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四环素残留量检查法中对照品溶液浓度分析验证

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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0.125 μg·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0.125 μg·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.
Analysis of Appropriate Concentration of Micrococcus luteus Suspension in Tetracycline Residue Test Method
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 0.125 μg·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 0.125 μg·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.

TetracyclineMicrococcus luteusConcentration

黄丽华、何昱彤、苏欣、吴伟平

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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

四环素 藤黄微球菌 浓度

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(5)