光纤传感过程分析利巴韦林片的溶出度

Analysis of the Dissolution of Ribavirin Tablets Based on Fiber-optic Sensing Process

目的:建立过程分析利巴韦林片溶出度的方法。方法:参照《美国药典》中利巴韦林片的溶出条件,采用光纤传感药物溶出度实时测定仪建立利巴韦林片的溶出度分析方法(简称FODT法),并与《美国药典》方法进行比较;同时建立可测定3种不同规格(0.02、0.05、0.1 g)利巴韦林片溶出度的FODT法条件(探头规格、检测波长);另外对11批不同厂家产品进行了考察。结果:两种方法所得溶出度结果均符合要求,但采用FODT法可以观察不同厂家样品及同一厂家不同片之间药物实时溶出情况的差异;3种规格样品采用FODT法时的探头规格和检测波长分别为5、2、1 mm和210、228、234 nm。结论:所建立的测定利巴韦林片溶出度的FODT法能够直观有效地监测药物的溶出过程,连续定量地反映了样品的体外溶出特性。

OBJECTIVE： To establish a process analysis method for the dissolution determination of Ribavirin tablets. METH- ODS ： According to the dissolution condition stated in American Pharmacopoeia, the release process of Ribavirin tablets was deter- mined using FODT system in water. FODT was established for the dissolution of 3 different specifications （0.02, 0.05, 0.1 g） of Ribavirin tablets （probe specification, detection wavelength）. Samples from 11 manufactories were studied. RESULTS： The disslu- tion of 2 methods were in line with the requirments, but FODT could used to detect the dissolution difference of samples from dif- ferent manufacturers and different tablets from same manufacturers. The probe specification and detection wavelength of 3 specifica- tions of samples were 5, 2, 1 mm and 210, 228, 234 nm. CONCLUSIONS： FODT method can directly monitor the dissolution of drugs effectively and reflect the in vitro dissolution characteristics of samples quantiflcationally and continuously.