国产二氯乙酸二异丙胺片剂与胶囊剂人体生物等效性评价

 目的评价国产二氯乙酸二异丙胺片剂和胶囊剂与进口片剂人体生物等效性。方法采用单剂量三制剂三周期拉丁方实验设计。用顶空气相色谱法测定18名健康受试者po二氯乙酸二异丙胺60 mg后,尿中二氯乙酸二异丙胺的浓度。结果 国产片剂、胶囊剂和进口片剂的t_max分别为(1.24±0.50),(1.11±0.31)和(1.03±0.23)h,c_max为(36.40±8.61),(37.45±7.89)和(38.79±6.16) mg·L^-1,AUC为(151.81±38.18),(147.29±34.61)和(146.82±33.93) mg·h·L^-1,t_1/2为(1.75±0.44),(1.70±0.40)和(1.70±0.39) h。国产片剂和胶囊剂的相对生物利用度分别为(105.68±27.46)% 和(101.43±14.48)%。结论经统计学分析,国产片剂和胶囊剂与进口片剂具有生物等效性。

Studies on bioequivalence of domestic diisopropylamine dichloroacetate tablet and capsule in healthy volunteers

OBJECTIVE To observe the bioequivalence of domestic diisopropylamine dichloroacetate tablet or capsule and imported tablet. METHODS A single oral administration of 60 mg domestic or imported diisopropylamine dichloroacetate tablet or capsule was given to 18 healthy volunteers.Diisopropylamine dichloroacetate concentrations in urine were determined by GC-HS methods. RESULTS The main pharmacokinetics of domestic tablet,capsule and imported tablet were as follow:t_max(1.24±0.50),(1.11±0.31) and (1.03±0.23) h;c_(max)(36.40±8.61),(37.45±7.89) and (38.79±6.16) mg·L^-1;AUC (151.81±38.18),(147.29±34.61) and (146.82±33.93) mg·h·L^-1,t_1/2 (1.75±0.44),(1.70±0.40) and (1.70±0.39) h respectively.The relative bioavailability of domestic tablet and capsule to imported tablet were (105.68±27.46)% and (101.43±14.48)% respectively. CONCLUSION There were no significant difference between domestic tablet or capsule and imported tablet (P＞0.05).The results demonstrated that the domestic tablet or capsule and imported tablet were bioquivalent.