光纤药物溶出度监测仪在线监测米非司酮片的溶出度

Monitoring of the Dissolution of Mifepristone Tablets with Fiber Optic Chemical Sensor Dissolution Test System

目的:采用光纤化学传感技术,实时、在位监测米非司酮片的溶出度。方法:运用E_(1cm)^(1%)值法监测米非司酮片的溶出全过程。结果:本法监测的溶出过程曲线与《中国药典》2005年版方法手动取样测定所拟合的曲线基本一致。结论:光纤药物溶出度监测仪可以准确测定固体药物的体外溶出度,真实地反映药物溶出的全过程。

Objective： To establish a processing analysis method of the dissolution test of mifepristone tablets-fiber optic chemical sensor dissolution test （FOCSDT）. Method： The real time process of mifepristone tablets was determined with the dissolution test system,and the E1%1cm method was used in data processing. Result： This procession analysis could test the whole process of the drug and get dissolution graph. The parameters obtained by FOCSDT had no significant difference compared with the method in ChP2005. Result： This method can reflect the real dissolution process and obtain the total information.