4家药厂卡马西平片溶出度和生物利用度考察

Dissolution Rate and Bioavailability Comparison of Carbamazepine Tablets from Different Factories

目的 对四家药厂卡马西平片溶出度、生物利用度及其相关性考察。方法 按照中国药典 2 0 0 0年版要求 ,测定四家药厂生产的卡马西平片含量、崩解时限、溶出度 ;家兔单次口服卡马西平 0 1g后 ,紫外分光光度法测定血药浓度 ,计算其药代动力学参数Tmax、Cmax、和AUC。结果 3个厂家的卡马西平片含量均符合 2 0 0 0年版中国药典规定 ,1个厂家溶出度不符合规定 ;溶出度、Tmax、Cmax、AUC均有显著性差异 ;体外溶出度参数T50 与体内吸收参数Cmax、AUC具有较好的相关性。结论 四家药厂的卡马西平片的质量及生物利用度差异大 ,同厂不同批号的生物利用度也存在很大差异 ;

Objective To compare the dissolution rates and biovailability of four carbamazepine (CBZ) tablets. Methods According to Chinese pharmacopoeia (Ch.P.2000),the dissolution rates,content and disintegration time of CBZ tablets were measured (the tables were made by three factories and totally four batches of sample had be tested);the concentration of CBZ were determined by UV spectrophotometry after a single 100 mg oral dose given to rabbits,calculated the parameters of T_(max),C_(max) and AUC.Results The contents and dissolution rates of CBZ samples complied with Ch.P.2000,with the exception of dissolution failure of one sample,however,there are significant difference of dissolution rates,T_(max),C_(max) and AUC between factories and batches.The correlations between T_(50),C_(max) and AUC had been observed.Conclusion The quality of CBZ provided by different factories was remarkably different.There were significant difference of biovailability between factories and batches.