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目的:研究盐酸地尔硫缓释片在正常人体内的药代动力学和相对生物利用度。方法:采用HPLC测定盐酸地尔硫在血浆中的浓度,研究8名健康志愿受试者单剂量po90mg被试制剂(A)和标准参比制剂(B)的体内药代动力学和相对生物利用度,并进行统计学分析。结果:A和B的AUC0～∞分别为(1059.6±113.5)和(1014.2±119.5)μg·h·L-1,tmax分别为(2.7±0.4)和(2.7±0.1)h,cmax分别为(102.1±13.7)和(96.3±18.6)μg·L-1,两者的AUC0～∞,tmax,cmax均无显著差异(P>0.05)。采用梯形法计算两者的AUC0～t分别为(1025.0±74.4)和(1020.4±146.2)μg·h·L-1,A的相对生物利用度为(101.82±11.91)%。结论:两种制剂为生物等效。
Objective: To study the pharmacokinetics and relative bioavailability of diltiazem hydrochloride sustained-release tablets in normal human. Methods: The concentration of diltiazem hydrochloride in plasma was determined by HPLC. The pharmacokinetics and relative bioavailability of single dose po90mg test preparation (A) and standard reference preparation (B) in eight healthy volunteers were studied. Utilization, and statistical analysis. Results: AUC0 ~ ∞ of A and B were (1059.6 ± 113.5) and (1014.2 ± 119.5) μg · h · L-1, respectively, and tmax were (2.7 ± 0.4) and 102.1 ± 13.7 and 96.3 ± 18.6 μg · L-1, respectively. There was no significant difference in AUC0 ~ ∞, tmax, cmax between the two groups (P> 0.05). The AUC0 ~ t calculated by trapezoidal method was (1025.0 ± 74.4) and (1020.4 ± 146.2) μg · h · L-1, respectively. The relative bioavailability of A was (101.82 ± 11.91)%. Conclusion: Both formulations are bioequivalent.