目的 明确冠心宁注射液（GXNI）在光照、温度等不同条件下的质量影响因素，为GXNI的仓储及运输提供参考。方法 以丹参素钠、原儿茶醛、阿魏酸、迷迭香酸和丹酚酸B的含量为定量指标，结合指纹图谱相似度分析，主成分分析和相对含量比较，评价不同影响因素对GXNI主要化学成分的影响。结果 GXNI在低温条件下洋川芎内酯I、洋川芎内酯H等4个化合物含量升高，香草酸、香草醛等5个化合物含量降低，原儿茶醛、阿魏酸等13个化合物含量无显著性差异；在冻融条件下5-羟甲基糠醛等4个化合物含量升高，香草酸、绿原酸等7个化合物含量降低，丹参素钠、阿魏酸等11个化合物含量无显著性差异；在高温条件下丹参素钠、原儿茶醛等7个化合物含量升高，阿魏酸、迷迭香酸等11个化合物含量降低，绿原酸、咖啡酸等4个化合物含量无显著性差异；在强光照射条件下洋川芎内酯H等2个化合物含量升高，阿魏酸、丹酚酸B等16个化合物含量降低，丹参素钠、原儿茶醛等4个化合物含量无显著性差异。结论 高温和强光照射会对GXNI的化学成分产生影响，冻融也会对部分成分产生一定影响，建议GXNI选择高于零度的低温环境保存。

Objective To identify the influencing factors (light, temperature, etc) of Guanxinning Injection (GXNI) in the storage and transportation process, and lay the foundation for the storage and transportation of GXNI. Methods Taking the content of sodium danshensu, protocatechuic aldehyde, ferulic acid, rosmarinic acid, and salvianolic acid B as quantitative indicators, combined with the common peak similarity analysis, principal component analysis, and relative content comparison in the fingerprint to evaluate the effect of different influencing factors on the main chemical composition of GXNI. Results After low temperature treatment, the content of four compounds, such as senkyunolide I and senkyunolide H, were increased, the content of five compounds, such as vanillic acid and vanillin aldehyde, were reduced, the content of 13 compounds, such as protocatechuic aldehyde and ferulic acid, showed no significant changes. Under the freezing-thawing conditions, the content of four compounds, such as 5-hydroxymethylfurfural, were increased, the content of seven compounds, such as vanillin acid and chlorogenic acid, was reduced, the content of 11 compounds, such as sodium danshensu and ferulic acid, showed no significant changes. Under high temperature, the content of seven compounds, such as sodium danshensu and protocatechuic aldehyde, were increased, the content of 11 compounds, such as ferulic acid and rosmarinic acid, were reduced, the content of four compounds, such as chlorogenic acid and caffeic acid, showed no significant changes. Under strong light conditions, the content of two compounds, such as senkyunolide H, were increased, the content of 16 compounds, such as ferulic acid and salvianolic acid B, were reduced, the content of four compounds, such as sodium danshensu and protocatechuic aldehyde, showed no significant changes. Conclusion High temperature and strong light will affect the components of GXNI, and some compounds will also be affected under freezing-thawing conditions. Thus, the GXNI should be stored under low temperature, but higher than 0 ℃.

R286.02

山西省重点科技创新平台（201705D151002）