匹多莫德颗粒剂的生物等效性研究  

Study on bioequivanlence of pidotimod granules

作　　者：韦阳[1] 张美云[1] 王恪申[1] 赵早瑞[1] 刘相勇[1] 吴定伟 邵庆翔[1] 

机构地区：[1]浙江省医学科学院,杭州310013 [2]浙江仙琚制药股份有限公司,仙居317300

出　　处：《中国新药杂志》2003年第6期461-463,共3页Chinese Journal of New Drugs

摘　　要：目的 :研究匹多莫德颗粒剂和片剂的生物等效性。方法 :18例健康男性志愿者 ,随机分为两个序列 ,交叉单剂量口服 80 0mg匹多莫德颗粒剂和片剂 ,给药前及给药后不同时间定时采取血样 ;以HPLC UV法测定血浆样本中匹多莫德的浓度 ,并对两种制剂进行生物等效性评价。结果 :口服匹多莫德颗粒剂或片剂 80 0mg后 ,匹多莫德的Cmax分别为 (4 .37± 1.6 6 )和 (4 .83± 1.5 5 ) μg·mL-1,Tmax分别为 (2 .4 2± 1.0 9)和 (2 .6 1± 1.0 9)h ,AUC0～∞分别为 (2 1.17± 8.4 3)和 (2 1.89± 9.0 2 ) μg·h·mL-1;t1/ 2 分别为 (2 .2 1± 0 .4 6 )和 (2 .2 3± 0 .36 )h。结论 :匹多莫德颗粒剂和片剂生物等效。Objective:To evaluate the bioequivalence between pidotimod granules and its tablets.Methods:18 healthy male volunteers were treated with a single dose of pidotimod granules and its tablets in a randomized crossover order.Plasma concentrations of pidotimod were determined by HPLC and the bioequivalence between two formulations were evaluated by 3P97 program.Results:The pharmacokinetc parameters of pidotimod in its granules and tablets were expressed as following: C max were (4.37±1.66) and (4.83±1.55)μg·mL -1 , T max were (2.42±1.09) and (2.61±1.09)h,AUC 0～∞ were (21.17±8.43) and (21.89±9.02) μg·h·mL -1 , t 1/2 were (2.21±0.46) and (2.23± 0.36)h.Conclusion:The pidotimod granules and its tablets are bioequivalent.

关 键 词：匹多莫德 颗粒剂 片剂 生物等效性 

分 类 号：R969.1[医药卫生—药理学]