光阻法测定预灌封注射器组合件中不溶性微粒的研究.pdfVIP

中国药事 2015 年5 月第29 卷第5 期 511 光阻法测定预灌封注射器组合件中不溶性微粒的 研究 王冬伟，董丹丹，钱承玉，张祥龙(国家食品药品监督管理局济南药品包装材料检测中心，济 南250101 ) 摘要 目的:研究光阻法测定预灌封注射器组合件不溶性微粒。方法:按包装材料不溶性微粒测定法 ( YBB0007204) ，采用光阻法，当用水做组合件微粒检查用溶剂，硅油不溶于水，在水中硅油以微 粒形式存在而被计数，为排除硅油充当微粒的影响，选取有机溶剂异丙醇，其对硅油有良好的溶解 能力，测得组合件不溶性微粒，并与显微镜法的结果进行对比证明光阻法的可靠性。结果:随机抽 取6 批预灌封注射器样品，在水中的不溶性微粒数值都偏大甚至不合格;当以水和异丙醇(体和、比 =1 : 1) 的混合溶剂做为组合件微粒检查用溶剂时，明显观察到在混合溶液的表面有油状液滴存在， 此油状液滴即为硅油;以异丙醇做为组合件的微拉检查用溶剂，测得组合件不溶性微粒数排除了硅 油的影响，与显微镜法的结果保持一致，准确反映了实际存在的微粒情况。结论:采用异丙醇做为 微粒检查用溶剂，通过光阻法可以测定预灌封注射器组合件的不溶性微粒。 关键词: 预灌封注射器组合件;硅油;不溶性微粒测定;光阻法 中图分类号: R95 文献标识码:A 文章编号: 1002-7777(2015)05-0511-04 doi: 10. 16153~. 1002-7777.2015.05.013 Study on the Test for Insoluble Particulates of Assemblages for Prefilled Syringes ßased on Light-blocking Theory Wang Dongwei , Dong Dandan, Qian Chengyu, Zhang Xianglong (Jinan Quality Inspection Center for Medical Pharmaceutical Packages , State Food and Drug Adminis位ration， Jinan 250101 , China) Abstract Objective: To test the insoluble particulate of assemblages for prefilled syringes based on light- blocking 也e。可. Methods: Relying on the test for insoluble particulates of packaging materials (YBB0007204) on light-blocking theory , ultra pure water and isopropanol were selected as the solvent respectively. As silicones were not dissolved in water, they were counted in the form of particles. We then selected the organic solvent of isopropanol to test the insoluble particulate , which can completely dissolve silicones, and compared the result with the microscopy method to demonstrate the reliability of the light-blocking theory. Results: Of the 6 batches of samples, the number of the insoluble particulate in water was too 1缸ge，. even unqualified. When we used the mix solvent ofwater and isopropanol (volume ratio 1 : 1), the oily liquid droplets were observed on the surface of the mixed solution. Then