CAJ | 학술논문

目的：建立乳酸左氧氟沙星氯化钠注射液的无菌检查方法。方法根据《中华人民共和国药典（二部）》2010年版所列方法，通过增加冲洗液用量和加入中和剂，采用薄膜过滤法进行实验研究。结果以0．1％蛋白胨水溶液作为冲洗液，每管冲洗液容量为700 ml ，每次冲洗100 ml ，金黄色葡萄球菌不能正常生长。然而，使用含中和剂的培养基时，冲洗量每管300 m l ，所有阳性对照菌均生长良好。结论本法简单方便，适用于乳酸左氧氟沙星氯化钠注射液的无菌检查。
목적：건립유산좌양불사성록화납주사액적무균검사방법。방법근거《중화인민공화국약전（이부）》2010년판소렬방법，통과증가충세액용량화가입중화제，채용박막과려법진행실험연구。결과이0．1％단백동수용액작위충세액，매관충세액용량위700 ml ，매차충세100 ml ，금황색포도구균불능정상생장。연이，사용함중화제적배양기시，충세량매관300 m l ，소유양성대조균균생장량호。결론본법간단방편，괄용우유산좌양불사성록화납주사액적무균검사。
Objective To establish a sterility test of levofloxacin lactate and sodium chloride injection .Methods The test was carried out by thin-membrane filtration method with different volume of flushing liquid or adding neutralization into culture medium according to the Appendix of Chinese Pharmacopoeia (2010 edition) .Results When 0 .1% peptone water was used as flushing liquid ,Staphylococcus aureus gave no evidence of growth until the amount of flushing liquid reached 700 ml per tube (100 ml each time) .At the same time ,all of the six positive control bacteria grew normally when there was 300 ml flushing liquid in each tube with neutralization as culture medium .Conclusion This method was simple and convenient ,suggesting that it was suitable for the sterility test of levofloxacin lactate and sodium chloride injection .