摘要
目的建立西他沙星细粒微生物限度检查法并对其进行验证。方法按2010年版中国药典微生物限度检查法验证实验的有关要求,对离心法、薄膜过滤、添加中和剂等去除西他沙星细粒抗菌活性的实验方法和条件进行验证,逐步建立西他沙星细粒微生物限度检查的标准操作方法。结果在对西他沙星细粒适当的处理基础上,采用薄膜过滤法,用45℃含4.0%聚山梨酯80的p H7.0无菌氯化钠-蛋白胨缓冲液600m L分次冲洗(每次100m L)后,每100m L培养基中加入2%硫酸锰溶液1m L可去除西他沙星对细菌的抑菌作用。结论西他沙星具有较强的抑菌活性,通过适当的样品处理、薄膜过滤法和添加硫酸锰溶液作为重金属络合剂,去除西他沙星抑菌活性,可对解决喹诺酮类抗生素微生物限度检查问题起到较好的参考作用。
Objective To establish and verify the microbial limit inspection method for sitafloxacin fine. Methods According to the Chinese pharmacopoeia（2010 edition）, validate the microbial limit test method of sitafloxacin fine that treated with membrane filter procedure and neutralizer by control bacteria. Which testify the antimicrobial activity was removed thoroughly or not. Results When the filter was washed with 45 degrees, including 4% polysorbate 80 pH7.0 sterile sodium chloride peptone buffer solution 600mL （100mL each） and 2% manganese sulfate solution lmL was added into per 100mL culture medium. The method can remove its bacteriostatic activity. Conclusion The high antimicrobial activity strongly of sitafloxacin fine is able to remove through membrane filter procedure and neutralizer of metal chelating agent as manganese sulfate. Th is method is not only an effective SOP in sterility test for sitafloxacin fine but a valuable reference for other quinolone.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2015年第6期429-432,共4页
Chinese Journal of Antibiotics
关键词
西他沙星细粒
微生物限度检查
中和剂
薄膜过滤法
冲洗温度
硫酸锰
Sitafloxacin fine
Microbial limit test
Neutralizing agent
Membrane filtration
Irrigation temperature
Manganese sulfate
