エノキサシン錠の粉砕後の安定性

Abstract

Although Enoxacin (ENX) tablet is a film-coated tablet with protection from light, it is often administered after grinding the tablets.In the present study, therefore, its stability after grinding was evaluated.After grinding the tablets, the particles were packed by using two different types of wrapping papers, and stored under three different conditions i.e.with protection from light at room temperature, at 30°C and 92% of relative humidity (RH), and with illumination by fluorescent light (800 lx) at room temperature.After the storage, the observation of appearances, the measurement of hygroscopic degree, and the measurement of ENX content and the identification and quantification of decomposition products by high-performance liquid chromatography (HPLC) were undertaken.The results revealed that there was no decline in the content of ENX under any conditions adopted for storage, except that some changes were found in color shade of the sample stored with illumination by fluorescent light at room temperature, together with formation of two kinds of decomposition products, and that weight gain by 8-10% due to hygroscopicity was noted after storage at 30°C and 92% RH.From these findings, it was concluded that ENX tablet after grinding should be stored with protection from humidity and light.