异维A酸胶丸的人体生物等效性研究  

Study on Bioequivalence of Isotretinoin Capsules in Healthy Volunteers

作　　者：陈白莹[1] 夏铮铮[2] 赵语[2] 

机构地区：[1]南方医科大学附属深圳市妇幼保健院药剂科,广东深圳518028 [2]重庆医科大学附属大学城医院药学部,重庆401331

出　　处：《中国药房》2013年第14期1287-1289,共3页China Pharmacy

摘　　要：目的:对比研究两种不同厂家生产的异维A酸胶丸在健康人体内的生物等效性。方法:22名健康男性受试者按交叉试验设计方案分别口服异维A酸胶丸受试制剂或参比制剂各40mg,采集服药后60h内动态血标本;采用高效液相色谱电喷雾串联质谱(HPLC-MS/MS)法测定人血浆中异维A酸质量浓度,计算药动学参数。结果:受试制剂与参比制剂在人体内的药动学过程符合二室模型,药动学参数分别为cma(x808.08±248.15)、(846.73±220.08)ng/ml,tma(x2.8±1.0)、(2.8±1.2)h,t1/(217.02±3.79)、(17.91±4.71)h,AUC0-60(h9993.55±2807.07)、(10059.79±3116.8)ng·h/ml,主要药动学参数无显著性差异。结论:两种制剂生物等效。OBJECTIVE： To study the bioequivalence of Isotretinoin capsules from 2 manufacturers in healthy volunteers com- paratively. METHODS ： Test preparation and reference preparation 40 mg of Isotretinoin capsules were given to 22 male healthy vol- unteers in randomized two-way crossover design. 60 h dynamic plasma samples were collected after medication; the concentrations of isotretinoin in human plasma were determined by HPLC-MS/MS, and the pharmacokinetic parameters were calculated. RE- SULTS： The pharmacokinetic behavior of test preparation and reference preparation conformed to two-compartment open model. cmax were （808.08 ＋ 248.15） ng/ml and （846.73 ± 220.08）ng/ml; tmax were （2.8± 1.0）h and （2.8± 1.2）h ; AUC0-60b were （9 993.55±2 807.07）ng.h/ml and （10 059.79 ±3 116.8）ng.h/ml; t1/2 were （17.02± 3.79）h and （17.91±.71） h, respectively. There was no significant difference in the basic pharmacokinetic parameters of them. CONCLUSIONS： The statistical analysis shows that the two products are bioequivalent.

关 键 词：异维A酸 高效液相色谱串联质谱法 药动学 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R979.1[医药卫生—药学]