中国药房2011，Vol.22Issue(17)：1556-1558,3.
2种罗格列酮钠制剂在犬体内的生物等效性研究
Bioequivalence of 2 Kinds of Rosiglitazone Sodium Preparations in Dogs
摘要
Abstract
OBJECTIVE: To compare pharmacokinetic characteristics and bioequivalence of Rosiglitazone sodium enteric-release capsule and Rosiglitazone sodium capsule in dogs.METHODS: 6 dogs were divided into two groups.Both groups were given Rosiglitazone sodium enteric-release capsule or Rosiglitazone sodium capsule 4 mg respectively in randomized cross-over study.Blood samples of hind legs vein were collected before administration and within 450 min after administration.The plasma concentration of rosiglitazone was measured by HPLC.The pharmacokinetic parameters of rosiglitazone were calculated using DAS 2.0 software.RESULTS: The pharmacokinetic parameters of same dosage of Rosiglitazone sodium enteric-release capsules vs.Rosiglitazone sodium capsules were as follows: AUC0～∞: (119.662 ± 8.451) mg· min· L- 1 vs.( 118.493 ± 15.325) mg· min· L- 1; t1/2Ka:(101.548 ± 6.526) min vs.(39.702 ± 26.293) min; cmax: (0.359 ± 0.035) mg·L-1 vs.(0.807 ± 0.208) mg·L-1.Compared with normal capsule, AUC0～∞ of enteric-release capsule had no significant difference, t1/2Ka extended and cmax decreased significantly (P＜0.05 or P＜0.01).CONCLUSION: Rosiglitazone sodium enteric-release capsules and common capsule are bioequivalente and characterized with sustained-release profile.关键词
罗格列酮钠/肠溶胶囊/普通胶囊/药动学/犬/生物等效性分类
医药卫生引用本文复制引用
胡思星,方大树,张检,李靖柯,周鸿睿,胡湘南..2种罗格列酮钠制剂在犬体内的生物等效性研究[J].中国药房,2011,22(17):1556-1558,3.基金项目
重庆自然科学基金项目(2006BB5286) （2006BB5286）
