莫匹罗星原料及软膏剂有关物质分析  

Analysis of related substances of mupirocin raw material and ointment

作　　者：崇小萌[1] 吴承芷 常祎卓 王立新[1] 李进[1] 戚淑叶 姚尚辰[1] 宁保明[1] 许明哲[1] CHONG Xiao-meng;WU Cheng-zhi;CHANG Yi-zhuo;WANG Li-xin;LI Jin;QI Shu-ye;YAO Shang-chen;NING Bao-ming;XU Ming-zhe(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国新药杂志》2024年第20期2159-2168,共10页Chinese Journal of New Drugs

摘　　要：目的:通过对不同厂家莫匹罗星原料及软膏剂的杂质谱进行分析,确定生产、贮存过程中的关键工艺参数,为莫匹罗星软膏剂质量评价提供数据支持。方法:采用柱切换HPLC-MS法确定莫匹罗星原料及制剂杂质谱,并对降解实验产生杂质进行定性分析,采用粉末X-射线衍射方法对原料晶型进行分析。结果:总结莫匹罗星原料及软膏剂特征杂质谱,共检出9种杂质,对杂质来源进行归属,不同厂家原料均为结晶型原料。结论:莫匹罗星软膏剂中主要杂质均来自原料,降解杂质主要受酸碱度、温度及光照的影响。可将原料及制剂中工艺杂质的相对含量作为考察生产工艺差异的指标,可将主要降解杂质作为分析生产、包装、贮存过程中温度及光照控制是否合理的指标。Objective:To determine the key process parameters during production and storage by analyzing the impurity profiles of mupirocin raw materials and ointments from different manufacturers,to provide data support for the quality evaluation of mupirocin ointment.Methods:Column switch HPLC-MS was applied to establish the impurity profiles of mupirocin raw material and ointment,and the impurities produced in the stressing test were analyzed.X-ray was applied to analyze the crystal form of the raw material.Results:The characteristic impurity profiles of mupirocin raw material and ointment were established,nine impurities were detected,and the sources of impurities were summarized.The raw materials of different manufacturers were all crystal form.Conclusion:The main impurities in mupirocin ointment come from raw materials,and the degradation impurities are mainly affected by pH,temperature and light.The relative content of process impurities in raw materials and preparations could be used as an index to investigate the differences in production processes,and the main degraded impurities could be used as an index to analyze whether the temperature and light control in the process of production,packaging and storage is reasonable.

关 键 词：莫匹罗星 杂质谱 晶型 柱切换HPLC-MS法 

分 类 号：R917[医药卫生—药物分析学]