全国药品集中采购中选口服调释制剂的药学研究分析

Pharmaceutical Research and Analysis of Selected Modified-release Oral Formulations in National Centralized Drug Procurement

目的:为进一步加快口服调释类仿制制剂的药学研究提供参考。方法:通过汇总统计全国药品集中采购中选的口服调释制剂情况,结合文献、专利调研和目前申报品种情况,重点分析了部分品种特殊研究项目的技术要求,从而提出仿制制剂相应的药学研究考虑。结果与结论:与普通常释制剂相比,仿制口服调释制剂的药学研究难度较大,需对使用的参比制剂深入剖析,并结合品种特性等进行全面药学研究,从而保证仿制制剂与参比制剂的质量和疗效一致性。

Objective:To provide references for further accelerating the pharmaceutical study of generic modified-release oral formulations.Methods:Based on the summary and statistics of selected modified-release oral formulations in national centralized drug procurement,combined with literature,patent investigation and current application of drugs,the technical requirements of special research projects of some drugs were analyzed,and the pharmaceutical research considerations of generic preparations were put forward.Results and Conclusion:Compared with common immediate-release formulations,it is more difficult to conduct pharmaceutical research on generic modified-release oral formulations.Therefore,it is necessary to conduct indepth analysis of reference preparations and comprehensive CMC study based on drug characteristics,so as to ensure the consistency of quality and efficacy of generic preparations and reference preparations.