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目的:建立舒筋健络油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,去除舒筋健络油的抗菌活性。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株验证菌株中金黄色葡萄球菌对舒筋健络油最敏感,可作为舒筋健络油微生物限度检查方法的质控菌株。结论:该方法可作为舒筋健络油的常规微生物限度检查方法。
Objective: To establish a microbial limit test method for Shujinjianluo oil. Methods: Membrane filtration and addition of solubilizer to the rinse solution were used to remove the antibacterial activity of Shujin Jianluo oil. Results: The basic requirements for the validation test of the 2005 edition of the “Pharmacopoeia of the People’s Republic of China” were met Staphylococcus aureus was the most sensitive to ShujinJinluo oil in the five tested strains, and it can be used as a quality control strain for the microbial limit test method of Shujinjianluo oil. Conclusion: This method can be used as a routine microbial limit test method for Shujinjianluo oil.