罗红霉素颗粒剂、胶囊剂及片剂人体生物利用度测定  

DETERMINATION OF THE BIOAVAILABILITY OF ROXITHROMYCIN GRANULE,CAPSULE AND TABLET

作　　者：栾连军[1] 邵青[1] 李士敏[1] 王萍[2] 

机构地区：[1]浙江医科大学药学院,杭州310006 [2]浙江亚东制药公司

出　　处：《中国新药杂志》1999年第8期527-528,共2页Chinese Journal of New Drugs

摘　　要：目的 :测定罗红霉素颗粒剂、胶囊剂及片剂的生物等效性。方法 :采用反相高效液相色谱法 ,测定 9名男性健康志愿受试者口服不同剂型罗红霉素后的血药浓度 ,并计算药代动力学参数。结果 :经 3P87药动学计算程序进行数据处理 ,得到罗红霉素片剂、胶囊剂及颗粒剂各种参数如下 :Tmax分别为 ( 2 .78± 0 .2 6) ,( 2 .2 2± 0 .5 1)及( 2 .67± 0 .83 )h ;Cmax分别为 ( 9.5 1± 1.0 1) ,( 9.3 1± 1.79)及 ( 9.3 3± 1.4 2 ) μg/ml;AUC分别为 ( 15 2 .8± 2 9.3 4) ,( 14 8.5± 2 9.70 )及 ( 15 7.7± 2 3 .12 ) μg·h/ml。结论 :以罗红霉素片剂为参比制剂 ,罗红霉素颗粒剂及胶囊剂的人体相对生物利用度分别为 ( 98.3 4± 16.5 7) %及 ( 10 5 .0± 15 .68) % 。OBJECTIVE:To determine the bioequivailability of roxithromycin granule,capsule and tablet.METHODS:9 healthy volunteers were recruited in the randomized,crossover study.The plasma concentration of roxithromycin was determined by HPLC after 1 single dose of each preparation.RESULTS:The data listed below were arranged in the order of tablet ,capsule ,and granule:T max (2.78±0.26),(2.22±0.51)and (2.67±0.83)h;C max (9.51±1.01),(9.31±1.79),and (9.33± 1.42) μg/ml;AUC (152.8±29.34),(148.5±29.70),and (157.7±23.12)(μg·h/ml).The relative bioavailability of granule and capsule were (98.34±16.57)% and (105.0±15.68)%.CONCLUSION:The results obtained indicated that the 3 preparations of roxithromycin are bioequivalent.

关 键 词：罗红霉素 生物利用度 HPLC 颗粒剂 胶囊剂 片剂 

分 类 号：R969.1[医药卫生—药理学]