药用胶塞质量对头孢菌素类注射剂澄清度的影响  

Effect of Medicinal Rubber Stopper Quality on the Clarity of Cephalosporin Injections

作　　者：吴红洋 韩海燕 任学毅 李莎 范能全 WU Hongyang;HAN Haiyan;REN Xueyi;LI Sha;FAN Nengquan(Chongqing Institute for Food and Drug Control,Chongqing,China 401121)

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121

出　　处：《中国药业》2022年第6期25-27,共3页China Pharmaceuticals

基　　金：重庆市药品、医疗器械、化妆品安全专项监测项目[渝食药监〔2018〕60号]。

摘　　要：目的探讨药用胶塞质量对头孢菌素类注射剂澄清度的影响。方法调研重庆市7家头孢菌素类注射剂在产企业,了解胶塞的使用贮存情况和配方信息,收集14个品种、39批样品,检测药品溶液澄清度及胶塞中环硅氧烷、2,6-二叔丁基对甲酚(BHT)和不饱和脂肪酸。结果39批头孢菌素类注射剂在加速试验条件下,8批样品的浊度值显著升高,胶塞和药品中环硅氧烷、BHT、棕榈酸、硬脂酸的检出率分别为7.7%和7.7%、11.5%和15.4%、96.2%和69.2%、100.0%和26.9%。结论胶塞质量对头孢菌素类注射剂的溶液澄清度有一定影响,研究结果可为企业选择适宜的胶塞提供参考。Objective To investigate the effect of medicinal rubber stopper quality on the clarity of cephalosporin injections.Methods The usage and recipe information of seven companies which were producing cephalosporin injections in Chongqing were studied.Thirty nine batches and forteen varieties were collected,the clarity of drugs and the levels of cyclosiloxane,butylated hydroxytoluene(BHT),unsaturated fatty acids in rubber stoppers were tested.Results The turbidity values of 8 batches increased significantly in 39 batches of cephalosporin injections in accelerated test.The detection rates of cyclosiloxane,BHT,palmitic acid,stearic acid in rubber stoppers and drugs were 7.7%and 7.7%,11.5%and 15.4%,96.2%and 69.2%,100.0%and 26.9%,respectively.Conclusion The quality of rubber stopper has an effect on clarity of cephalosporin injections,which could provide a reference for the choose of rubber stopper for manufacturers.

关 键 词：药用胶塞 头孢菌素类 注射剂 澄清度 环硅氧烷 2 6二叔丁基对甲酚 不饱和脂肪酸 

分 类 号：R95[医药卫生—药学]