注射用头孢哌酮钠舒巴坦钠与胶塞相容性研究  

Compatibility Study Between Cefoperazone Sodium and Sulbactam Sodium for Injection and Rubber Stoppers

作　　者：马冬阳 陈蓉 MA Dongyang;CHEN Rong(Suzhou Institute of Drug Control,Suzhou,Jiangsu,China 215104)

机构地区：[1]江苏省苏州市药品检验检测研究中心,江苏苏州215104

出　　处：《中国药业》2024年第2期63-67,共5页China Pharmaceuticals

摘　　要：目的探讨药用胶塞中的挥发物成分与注射用头孢哌酮钠舒巴坦钠溶液澄清度的相关性。方法从2020年国家药品抽检计划样品(共260批,来自39个企业)中选择规格一致、生产日期接近(2020年1月1日至1月12日)、胶塞种类不同的样品25批,采用气相色谱-质谱联用(GC-MS)法分析样品中胶塞挥发物成分,测定溶液浊度值,并分析二者的相关性。选取50批样品,采用GC-MS法测定胶塞挥发物的含量,并进行聚类分析。结合260批样品检测数据,探究药物与胶塞作用的时间、产品规格、胶塞种类对溶液浊度值的影响。结果共获得挥发物成分7种,包括环硅氧烷类4种,抗氧剂1种[2,6-二叔丁基对甲酚(BHT)],酮类1种,烃类1种;样品浊度值与BHT、环硅氧烷类含量均呈正相关(r=0.840,0.804),且与BHT含量的相关性更强。聚类分析中,环硅氧烷类和BHT含量较高的胶塞样品各聚为一类。产品未在效期内、规格小、使用氯化丁基胶塞均会增加溶液的浊度值。结论胶塞中的挥发物会迁移到药物中而影响溶液的浊度,建议企业优先选择环硅氧烷类和BHT含量较低的胶塞,从而为药品质量和用药安全提供保障。Objective To investigate the correlation of volatiles from pharmaceutical rubber stoppers with the clarity of Cefoperazone Sodium and Sulbactam Sodium for Injection solution.Methods A total of 25 batches of samples with consistent specifications,similar manufacture dates(from January 1st to January 12th,2020)and different rubber stoppers were selected from 260 batches of samples(involving 39 enterprises)in the national drug inspection plan in 2020.Gas chromatography-mass spectrometry(GC-MS)method was used to analyze the volatiles from rubber stoppers in samples,the turbidity of solution was determined,and the correlation between the above two factors was analyzed.Fifty batches of samples were selected to determine the volatiles from rubber stoppers by the GC-MS method,and the cluster analysis was performed.The effects of the interaction time between drug and rubber stoppers,product specifications and type of rubber stoppers on the turbidity of the solution were explored based on the testing data of 260 batches of samples.Results A total of seven volatiles from rubber stoppers in samples were obtained,including four cyclosiloxanes,one antioxidant[butylated hydroxytoluene(BHT)],one ketone and one alkane.The turbidity was significantly positively correlated with the content of BHT and cyclosiloxanes(r=0.840,0.804),and the correlation of turbidity with BHT content was stronger.The cluster analysis showed that the rubber stoppers with high content of cyclosiloxanes and BHT were classified as different groups.The products that were not within the expiration date,small specifications and chlorinated butyl rubber stoppers could increase the turbidity of the solution.Conclusion The volatiles in the rubber stoppers can migrate into the drug and affect the turbidity of the solution.It is suggested that enterprises should choose rubber stoppers with low content of cyclosiloxanes and BHT to improve the drug quality and ensure the medication safety.

关 键 词：注射用头孢哌酮钠舒巴坦钠 胶塞 相容性 环硅氧烷 2 6-二叔丁基对甲酚 浊度 

分 类 号：R917[医药卫生—药物分析学]