磷酸川芎嗪胶囊的人体生物等效性研究  

Study on Bioequivalence of Ligustrazine Phosphate Capsules in Healthy Volunteers

作　　者：文爱东[1] 周敏[1] 杨志福[1] 毕琳琳[1] 王志睿[1] 贾艳艳[1] 吴寅[1] 

机构地区：[1]第四军医大学西京医院药剂科,西安710032

出　　处：《中国药师》2007年第6期520-522,共3页China Pharmacist

摘　　要：目的:评价两种磷酸川芎嗪胶囊的生物等效性。方法:20名健康志愿者单剂量随机交叉口服两种磷酸川芎嗪胶囊100mg,采用HPLC法测定血浆中磷酸川芎嗪浓度;用DAS 2.0生物等效性软件计算主要药物动力学参数和生物等效性。结果:受试制剂和参比制荆其主要药动学参数t_(1/2)分别为(0.82±0.37)和(0.97±0.42)h;C_(max)分别为(2.12±0.62)和(1.96±0.52)mg·L^(-1),t_(max)分别为(0.33±0.09)和(0.36±0.10)h,AUC_(0-1)分别为(1.84±0.38)和(1.75±0.39)mg·h·L^(-1),AUC_(0-∞)分别为(1.86±0.40)和(1.78±0.39)mg·h·L^(-1),经方差分析和双单侧t检验,C_(max),t_(max),AUC_(0-1),AUC_(0-∞)均无统计学差异,受试制剂的相对生物利用度为105.5%。结论:两种磷酸川芎嗪胶囊在健康人体内具有生物等效性。Objective： To evaluate the bioequivalence of ligustrazine phosphate capsules in healthy volunteers. Method： Twenty healthy volunteers were randomly administrated with an oral single and crossover dose of 100 mg test or reference ligustrazine phosphate capsules. The plasma concentration of ligustrazine phosphate was measured by HPLC and the pharmacokinetic parameters were calculated using a DAS 2.0 practical pharmacokinetics program. Result： The pharmacokinetic parameters for test and reference ligustrazine phosphate were as follows： t1/2 were（0. 82 ±0.37） vs. （0.97 ±0.42） h;Cmax were（2.12 ±0.62）vs. （1.96 ±0.52）mg.L^-1 ;tmax（0. 33 ±0.09）vs. （0.36±0. 10）h,;AUC0-t were（1.84 ±0.38）vs. （1.75 ±0.39）mg.h.L^-1;AUC0-∞ were （1.86 ±0.40） vs. （1.78 ± 0.39 ） mg·h·L^-1, respectively. There were no significantly differences in main pharmacokinetic parameters between two treatments, The relative bioavailability of test ligustrazine phosphate capsules was 105.5%. Conclusion： The test capsules are bioequivalent to the reference capsules.

关 键 词：磷酸川芎嗪 生物等效性 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]