国产塞克硝唑片剂与胶囊剂的生物利用度研究  

Study on bioavailability of domestic secnidazole tablet/capsule

作　　者：张铃敏[1] 蒋学华[1] 杨俊毅[1] 周静[1] 

机构地区：[1]四川大学华西药学院,成都610041

出　　处：《中国抗生素杂志》2005年第2期114-116,共3页Chinese Journal of Antibiotics

摘　　要：目的比较供试制剂国产塞克硝唑片剂、胶囊剂与参比制剂进口塞克硝唑片的生物等效性。方法采用反相高效液相色谱法测定24名健康志愿受试者单剂三交叉口服供试制剂塞克硝唑片(T1)、塞克硝唑胶囊(T2)和参比制剂塞克硝唑片(R)相同剂量后,塞克硝唑血药浓度变化情况,经3P87药动学程序处理,并对实验结果进行方差分析和双单侧t检验。结果三种制剂塞克硝唑药-时曲线下面积AUC0→t分别是(780.86±139.51)、(722.62±113.33)和(720.47±126.83)(μg·h)/ml;达峰时间分别为(1.44±0.37)、(1.35±0.43)和(1.54±0.51)h;峰浓度分别是(26.23±4.99)、(24.85±4.40)和(22.69±3.69)μg/ml。三种制剂的lnAUC0→∞、lnAUC0→t和lnCmax经双单侧t检验,Tmax采用秩和检验进行生物等效性评价,表明T1、T2分别与R为生物等效制剂。供试制剂T1中塞克硝唑的相对生物利用度为(109.3±15.7)%;T2中塞克硝唑的相对生物利用度为(101.0±8.6)%。结论三种制剂为生物等效制剂。Objective To study the bioequivalence of domestic secnidazole tablet/capsule in healthy volunteers. Methods Twenty four volunteers were randomly divided into 3 groups (T_1, T_2 and R) with three crossover design. The concentration in plasma was detected by RP-HPLC after single oral dose of 1.0g domestic secnidazole tablet/capsule and imported secnidazole tablet. respectively. The experiment data were calculated with 3P87 program. The results were analyzed by ANOVA and two-and one-sided t tests. Results The pharmacokinetic parameters of secnidazole of three preparations (T_1, T_2, R) were as follows: AUC_~0→t were (780.86±139.51)(μg·h)/ml, (722.62±113.33)(μg·h)/ml and (720.47±126.83)μg·h/ml; T_~max were (1.44±0.37)h, (1.35±0.43)h and (1.54±0.51)h; C_~max were (26.23±4.99)μg/ml, (24.85±4.40)~μg/ml and (22.69±3.69)μg/ml. The relative bioavailability of secnidazole tablet was (109.3±15.7)% and that of secnidazole capsule was (101.0±8.6)%. These parameters by analyzing with two-and one-sided t tests and rank sum test showed that the tests and reference were bioequivalent. Conclusion The statistical analysis showed that the tests and reference were bioequivalent.

关 键 词：塞克硝唑片 塞克硝唑胶囊 生物利用度 生物等效性 RP—HPLC 

分 类 号：R965[医药卫生—药理学]