国产西沙必利胶囊人体生物利用度研究

 目的 研究国产西沙必利胶囊和普瑞博思片药代动力学和人体生物等效性。方法 采用高效液相色谱法测定12名健康受试者 po 15 mg后，血浆中西沙必利的浓度。结果 经3P97拟合，两者在体内的过程皆符合血管外给药二室开放模型，国产西沙必利胶囊和普瑞博思片的：AUC 分别为(822.98±80.60)和(802.39±73.59)μg·h·L^-1，t_mas分别为(1.58±0.31)和(1.65±0.36)h，c_mas分别为(65.52±5.15)和(64.29±5.42) μg·L^-1，t_1/2β分别为(9.111±0.893)和(8.713±1.006)h，采用梯形法计算的两者的 AUC 0～t均值分别为(817.35±80.67)和(801.94±73.33)μg·h·L^-1，实测c_mas均值分别为(70.74±6.03)和(70.61±6.93)μg·L^-1，实测t_mas均值分别为(1.8±0.3)和(1.6±0.2)h，国产西沙必利胶囊的相对生物利用度为(102.0±4.9)%。结论 经统计学分析，国产西沙必利胶囊和普瑞博思片具有生物等效性。

Bioequivalent evaluation of domestic cisapride capsule

OBJECTIVE To observe the bioavailability of domestic cisapride capsule and Prepuside. METHODS A single oral dose of 15 mg domestic Cisapride capsule or Prepuside was given to 12 healthy volunteers in a randomized crossover study.Cisapride concentrations in plasma were determined by HPLC method. RESULTS The results showed that the plasma concentration-time curves of the two products were all fitted to two-compartment model.:-t-peak of domestic Cisapride capsule and Prepuside were (1.58±0.31) and (1.65±0.36) h，AUC were (822.98±80.60) and (802.39±18.59) μg·h·L^-1,c_max(65.52±5.15) and (64.29±5.42) μg·L^-1，respectively.AUC_0～tof two products were (817.35±80.67) and (801.94±73.33) μg·h·L^-1，Actual mesured c_max(70.74±6.03)and (70.61±6.93) μg·L^-1，Actual measured t_max(1.8±0.3) and (1.6±0.2) h，respectively.The relative bioavailability of domestic to imported tablets was (102.0±4.9)%. CONCLUSION There were no statistically significant difference between the two products (P＞0.05).The results demonstraed that the two preparations were bioequivalent.