光纤药物溶出度实时测定仪监测氨茶碱片溶出度

摘要

目的 比较光纤法与药典法测定氨茶碱片溶出度的利弊.方法 采用FODT -601光纤药物溶出度实时测定仪,测定某厂家8批次氨茶碱片溶出度,并与药典法测定结果进行比较.结果 光纤法测定结果普遍高于药典法,且该厂家8批次氨茶碱片间的溶出曲线差异较大.结论 光纤法溶出度可实现在线测定氨茶碱片溶出度,且能客观反映氨茶碱片溶出全过程.%Objective To make comparison of advantages and disadvantages between fiber optic method and pharmacopia -recommended method for the assay of aminophylline tablets dissolution. Methods A fiber optic dissolution test system, FODT - 601, was used to determine eight batches of aminophlline made in a domestic factory. The results were compared with those obtained by pharmacopia - recommended method. Results In general, dissolution rates of aminophylline samples assayed by fiber optic method were higher than those by pharmacopia - recommended method. There were great differences in real - time dissolution curve among eight batches of aminophylline. Conclusion Fiber optic dissolution test system can fulfil real - time assay of aminophylline dissolution. Moreover, it can objectively reflect the whole dissolving process of aminophylline.