流通池法在药物制剂中的应用进展

Application Progress of Flow-Through Cell Method In Preparations

流通池法是2020年版《中国药典》最新收载的溶出度测定方法,广泛应用于微球,纳米混悬剂、栓剂、膜剂及药物洗脱支架等的溶出度测定。在国外,应用流通池法以及对流通池法各种仪器参数的研究正逐渐成为溶出度研究的热点。在国内,关于流通池法的应用研究较少且缺乏针对性。笔者对流通池法的仪器、原理及特点进行整理,并对其在药物制剂中的应用进行归纳总结,旨在推动流通池法在我国制剂质量评价及溶出度测定等方面的应用,并与国际研究接轨。

The flow-through cell method is the latest dissolution method included in the Chinese Pharmacopoeia. It is widely used in the dissolution texts of microspheres, nanosuspensions, suppositories, membranes, and drug-eluting stents. Abroad, the applications of the flow-through cell method and the studys of various instrument parameters of the flow-through cell method are gradually becoming the hotspot of dissolution researches. In China, there are few applied researches on the flow-through cell method and lack of targeted researches. This article sorts out the instruments, principles, and characteristics of the flow-through cell method, and summarizes the applications of the flow-through cell method in Preparations. It aims to promote the applications of the flow-through cell method in the quality evaluations and dissolution texts in our country and catch up international researches.