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目的 :了解国产盐酸乙哌立松片剂的相对生物利用度 ,评价其生物等效性。方法 :1 2名健康受试者单剂量口服被试制剂或参比制剂 1 5 0mg后 ,采用高效液相 质谱联用 (HPLC MS)测定血浆中盐酸乙哌立松的浓度。 结果 :经 3P97拟合 ,两者的体内过程皆符合血管外口服给药一室模型 ,采用梯形法计算的两者AUC0～t均值分别为 (1 2 .6 1± 7.79) ,(1 3.1 7± 7.44 ) μg·h·L-1,实测cmax均值分别为 (7.2 2± 4.6 3) ,(7.2 3± 4.0 3) μg·L-1,实测tpeak均值分别为 (0 .92± 0 .1 2 ) ,(0 .94± 0 .1 1 )h。经统计学分析 ,被试制剂和标准参比制剂具有生物等效性。被试制剂的相对生物利用度为 (94.1± 1 2 .3) %。结论 :国产盐酸乙哌立松片剂和进口片剂具有生物等效性。
Objective: To understand the relative bioavailability of domestic Eperisone tablets and evaluate the bioequivalence. METHODS: One hundred two healthy volunteers were dosed with 150 mg of test preparation or reference preparation. The concentrations of eperisone hydrochloride in plasma were determined by high performance liquid chromatography-mass spectrometry (HPLC-MS). Results: The results of 3P97 fitting showed that both the in vivo and in vitro models were consistent with the one-compartment oral administration model. The mean AUC0 ~ t calculated by trapezoidal method was (12.6 ± 7.79) ± 7.44) μg · h · L-1, respectively. The measured mean values of cmax were (7.2 2 ± 4.6 3) and (7.2 3 ± 4.0 3) μg · L -1, respectively. The mean tpeak values were (0.92 ± 0. 1 2), (0 .94 ± 0 .1 1) h. Through statistical analysis, the test preparation and standard reference preparation have bioequivalence. The relative bioavailability of the test preparation was (94.1 ± 12.3)%. Conclusion: Eperisone hydrochloride tablets and imported tablets are bioequivalent.