复方法莫替丁咀嚼片人体药动学研究

目的:研究复方法莫替丁咀嚼片人体药动学。方法:采取开放试验,选取10名健康受试者,男女各半,单剂量口服复方法莫替丁咀嚼片40mg,用高效液相色谱法测定人血浆中法莫替丁浓度,所得数据经上海宏能软件有限公司PKS软件处理。结果:受试制剂符合血管外给药一室模型,法莫替丁主要药动学参数分别为:tm ax(2.3±0.4)h,Cm ax(88.73±15.07)ng.mL-1,AUC0~14(436.6±49.6)ng.h.mL-1,AUC0~∞(562.4±63.3)ng.h.mL-1,Ka(0.7±0.4)h-1,t1/2Ka(1.36±0.84)h,t1/2K(3.8±0.7)h,CL/F(0.08±0.01)mg.mL.ng-1.h-1,MRT0~14(5.0±0.3)h,MRT0~∞(9.6±2.3)h。结论:所得结果与文献报道一致,碳酸钙与氢氧化镁2种成分不影响法莫替丁的吸收与代谢。

Pharmacokinetics of Compound Famotidine Chewable Tablets in Healthy Volunteers

OBJECTIVE: To study the pharmacokinetics of compound famotidine chewable tablets in healthy volunteers.METHODS: An open study was performed in which 10 healthy volunteers(5 males and 5 females) were assigned to receive 40mg single dose of compound famotidine chewable tablets orally.The plasma concentrations of famotidine were determined by HPLC,and the pharmacokinetic parameters were calculated with the aid of PKS software(magnsoft,shanghai).RESULTS: The main pharmacokinetic parameters of famotidine after oral single dose of 40mg compound famotidine chewable tablets were fitted one-compartment model,which were stated as follows: tmax=(2.3± 0.4) h,Cmax=(88.73± 15.07) ng· mL-1,AUC0～ 14 =(436.6± 49.6) ng· h· mL-1,AUC0～ ∞ =(562.4± 63.3) ng· h· mL-1,Ka=(0.7± 0.4) h-1,t1/2 Ka=(1.36± 0.84) h,t1/2 K=(3.8± 0.7) h,CL/F=(0.08± 0.01) mg· mL· ng-1· h-1,MRT0～ 14=(5.0± 0.3) h and MRT0～ ∞ =(9.6± 2.3) h.CONCLUSION: We concluded that the absorption and metabolism of famoidine won' t be affected by calcium carbonate and magnesium hydroxide,our result is consistent with that reported in literature.