左乙拉西坦注射用浓溶液的配伍溶液与给药器具的相容性研究  

Study of the Compatibility between Levetiracetam Concentrated Solution for Injection and Medical Devices

作　　者：蒋雪琴 张发成 杨菡 JIANG Xue-qin;ZHANG Fa-cheng;YANG Han(Polifarma(Nanjing)Co.,Ltd.,Nanjing 210038,China)

机构地区：[1]宝利化(南京)制药有限公司,江苏南京210038

出　　处：《海峡药学》2025年第2期27-32,共6页Strait Pharmaceutical Journal

摘　　要：目的建立左乙拉西坦注射用浓溶液与氯化钠注射液、葡萄糖注射液、乳酸钠林格注射液配伍后在不同输液器具中的抗氧剂和塑化剂邻苯二甲酸二辛酯(DEHP)提取及迁移的分析方法。方法采用高效液相色谱法,菲罗门C18色谱柱(4.6 mm×150 mm);流动相:甲醇-水,梯度洗脱;柱温40℃,流速1.0 mL·min^(-1),进样量100μL,检测波长275 nm。结果各抗氧剂和DEHP的响应值和浓度均呈线性相关,相关系数均大于0.998,定量限均远低于各抗氧剂和DEHP的控制限度。结论建立的方法适合检测左乙拉西坦注射用浓溶液的配伍溶液使用给药器具后的各抗氧剂和DEHP的含量。OBJECTIVE To establish an analytical method for the migration of antioxidants and plasticizer bis(2-ethylhexyl)phthalate(DEHP)in different medical devices after the combination of Levetiracetam Concentrated Solution for Injection with sodium chloride injection,glucose injection,and sodium lactate Ringer injection.METHODS High performance liquid chromatography was used,with a Pheromone C 18 column(4.6 mm×150 mm),methanol water mobile phase,gradient elution,column temperature of 40℃,flow rate of 1.0 mL·min^(-1),injection volume of 100μL,and detection wavelength of 275 nm.RESULTS The response values and concentrations of each antioxidant and DEHP were linearly correlated,with correlation coefficients greater than 0.998.The quantification limits were far below the control limits of each antioxidant and DEHP.CONCLUSION The established method is suitable for detecting the content of various antioxidants and DEHP in the compatibility solution of levetiracetam concentrated solution for injection used in the medical devices.

关 键 词：左乙拉西坦注射用浓溶液 给药器具 相容性 抗氧剂 高效液相色谱法 

分 类 号：R927[医药卫生—药学]