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健康志愿者 8名 ,随机交叉单次口服西安杨森制药有限公司 (简称西安杨森 )生产的参比普瑞博思片剂 (简称R)和广西田丰制药有限公司 (简称广西田丰 )研制的试验西沙必利片剂 (简称T) .用高效液相色谱法测定血药浓度 .结果求得R和T的Cmax为 (85 2 1± 2 1 2 2 )ng/mL和 (78 0 2±2 8 2 0 )ng/mL ,Tmax为 (0 97± 0 4 5)h和 (1 0 6± 0 4 2 )h ;AUC(0 -n)为 (80 2 57± 1 77 4 )ng/mL·h和(82 0 3 9± 2 4 5 1 0 )ng/mL·h .广西田丰西沙必利片剂的人体相对生物利用度为 (1 0 0 0± 1 4 7) % .两种制剂的AUC(0 -n)和Cmax经统计分析 ,均无显著性差异 .
Eight healthy volunteers were randomized to receive a single oral crossover trial of Xi’an Purcell Pharmaceutical Co., Ltd. (referred to as Xi’an Janssen), a reference Purifus tablet (referred to as R) and Guangxi Tian Feng Pharmaceutical Co., Ltd. (hereinafter referred to as Guangxi Tian Feng) Cisapride tablet (referred to as T) .HPLC was used to determine plasma concentration.Results The C max of R and T were (85 2 1 ± 2 1 2 2) ng / mL and (78 0 2 ± 2) (0 97 ± 0 4 5) h and (1 0 6 ± 0 4 2) h; AUC (0 -n) was (80 2 57 ± 1 77 4) ng / mL · H and (82 0 39 ± 2 451 10) ng / mL · h, respectively. The relative bioavailability of cisplatin in Tianfeng of Guangxi was (100 ± 147)% There was no significant difference in the AUC (0-n) and Cmax of the preparation by statistical analysis.