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目的评价两种国产氟桂利嗪胶囊剂人体生物等效性。方法采用单剂量双交叉实验设计,用HPLC-MS法测定20名健康受试者口服两种氟桂利嗪胶囊20mg后的血药浓度。结果受试制剂和参比制剂药-时曲线均符合一房室模型,t1/2分别为(2.43±0.56)和(2.38±0.43)h,tmax为(2.67±0.82)和(2.74±0.80)h,cmax为(63.37±15.36)和(64.07±14.43)ng/mL,AUC为(130.36±15.20)和(128.47±20.87)ng/(h·mL),受试制剂的相对生物利用度为(101.5±6.3)%。结论经统计学分析,两种国产胶囊具有生物等效性。
Objective To evaluate the bioequivalence of two domestic flunarizine capsules. Methods The single-dose double-crossover design was used to determine the plasma concentrations of 20 mg flunarizine capsules in 20 healthy volunteers by HPLC-MS. Results The drug-time curves of the test preparations and the reference preparations were in accordance with the one-compartment model with t1 / 2 of (2.43 ± 0.56) and (2.38 ± 0.43) h and tmax of (2.67 ± 0.82) and (2.74 ± 0.80) h, cmax of (63.37 ± 15.36) and (64.07 ± 14.43) ng / mL, AUC of (130.36 ± 15.20) and (128.47 ± 20.87) ng / (h · mL) respectively. The relative bioavailability of the test preparation was ( 101.5 ± 6.3)%. Conclusion According to statistical analysis, the two domestic capsules have bioequivalence.