts on the dissolution characteristics as well as dissolution device and so on. CONCLUSION In order to develop the method for dissolution test of soft capsules, the dissolution device and medium, rupture test and in vitro-in vivo correlation etc. should be studied.