非洛地平缓释片的原辅料相容性研究  

Study on the compatibility of raw materials and excipients of felodipine sustained-release tablets

作　　者：莫丽娟 于姝燕 王国英 纪紫薇 周刚 陈建平 MO Li-juan;YU Shu-yan;WANG Cuo-ying;JI Zi-wei;ZHOU Gang;CHEN Jian-ping(School of Pharmacy,Inner Mongolia Medical University,Hohhot 010110,China;Institute for Inner Mongolia Drug Testing,Inner Mongolia,Hohhot 010020,China)

机构地区：[1]内蒙古医科大学药学院,内蒙古呼和浩特010110 [2]内蒙古自治区药品检验研究院,内蒙古呼和浩特010020

出　　处：《化学研究与应用》2025年第4期781-791,共11页Chemical Research and Application

基　　金：国家药典委员会项目(2023H024)资助。

摘　　要：考察非洛地平缓释片中各辅料与非洛地平原料药的相容性,研究主成分与各辅料之间的物理化学反应,并对各辅料在加速试验条件下与主成分发生不相容反应进行探索。对非洛地平原料药进行强制降解试验,对其所含杂质进行杂质归属,推测杂质A、杂质B及杂质C的裂解途径。并开展非洛地平与30种辅料的相容性研究,将非洛地平原料药与各辅料混合后,通过稳定性影响因素试验,HPLC法检测有关杂质含量的变化,结合两种试验结果进一步探索原辅料产生不相容的原因。通过强制降解实验,进一步确证了杂质A为降解杂质,杂质B和杂质为工艺及降解杂质,原辅料相容性试验共发现非洛地平与7种辅料混合后,在高湿、光照及高温条件下有不相容情况。To investigate the compatibility of the excipients of felodipine sustained-release tablets with felodipine bulk drug,and to study the physicochemical reaction between the main components and excipients,the incompatible reaction between the excipients and the principal component was studied under the accelerated test condition.The degradation test of felodipine was carried out,the impurities in felodipine were assigned,and the decomposition pathways of impurities A,B and C were inferred.The compatibility of felodipine with 30 kinds of excipients was studied.After mixing felodipine with the excipients,the changes of impurities were detected by HPLC and stability test,the reason of incompatibility between raw materials and excipients was further explored based on the two test results.Through the forced degradation experiment,it was further confirmed that impurity A was the degradation impurity,and impurity B and impurity C were the process and degradation impurity,the compatibility test of felodipine with 7 kinds of excipients showed that felodipine was incompatible with 7 kinds of excipients under high humidity,light and high temperature.

关 键 词：非洛地平 原辅料相容性 强制降解试验 稳定性 处方工艺 

分 类 号：O642.5[理学—物理化学]