摘要
目的:研究血栓通注射液与中硼硅安瓿直接接触包装材料的相容性。方法:采用电感耦合等离子体质谱仪检测中硼硅玻璃安瓿元素迁移量,电镜扫描包材内表面,并对血栓通注射液的质量进行长期稳定性考察。结果:血栓通注射液长期稳定性样品的玻璃主成分元素迁移量低于脱片样品含量,包材内表面平整;有害元素摄入量远低于每日允许暴露量。结论:血栓通注射液与中硼硅玻璃安瓿直接接触质量稳定,药品安全风险低,具有较好的相容性。
Objective: To study the compatibility of Xueshuantong injection with direct contact packaging material of neutral borosilicate glass ampoule. Methods:Elemental migration in borosilicate glass ampoule was detected by inductively coupled plasma mass spectrometry, the inner surface of neutral borosilicate glass ampoule was observed by scanning electron microscope, and investigate the long-term stability of the quality of Xueshuantong injection. Results:The migration of glass main elements in long-term stability samples of Xueshuantong injection is lower than that of positive desquamation sample, the inner surface of neutral borosilicate glass ampoule is smooth, and the intake of harmful elements are far less than their permitted daily exposure. Conclusion:The quality of Xueshuantong injection is stable and the risks in drug safety are low when Xueshuantong injection is in direct contact with neutral borosilicate glass ampoule, both are compatible with each other.
出处
《大众科技》
2023年第1期66-69,共4页
Popular Science & Technology
基金
中央引导地方科技发展资金资助(桂科ZY22096004)。
关键词
血栓通注射液
中硼硅玻璃安瓿
包材相容性
电感耦合等离子体质谱
扫描电镜
Xueshuantong injection
neutral borosilicate glass ampoule
compatibility
inductively coupled plasma mass spectromelry
scanning electron microscope
