摘要
目的考察辛伐他汀片的稳定性。方法稳定性研究:样品经高温、高湿、光照、加速试验及长期留样试验考察了本品的稳定性。结果影响因素各条件下样品的溶出度、硬度、含量等均无明显变化,但光照和60℃条件下溶出度有所下降,加速试验及长期留样试验本品的各项指标与试验前比较均无明显变化。结论本品在高温和光照条件下稳定性不好,但对湿度有较好的稳定性。
Objective To determine the stability of Simvastatin（SIM） tablets. Methods The stability of SIM tablets was examined by exposure to high temperature,high humidity and light for a suitable duration. The samples were test by accelerating and long-time experiment. Results No obvious changes were noted in dissolution ,hardness, content and related substances at various condition,but the dissolution of SIM tablets was descended slightly at 60℃ and light. Conclusion SIM tablets were not stable in the case of high temperature and light,but they were stable under high humidity.
出处
《中国现代医生》
2008年第21期64-65,共2页
China Modern Doctor
