去铁酮缓释片在犬体内的药动学及生物等效性  

Pharmacokinetics and bioequivalence of deferiprone extended-release tablets in Beagle dogs

作　　者：何萍[1] 顾炳[1] 王晨瑜[1] 陆伟跃[1] 

机构地区：[1]复旦大学药学院药剂学教研室,上海200032

出　　处：《中国临床药学杂志》2008年第4期220-223,共4页Chinese Journal of Clinical Pharmacy

摘　　要：目的建立犬血清中去铁酮浓度测定的HPLC法,评价去铁酮缓释片与其普通片的生物等效性。方法采用双交叉进行动物实验,内标HPLC法检测血药浓度,矩形法求算药动学参数。结果与普通片相比,去铁酮缓释片的t(1/2)延长,t_(max)和MRT明显延长(P<0.05),ρ_(max)显著降低(P<0.01),相对生物利用度为(99.06±7.10)%。结论本方法专属性强,灵敏度高,准确性好;去铁酮缓释片与其普通片具有生物等效性,且具有明显的缓释特征。AIM To establish a HPLC method for the evaluation of bioavailability and pharmacokinetic studies of deferiprone in Beagle dogs. METHODS A random two-way crossover study in 6 dogs was adopted. The drug serum concentrafion was determined by intemal standard HPLC method. The pharmaeokinetie parameters were calculated by moment method. RESULTS The results indicated that the tmax and MRT of extended-release tablets （ER） were longer than those of immediate-release tablets （IR） （ P 〈 0.05）, and the pmax of ER was lower than that of IR（ P 〈 0.01 ）. The bioavailability of ER relative to IR was （99.06 ± 7.10） %. CONCLUSION The method is proved to be simple, sensitive and rapid. The two formulations have the same absorption extent. Comparing with IR, the ER exhibits good extended release tendency.

关 键 词：去铁酮 HPLC 药动学 生物等效性 

分 类 号：R96[医药卫生—药理学]