摘要
目的考察伏立诺他胶囊的稳定性。方法依据2010年版《中国药典(二部)》附录"原料药与药物制剂稳定性试验指导原则"的有关技术要求,进行稳定性试验,包括影响因素试验、加速试验、长期试验。结果 2年考察结果显示,3批样品的内容物色泽、溶出度、含量、有关物质均无显著变化,外观上稍有吸湿性。结论伏立诺他胶囊应密闭于阴凉干燥处贮藏,有效期暂定2年。
OBJECTIVE Vorinostat investigate the stability of capsules. METHODS Based on 2010 edition of ＂Chinese Pharmacopoeia （two）＂ Appendix ＂bulk drugs and pharmaceutical preparations stability test guidehnes＂ the relevant technical requirements of the stability tests, including stress testing, accelerated testing, long-term tri- al. RESULTS 2-year study showed that the contents of the three samples the color, dissolution, content and related substances were sules should be no significant changes in the appearance of a slightly hygroscopic. CONCLUSION Vorinostat cap- stored airtight in a cool dry place ,valid tentative two years
出处
《海峡药学》
2017年第11期8-9,共2页
Strait Pharmaceutical Journal
