两相溶出系统及其在难溶性药物制剂评价中的应用

Biphasic dissolution test and its application in the evaluation of poorly soluble drug preparations

两相溶出系统由水相和有机相组成,是一个同时测定药物溶出和分配的体外溶出方法,具有模拟体内吸收、克服表面活性剂对溶出的影响等优点,在评价难溶性药物的体外溶出方面具有良好的应用前景。本文综合近年来该领域的相关研究,对两相溶出系统的发展历史、溶出装置、理论模型及应用作简要综述,并对研究前景进行了总结与展望。

Biphasic dissolution test,consisting of immiscible aqueous and organic phase,is an in vitro dissolution method that simultaneously measures the dissolution and partition of drugs.Due to the advantages of simulating in vivo absorption and overcoming the influence of surfactants on dissolution,it has been widely used to evaluate the poorly soluble drugs in vitro dissolution.Based on the relevant research in this field in recent years,this review summarizes the history,dissolution device,theoretical model and application of the biphasic dissolution test.Finally,the prospects in the development of biphasic dissolution test are also outlined.