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目的:在8名健康志愿者体内研究了国产舒他西林片和对照片的药动学和生物利用度。方法:受试者交叉口服单剂量(750 mg)国产片和进口片后，采用高效液相色谱法检测血药浓度。结果:国产片和对照片中两种成分的主要药动学参数分别为：舒巴克坦Cmax为(5.6±0.8) μg·ml~（-1）和(6.1±1.3) μg·ml~（-1）；Tmax为(0.98±0.25) h和(0.91±0.19) h；AUC为(12.8±1.8) mg·h·L~（-1）和(13.1±2.4) mg·h·L~（-1）；其国产片相对生物利用度F为(98.3±10.6)%。氨苄西林Cmax为(7.9±1.2) μg·ml~（-1）和(8.1±1.1) μg·ml~（-1），Tmax为(0.97±0.28) h和(0.84±0.33) h；AUC为(17.5±1.8) mg·h·L~（-1）和(17.1±1.0) mg·h·L~（-1），其国产片相对生物利用度F为(102.2±8.5)%。结论:两种剂型的两种组分的各药动学参数之间差异均无显著性(P＞0.05))，经双向单测t检验，两制剂具生物等效性。
OBJECTIVE: To study the pharmacokinetics and bioavailability of domestic sultamicillin tablets in eight healthy volunteers. Methods: After taking a single dose (750 mg) of domestic product and imported tablets at the crossover point of the subjects, the blood concentration was measured by HPLC. Results: The main pharmacokinetic parameters of the two components in domestic tablets and in the control were: Cmax of Sbactam of (5.6 ± 0.8) μg · ml -1 and (6.1 ± 1.3) μg · ml -1 ~ (-1); Tmax was (0.98 ± 0.25) h and (0.91 ± 0.19) h; AUC was (12.8 ± 1.8) mg · h · L -1 and (13.1 ± 2.4) mg · h · L -1. The relative bioavailability of domestic tablets was F (98.3 ± 10.6)%. The ampicillin Cmax was (7.9 ± 1.2) μg · ml -1 and (8.1 ± 1.1) μg · ml -1, Tmax was (0.97 ± 0.28) h and (0.84 ± 0.33) ) h; AUC was (17.5 ± 1.8) mg · h · L -1 and (17.1 ± 1.0) mg · h · L -1, and the relative bioavailability (102.2 ± 8.5)%. CONCLUSION: There was no significant difference in the pharmacokinetic parameters between the two formulations (P> 0.05)). After two-way single test t test, the two formulations were bioequivalent.