摘要
目的建立考察注射用帕瑞昔布钠与中硼硅玻璃管制注射剂瓶相容性的方法。方法采用ICP-MS法测定26种元素迁移情况,并结合扫描电子显微镜、亚甲蓝染色试验和质量常规项目,考察了药品对玻璃瓶内表面微观形貌影响。结果在加速试验条件下,26种元素迁移量均在安全限度内且无明显变化趋势;亚甲蓝染色试验中均无染色现象;pH值、不溶性微粒等质量常规项目均无明显变化趋势;中硼硅玻璃管制注射剂瓶的内表面形貌均无腐蚀的裂痕、玻璃脱片。结论多维度考察中硼硅玻璃管制注射剂瓶与注射用帕瑞昔布钠相容性,二者相容性良好,该方法为效期内药品的安全性和可靠性提供有效的评价依据。
Objective To establish a method investigate the compatibility of medium borosilicate glass tube injection bottle and parecoxib sodium for injection.Methods ICP-MS method was used to determine the migration of 26 elements,and scanning electron microscopy,methylene blue staining test and quality routine items were used to investigate the changes in the microscopic morphology of the inner surface of the glass bottles.Results Under accelerated test condition,the contents of 26 elements in the migration test were within the safe limit and had no obvious change trend.Methylene blue staining in no dyeing phenomenon.pH value and insoluble particles and other quality routine items had no significant change trend.There were no corrosion cracks and glass peeling on the inner surface of the borosilicate glass tube injection bottle.Conclusion The compatibility of medium borosilicate glass tube injection bottle and parecoxib sodium for injection is good through multi-dimensional investigation.This method provides an effective evaluation basis for the safety and reliability of the drug during the effective period.
作者
王晓兰
曾念利
张小春
杨继丞
任锟
江燕
WANG Xiaolan;ZENG Nianli;ZHANG Xiaochun;YANG Jicheng;REN Kun;JIANG Yan(Sichuan Institute for Drug Control,Ministry of Industry and Information Technology Industrial Technology Foundation Public Service Platform,Sichuan Province,Chengdu 611731,China)
出处
《中国医药导报》
2025年第24期100-106,共7页
China Medical Herald
基金
四川省科技厅高新技术领域重点研发计划项目(2021YFG0089)。
关键词
注射用帕瑞昔布钠
中硼硅玻璃管制注射剂瓶
内表面微观形貌
元素迁移
Parecoxib sodium for injection
Medium borosilicate glass tube injection bottle
Inner surface micromorphology
Element migration
