复方胆氨胶囊中氨茶碱在健康人体的生物等效性研究  

Bioequivalence of Aminophylline in Compound Bile and Ammonia Capsules in Chinese Health Volunteers

作　　者：黄露 熊欣 郭源源 熊桂斌 Huang Lu;Xiong Xin;Guo Yuanyuan;Xiong Guibin(Department of Pharmacy,Liyuan Hospital of Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430077,China)

机构地区：[1]华中科技大学同济医学院附属梨园医院药剂科,武汉430077

出　　处：《中国药师》2020年第9期1873-1875,共3页China Pharmacist

摘　　要：目的:建立人血浆中氨茶碱浓度的HPLC测定方法,研究复方胆氨胶囊中氨茶碱在中国健康男性志愿者的主要药动学参数及与参比制剂的生物等效性。方法:采用两试剂双周期交叉试验设计,20名健康受试者分别单剂量口服受试制剂和参比制剂100 mg,采用HPLC法测定血浆中氨茶碱的浓度,DAS 2.0软件计算药动学参数并考察生物等效性。结果:受试制剂和参比制剂在受试者体内氨茶碱的药动学参数如下:药峰浓度(Cmax)分别为(3.48±0.61)和(3.75±0.66)μg·ml^-1;达峰时间(tmax)分别为(1.59±1.32)和(1.23±0.89)h;消除半衰期(t1/2)分别为(12.19±5.31)和(10.33±2.80)h;药时曲线下面积(AUC)0-t分别为(47.70±10.06)和(46.05±8.75)μg·ml^-1·h;AUC0-∞分别为(50.75±11.36)和(48.56±9.14)μg·ml^-1·h;受试制剂对参比制剂氨茶碱的相对生物利用度为(98.5±17.7)%。结论:两制剂中氨茶碱组分具有生物等效性。Objective:To establish an HPLC method to determine the concentration of aminophylline in human plasma and to evaluate the bioavailability and bioequivalence of aminophylline in compound bile ammonia capsules in Chinese health male volunteers.Methods:A randomized,two-period and crossover bioequivalence trial was designed,and 20 Chinese health volunteers were randomly divided into two groups respectively treated with 100 mg single dose of test capsules or reference capsules.The concentration of aminophylline in plasma was determined by a valid HPLC method.The pharmacokinetic parameters and relative bioavailability were processed by DAS 2.0 software to evaluate the bioequivalence of test and reference capsules.Results:The pharmacokinetic parameters of test and reference capsules were as follows:Cmax were(3.48±0.61)and(3.75±0.66)ng·ml^-1;tmax were(1.59±1.32)and(1.23±0.89)h;t1/2 were(12.19±5.31)and(10.33±2.80)h;AUC0-twere(47.70±10.06)and(46.05±8.75)μg·ml^-1·h;AUC0-∞were(50.75±11.36)and(48.56±9.14)μg·ml^-1·h.The relative bioavailability of aminophylline in the test capsules was(98.5±17.7)%.Conclusion:Aminophylline in the two preparations is bioequivalence.

关 键 词：氨茶碱 复方胆氨胶囊 高效液相色谱法 生物等效性 

分 类 号：R969.1[医药卫生—药理学]