盐酸莫雷西嗪片剂人体生物等效性研究

 目的评价两种盐酸莫雷西嗪片剂的生物等效性。方法18名健康男性志愿者分别单剂量po受试制剂和参比制剂200mg,采用高效液相色谱-质谱联用法测定血浆中莫雷西嗪的浓度。结果受试制剂和参比制剂在受试者体内的药动学参数如下:血浆中莫雷西嗪的t_max分别为(1.4±0.4)和(1.4±0.5)h,ρ_max分别为(595±318)和(589±283)μg·L^-1,t_1/2分别为(2.4±0.9)和(2.7±1.5)h,用梯形法计算,AUC_0-t分别为(1.60±0.89)和(1.57±0.76)mg.h·L^-1,AUC_0-∞分别为(1.66±0.90)和(1.63±0.76)mg.h·L^-1,以AUC_0-t计算,莫雷西嗪的相对生物利用度平均为(103.6±28.8)%。结论两种制剂生物等效。

Study on Bioequivalence of Moricizine Hydrochloride Tablets in Healthy Volunteers

OBJECTIVE To study the relative bioavailability of two moricizine hydrochloride tablets in 18 healthy volunteers.METHODS A single oral dose of 200 mg moricizine hydrochloride tablets was given according to a randomized crossover design. The plasma concentrations of moricizine were determined by a high performance liquid chromatography-mass spectrometry method. RESULTS The main pharmacokinetic parameters of the test and the reference tablets were as follows:t_max were (1.4±0.4) and (1.4±0.5) h;ρ_max were (595±318) and (590±283) μg·L^-1;t_1/2 were (2.4±0.9) and (2.7±1.5) h; AUC_0-t were (1.60±0.89) and (1.57±0.76) mg·h·L^-1 ,AUC_0-∞ were (1.66±0.90) and (1.63±0.76) mg·h·L^-1,respectively. The relative bioavailability of the test formulation was(103.6±28.8)%.CONCLUSION The two tablets are bioequivalent.