风油精与聚丙烯滚珠和低硼硅玻璃内包材的相容性研究

Compatibility of Fengyoujing with polypropylene balls and low borosilicate glass inner packaging material

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。

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,antimony,lead,cadmium and mercury were determined by coupled plasma-mass spectrometry at various time points under the accelerated condition.Results:The side and bottom of each batch of Fengyoujing sample bottle were smooth and flat,the stress ring(accelerated for 3 or 6 months)and neck(accelerated for 6 months)of the sample bottle were slightly uneven,the ion migration was small and far less than the daily allowable intake(oral)under the accelerated condition,which met safety requirements.Conclusion:Fengyoujing has good compatibility with PP ball and the low borosilicate glass inner packaging material.