风油精与聚丙烯滚珠和低硼硅玻璃内包材的相容性研究
汪弼晔摘 要 目的:研究PP滚珠风油精与低硼硅玻璃内包材的相容性。方法:采用扫描电子显微镜考察玻璃瓶内壁微观形貌变化,研究各时间点加速样品瓶被药品侵蚀情况;采用电感耦合等离子体-质谱仪测定加速条件下各时间点样品中砷、锑、铅、镉、汞含量。结果:风油精各批次样品瓶的侧面和底部均光滑平整,样品应力环(加速3月、6月)和颈部(加速6月)轻微不平整;PP滚珠风油精加速条件下离子迁移量均较小,且远小于每日允许摄入量(口服)的规定,符合安全要求。结论:PP滚珠风油精(滚珠)与低硼硅玻璃内包材具有良好的相容性。
关键词 风油精 内包材 相容性 扫描电子显微镜 ICP-MS
中图分类号:R286 文献标志码:A 文章编号:1006-1533(2020)17-0075-04
Compatibility of Fengyoujing with polypropylene balls and low borosilicate glass inner packaging material
WANG Biye*
(Shanghai Zhonghua Pharmaceutical Co., Ltd., Shanghai 201707, China)
ABSTRACT Objective: To study the compatibility of Fengyoujing with polypropylene balls (PP ball) and the low borosilicate glass inner packaging material. Methods: The changes of the microscopic morphology of the inner wall of the glass bottle were observed by scanning electron microscopy and the corrosion of the sample glass bottle by the drug was also studied at each time point. The contents of arsenic ......
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