目的 研究注射用奥美拉唑钠与3种硼硅玻璃注射剂瓶的相容性。方法 通过扫描电镜(SEM)、亚甲蓝染色考察注射剂瓶被侵蚀情况,电感耦合等离子体质谱法(ICP-MS)与电感耦合等离子体原子发射光谱法(ICP-OES)测定药物中24种元素含量的变化,并结合性状、可见异物、pH值、不溶性微粒的变化评价相容性结果。结果 玻璃中硅、硼、铝有微量迁出,且随加速时间延长呈上升趋势,镁、钡、砷、铬元素迁移量略有波动,但明显低于控制阈值。两种管制瓶可见侵蚀,模制瓶未见侵蚀。药品质量无明显变化。结论 中硼硅玻璃模制注射剂瓶与注射用奥美拉唑钠的相容性较好,其他两种管制注射剂瓶可被侵蚀,有更多成分迁出,虽未最终影响药品质量,但应持续关注其可能产生玻璃脱片的风险。
Abstract
OBJECTIVE To study the compatibility between omeprazole sodium for injection and three injection vials made of borosilicate glass. METHODS The compatibility was investigated by studying the corrosion of glass injection bottles and the changes of element contents, visible particles, pH, and insoluble particles. The corrosion of glass injection bottles by the drug solution was investigated via SEM and methylene blue staining. The changes of 24 elements in omeprazole sodium for injection were determined by ICP-MS and ICP-OES. RESULTS Si, B and Al in the glass migrated out in small amounts and increase with time. The migration of Mg, Ba, As, and Cr fluctuated slightly, but their contents were all significantly lower than the required control thresholds. Erosion was visible for both tubing vials, but not for the molded vials. There was no significant change in drug quality. CONCLUSION Injection vial made of molded middle borosilicate glass has good compatibility with omeprazole sodium for injection. While the other two tubing vials may be corroded and more components migrate out. Although the quality of the drug is not ultimately affected, the risk of possible glass delamination should be concerned.
关键词
注射用奥美拉唑钠 /
硼硅玻璃管制注射剂瓶 /
硼硅玻璃模制注射剂瓶 /
相容性
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Key words
omeprazole sodium for injection /
injection vial made of borosilicate glass tubing /
injection vial made of molded borosilicate glass /
compatibility
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中图分类号：
R917
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参考文献
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脚注
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基金
中国食品药品检定研究院中青年发展基金资助(2019C8)
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