口服固体制剂溶出度测定方法的研究与应用进展

摘要

Solid oral drugs must undergo dissolution in gastrointestinal fluid before they can be absorbed and reach the systemic circulation. Dissolution test is an in vitro method that simulates the disintegration and dissolution of solid oral drugs in the gastrointestinal tract, which plays a more and more important role in the prescription optimization and quality evaluation. A lot of studies on dissolution technology have been made to obtain higher levels of in vivo and in vitro correlation and ensure the consistency of the quality and efficacy of oral dosages. This paper summarized the re-search progress of dissolution medium and dissolution device and their applications in some particular dosages, it is hoped to provide some reference for other researchers committed to quality evaluation of oral solid preparation and de-velopment of generic drugs.%口服固体制剂只有经过胃肠道的溶出释放并且到达体循环被吸收才能发挥药效。溶出度试验是模拟药物在胃肠道中崩解和溶出的体外试验方法，其在处方优化和制剂质量评价方面发挥着越来越重要的作用。国内外研究者对口服药物溶出技术进行了大量的研究和改进，以提高制剂溶出的体内外相关性水平，保证药品质量和疗效的一致性。本研究从溶出介质和溶出装置两方面综述了溶出度测定方法的研究进展和应用情况，以期为口服固体制剂品质评价和仿制药研发提供一定的参考。