药品无菌检查法和微生物计数法培养基适用性检查及分析

Applicability Inspection and Analysis of Drug Sterility Inspection Method and Microbial Counting Method Culture Medium

对药品无菌检查法和微生物计数法培养基开展适用性检查,并对过程进行分析,保障药品检验的顺利开展。按照《中华人民共和国药典》(2020版四部)相关规定对硫乙醇酸盐流体培养基、胰酪大豆胨液体培养基、胰酪大豆胨琼脂培养基、沙氏葡萄糖琼脂培养基进行适用性检查。上述4种培养基符合药典要求。对实验过程可能出现的问题的原因进行分析并提出解决方法。上述4种培养基能够满足药品检验需要。试验发现在对无菌检查法用培养基开展灵敏度检查时,10mL装量培养基的培养管加入1mL菌悬液或孢子悬液,菌生长良好,可为相关试验提供参考。通过分析实验过程中可能出现的问题的原因并提出相应解决方法,能够确保培养基的质量,保障药品检验工作顺利进行。

The suitability of drug sterility inspection method and microbial counting method medium is checked,and the process is analyzed to ensure the smooth development of drug testing.In accordance with the relevant provisions of the Pharmacopoeia of the People's Republic of China(2020 Edition Part IV),the suitability of fluid thiogly collate medium,trypticase soy broth medium,trypticase soy agar medium and sabouraud dexrose agar medium were checked.The above four media meet the requirements of pharmacopoeia.Analyze the causes of possible problems during the experiment and propose solutions.The above four culture media can meet the needs of drug testing.The experiment found that when the sensitivity test was performed on the aseptic test medium,the culture tube of 10 mL of medium was added with 1 mL of bacterial suspension or spore suspension,and the bacteria grew well,which could provide a reference for related experiments.By analyzing the causes of possible problems during the experiment and proposing corresponding solutions,the quality of the culture medium can be ensured and the drug inspection work can be carried out smoothly.