微波萃取-气相色谱法测定三层共挤输液袋中苯乙烯含量及其在注射液中的迁移量  

Determination of Styrene Content in Three-layer Co-extrusion Infusion Bag and Its Migration in Two Drug Solutions by Microwave Extraction-gas Chromatography

作　　者：李樾[1] 仪忠勋 孙会敏[1] LI Yue;YI Zhongxun;SUN Huimin(National Institute for the Drug and Food Control,Beijing 100050)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国医药工业杂志》2020年第1期113-117,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了考察塑料输液包装材料及药品中苯乙烯的含量及迁移量的微波萃取-气相色谱法。采用Agilent DB-624(0.25 mm×60 m×1.4μm)色谱柱,以高纯氮为载气,柱流速为1.2 ml/min,分流比为10∶1,进样口温度为200℃,FID检测器温度为260℃,柱温为程序升温的气相色谱法测定苯乙烯含量及迁移量。苯乙烯在0.007~0.034 mg/ml的范围内线性关系良好(r=0.999 9),输液袋中可检出苯乙烯,加速放置的注射液中未检出迁移的苯乙烯。本方法准确、有效、可行,可用于考察输液袋中苯乙烯含量及其在注射液中的迁移量。A gas chromatography assisted with microwave extraction was established to investigate the content and migration of styrene in plastic infusion packaging materials and injections. The chromatographic column was Agilent DB-624(0.25 mm×60 m×1.4 μm). The shunt ratio is 10∶1. Injection port temperature is 200 ℃, FID detector temperature is 260 ℃. The column temperature is programmed. The calibration curve was linear over the concentration range of 0.007-0.034 mg/ml(r=0.999 9). Styrene can be detected in the infusion bag, and the transferred styrene can not be detected in the accelerated drug solution. This method is simple, rapid, accurate and suitable for the determination of styrene in plastic infusion packaging materials and injections.

关 键 词：微波萃取 气相色谱法 三层共挤输液袋 苯乙烯 

分 类 号：R917[医药卫生—药物分析学]