基于HPLC指纹图谱和主成分分析考察醒脑静注射液的配伍稳定性

Investigation of Compatible Stability of Xingnaojing Injection Based on HPLC Fingerprint and Principal Component Analysis

目的:考察醒脑静注射液与9种联用药物配伍的稳定性,为该药物的临床安全应用提供参考。方法:根据临床使用情况,将醒脑静注射液分别与9种联用药物进行配伍并置于室内避光条件下和光照条件下6 h,考察配伍溶液的外观性状变化,并采用相似性评价及主成分分析方法对配伍溶液的HPLC指纹图谱进行分析。结果:醒脑静注射液与吡拉西坦氯化钠注射液等9种药物配伍后外观均未发生明显变化。相似度评价结果显示,醒脑静注射液与吡拉西坦氯化钠注射液等9种药物配伍0 h,放置6 h及光照6 h的指纹图谱相似度均> 0. 98。主成分分析结果显示,9组配伍溶液聚为两类;其中与吡拉西坦氯化钠注射液等8种药物的配伍溶液聚为一类,且配伍后醒脑静注射液的特征成分相对峰面积均无明显变化;与丹参川芎嗪注射液的配伍溶液聚为一类,配伍0,6 h后醒脑静注射液的某些特征成分相对峰面积增大,光照6 h后更加明显。结论:醒脑静注射液与吡拉西坦氯化钠注射液等8种药物的配伍稳定性良好,与丹参川芎嗪注射液配伍则存在稳定性问题,提示临床应用时需注意其配伍问题。

Objective:To investigate the compatible stability of Xingnaojing injection in combination with9 common medicines,and to provide a reference for clinical application of this injection.Method:According to the clinical application,Xingnaojing injection was mixed with 9 common medicines and placed in the room under dark and light conditions for 6 h.The appearance of compatible solutions was observed,and the HPLC fingerprint was analyzed by similarity evaluation and principal component analysis(PCA).Result:There were no significant changes in the appearance of compatibility of Xingnaojing injection and 9 common medicines,including piracetam and sodium chloride injection,sodium chloride injection and others.The similarities of fingerprint among compatibility of Xingnaojing injection and 9 common medicines were>0.98 at 0 h of compatibility,6 h of placement and 6 h of illumination.The results of PCA showed that 9 groups of compatible solutions were clustered into 2 categories,the compatibility of Xingnaojing injection and 8 groups including piracetam and sodium chloride injection clustered into one category,and the relative peak areas of the characteristic components of Xingnaojing injection did not change significantly after compatibility,the compatibility of Xingnaojing injection and Danshen Chuanxiongqin injection clustered into another category,the relative peak areas of some characteristic components of Xingnaojing injection increased after compatibility of 0 h and 6 h,and it was more obvious after 6 h of illumination.Conclusion:The compatibility of Xingnaojing injection and 8 common medicines including piracetam and sodium chloride injection has good stability,while the compatibility has stability problems after Xingnaojing injection mixed with Danshen Chuanxiongqin injection.It is suggested that clinical attention should be paid to their compatibility and rational combination of medicines.