摘要
目的:评价2种辛伐他汀片的相对生物利用度和生物等效性。方法:选择18名健康受试者随机分为2组,先后予单剂量、交叉口服辛伐他汀受试制剂和参比制剂各40mg,采用液相色谱-质谱-质谱联用法测定给药后不同时间受试者血浆中辛伐他汀的浓度,对辛伐他汀受试制剂和参比制剂进行生物等效性评价。结果:辛伐他汀受试制剂和参比制剂的主要药代动力学参数:cmax分别为(9.70±6.62)及(10.06±6.29)μg/L;tmax分别为(1.64±1.01)及(1.64±0.68)h;t1/2分别为(3.48±1.16)及(4.15±1.90)h;AUC0～14h分别为(29.96±16.28)及(32.78±18.53)μg.h.L-1;AUC0～∞分别为(31.49±16.65)及(36.39±21.71)μg.h.L-1。受试制剂的相对生物利用度为(97.79±26.63)%。结论:2种制剂具有生物等效性。
Objective：To establish LC/MS/MS method for determination of Simvastatin in plasma and to study the pharmacokinetics and relative bioavailability following oral administration of trail Simvastatin tablets and reference simvastatin tablets in Chinese healthy volunteers. Methods：Eighteen volunteers were randomly divided into 2 groups. A LC-MS-MS method was used for the determination of Simvastatin in plasma after a single oral dose of 40 mg Simvastatin trail or reference samples in a crossover design. The pharmacokinetic parameters as well as relative bioavailability were analyzed based on a non-compartment model of DAS2.0 statistical software,variation analysis and a two-sided t-test. Results：The main pharmacokinetic parameters of Simvastatin test and reference tablets were as follows ：camx （9.70 ± 6.62）, （ 10.06 ± 6.29） μg/L;tmax：（1.64±1.01）,（1.64 ±0.68）h; t1/2：（3.48 ±1.16）,（4.15 ± 1.90） h;AUC0-14h：（29.96 ± 16.28）,（32.78 ± 18.53 ） μg· h · L^-1 ;AUC0-∞ ：（ 31.49 ± 16.65）, （36.39 ± 21.71 ） μg · h · L^-1respectively. The relative bioavailability of the test to reference tablets was（97.79 ± 26.63）%. Conclusion：The two preparations are bioequivalent.
出处
《华北国防医药》
2008年第3期62-64,共3页
Medical Journal of Beijing Military Region
