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目的建立克拉霉素缓释片微生物限度检查方法。方法采用薄膜过滤并在冲洗液中加入增溶剂的方法,去除克拉霉素缓释片的抗菌活性。结果满足《中华人民共和国药典》2005版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对克拉霉素缓释片最敏感,可作为克拉霉素缓释片微生物限度检查方法的质控菌株。结论该方法可作为克拉霉素缓释片的常规微生物限度检查方法。
Objective To establish a microbial limit test for clarithromycin sustained-release tablets. Methods The antibacterial activity of clarithromycin sustained-release tablets was removed by membrane filtration and solubilizing agent was added to the rinse solution. The results meet the "People’s Republic of China Pharmacopoeia 2005 version of the validation test of the basic requirements. Bacillus subtilis was the most sensitive to clarithromycin sustained-release tablets in the five strains, which could be used as the quality control strain for the screening method of microorganisms in clarithromycin sustained-release tablets. Conclusion This method can be used as a routine microbial limit test for clarithromycin sustained-release tablets.