复方法莫替丁咀嚼片的人体药动学

Pharmacokinetics of compound famotidine chewing tablets

目的：研究健康受试者单剂量口服复方法莫替丁咀嚼片的人体药动学。方法：12名健康受试者分别单剂量口服复方法莫替丁咀嚼片,以氨甲苯酸为内标,采用液相色谱-质谱-质谱(LC-MS/MS)正离子选择性反应检测法测定法莫替丁血浆及尿药浓度,用3P97软件计算药动学参数。结果：口服法莫替丁咀嚼片10 mg后,血浆药动学参数分别为c_(max)(53±s17)μg·L^(-1),t_(max)(2．7±0．8)h,t_(1/2)(3．2±0．5)h,AUC_(0-24)(309±91)h·μg·L^(-1),AUC_(0-∞)(312±91)h·μg·L^(-1),MRT(5．2±0．5)h；24 h尿药累积排泄量为(41±20)%。结论：建立的LC-MS/MS测定法专属准确,灵敏度适宜。可用于药动学参数的测定。

AIM： To study the pharmacokinetics of famotidine chewing tablets in healthy Chinese volunteers. METHODS： A single dose of 10 mg compound famotidine test chewing tablets was given to each of 12 healthy volunteers. The concentrations of famotidine in plasma and urine were determined by LC-MS/MS with positive ion SRM detection using aminomethylbenzoic acid （AMBA） as internal standard and the pharmacokinetic parameters were calculated by 3P97 software. RESULTS： The main plasma pharmacokinetic parameters after po a single dose of the tablets were as follows： Cmax （53 ± S 17） μg·L^-1, tmax （2.7 ± 0.8） h, t1/z （3.2 ± 0.5） h, AUCo-24 （309 ± 91） h·μg·L^-1, AUC0-∞ （312 ± 91） h·μg·L^-1, MRT （5.2 ±0.5） h. The 24 h accumulative urinary drug excretion rate was （41 ±20） %. CONCLUSION： The established LC-MS/MS detection method is proven to be sensitive, accurate, and suitable for pharmacokinetic study of famotidine.