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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。
The relative bioavailability of famotidine tablets produced by Henan Xinxiang People’s Pharmaceutical Factory (A) and state-owned Qingdao Pharmaceutical Factory (B) was compared. Methods: Eight healthy male subjects oral administration of 40mg famotidine tablets, plasma concentrations were determined by high performance liquid chromatography. Pharmacokinetic parameters were calculated using a practical pharmacokinetic program, 3P87, developed by the Chinese Pharmacopoeia. Results: The Cmax of plant A and plant B were (122.5 ± 11.9) ng · ml-1 and (1179 ± 137) ng · ml-1, respectively; the Tmax were (1.9 ± 0.4) h and (1.9 ± 0) 3) h; AUC were (709.8 ± 90.6) ng · h · ml-1 and (736.1 ± 115.6) ng · h · ml-1 respectively. The relative bioavailability of A to the famotidine tablets produced by B (97.4 ± 11.3)%. Conclusion: Plant A is equivalent to famotidine in plant B.