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目的测定79批脉络宁注射液中5-羟甲基糠醛、绿原酸和咖啡酸的含量,并对这3种既有效又可能导致不良反应成分的安全性作出分析。方法色谱柱为Agilent Zorbax SB-C18(4.6 mm×150 mm,5μm);流动相为甲醇-0.1%甲酸,梯度洗脱;DAD检测,定量波长5-羟甲基糠醛为283 nm,绿原酸和咖啡酸为325 nm;柱温为20℃。结果 5-羟甲基糠醛、绿原酸和咖啡酸的含量分别为0.15%~0.41%(RSD=19.34%)、0.03%~0.07%(RSD=15.83%)和0.02%~0.05%(RSD=18.88%),平均含量分别为0.28%、0.05%和0.03%。结论从79批测定数据来看,本制剂中5-羟甲基糠醛、绿原酸及咖啡酸的含量均波动较大,其中5-羟甲基糠醛平均含量达到0.28%,参照葡萄糖类注射液有关标准,此含量偏高,可能存在一定的安全风险。
Objective To determine the contents of 5-hydroxymethylfurfural, chlorogenic acid and caffeic acid in 79 batches of Mailuoning injection and to analyze the safety of these 3 ingredients which may cause adverse reactions. Methods The column was Agilent Zorbax SB-C18 (4.6 mm × 150 mm, 5 μm). The mobile phase consisted of methanol-0.1% formic acid with gradient elution. DAD was used to quantify the 5-hydroxymethylfurfural at 283 nm. And caffeic acid was 325 nm; column temperature was 20 ° C. Results The contents of 5-hydroxymethylfurfural, chlorogenic acid and caffeic acid were 0.15% -0.41% (RSD = 19.34%), 0.03% -0.07% (RSD = 15.83%) and 0.02% -0.05% 18.88%) with the average contents of 0.28%, 0.05% and 0.03% respectively. CONCLUSIONS From the data of 79 batches of determination, the contents of 5-hydroxymethylfurfural, chlorogenic acid and caffeic acid in this preparation all fluctuated greatly, and the average content of 5-hydroxymethylfurfural reached 0.28%. According to the reference glucose injection The relevant standards, this content is high, there may be some security risks.