注射用泮托拉唑钠与玻璃容器的相容性研究.docVIP

注射用泮托拉唑钠与玻璃容器的相容性研究 应志洪 蒋红梅 姜小林 蔡华路 陈冠华 浙江金华康恩贝生物制药有限公司 X 关注成功！ 加关注后您将方便地在 我的关注中得到本文献的被引频次变化的通知！ 新浪微博 腾讯微博 人人网 开心网 豆瓣网 网易微博 摘????要： 目的:确认注射用泮托拉唑钠与低硼硅玻璃管包装容器的相容性和适用性, 避免因药物与药用包装容器的相容性问题可能导致的安全性风险。方法:对经强降解试验14d、加速试验6个月和长期试验12月前后的注射用泮托拉唑钠与玻璃瓶, 分别采用HPLC法、微粒计数法、金相显微法和ICP-MS法等分析检测方法对可见异物、不溶性微粒、迁移离子、p H和有关物质等主要指标进行检测。结果:表明注射用泮托拉唑钠用低硼硅玻璃管制注射剂瓶包装容器存放, 经强降解试验、加速试验和长期试验后, 发现注射用泮托拉唑钠中硅、钙是有上升趋势, 铝、硼也有一定程度的上升, 镁、镉、铅、砷、锑迁移数值略有波动, 但均明显低于PDE值要求;玻璃容器及其迁移离子对药物的质量影响较小, 未发生明显的变化;药物对玻璃容器稳定性的略有影响, 但玻璃瓶内表面未发现有明显的脱片、麻点、裂痕和侵蚀痕迹等现象。结论:公司目前采用的低硼硅玻璃管制注射剂瓶基本满足药品包装要求, 现有的包装材料包装的药品质量仍是安全、稳定、可靠的。 关键词： 注射用泮托拉唑钠; 玻璃容器; 低硼硅; 药包材; 相容性; 迁移离子; ICP-MS; 金相显微法; 风险; 药物安全性; 作者简介：陈冠华 TelE-mail:chengh@ 作者简介：应志洪 TelE-mail:yingzh3388@163.com 收稿日期：2017年11月1日 Compatibility study of pantoprazole sodium for injection and glass container YING Zhi-hong JIANG Hong-mei JIANG Xiao-lin CAI Hua-lu CHEN Guan-hua Zhejiang Jinhua Conba Bio-Pharm.Co., Ltd.; Abstract： Objective:To confirm the suitability and compatibility between pantoprazole sodium for injection and low borosilicate glass ampoule, and prevent the safety risk potentially caused by the compatibility between drug and container.Methods:During 14-days stress test, 6-months accelerated test and 12-months long-term test, pantoprazole sodium for injection and glass ampoules were tested respectively by HPLC, particle counting, metallurgical microscopy and ICP-MS method, to monitor visible particles, sub-visible particles, ion migration, p H and related substances.Results:The testing results indicated that after stress, accelerated and long-term test, Si and Ca contented in pantoprazole sodiμm for injection increased obviously, Al and B contents increased slightly, Mg, Cd, Pb, As and Sb contented fluctuated slightly but obviously less than PDE value;the glass container and its migration ions had little influence on drug quality.The drug had a little influence to glass container stability, but no evidence of shedding, pits, crack