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(体积比=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粒检查用溶剂,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。
Objective： To test the insoluble particulate of assemblages for prefilled syringes based on light- blocking theory. 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 large, even unqualified. When we used the mix solvent of water and isopropanol （volume ratio 1 ： 1）, the oily liquid droplets were observed on the surface of the mixed solution. Then isopropanol was used as the only solvent, it excluded the effect of silicones and kept consistent with the result of microscopy, hence accurately reflecting the actual existence of particles. Conclusion： Light-blocking theory was suitable for testing the insoluble particulate of assemblages for prefilted syringes when isopropanol was used as the solvent.
出处
《中国药事》
CAS
2015年第5期511-514,共4页
Chinese Pharmaceutical Affairs
关键词
预灌封注射器组合件
硅油
不溶性微粒测定
光阻法
assemblages for prefilled syringes
silicones
insoluble particulates
light-blocking theory
