注射液用溴化丁基胶塞中肉桂醛的含量测定及迁移研究

Determination of Cinnamaldehyde and Its Migration of Brominated Butyl Rubber Plug for Injection

建立了固相萃取-高效液相色谱法对氯化钠注射液进行富集处理,并对注射液用溴化丁基胶塞提取实验及其在氯化钠注射液迁移实验中可能残留的硫化剂N,N-双肉桂醛-1,6-己二胺降解物肉桂醛含量进行测定。结果显示,肉桂醛在0.03098~3.098μg/m L范围内线性良好(R=0.9973),仪器检测限为0.007744μg/m L,氯化钠注射液平均加标回收率为106.6%,对应RSD值为3.34%。该方法测定快速、灵敏度高、准确性和重复性均良好,可用于注射液用溴化丁基胶塞及氯化钠注射液中肉桂醛和硫化剂的质量检测。

A solid phase extraction coupled with high performance liquid chromatographic method was developed to detect the cinnamaldehyde—the degradation product of N,N＇-dicinnamylidene-1,6-hexamethylenediamine, which is the possible residual vulcanizing agent in halogenated butyl rubber stopper. Cinnamaldehyde had a good linearity（R=0.9973） in the range of 0.03098~3.098μg/m L; the limit of detection was 0.007744μg/m L. The average recovery was 106.6%, of which the relative standard deviation was 3.34%. The method is rapid and accurate with high sensitivity and good repeatability, which can be utilized for the detection of cinnamaldehyde and its migration in sodium chloride injection of brominated butyl rubber plug for injection.