【摘 要】 目的 研究两种茴拉西坦胶囊在健康中国人体的生物等效性。 方法 20名健康志愿者随机分为试验组和对照组，采用双交叉设计和单剂量口服方式，HPLC法测定血清中茴拉西坦活性代谢产物对甲氧基苯甲酰氨基丁酸(ABA)血药浓度)。经DAS2.0统计软件处理，计算主要药代动力学参数，并进行两种制剂的生物等效性评价。 结果 口服600mg受试制剂和参比制剂后，其主要活性代谢物ABA的血清t1/2 分别为(0.63±0.25)h和(0.86±0.59)h，Cmax 分别为(14.81±3.26)mg/L和(15.84±2.89)mg/L，Tmax 分别为(0.68±0.25)h和(0.60±0.19)h，AUC0～3.5h 分别为20.33±4.58和(20.86±5.76)mg·h -1 ·L -1 。受试制剂的相对生物利用度为(101.14%22.05%)。 结论 两种茴拉西坦胶囊具有生物等效性，临床上可替代使用。

    【关键词】 茴拉西坦;生物等效性;药代动力学;高效液相色谱法

    Bioeqivalence and pharmacokinetics of aniracetam capsules in healthy volunteers ZHANG Zhi-tao，ZHAO Huai-qing，LI Jian-chun.(Bengbu Medical College，Bengbu233030，Anhui，China)

    【Abstract】 Objective To study the bioequivalence of aniracetam capsules in Chinese healthy volunteers.Methods Twenty volunteers were randomly divided into two groups(test and reference)，with double cross-over design and sin-gle dose oral administration.The concentration of4panisamidobutyric acid(ABA)，the main active metabolite of aniracetam in serum was determined by HPLC.The main pharmacokinetic parameters were calculated and the bioe-quivalence was evaluated with DAS2.0practical pharmacokinetics program.Results After taking a single oral dose of600mg for test and reference ......