口服固体制剂溶出方法建立和验证的技术探讨-药学学报.PDF

服固体制剂溶出方法建立和验证的技术探讨 赵悦清，周仕海，柳文洁，程泽能*1 （中南大学湘雅药学院，湖南长沙410000 ） 摘要：体外溶出检查通常被认为可反映药物的体内溶出行为和生物利用度情况， 其在药物制剂研发和上市产品的质量控制中发挥着巨大的作用。一种溶出度实验方法 的建立，需要综合考虑药物的物理化学性质和制剂学特征，确立合适的溶出条件以模 拟药物的体内溶出行为。新建立的溶出方法不仅需要具有良好的准确性和耐用性，还 要能区分不同质量属性的药物制剂。本文依据国内外药品监管机构关于建立和验证药 物溶出方法的最新指导原则，通过查阅文献，综述了口服固体制剂溶出方法建立和溶 出度标准制定的常见问题及研究进展，以期为药物的溶出方法的建立和验证提供参考。 关键词：口服制剂；溶出方法；开发和验证；体内外相关性 中图分类号: R943 文献标识码: A 文章编号: 0513-4870 (2018) Technical discussion on development and validation of dissolution methods for solid oral dosage forms ZHAO Yue-qing，ZHOUShi-hai ，LIU Wen-jie，CHENG Ze-neng* (Xiangya School of Pha rmaceutical Science Central South University Changsha410000 China) Abstract:It is generally assumed that In vitro dissolution studies can reveal the in vivo behavior and bioavailability of a drug, and the dissolution test indisputably play a vital role in the research and development of pharmaceutical preparations as well as routine quality control of approved drugs. In order to develop adesirable dissolution method, the physicochemical properties of drug and the characteristics of its dosage form should be considered, and a proper dissolution condition is supposed to be established to necessarily simulate the in vivo dissolution behavior of drugs. The developed dissolution method should not only have the required characteristics of accuracy and durability, but also could distinguish pharmaceutic preparations with different quality. In recent years, there have 收稿日期: 20 17-10-09; 修回日期: 2017-11-13 基金项目：国家自然科学基金资助项目 ） *通讯作者 Tel ：0731805 ，E-mail ：chengzn@ 1 页共1 页 been more and more experimental articles and reports on the establishment and verification of dissolution methods for o