【摘要】 目的评价国产尼扎替丁胶囊在中国健康志愿受试者中的药动学和生物等效性。方法采用高效液相色谱-紫外检测法测定20名健康志愿者单次口服300mg尼扎替丁胶囊试验制剂或参比制剂后血浆中的尼扎替丁浓度。采用DAS软件计算药动学参数,并评价其生物等效性。结果尼扎替丁胶囊试验制剂和参比制剂的Tmax分别为(1.20±0.56)h和(1.38±0.60)h,Cmax分别为(2371.0±534.3)ng/mL和(2413.4±586.2)ng/mL,MRT分别为(3.05±0.49)h和(2.97±0.47)h,AUC0-8.5h分别为(6753.2±873.6)ng·h-1·mL-1和(6681.9±1087.3)ng·h-1·mL-1,T1/2分别为(1.56±0.33)h和(1.51±0.21)h。尼扎替丁试验制剂相对于参比制剂的相对生物利用度102.3%。结论经统计学分析,两种尼扎替丁胶囊制剂具有生物等效性。更多还原

【Abstract】 Objective To evaluate the human pharmacokinetics and bioequivalence of a generic and innovator formulation of nizatidine capsules in healthy volunteers. Methods A single oral dose of 300 mg nizatidine test or reference capsule was given to 20 healthy male volunteers in a randomized crossover study. Nizatidine concentrations in plasma were determined by HPLC method, and pharmacokinetic parameters were determined by the DAS salfware. Results The main pharmacokinetic parameters of the two preparations were as follows: T_ max (1.20± 0.56)h and (1.38±0.60) h,C_ max (2371.0±534.3)ng/mL and (2413.4±586.2) ng/mL, MRT (3.05±0.49)h and (2.97±0.47) h, AUC_ 0-8.5h (6753.2±873.6) ng·h~ -1 ·mL~ -1 and (6681.9±1087.3) ng·h~ -1 ·mL~ -1 , T_ 1/2 (1.56±0.33)h and (1.51± 0.21) h, respectively. The relative bioavailability was 102.3%. There was no significant difference between the parameters of the two products (P>0.05). Conclusion The two nizatidine capsule preparations are bioequivalent.更多还原