摘要
目的考察硝苯地平缓释片中原料药与辅料的相容性,为更好地设计处方,控制和提高质量提供依据和信息。方法采用中国药典2015年版二部硝苯地平原料药项下有关物质检查方法,考察有关物质变化,作为不同辅料对硝苯地平缓释片光稳定性的影响指标。结果在光照条件下,硝苯地平易产生光降解杂质2,且微晶纤维素和硬脂酸镁会加速杂质2的产生。结论在满足相关制剂要求的条件下,建议尽量少加或不加微晶纤维素和硬脂酸镁。
OBJECTIVE To investigate the compatibility of APIs with nifedipine sustained release tablets and to provide basis and information for better prescription design, control and quality improvement. METHODS According to the determination methods for the relative substances in nifedipine in Ch P2015, to examine the changes of relative substances, as effects of different excipients on the photostability of nifedipine sustained-release tablets. RESULTS In the light conditions, nifedipine could produce photodegradation impurities 2, and microcrystalline cellulose and magnesium stearate will accelerate the production of impurities 2. CONCLUSION Under the conditions required to meet the requirements of the relevant preparation, it is recommended to use as little or no microcrystalline cellulose and magnesium stearate.
出处
《中国现代应用药学》
CAS
CSCD
2017年第11期1557-1559,共3页
Chinese Journal of Modern Applied Pharmacy
基金
绿色制药协同创新课题
药品医疗器械审评审批制度改革专项课题(ZG2016-4-06)
关键词
硝苯地平缓释片
杂质
辅料
微晶纤维素
硬脂酸镁
nifedipine sustained-release tablets
impurity
excipients
microcrystalline cellulose
magnesium stearate
