注射用盐酸万古霉素无菌检查方法学验证研究

目的：确定可行的注射用盐酸万古霉素无菌检查方法。方法：采用薄膜过滤法,以不同的冲洗量,消除抗生素的抑菌活性。结果：样品、阴性对照及试验组菌在5 d内生长良好。结论：注射用盐酸万古霉素对金黄色葡萄球菌有较强的抑菌活性,采用薄膜过滤法,用0.1%蛋白胨缓冲液冲洗500 ml,可有效除去注射用盐酸万古霉素中的抑菌成分,使检验结果更准确、可靠。

Studies on test for sterility of Vancomycin hydrochloride for Injection

Objective： To establish a method for slerility test of Vancomycin hydrochloride for Injection.Methods： Mem-brane filtration method was used by modifying the amount of rinsing fluid.Results： All of positive strains and test strains reveaded growth of microorganism in five days and the substance control and negative control gave no evidence of growth.Conclusion： Vancomycin hydrochloride for Injection have higher antibacterial activity on staphylococcus aureus.It can ob-tain satisfied results by using membrane filtration method and 0.1% peptone buffer solution and flushing dose 500 ml which can eliminate the antibacterial activity.