盐酸特比萘芬与硬脂酸的原辅料相容性研究

ZHOU Ying,XIE Yingying,ZHENG Jinfeng,LIU Yanming

Drug Standards of China（2022）

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Abstract

目的:考察盐酸特比萘芬与硬脂酸的化学相容性.方法:将原料药盐酸特比萘芬与辅料硬脂酸混合后,通过稳定性影响因素实验,采用高效液相色谱法,考察有关物质的变化.结果:在高温60℃和照度4500 lx条件下,盐酸特比萘芬与硬脂酸配伍后,特比萘芬杂质A、特比萘芬杂质B及杂质总量均有不同程度的增长,并新增1个未知杂质,且不同型号的硬脂酸对盐酸特比萘芬有关物质的影响有差异.结论:盐酸特比萘芬和硬脂酸在高温和光照条件下存在相容性风险,提示生产企业应优化处方,选择质量更优的辅料,提升产品安全性和质量.

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