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目的:建立人血清中石杉碱甲浓度的高效液相色谱-质谱(LC-MS/MS)测定方法,研究石杉碱甲在健康人体内的药动学行为,评价2种制剂的生物等效性。方法:乙酸乙酯提取,LC-MS/MS内标法分析,检测离子为m/z243.2→210.9,m/z229.9→212.9。20例健康志愿者交叉口服试验制剂或参比制剂石杉碱甲片剂200μg,血药浓度-时间数据经DAS 2.0统计软件处理,计算主要药动学参数,并对2种制剂进行等效性评价。结果:石杉碱甲的线性范围为0.08~8 ng.mL-1,石杉碱甲片试验制剂与参比制剂的主要药动学参数分别是:Cmax为(2.596±0.914)和(2.675±0.848)ng.mL-1,Tmax为(1.125±0.329)和(1.113±0.358)h,AUC0~72h为(31.275±6.889)和(30.476±7.051)ng.h.mL-1。结论:该方法操作简单、灵敏度高、专属性强;统计学分析结果显示2种制剂具有生物等效性。
Objective: To establish a liquid chromatography-mass spectrometry (LC-MS/MS) method for determination of huperzine A in human serum, study the pharmacokinetics of huperzine A in healthy volunteers, and evaluate the bioavailability of the two preparations. Sex. Methods: Ethyl acetate extraction, LC-MS/MS internal standard method analysis, detection of ions was m/z243.2 → 210.9, m/z229.9 → 212.9. 20 healthy volunteers cross oral test preparation or reference preparation stone A total of 200μg of Susanine A tablets were used. The plasma concentration-time data were processed by DAS 2.0 statistical software to calculate the main pharmacokinetic parameters and the equivalence of the two preparations was evaluated. RESULTS: The linear range of Huperzine A was 0.08-8 ng.mL-1. The main pharmacokinetic parameters of the Huperzine A tablet test preparation and the reference preparation were: Cmax was (2.596±0.914) and (2.675±). 0.848) ng.mL-1, Tmax were (1.125±0.329) and (1.113±0.358) h, and AUC0-72h were (31.275±6.889) and (30.476±7.051) ng.h.mL-1. Conclusion: This method is simple, sensitive and specific; statistical analysis results show that the two formulations are bioequivalent.