注射用阿莫西林钠克拉维酸钾包材密封完整性的研究和考察  

Research on sealing integrity of packaging material of Amoxicillin Sodium and Clavulanate Potassium for Injection

作　　者：杨蕙如 王松 赵海云 刘文坤 陈德俊 YANG Huiru;WANG Song;ZHAO Haiyun;LIU Wenkun;CHEN Dejun(NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Shandong Research Center of Engineering ang Technology for Consistency Evalution of Generic Drugs,Shandong Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]山东省食品药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,山东省仿制药一致性评价工程技术研究中心,山东济南250101

出　　处：《药学研究》2022年第10期650-652,677,共4页Journal of Pharmaceutical Research

摘　　要：目的考察注射用阿莫西林钠克拉维酸钾包材密封完整性,为检测产品包材密封完整性提供新的思路。方法采用真空衰减法,选用质量较好的产品作为对照品,对4家制药企业生产的共5批注射用阿莫西林钠克拉维酸钾进行包材密封完整性检测,并采用单变量显著性分析法和Mann-Whitney U检验分析法进行数据分析;为了验证结果的可靠性,对厂家A和厂家C产品进行加速试验,并采用《中国药典》2020年版(四部)通则0901第一法进行溶液颜色检查。结果厂家A、C生产的产品的压差均值均高于对照组厂家B、D的产品,且结果离散程度较大,与对照组相比存在统计学差异;厂家A和厂家C产品进行加速试验,溶液颜色显著加深,进一步说明2家企业产品的密封性较差。结论厂家A、C生产的产品的包材密封完整性明显差于对照组,且溶液颜色显著加深,说明两家企业产品的密封性存在问题;选用质量较好的产品作为对照品,采用真空衰减法进行包装密封完整性检测方法可行、结果可靠。Objective To investigate the sealing integrity of packaging material of amoxicillin sodium and clavulanate potassium for injection,to provide a new idea for testing the sealing property of product packaging.Methods Products of definite quality were selected as reference substances,5 batches of Amoxicillin Sodium and Clavulanate Potassium for Injection from 4 pharmaceutical companies were tested by vacuum attenuation method,and the data were analyzed by univariate significance analysis and Mann-Whitney U test;Accelerated tests on the products of manufacturer A and C were performed to examine the reliability of the results,and the solution color were examined according to 2020 edition of"Chinese Pharmacopoeia"fourth,general rule 0901 first method.Results The mean pressure drop of products produced by manufacturers A and C was higher than that of products produced by manufacturers B and D,and the dispersion degree was greater accordingly,and there was a statistical difference compared with the control case;Accelerated tests show that the solution color of the products A and C was significantly darker,which further verified that the products of these two companies have poor airtightness.Conclusion The package sealing integrity of the products produced by manufacturers A and C was significantly worse than that of the control group,and the solution color was significantly darker,showing that the sealing performance of the two firms'products was faulty;It is feasible and reliable to utilize the vacuum attenuation method to test the integrity of packaging seal by using a higher-quality product as a reference.

关 键 词：注射用阿莫西林钠克拉维酸钾 密封完整性 真空衰减法 对照品 溶液颜色检查法 

分 类 号：TQ460.69[化学工程—制药化工]