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

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2020年版《中国药典》第四部通则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。

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

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.