药品微生物限度检查方法适用性中存在的问题及改进建议

Problems in the Applicability of Microbial Limit Test Methods of Drugs and Suggestions for Improvement

本文按照《中华人民共和国药典》2020年版四部通则1105、1106和1107有关非无菌产品微生物限度检查方法的要求,对药品生产企业提供的541份方法适用性资料进行审核,发现微生物计数法方法适用性中主要问题存在于稀释液的使用、试验菌液的使用、试验菌株的回收试验、抑菌活性的去除、对照试验的开展等方面;控制菌检查法方法适用性中主要问题存在于加菌方式以及耐胆盐革兰阴性菌检查等方面。本文针对上述问题进行分析并给予针对性解决办法,同时提出改进建议形成综述,帮助药品生产企业不断完善和提高规范开展方法适用性试验的能力,保证试验结果的准确性和可靠性,为确保人民群众的用药安全有效提供保障。

According to the requirements of microbial limit test methods for non-sterile products in the general rules 1105,1106and 1107 of the fourth part of the Chinese Pharmacopoeia(2020 edition),the applicability of the methods provided by drug manufacturers was examined.It was found that the main problems in the applicability of microbial counting method were the use of diluent,the use of test bacteria solution,the recovery test of test strains,the removal of antimicrobial activity,and the development of control test;the main problems in the applicability of control bacteria examination method were the way of adding bacteria and the examination of gram-negative bacteria resistant to bile salts.In this paper,the above problems are analyzed and targeted solutions are proposed,and suggestions for improvement are put forward to form a summary.It can help enterprises to continuously improve and improve the ability to standardize the applicability test of methods,ensure the accuracy and reliability of test results,and thus ensure the safety and effectiveness of drug use for the people.