论文部分内容阅读
目的 建立人血浆中米氮平的HPLC ESI MS测定法 ,以测定志愿者口服米氮平片剂 (30mg 片 )后的血药浓度 ,并对受试制剂和参比制剂的生物等效性进行评价。方法 2 0名健康志愿者交叉口服供试片和参比片 ,剂量均为 30mg。采用HPLC ESI MS法测定人血浆中米氮平浓度。计算主要药动学参数及相对生物利用度。结果 在 0 3- 2 0 0ng·mL- 1 范围内米氮平与内标峰面积比值与浓度线性关系良好 ,最低定量限为 0 1ng·mL- 1 。受试制剂及参比制剂的生物半衰期分别为 (2 4 7±4 1)h和 (2 3 6± 4 3)h ,达峰时间分别为 (1 6± 0 8)和 (1 5± 0 8)h ,峰浓度分别为 (95 9± 2 9 8)和 (91 9± 2 6 7)ng·mL- 1 。以AUC0 - 1 2 0 计算的受试制剂的相对生物利用度为 (10 0 0± 10 8) %。结论 本实验建立的人血浆中米氮平的HPLC MS分析方法灵敏、准确、简便。统计学结果表明两种米氮平制剂生物等效
Objective To establish an HPLC ESI MS method for the determination of mirtazapine in human plasma in order to determine the plasma concentration of volunteers after oral administration of mirtazapine (30 mg tablets) and to evaluate the bioequivalence of the test and reference preparations Evaluation. Methods Twenty healthy volunteers were given oral administration of the test and reference tablets at doses of 30 mg. The concentration of mirtazapine in human plasma was determined by HPLC ESI MS. Calculate the main pharmacokinetic parameters and relative bioavailability. Results There was a good linear relationship between the ratio of peak area of mirtazapine and internal standard in the range of 0 3 0 2 ng · mL-1 to concentration, the lowest limit of quantification was 0 1 ng · mL-1. The biological half-lives of the tested and reference preparations were (247 ± 4 1) h and (23 6 ± 4 3) h, respectively, with peak times of (1 6 ± 0 8) and 1 5 ± 0 8) h, the peak concentrations were (95 9 ± 2 98) and (91 9 ± 2 6 7) ng · mL -1, respectively. The relative bioavailability of the test formulations calculated as AUC0 - 120 was (10 0 ± 10 8)%. Conclusion The established HPLC method for the analysis of mirtazapine in human plasma is sensitive, accurate and simple. The statistical results show that the two mirtazapine formulations are bioequivalent