特殊制剂体外群体生物等效性研究案例分析  

Case study of in vitro population bioequivalence of special preparations

作　　者：潘琦 石友权 胡大裕 郑恒[1] PAN Qi;SHI You-quan;HU Da-yu;ZHENG Heng(Department of Pharmacy,Tongji Hospital Affiliated with Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430030,China;Hubei Topgene Biotechnology Co.,Ltd.,Hubei Wuhan 430075,China)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,湖北武汉430030 [2]湖北天勤生物科技有限公司,湖北武汉430075

出　　处：《中国医院药学杂志》2022年第19期2028-2033,共6页Chinese Journal of Hospital Pharmacy

摘　　要：目的:采用体外群体生物等效性评价方法评估4种特殊制剂的等效性。方法:对国内外指南中关于群体生物等效性的内容进行总结,选择混合标度法,针对不同制剂,主要考察粒径参数、给药装置等体外测量数据参数,将指南中的公式和方程运用于2种吸入制剂(吸入用布地奈德混悬液和左沙丁胺醇雾化吸入溶液)以及2种脂质纳米注射剂(阿扎胞苷注射剂和注射用白蛋白结合型紫杉醇)的等效性研究。结果:该文的体外群体生物等效性研究取得良好的实践结果,除了阿扎胞苷注射剂的受试制剂与参比制剂不等效,需要对粒径继续加以改进外,其他3种制剂有95%的把握度说明受试制剂与参比制剂等效。结论:该研究成功将指南中的公式运用在实际案例中,对特殊制剂体外群体生物等效性在制剂研发中的应用有指导意义。OBJECTIVE To evaluate the equivalence of four special preparations by in vitro population bioequivalence evaluation method.METHODS The contents of population bioequivalence in the guidelines at home and abroad were summarized.The mixed scale method was selected to investigate the in vitro measurement data parameters such as particle size parameters and drug delivery devices for different preparations.The formulas and equations in the guidelines were applied to the equivalence study on two inhalation preparations(budesonide inhaler and atomized inhalation solution of levalbuterol)and two lipid nanoinjections(azacytidine injection and injection of paclitaxel in albumin combined type).RESULTS In this paper,the in vitro population bioequivalence study achieved good results,except that the tested preparation of azacytidine injection was not equivalent to the reference preparation,and the particle size should to be improved.The other three preparations were equivalent to the reference preparations in 95%confidence interval.CONCLUSION This study successfully applied the formulas in the guidelines to practical cases,which is of guiding significance for the application of in vitro population bioequivalence of special preparations to the research and development of preparations.

关 键 词：吸入制剂 纳米注射剂 体外群体生物等效性 粒径分布 递送速率 

分 类 号：R943[医药卫生—药剂学]