疏水型药用玻璃包装瓶的制备及微量元素溶出实验研究

Preparation of Hydrophobic Medical Glass Packaging Bottle and Study on the Dissolution of Trace Elements

摘要: 本文采用单因素变量法研究了二甲硅油NF乳液喷涂时间、二甲硅油NF乳液浓度以及镀层烤制温度对镀层疏水角度的影响，初步获得制备疏水型药用玻璃瓶的最佳条件为二甲硅油NF乳液喷涂时间、二甲硅油NF乳液浓度以及镀层烤制温度分别为60 s、5%和250℃，此时镀层疏水角度最大为107˚。通过对最佳条件下获得的疏水型药用玻璃瓶进行微量元素溶出实验检测，结果表明，经过对药用玻璃瓶内壁进行疏水镀层处理后，玻璃中的重金属离子Pb、Cd、V、Se、Ni、Sb、Hg、Cu、Sn、Mo、As的溶出量均远远低于USP<232,233>、Ph.Eur.5.20、EMEA等重金属限度规定指导原则中的规定。对保证药品质量及保质期、提高药用玻璃包材的综合品质具有重要意义。通过进一步的完善工艺参数，为制备不同规格型号的疏水型药用玻璃包装瓶、降低或阻止玻璃中有毒有害微量元素溶出导致药物变质的不良结果提供参考。

Abstract: In this paper, the effects of spraying time of dimethicone NF lotion, concentration of dimethicone NF lotion and coating baking temperature on the hydrophobic angle of coating were studied by single factor variable method. It was preliminarily obtained that the best conditions for preparing hydrophobic pharmaceutical glass bottles were spraying time of dimethicone NF lotion, concentration of dimethicone NF Lotion and coating baking temperature of 60 s, 5% and 250˚C, respectively. At this time, the maximum hydrophobic angle of coating was 107˚. Through the test of trace elements dissolution in the hydrophobic medical glass bottle obtained under the best conditions, the results show that after the hydrophobic coating treatment on the inner wall of the medical glass bottle, the dissolution of heavy metal ions Pb, Cd, V, Se, Ni, Sb, Hg, Cu, Sn, Mo and As in the glass are far lower than usp, ph.eur 5.20. EMEA and other guidelines for heavy metal limit regulations. It is of great significance to ensure the quality and shelf life of drugs and improve the comprehensive quality of pharmaceutical glass packaging materials. By further improving the process parameters, it provides a reference for preparing hydrophobic pharmaceutical glass packaging bottles of different specifications and models, and reducing or preventing the adverse results of drug deterioration caused by the dissolution of toxic and harmful trace elements in the glass.