乌拉地尔渗透泵片稳定性研究

Investigation on Stability of Urapidil Osmotic Pump Tablets

目的研究乌拉地尔渗透泵片的稳定性。方法将乌拉地尔渗透泵片在光照、高温、高湿条件下露置,并进行加速试验和室温留样观察,定时取样,观察样品形态、含量及释放度。结果乌拉地尔渗透泵片在光照条件下稳定;高温条件下释放有所减慢;在相对湿度(90±5)%条件下放置,有内容物从片孔流出;加速试验及室温条件下稳定。结论该制剂在光照条件下表现良好的稳定性,在高湿条件下极不稳定,应注意包装材料的隔湿性能,并在阴凉、干燥条件下保存。

Objective To establish a method of analysis for stability of urapidil osmotic pump tablets （UOPT）,and to investigate its stability. Methods UOPT was exposed to strong light, high temperature, high moisture of air respectively, and accelerating test was performed. Study the appearance and content, determine the release in vitro of sample were determined by same time. Results Under strong light, the UOPT sample had good stability. The release of sample became slowly. Something flow from orifice at 90%±5% humidity. Conclusions UOPT has good stability under strong light , but at high moisture of air it shows unstable. Attention should be paid to the property of moisture insulation of wrapper.