阿普唑仑口腔崩解片的稳定性研究

Stability of Alprazolam Oral Disintegrating Tablets

目的:研究阿普唑仑口腔崩解片的稳定性。方法:考察高湿、高温、光照下及加速试验和长期试验下阿普唑仑口腔崩解片的外观和色泽、硬度和崩解时限、有关物质和含量测定等。结果:高湿、高温、光照下片剂含量和有关物质均无明显变化,但外观、硬度和崩解时限均有一定改变,尤其在高湿条件下。加速试验和长期试验结果显示,除加速试验第6个月时片剂有关物质量均>1%外,其余检测指标均符合质量标准的有关规定。结论:阿普唑仑口腔崩解片应选用防潮性能好的避光材料,用包装机进行包装,并置阴凉处保存,以保证本品的稳定。

OBJECTIVE： To study the stability of alprazolam orall disintegrating tablet（AODT）. METHODS： The change in appearance, color, hardness, disintegration time, the related substance and the contents of AODT under high humidity, high temperature, strong light, accelerated test and long term test were investigated. RESULTS： Under high humidity, high temperature or strong light, no obvious change was noted for the content and related substance of AODT, but a little change was noted in hardness and disintegrating time much as in the condition of high humidity. The accelerated test and long term test showed that the except the content of the related substance in the tablets was above 1% on the sixth month of accelerated test, all the other indexes were up to the quality standard. CONCLUSIONS： AODT should be packaged with moistureproof and lightproof material by package machine and stored in cool place to assure its stability.