盐酸特比萘芬分散片在健康人体的药动学研究  

Pharmacokinetics of Terbinafine Hydrochloride Dispersible Tablets in Healthy Volunteers

作　　者：王海英[1] 蒋学华[2] 邹琴[1] 苏旭[1] 陈卓[1] WANG Haiying;JIANG Xuehua;ZOU Qin;SU Xu;CHEN Zhuo(Institute of Drug Clinical Trials, West China Second University Hospital, Sichuan University, Sichuan Chengdu 610041, China;West China School of Pharmacy, Sichuan University, Sichuan Chengdu 610041, China)

机构地区：[1]四川大学华西第二医院药物临床试验机构,四川成都610041 [2]四川大学华西药学院,四川成都610041

出　　处：《中国医院用药评价与分析》2020年第7期824-827,共4页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:探讨中国健康受试者单次口服盐酸特比萘芬分散片的药动学。方法:将24例健康男性受试者随机分为两组,分别单剂量口服给予受试制剂(盐酸特比萘芬分散片)或参比制剂(盐酸特比萘芬片)各1片,洗脱1周后,交叉给药,采用高效液相色谱法测定血药浓度,计算两者的主要药动学参数和相对生物利用度。结果:口服受试制剂或参比制剂后,两组受试者血浆中特比萘芬的主要药动学参数如下,Tmax分别为(1.545±0.999)h和(1.636±0.978)h,Cmax分别为(925.158±304.526)ng/ml和(907.765±355.11)ng/ml,以AUC0→∞计,受试制剂的相对生物利用度为108.2±27.6。结论:受试制剂与参比制剂在健康受试者体内具有生物等效性。OBJECTIVE:To investigate the pharmacokinetics of single oral Terbinafine dispersible tablets in healthy volunteers in China.METHODS:Twenty-four healthy male subjects were randomly divided into two groups,and the test preparation(Terbinafine hydrochloride dispersible tablets)or the reference preparation(Terbinafine hydrochloride tablets)was administered orally in a single dose.After elution for 1 week,cross-dose was performed.The blood drug concentration was determined by HPLC,and the main pharmacokinetic parameters and relative bioavailability of two drugs were calculated.RESULTS:After oral administration of the test or reference preparation,the main pharmacokinetic parameters of terbinafine in the plasma of the subjects were as follows,Tmax was(1.545±0.999)h and(1.636±0.978)h,and Cmax was(925.158±304.526)ng/ml and(907.765±355.11)ng/ml,respectively.The relative bioavailability of the test preparation was 108.2±27.6,which was calculated in AUC0→∞.CONCLUSIONS:The test preparation and reference preparation are bioequivalent in healthy volunteers.

关 键 词：盐酸特比萘芬 高效液相色谱法 生物等效性 健康受试者 药动学参数 

分 类 号：R969.1[医药卫生—药理学]