注射用哌拉西林钠舒巴坦钠对中硼硅模制注射剂瓶中铝、硅、硼元素迁移量及其表面脱片趋势的影响  

Effect of piperacillin sodium and sulbactam sodium for injection on the migration amount of aluminum,silicon and boron elements in medium borosilicate injection bottle and surface erosion

作　　者：吴统选 吴秋蓉 张聪 祝宇欣 赵龙山[3] WU Tong-xuan;WU Qiu-rong;ZHANG Cong;ZHU Yu-xin;ZHAO Long-shan(Pharmaceutical Research Institute of Tiansheng Pharmaceutical Group Co.,Ltd.,Chongqing 401120;Chongqing Shenghuaxi Pharmaceutical Co.,Ltd.,Chongqing 400072;School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016)

机构地区：[1]天圣制药集团药物研究院有限公司,重庆401120 [2]重庆圣华曦药业股份有限公司,重庆400072 [3]沈阳药科大学药学院,沈阳110016

出　　处：《中南药学》2023年第1期82-86,共5页Central South Pharmacy

摘　　要：目的研究注射用哌拉西林钠舒巴坦钠与中硼硅模制注射剂瓶中铝(Al)、硅(Si)、硼(B)元素的迁移量及其内表面脱片的趋势。方法用电感耦合等离子体发射光谱仪(ICPOES)考察Si、B和Al等元素的迁移量及变化趋势,并通过亚甲蓝染色法与扫描电子显微镜(SEM)观察中硼硅模制注射剂瓶被侵蚀后的脱片情况,根据迁移量的变化及脱片的趋势确定药物对中硼硅模制注射剂瓶的影响。结果经加速与长期试验处理后,电感耦合等离子体发射光谱法测定的Al元素在一定范围内波动,但未见明显迁移,B元素的测定值小于检测限,而Si元素的迁移量有上升趋势,但仍明显低于PDE限值;相对于阳性试验采用的碱性溶液,通过染色和SEM扫描显示中硼硅模制注射剂瓶内表面平整,未出现明显被侵蚀和染色现象。结论注射用哌拉西林钠舒巴坦钠对中硼硅模制注射剂瓶中Al、Si、B元素的迁移量及其表面脱片无明显影响。Objective To determine the effect of piperacillin sodium and sulbactam sodium for injection on the migration amount of aluminum(Al),silicon(Si)and boron(B)elements and the inner surface delamination in medium borosilicate injection bottle.Methods Inductively coupled plasma optical emission spectrometer(ICP-OES)was used to determine the migration amount and variation trend of Si,B and Al elements.In addition,methylene blue staining and scanning electron microscope(SEM)were used to observe the erosion of the medium borosilicate molded injection bottle,and the effect of drugs on the medium borosilicate injection bottle was determined according to the migration amount and the trend of stripping.Results After accelerated and long-term experimental treatment,the content of Al measured by ICP-AES fluctuated within a certain range,but no significant migration was observed.The content of B was smaller than the detection limit,while the content of Si was obviously lower than the PDE limit.Compared with the alkaline solution used in the positive test,the inner surface of the medium borosilicate injection bottle was smooth and no obvious erosion and staining were observed by staining and scanning electron microscopy.Conclusion Piperacillin sodium and sulbactam sodium for injection has no significant effect on the migration of Al,Si and B in medium borosilicate injection bottle and its surface erosion.

关 键 词：包材相容性 中硼硅模制注射剂瓶 电感耦合等离子体发射光谱仪 脱片 

分 类 号：R927[医药卫生—药学]