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建立了测定人血浆中氨苄西林和舒巴坦浓度的高效液相色谱紫外检测法，采用此方法测定１０ 名健康男性志愿者单剂量交叉口服７５０ ｍｇ 甲苯磺酸舒他西林分散片（ 受试制剂） 和优立新片（ 参比制剂） 后血浆中氨苄西林和舒巴坦的浓度，发现受试者服用优立新后，血浆中氨苄西林和舒巴坦的Ｃｍａｘ 分别为（１０－３２ ±２－９４） 和（１０－１６ ±３－１３）μｇ／ｍＬ，摩尔比为０－６８∶１ ．同时考察氨苄西林和舒巴坦的药物动力学特性，进行生物等效性评价．结果为受试制剂中氨苄西林的相对生物利用度为（１１０－３ ±２０－６） ％ ；舒巴坦为（１０８－０ ±２０－１）％ ．对受试制剂和参比制剂的主要药物动力学参数进行统计学分析，结果表明２ 种制剂生物等效
A high-performance liquid chromatography-ultraviolet detection method for the determination of ampicillin and sulbactam concentrations in human plasma was established. Ten healthy male volunteers were randomized to receive 750 mg of sultamicillin tosylate dispersible tablets Formulation) and Urethane (reference preparation) plasma concentrations of ampicillin and sulbactam and found that the subjects taking You Lixin, the plasma Cmax of ampicillin and sulbactam were (10-32 ± 2 -94) and (10-16 ± 3-13) μg / mL in a molar ratio of 0-68: 1. At the same time, the pharmacokinetics of ampicillin and sulbactam were investigated and the bioequivalence was evaluated. The results showed that the relative bioavailability of ampicillin in the test formulation was (110-3 ± 20-6)% and that of sulbactam (108-0 ± 20-1)%. The main pharmacokinetic parameters of the test and reference preparations were statistically analyzed and the results showed that the two preparations were bioequivalent