基于原辅料相容性的注射用盐酸甲氯芬酯的水分控制  

Research on water control strategy of Meclofenoxate hydrochloride for injection based on drug-excipient compatibility

作　　者：赵巍 胡琴 王琳 杨舒 ZHAO Wei;HU Qin;WANG Lin;YANG Shu(Shengyang Pharmaceutical University,Shengyang,Liaoning,110016 P.R.China;Beijing Institute for Drug Control,Bejing,102206 P.R.China;West China School of Pharmacy,Sichuan University,Chengdu,Sichuan,610041 P.R.China)

机构地区：[1]沈阳药科大学,辽宁沈阳110016 [2]北京市药品检验研究院,北京102206 [3]四川大学华西药学院,四川成都610041

出　　处：《华西药学杂志》2022年第6期619-622,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的考察注射用盐酸甲氯芬酯原辅料的相容性,为合理控制样品的水分提供依据。方法采用差示扫描量热法分析盐酸甲氯芬酯和辅料的相容性,以铟为参比,升温速度10℃·min^(-1),升温范围10~210℃;采用常压干燥失重法及费休氏法考察样品的水分。结果盐酸甲氯芬酯与辅料甘露醇混合后,差示扫描量热法分析曲线的峰形、峰位均发生明显变化,并在105℃出现熔融现象。66批注射用盐酸甲氯芬酯的干燥失重结果为0~0.7%,费休氏法测定水分的含量为0~0.3%;经相关性分析,水解杂质的含量与水分测定结果呈正相关,与干燥失重的结果无相关性。结论注射用盐酸甲氯芬酯原辅料的相容性存在配伍风险,干扰干燥失重的检查,建议质量控制中采用水分代替干燥失重,提高药品的质量及安全性。OBJECTIVE To investigate the compatibility of Meclofenoxate hydrochloride(MH)for injection raw and auxiliary materials for injection.METHODS The compatibility of MH and excipients was analyzed by differential scanning calorimetry.Indium was used as a reference,with heating rate is 10℃·min^(-1)and heating range is 10-210℃.The moisture content of the samples was investigated by atmospheric pressure loss on drying and Fischer′s method.RESULTS After the mixture of MH and the excipient mannitol,the peak shape and peak position of the differential scanning calorimetry analysis curve changed obviously,and the melting phenomenon appeared at 105℃.The weight loss on drying of 66 batches of MH for injection was 0 to 0.7%,and the moisture content measured by Fischer′s method was between 0 and 0.3%.The content of hydrolyzed impurities in MH for injection was positively correlated with the result of water measurement,but had no correlation with the result of loss on drying.CONCLUSION There is a compatibility risk in the compatibility of raw and excipients of MH for injection,which interferes with the inspection of loss on drying.It is recommended to use water instead of loss on drying in quality control to improve the quality and safety of the drug.

关 键 词：注射用盐酸甲氯芬酯 水分 干燥失重 差示扫描量热法 相容性 甘露醇 质量控制 水解杂质 

分 类 号：R917[医药卫生—药物分析学]