聚二甲基硅氧烷膜对中硼硅玻璃管制注射剂瓶质量特性的影响研究  

Effect of polydimethylsiloxane membrane on the quality characteristics of medium borosilicate glass tube injection bottles

作　　者：刘建章 张韬 鲍剑 胡宇驰 陈志舜 柳絮 江楠 LIU Jianzhang;ZHANG Tao;BAO Jian;HU Yuchi;CHEN Zhishun;LIU Xu;JIANG Nan(Beijing Pharmaceutical Packaging Materials Inspection Institute,Beijing 100035,China)

机构地区：[1]北京市药品包装材料检验所,北京100035

出　　处：《中国药品标准》2024年第3期307-312,共6页Drug Standards of China

摘　　要：目的:研究镀聚二甲基硅氧烷膜后对中硼硅玻璃管制注射剂瓶质量特性和质控方法操作的影响,包括外观、鉴别、物理性能、内表面耐水性和元素浸出量的影响。方法:采用3家企业的9批镀膜中硼硅玻璃管制注射剂瓶和对应的中硼硅玻璃管制注射剂瓶,评估聚二甲基硅氧烷膜后中硼硅玻璃管制注射剂瓶质量控制方法是否需要进行针对性修改,以及评估评估镀膜对瓶质量特性的影响。结果:镀膜对中硼硅玻璃管制注射剂瓶的外观、鉴别、物理性能没有影响,镀膜过程并不会损害中硼硅玻璃管制注射剂瓶的原有性能,也不会导致检验方法出现需要特别关注的注意事项;镀膜后的中硼硅玻璃管制注射剂瓶在内表面耐水性方面有所改善。镀膜前后砷、锑、铅、镉等有害元素的浸出量均低,说明镀膜过程并未增加这些有害元素的浸出风险。通过ICP-OES测定元素浸出量,多数金属元素也未发现明显变化。结论:镀聚二甲基硅氧烷膜后中硼硅玻璃管制注射剂瓶的外观、鉴别、物理性能和元素浸出量质控方法操作不需要做针对性改变,镀膜后内表面耐水性有改善,对其他质量特性项目没有显著不利影响。Objective:To investigate effects of polydimethylsiloxane coating on the quality characteristics and quality control methods of medium borosilicate glass tube injection bottles,including appearance,identification,physical properties,water resistance of inner surface and element leaching amount.Methods:Nine batches of coated medium borosilicate glass tube injection bottles and corresponding medium borosilicate glass tube injection bottles from three companies were used to evaluate whether the quality control method of medium borosilicate glass tube injection bottles after polydimethylsiloxane film was modified,and to evaluate the effect of coating on the quality characteristics of bottles.Results:The coating did not have effect on appearance,identification and physical properties of medium borosilicate glass tube injection bottle.The coating process did not damage the original performance of the medium borosilicate glass tube injection bottle,and lead to the matters with special attention on the inspection method.The water resistance of the inner surface of the coated medium borosilicate glass tube injection bottle was improved.The leaching amounts of harmful elements such as arsenic,antimony,lead and cadmium before and after coating were low,indicating that the coating process did not increase the leaching risk of these harmful elements.The leaching amounts of elements were determined by ICP-OES,and no significant changes were found in most metal elements.Conclusion:The appearance,identification,physical properties and element leaching quality control method of medium borosilicate glass tube injection bottle after polydimethylsiloxane film coating do not need to be changed.The water resistance of the inner surface after coating is improved,and there is no significant adverse effect on other quality characteristics.

关 键 词：聚二甲基硅氧烷膜 中硼硅玻璃管制注射剂瓶 质量特性 内表面耐水性 物理性能 元素浸出量 

分 类 号：R921.2[医药卫生—药学]