阿奇霉素分散片的人体生物等效性研究

目的评价国内不同厂家阿奇霉素分散片的相对生物利用度和生物等效性。方法对18名男性健康受试者采用随机、自身对照、交叉法单剂量口服2个不同厂家的阿奇霉素分散片后,采用微生物法测定血浆中阿奇霉素的质量浓度。结果单剂量口服500 mg受试和参比阿奇霉素分散片制剂后的达峰时间Tmax分别为(2.44±0.68)h和(2.50±0.60)h;峰值血药质量浓度Cmax分别为(403.47±84.48)μg/L和(424.60±68.34)μg/L;T1/2β分别为(40.24±2.48)h和(39.26±1.97)h;药时曲线下面积AUC(0→48)分别为(5 465.88±1 029.15)μg.h/L和(5 381.40±1 135.47)μg.h/L。2种片剂所有的药物动力学参数无显著性差异(P均>0.05),受试制剂的相对生物利用度F为(101.57±22.64)%。结论2种制剂具有生物等效性。

Study of bioequivalence of azithromycin dispersible tablets in healthy volunteers

Objective It is to evaluate the relative bioavailability and bioequivalence of azithromycin dispersible tablets made in different drug factory.Methods 18 male healthy volunteers orally took a single dose of 500 mg tablets made in 2 drug factories by the ways by randomly and self-crossover.The plasma concentrations of azithromycin were detected by microbiological method.Results The pharmacokinetic parameters of reference and test drugs were as follows: Tmax(2.44±0.68) h and(2.50±0.60) h;Cmax(403.47±84.48) μg/L and(424.60±68.34) μg/L;T1/2β(40.24±2.48)h and(39.26±1.97) h;AUC(0→48)(5 465.88±1 029.15) μg·h/L and(5 381.40±1 135.47) μg·h/L,respectively.There was no statistical difference between azithromycin tablets in pharmacokinetic parameters(P>0.05).The relative bioavailability of test azithromycin tablets was(101.57±22.64) %.Conclusion The two type azithromycin dispersible tablets are bioequivalent.