国产阿奇霉素颗粒剂人体药代动力学研究及生物等效性评价  

Clinical Pharmacokinetic Study and Bioequivalence Assessment of Domestic Azithromycin Granule

作　　者：张贵军[1] 李可欣[1] 孙春华[1] 曹国颖[1] 宋友华[1] 

机构地区：[1]卫生部北京医院药剂科,北京市100790

出　　处：《中国药房》1998年第4期173-174,共2页China Pharmacy

摘　　要：8名健康志愿者交叉口服500mg国产阿奇霉素颗粒剂和进口胶囊剂，对国产与进口制剂的生物等效性进行了研究。血药浓度采用微生物法进行测定。结果表明：口服国产和进口两种制剂的血药浓度一时间曲线均符合二室模型，Cmax分别为0．4±0．036与0．427±0．038mg／L，Tmax为2．07±0．16与2．03±0．13h，t1／2β为47．29±3．25与48．46±1．99h，AUC为7．28±0．48与7．33±0．66mg·h／L。比较两种制剂的药代动力学参数均无显著性差异（P＞0．05）。国产阿奇霉素颗粒剂的相对生物利用度为99．70％，两种制剂生物等效。本项研究将为国产阿奇霉素颗粒剂的临床应用提供指标和依据。A single oral dose of 500mg azithromycin of domestic granule and imported capsule were given to 8 adult malevolunteers in a randomized cross over study.Plasma concentrations were measured by microbial method.lt was found that theplasma concentration-time curves of both preparations were fitted to a two-compartment model.Cmax of granule and capsule were0.4311±0.061 and 0.38±0.043mg/L,Tmax2.07±0.16 and 2.03±0.16h,t1/2β47.29±3.25 and 48.46±1.99h,AUC 7.28±0.48 and 7.33±0.66mg.h/L respectively.There was no significant difference between the pharmacokinetic parameters of these two preparations.Therelative bioavailability of the test granule was 99.70% to the reference capsule.The urinary recover rate of the azithromycin was 10.44±1.19% during the period of 144h after oral administration of domestic granule,In conclusion,the pharmacokinetic profile ofdomestic azithromycin is similar to that of imported one,which indicates that two preparations are bioequivalent.

关 键 词：阿齐霉素 药代动力学 生物利用度 生物等效性 

分 类 号：R978.15[医药卫生—药品]