2种舒他西林片的人体生物等效性

目的：比较口服2种舒他西林片的相对生物利用度。方法：20名健康男性受试者采用随机交叉试验设计。反相高效液相色谱法测定单剂量口服2种舒他西林片750 mg后的氨苄西林、舒巴坦血药浓度。DAS程序计算药动学参数,AUC,c_(max)对数转换后进行分析。结果：口服舒他西林受试制剂和参比制剂氨苄西林的c_(max)分别是(10.8±s 1.9),(10.4±1.8)mg·L~(-1)；t_(max)分别是(0.68±0.14),(0.66±0.12)h；AUC_(0-t)分别为(22±4),(22±4)mg·h·L~(-1)；AUC_(0-∞)分别为(24±5),(23±4)mg·h·L~(-1)；t_(1/2)分别是(1.07±0.26),(1.13±0.25)h。口服舒他西林受试制剂和参比制剂舒巴坦的c_(max)分别是(7.4±1.3),(7.3±1.2)mg·L~(-1),t_(max)分别是(0.66±0.12),(0.70±0.10)h,AUC_(0-t)分别为(13.7±2.8),(13.2±2.3)mg·h·L~(-1)；AUC_(0-∞)分别为(14.2±2.9),(13.7±2.5)mg·h·L~(-1)；t_(1/2)分别是(0.97±0.19),(0.87±0.24)h。结论：2种舒他西林片具有生物等效性。

Bioequivalence study of two formulations of domestic sultamicillin in healthy volunteers

AIM:To evaluate the bioavailability of sultamicillin tablets from two companies.METHODS: Randomized,cross over designed trial conducted in 20 healthy volunteers.The plasma concentration of ampicillin and sulbactam were tested by reversed-phase high pressure liquid chromatography after a single oral dose of 750 mg tablets of study drug or reference drug.The pharmacokinetic parameters were calculated by pharmaceutic software named DAS.AUC and c_(max)were analyzed after logarithmic transform.RESULTS:The pharmacokinetic parameters of study drug vs reference drug were as follows:ampieillin c_(max),(10.8±s 1.9)mg·L~(-1) and(10.4±1.8)mg·L~(-1);t_(max), (0.68±0.14)h and (0.66±0.12)h;AUC_(0-t),(22±4)mg·h·L~(-1) and(22±4)mg·h·L~(-1);AUC_(0-∞),(24±5)mg·h·L~(-1)and(23±4)mg·h·L~(-1);t_(1/2),(1.07±0.26)h and(1.13±0.25)h;sulbactam c_(max),(7.4±1.3)mg·L~(-1) and (7.3±1.2)mg·L~(-1);t_(max),(0.66±0.12)h and(0.70±0.10)h;AUC_(0-t),(13.7±2.8)mg·h·L~(-1) and(13.2±2.3)mg·h·L~(-1);AUC_(0-∞),(14.2±2.9)mg·h·L~(-1)and(13.7±2.5)mg·h·L~(-1);t_(1/2),(0.97±0.19)h and(0.87±0.24)h. CONCLUSION:The two formulations of sultamicillin tablets are bioequivalent.