四环素残留量检查法中对照品溶液浓度分析验证  

Analysis of Appropriate Concentration of Micrococcus luteus Suspension in Tetracycline Residue Test Method

作　　者：黄丽华 何昱彤 苏欣 吴伟平 HUANG Li-hua;HE Yu-tong;SU Xin;WU Wei-ping(Guangdong institute for Drug Control,Guangdong Food and Drug Administration Key Laboratory of Quality Control and Risk Assessment of Blood Products,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所生物制品室,国家药品监督管理局血液制品质量控制重点实验室,广东省药品监督管理局血液制品质量控制研究重点实验室,广东广州510663

出　　处：《海峡药学》2024年第5期35-38,共4页Strait Pharmaceutical Journal

基　　金：广东省药品监督管理局科技创新项目(2023TBD02)。

摘　　要：目的探索四环素残留量检查法中藤黄微球菌悬液适宜浓度范围及验证通则3408中对照品溶液浓度适用性。方法参照《中国药典》(2020版)四部附录3408抗生素残留量检查法(培养法)、《药品微生物检验手册》,考察藤黄微球菌的生长曲线,采用管碟法验证四环素标准浓度为0.125μg·mL^(-1)时,对处于生长期的藤黄微球菌(Micrococcus luteus)CMCC(B)28001不同浓度下产生的抑菌性能。结果实验证明0.125μg·mL^(-1)的四环素对照品溶液不能对藤黄微球菌产生抑菌作用。结论四环素残留量检查法中菌悬液对抑菌圈结果影响不大,需更换标准菌株或调整四环素标准品浓度。OBJECTIVE To determine the appropriate concentration range of Micrococcus luteus suspension in tetracycline residue inspection method.METHODS The growth curve of Micrococcus luteus was investigated with reference to the four appendixes 3408 of the CP 2020 for the inspection method of antibiotic residues(cultivation method)and the“Manual for Microbiological Inspection of Drugs”.When the standard concentration of tetracycline was verified to be 0.125μg·mL^(-1)by the tube-disk method,the antibacterial properties of Micrococcus luteus CMCC(B)28001 at different concentrations in the growth phase.RESULTS The experiment proved that 0.125μg·mL^(-1)tetracycline reference solution could not produce bacteriostatic effect on Micrococcus luteus.CONCLUSION The tetracycline residue inspection method needs to replace the standard strain or adjust the standard concentration.

关 键 词：四环素 藤黄微球菌 浓度 

分 类 号：R927[医药卫生—药学]