论文部分内容阅读
目的:建立那格列奈血药浓度的HPLC-MS测定法,并用于人体生物等效性研究。方法:采用随机双交叉试验设计,20名健康受试者分别口服受试制剂和参比制剂60 mg,用HPLC-MS法测定血浆中的那格列奈浓度。结果:受试制剂和参比制剂的AUC_(0→10)分别为(8.47±1.01)和(8.19±0.99)mg·h·L~(-1);AUC_(0→∞)分别为(8.86±1.25)和(8.68±1.12)mg·h·L~(-1);C_(max)分别为(3.44±1.07)和(3.31±0.84)mg·L~(-1);t_(max)分别为(0.99±0.35)和(1.09±0.56)h;t_(1/2)分别为(1.78±0.39)和(1.83±0.41)h。受试制剂的相对生物利用度为(102.1±13.5)%。结论:两种那格列奈片具有生物等效性。
Objective: To establish an HPLC-MS method for the determination of nateglinide in plasma and to study its bioequivalence. Methods: Randomized double-crossover design was adopted. Twenty healthy subjects were orally administered with 60 mg of test and reference preparations, respectively, and plasma concentrations of nateglinide were determined by HPLC-MS. RESULTS: The AUC_ (0 → 10) of the tested and reference preparations were (8.47 ± 1.01) and (8.19 ± 0.99) mg · h · L -1, respectively. The AUC_ (0 → ∞) ± 3.80 ± 1.12 and mg · h · L -1, respectively. The maximal C max values were (3.44 ± 1.07) and (3.31 ± 0.84) mg · L -1, respectively. (0.99 ± 0.35) and (1.09 ± 0.56) h, respectively; t 1/2 was 1.78 ± 0.39 and 1.83 ± 0.41 h respectively. The relative bioavailability of the test preparation was (102.1 ± 13.5)%. Conclusion: The two nateglinide tablets are bioequivalent.