摘要
比较河南省新乡人民药厂（A）与国营青岛制药厂（B）生产的法莫替丁片的人体相对生物利用度。方法：8名健康男性受试者口服40mg法莫替丁片后，血药浓度采用高效液相色谱法测定。用中国药理学会制订的实用药物动力学计算程序3P87，计算药动学参数。结果：A厂与B厂的Cmax分别为（122.5±11.9）ng·ml-1和（1179±137）ng·ml－1；Tmax分别为（1.9±0．4）h和（1.9±0．3）h;AUC分别为（709.8±90.6）ng·h·ml－1和（736．1±115.6）ng·h·ml-1，A对B生产的法莫替丁片的相对生物利用度为（97.4±11.3）％。结论：A厂与B厂法莫替丁片等效。
To compare the bioavailability of famotidine (FT) tablets between Xinxiang Pcople's PharmaceuticalFactory of Henan Province(A) and Qingdao Pharmceutical Factory(B). METHODS: After single oral administration of 40 mg FTtablets in eight male volunteers. An HPLC method was used to determine FT concentration in plasrna Sample. The pharmacokineticparametere were analyzed by 3P87. RESULTS: The pharmacokinetic parameters of FT tablets of the A and B were: Cmax (122. 5 ±11. 9) ng.ml-1 and (117. 9±13. 7) ng.ml- 1, Tra(1. 9 ±0. 4) h and (1. 9 ± 0. 3) h,AUC(709. 8 ±90. 6) ng.h.ml-1 and (736. 1±115. 6) ng· h·ml-1. Relative bioavailability of FT was (97. 4 ±11. 3 ) %. CONCLUSIONS: Preduct A was bioequivalent toproductB.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1999年第10期587-589,共3页
Chinese Journal of Hospital Pharmacy
