盐酸氟桂利嗪片人体生物等效性研究  

Study on Bioequivalence of Flunarizine Hydrocloride Tablets

作　　者：李扬[1] 王威[1] 刘蕾[1] 史爱欣[1] 赫广威[1] 李可欣[1] 孙春华[1] 宋友华[1] 

机构地区：[1]卫生部北京医院临床药理基地,北京市100730

出　　处：《中国药房》2000年第3期120-122,共3页China Pharmacy

摘　　要：目的 :12名健康受试者随机自身交叉口服20mg盐酸氟桂利嗪片和孚瑞尔进行药代动力学和生物等效性研究。方法 :采用高效液相色谱荧光检测法 ,测定血浆中盐酸氟桂利嗪的浓度。结果 :经3p97生物利用度计算程序处理拟合 ,得盐酸氟桂利嗪片和孚瑞尔AUC0～∞ 分别为 (328 15±24 52) μg/ (h·L)和 (351 93±35 86) μg/ (h·L) ,Cmax 分别为 (39 41±5 67) μg/L和 (39 89±3 39) μg/L ,Tmax 分别为 (2 56±0 57)h和 (2 64±0 52)h ,经配对t检验 ,两者的主要药动学参数均无显著性差异 (P>0 05)。采用梯形法计算的盐酸氟桂利嗪片和孚瑞尔的AUC0～t 分别为 (360 40±23 50) μg/(h·L)和 (377 81±28 59) μg/(h·L)。结论 :经方差分析和双单侧检验 ,结果表明 ,两者具有生物等效性 ,盐酸氟桂利嗪片剂的相对生物利用度为 (95 7±6 6) %。OBJECTIVE:The bioequivalence and pharmacokinetics of two kinds of flunarizine hydrocloride tablets were studied in 12 healthy male volunteers METHODS:An oral dose of 20mg of test or reference flunarizine hydrocloride was given according to a randomized 2-way cross-over design,blood samples were withdrawn up to 24 hours post administration,and plasma concentrations of flunarizine hydrocloride were determined by high performance liquid chromatography(HPLC)fluorescence detection RESULTS:Concentration-time curves of two preparations fitted to a one-compartment model The peak plasma levels(Cmax)of flunarizine hydrocloride test drug and reference drug were(48 71±5 40)μg/L and (48 83±4 51)μg/L respectively, the peak time(Tmax)were(3 17±0 39)h and (3 13±0 38)h respectively,and AUC0～t were(360 40±23 50)μg/(h·L)and(377 81±28 59)μg/(h·L) respectively CONCLUSION:The pharmacokinetics and relative bioavailability data obtained in the study furnished definete proof of bioequivalence of both test and reference flunarizine hydrocloride tablets

关 键 词：盐酸氟桂利嗪 高效液相色谱法 生物等效性 

分 类 号：R972[医药卫生—药品]