HPLC-MS／MS评价阿奇霉素颗粒剂的人体生物等效性  

Bioequivalence Study of Azithromycin Granules in Human by HPLC-MS/MS

作　　者：任静[1,2] 李珂佳[1] 叶利明[1] 蒋学华[1] 熊梅瑾[1] 张川川[1] 

机构地区：[1]四川大学华西药学院,成都610041 [2]成都中医药大学,成都611137

出　　处：《中国药学杂志》2008年第19期1500-1503,共4页Chinese Pharmaceutical Journal

摘　　要：目的建立一种改良的HPLC-MS/MS和简化的预处理方法,测定人血浆中阿奇霉素浓度,并对受试制剂与参比制剂进行生物等效性评价。方法24例男性健康志愿受试者进行双交叉试验,随机单剂量po阿奇霉素颗粒(500mg)受试或参比制剂后,血浆样品经简便的液液萃取后,采用多反应监测(MRM)进行HPLC-MS/MS分析。利用DAS软件计算主要药动学参数,并进行生物等效性评价。结果受试者单剂量po供试制剂和参比制剂后,主要药动学参数均无统计学差异。相对生物利用度(F)为(99.9±37.7)%。结论改进的测定方法灵敏准确,简便易行,适用于阿奇霉素血浆样品的测定。阿奇霉素颗粒试验和参比制剂生物等效。OBJECTIVE To develop a HPLC-MS/MS method for the determination of the concentration of azithromycin in human plasma, and to evaluate the bioequivalence of test azithromycin granules with reference one. METHODS A single oral dose of 500 mg azithromycin of test or reference was given to 24 healthy male volunteers in a two-way cross-over design. After simple liquid-liquid extraction, a HPLC-MS/MS method was employed to determine drug concentrations in plasma. The pharmacokinetic parameters were calculated using DAS statistic software. RESULTS No significant differences were found between the test and the reference. Relative bioavailability （F） was （99.9 ± 37.7） %. CONCLUSION The modified HPLC-MS/MS method was sensitive,accurate and easy to process,which is suitable for the determination of the plasma samples. The results showed that the test and the reference azithromycin granules were bioequivalence.

关 键 词：阿奇霉素颗粒剂 生物等效性 高效液相色谱串联质谱法 

分 类 号：R945.2[医药卫生—微生物与生化药学]