辅料干扰对原位光纤实时测定溶出度的影响

Effect of excipient interference on in-situ fiber-optic dissolution test

目的考察辅料沉积对原位光纤实时测定溶出度的影响,探索消除辅料沉积干扰的有效方法。方法以测定盐酸小檗碱片溶出度为例,用滤网包裹光纤检测探头,考察不同孔径滤网对辅料干扰的消除效果以及对溶出度检测的影响。结果 100目以上的滤网可以有效阻挡辅料颗粒在反射镜面的沉积,但滤网目数越大越影响溶出药物在检测窗处的交换,导致检测出现误差。结论用100目滤网包裹光纤检测探头可有效消除辅料颗粒沉积对原位光纤实时测定溶出度的影响。

Objective To investigate the effect of the deposition of excipients on in-situ fiber-optic dissolution test（FODT）,and to explore an effective method to eliminate the interference of the excipients.Methods Taking the dissolution of Berberine Hydrochloride Tablets as an example,the fiber optical probes were wrapped with filter.The elimination effects of different aperture filters on the interference of excipients and the effect on dissolution detection were investigated.Results The filter screen over 100 meshes can effectively prevent the deposition of the auxiliary particles on the reflecting surface,but the bigger mesh affected the exchange of dissolved drug in the detection window and led to detection error.Conclusion The fiber optical probe wrapped with 100 meshes filter can effectively eliminate the effect of auxiliary material deposition on in-situ FODT.