一次性无菌注射器的浸出有机物研究  

Study on the Organic Extract of Disposable Sterile Syringe

作　　者：管璐晗 赵静 张颖 

机构地区：[1]重庆华邦制药有限公司,重庆401121

出　　处：《中国药房》2014年第45期4256-4259,共4页China Pharmacy

摘　　要：目的：研究一次性无菌注射器（简称一次性注射器）与有机助溶剂接触后的浸出有机物,确定其结构并测定含量。方法：采用含橡胶活塞的三件式一次性注射器及不含橡胶活塞的二件式一次性注射器与注射剂中常用的乙醇、丙二醇、聚乙二醇400及甘油等有机助溶剂接触,采用高效液相色谱-二极管阵列检测器、质谱确定浸出有机物的结构;模拟已上市注射剂处方,以高效液相色谱法定量测定一次性注射器分别与5%~20%乙醇溶液、20%~60%丙二醇溶液及20%~60%聚乙二醇400溶液接触后浸出有机物的含量。结果：三件式一次性注射器与甘油接触后无明显浸出有机物;与乙醇、丙二醇及聚乙二醇400接触后有有机物浸出,其中乙醇中浸出量最高;二件式一次性注射器与上述有机助溶剂接触均无浸出物出现。浸出有机物来源于注射器中的橡胶活塞,为增塑剂邻苯二甲酸二异辛酯（DEHP）。一次性注射器与不同浓度的有机助溶剂接触5 min以内,浸出的DEHP含量均低于1.5μg/ml,远低于人体可耐受的日摄入量。结论：采用一次性注射器注射含有机助溶剂的注射剂,短时间内使用安全性风险较低。OBJECTIVE： To study organic extract after disposable sterile syringe contact with organic cosolvent, and to determine its molecular structure and content. METHODS： Three-piece disposable sterile syringes containing rubber piston and two-piece disposable sterile syringes without rubber piston contacted with ethanol, propylene glycol, glycerol and polyethylene glycol 400, etc. which were usually used in injection. The HPLC-DAD and mass spectrometry were adopted to confirm its molecular structures of organic extract. By simulating the formulation of injection in the market, HPLC method was adopted to study the content of extract after disposable sterile syringes contacted with 5%-2% ethanol, 20%-60% propanediol and 20%-60% polyethylene glycol 400. RESULTS： There was no obvious extract after three-piece disposable sterile syringes contacted with glycerol. The extract was found after three-piece disposable sterile syringes contacted with ethanol, propylene glycol and polyethylene glycol 400, among which the content of ethanol was the highest. No extract was found after two-piece disposable sterile syringes contacted with above organic cosolvents. The extract derived from rubble piston of syringe and was plasticizer DEHP. The content of DEHP was less than 1.5 μg/ml within five minutes after the syringe contacted with organic solutions with different concentrations; it was far below the tolerable daily intake of DEHP. CONCLUSIONS： The security risk of the injections which contain organic solvent by using disposable sterile syringe is in low level relatively for a short time.

关 键 词：一次性无菌注射器 浸出物 邻苯二甲酸二异辛酯 含量测定 

分 类 号：R927[医药卫生—药学]