生物相关性溶出度方法研究进展

Research Advances of Bio-relevance Dissolution Method

综述具有生物相关性的溶出度方法,以通过理想的体外溶出试验预测体内药动学过程。近年来,研究表明在生物相关性溶出介质中选择合适的溶出装置进行溶出试验得到的溶出曲线能较好地反映其在体内的溶出行为,计算机模拟软件可为建立合理的体外溶出度方法提供指导和依据。通过采用合适的生物相关性溶出介质、溶出装置,结合计算机模拟软件可建立A级水平的体内外相关性(in vitro-in vivo correlation,IVIVC),可能代替生物等效性研究。

The aim of establishing a bio-relevance dissolution method is to predict pharmacokinetics process in vivo via an appropriate dissolution test. In recent years, studies have shown that the dissolution profile obtained in bio-relevance dissolution medium with suitable dissolution test device can reflects the dissolution process in vivo. Computer simulation software can offer a guide and basis for establishing a reasonable dissolution test. By using suitable bio-relevance dissolution medium, dissolution test device and computer simulation software, level A IVIVC（in vitro-in vivo correlation） could be established, which could replace bioequivalence studies.