泛昔洛韦片的人体相对生物利用度及究生物等效性研.docVIP

泛昔洛韦片的人体相对生物利用度及究生物等效性研 本文档由【中文word文档库】提供，转载分发敬请保留本信息； 中文word文档库免费提供海量范文、教育、学习、政策、报告和经济类word文档。 （1 2 4．温州医学院药学院 浙江温州 325000，3. 温州医学院附属第一医院 浙江温州 325027 5. 华中科技大学同济医学院临床药理研究所，湖北 武汉　430030） 摘 要健康志愿者名，随机双交叉单剂量口服试验制剂和参比制剂g，剂间间隔为周。分别于服药后h内多点取静脉血；用HPLC）法测定血浆中的浓度。结果单口服试验和的的Cmax分别为±0.729) μg·mL-1和±0.990) μg·mL-1；Tmax分别为±0.469) h和±0.619)h；AUC(0-)分别为±2.746) μg·mL-1和±2.675) μg·mL-1；AUC(0-inf)分别为±2.979) μg·mL-1和± 2.763) μg·mL-1。AUC(0-)的90%可信区间为%～%，AUC(0-inf)的90%可信区间为%～%，Cmax的90%可信区间为%～%。试验与参比的人体相对生物利用度为±22.6)%，试验制剂与参比制剂具有生物学等效性。Famciclovir Tablets in Healthy Volunteers Yang daizheng 1 Xu peng 2 Zhang xiuhua3 Hu guoxin4 Dai zongshun5 （1 2 4 . School of pharmacy Wenzhou Medical College ,Wenzhou Zhejiang 325027 ; 3. The First Affiliated Hospital of Wenzhou Medical College， Wenzhou Zhejiang 325000 5. Institute of Clinical Pharmacology, Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430030） ABSTRACT OBJECTIVE: To study the relative bioavailability and bioequivalence of Famciclovir tablets in healthy volunteers. METHODS: A single oral dose (0.5g of tested and reference formulation) were given to 18 healthy volunteers in a randomised crossover study. The concentrations of Penciclovir in plasma were determined by HPLC. The harmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS program. RESULTS: After a single dose, the 作者简介：杨代正，男，硕士在读， 电话：013282701230，E-mail：yd 通讯作者：胡国新，教授，硕士生导师，电话：013506660881，E-mail：wzhhgx@ pharmacokineticsparameters for Penciclovir were as follows: Cmax were (3.053±0.729) μg·mL-1 and( 3.158±0.990) μg·mL-1; Tmax were (1.028±0.469)h and (1.153±0.619)h; AUC(0-12) were (9.109±2.746) μg·mL-1 and (9.534±2.675) μg·mL-1; AUC(0-inf) were (9.493±2.979) μg·mL-1 and (9.493±2.979) μg·mL-1 for T and R respectively. The 90% confidential interval of AUC(0-12) 、AUC(0-inf) and Cmax of tested formulation were %～%、87.9%～%and 91.4%～% respectively. CON