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目的:建立LC/MS法测定人血浆中盐酸美金刚浓度,研究盐酸美金刚在健康人体的药代动力学。方法:30名健康受试者分别服用受试制剂盐酸美金刚片5,10,20mg,用LC/MS法测定血药浓度,计算药代动力学参数。结果:口服盐酸美金刚片5,10,20mg后主要药代动力学参数:Cmax(ng·mL-1)分别为6.20±0.75,11.60±1.95,25.34±8.34;t1/2(h)分别为66.86±11.75,63.57±12.58,62.06±9.26;Tmax(h)分别为5.70±1.64,6.00±1.33,6.89±1.41;MRT(h)分别为99.37±16.96,91.73±18.16,89.56±13.77;AUC0-t(ng·h·mL-1)分别为486.19±80.00,889.32±239.49,1772.91±784.07;AUC0-∞(ng·h·mL-1)分别为540.05±89.68,932.07±230.82,1853.29±776.85。结论:建立的LC/MS方法适合于盐酸美金刚的临床研究。
Objective: To establish a method for the determination of memantine hydrochloride in human plasma by LC / MS and the pharmacokinetics of memantine hydrochloride in healthy volunteers. Methods: Thirty healthy volunteers took 5, 10, and 20 mg of the test compound memantine hydrochloride respectively. The plasma concentrations were determined by LC / MS, and the pharmacokinetic parameters were calculated. Results: The main pharmacokinetic parameters of Cmax (ng · mL-1) after oral administration of memantine hydrochloride tablets were 6.20 ± 0.75, 11.60 ± 1.95 and 25.34 ± 8.34, respectively; t1 / 2 66.86 ± 11.75,63.57 ± 12.58,62.06 ± 9.26; Tmax (h) were 5.70 ± 1.64,6.00 ± 1.33,6.89 ± 1.41; MRT (h) were 99.37 ± 16.96,91.73 ± 18.16,89.56 ± 13.77 respectively; AUC0- t (ng · h · mL-1) were 486.19 ± 80.00, 889.32 ± 239.49 and 1772.91 ± 784.07, respectively. AUC0-∞ (ng · h · mL-1) were 540.05 ± 89.68, 932.07 ± 230.82 and 1853.29 ± 776.85, respectively. Conclusion: The established LC / MS method is suitable for the clinical study of memantine hydrochloride.