Verification and improvement of problems existing in detection method for antibiotic residues in General Chapter 3408 of Chinese Pharmacopoeia(Volume Ⅳ, 2020 edition)
10.13200/j.cnki.cjb.004524
- VernacularTitle:《中国药典》四部（2020版）通则3408抗生素残留量检查方法中存在问题的验证及改进
- Author:
MA Bufang
- Publication Type:Journal Article
- From:
Chinese Journal of Biologicals
2025;38(07):833-836+842
- CountryChina
- Language:Chinese
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Abstract:
Antibiotics;Residues;Tetracycline;Staphylococcus aureus;Micrococcus luteus :Objective To verify the problem that the tetracycline residues test is difficult to carry out in daily work due to the absence of inhibition zone of the positive control solution in the antibiotic residues test(cultivation method) in the section General Chapter 3408 of Chinese Pharmacopoeia(Volume Ⅳ, 2020 edition), and try to put forward solutions.Methods According to the operating steps specified in the tetracycline residues section of General Chapter 3408 of Chinese Pharmacopoeia(Volume Ⅳ, 2020 edition), Micrococcus luteus [CMCC(B) 28001] and Staphylococcus aureus(ATCC 29213) were used as test strains to verify the antibacterial performance of the negative and positive control solution by tube-dish method,respectively.Results Neither the negative control solution nor the positive control solution produced an inhibition zone when Micrococcus luteus [CMCC(B) 28001] was used as the test strain, which leaded to abnormal testing work. The negative control solution had no inhibition zone while the positive control solution exhibited an inhibition zone when Staphylococcus aureus(ATCC 29213) was used as the test strain, which could meet the requirements of method applicability.Conclusion It has been found that Micrococcus luteus [CMCC(B) 28001] cannot be used as an indicator bacterium for the tetracycline residues test in General Chapter 3408 of Chinese Pharmacopoeia(Volume Ⅳ, 2020 edition) through literature review, daily work experience, and multiple experimental verifications, and the fundamental reason for this situation is still unclear. It is recommended to replace the strain with Staphylococcus aureus(ATCC 29213) while keeping other experimental conditions unchanged to ensure successful detection of tetracycline residues.
