不同药用包装材料包装小儿氨酚黄那敏颗粒的影响因素试验  

Experiment of Affecting Factors of Different Medicinal Packaging Materials for Children's Aminophen Xanamin Granules

作　　者：梅丽芳 谢新艺[1] 杨芳芳[1] 肖洁玲[1] Mei Lifang;Xie Xinyi;Yang Fangfang;Xiao Jieling(Guangdong Medical Device Quality Surveillance and Test,Guangzhou 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《广东化工》2021年第21期6-7,共2页Guangdong Chemical Industry

基　　金：广东省药监局2018年科技创新项目(科研单位:药包材料与药品相容性研究重点实验室,项目编号:2018ZDZ05)。

摘　　要：目的:通过使用不同药用包装材料包装小儿氨酚黄那敏颗粒的影响因素实验,为小儿氨酚黄那敏颗粒快速筛选适宜的药用包装材料提供科学依据。方法:不同药用包装材料包装的样品经过高温处理5天、10天后,用高效液相色谱法测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏的含量,色谱柱为Symmetry C18,流动相为磷酸盐缓冲液-乙腈(75︰25),流速为1.2 mL/min,检测波长为262 nm。结果:高硼硅玻璃瓶、聚酯/镀铝聚酯/聚丙烯包装的样品下降含量分别为2.1%,2.6%,聚酯/镀铝聚酯/聚乙烯包装的样品下降含量为15.4%。结论:高硼硅玻璃瓶、聚酯/镀铝聚酯/聚丙烯可初筛应用于小儿氨酚黄那敏颗粒的包装。Objective:By using different pharmaceutical packaging materials to package the influencing factors of children's aminophen xanamin granules to provide scientific basis for the rapid screening of appropriate pharmaceutical packaging materials for children's aminophen xanamin granules.Methods:After high temperature treatment for 5 days and 10 days,chlorpheniramine maleate was determined by high performance liquid chromatography(HPLC)on a Symmetry C18 column with mobile phase consisted of phosphate buffer and acetonitrile(75︰25)at the flow rate of 1.2 mL/min.The detection wavelength was 262 nm.Results:The contents of high borosilicate glass bottles,polyester/aluminized polyester/polypropylene packaging samples decreased by 2.1%,2.6%,respectively,polyester/aluminized polyester/polyethylene packaging samples decreased by 15.4%.Conclusion:High borosilicate glass bottles,polyester/aluminized polyester/polypropylene can be initially screened for the packaging of children's aminophen xanamin granule.

关 键 词：小儿氨酚黄那敏颗粒 药用包装材料 影响因素试验 高效液相色谱法 高温处理 

分 类 号：TQ[化学工程]