米氮平片在中国健康受试者的生物等效性研究  

Bioequivalence study of mirtazapine tablets in Chinese healthy adults

作　　者：刘亮亮 董海军 宋如昕 陈刚 李光早[3] LIU Liang-liang;DONG Hai-jun;SONG Ru-xin;CHEN Gang;LI Guang-zao(Shanxi Kangbao Biological Products Co.,Ltd,Changzhi 046000,Shanxi Province,China;Nanjing CMSB Testing Technology Co.,Ltd,Nanjing 210000,Jiangsu Province,China;National Institute for Clinical Trials,The First Affiliated Hospital of Bengbu Medical College,Benbu 233000,Anhui Province,China)

机构地区：[1]山西康宝生物制品股份有限公司,山西长治046000 [2]南京西默思博检测技术有限公司,江苏南京210000 [3]蚌埠医学院第一附属医院国家药物临床试验机构,安徽蚌埠233000

出　　处：《中国临床药理学杂志》2021年第21期2951-2955,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价两种米氮平片在中国健康受试者的生物等效性和安全性。方法用液相色谱串联质谱(LC-MS/MS)法测定空腹及餐后条件下口服米氮平片后受试者血浆中药物浓度,计算两种条件下药代动力学参数,并进行生物等效性评价。结果用非房室模型计算药代动力学参数,空腹组血浆中米氮平的主要药代动力学参数如下:米氮平受试制剂/参比制剂的C_(max)、AUC_(0-t)、AUC_(0-∞)几何均数比分别为98.98%,101.13%,100.95%,其90%CI分别为90.81%~107.89%,96.50%~105.98%,96.41%~105.70%,90%CI均完全落在80.00%~125.00%。餐后组血浆中米氮平的主要药代动力学参数如下:米氮平受试制剂/参比制剂的C_(max)、AUC_(0-t)、AUC_(0-∞)几何均数比分别为106.75%,102.17%,102.32%,其90%CI分别为94.46%~120.63%,98.35%~106.14%,98.48%~106.32%,90%CI均完全落在80.00%~125.00%。结论受试制剂米氮平片与参比制剂米氮平片在中国健康受试者中具有生物等效性。Objective To evaluate the bioequivalence and safety of the two mirtazapine tablets in Chinese healthy subjects.Methods Liquid chromatography tandem mass spectrometry(LC-MS/MS)was used to determine the drug concentration in plasma of subjects after oral administration of mirtazapine under fasting and postprandial conditions.Pharmacokinetic parameters under both conditions were calculated and bioequivalence was evaluated.Results Non-atrioventricular model was used to calculate pharmacokinetic parameters,the main pharmacokinetic parameters of the fasting group in plasma were as follows:the geometric mean ratio of C_(max),AUC_(0-t),AUC_(0-∞) were 98.98%,101.13%and 100.95%,respectively.The 90%CI were 90.81%-107.89%,96.50%-105.98%,96.41%-105.70%,and 90%CI are completely fell between 80.00%-125.00%.The main pharmacokinetic parameters of the fed group in plasma were as follows:the geometric mean ratios of C_(max),AUC_(0-t),AUC_(0-∞) were 106.75%,102.17%and 102.32%,respectively;the 90%CI were 94.46%-120.63%,98.35%-106.14%and 98.48%-106.32%,respectively.The 90%CI was completely fell in 80.00%-125.00%.Conclusion Two kinds of mirtazapine tablets are determined to be bioequivalent in Chinese healthy volunteers.

关 键 词：米氮平片 药代动力学 血药浓度 生物等效性 

分 类 号：R971[医药卫生—药品]