Establishment and validation of sterility test of levofloxacin lactate and sodium chloride injection

LIU Dong; TANG Changming; HAO Zhe

doi:10.3969/j.issn.1006-0111.2015.06.019

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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.

Establishment and validation of sterility test of levofloxacin lactate and sodium chloride injection

Department of Pharmacy, No.153 Central Hospital of PLA, Zhengzhou 450042, China

Received Date: 2014-03-29

Rev Recd Date: 2014-09-01

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Abstract: 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.

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Reference (14)

[1]	陈新谦, 金有豫, 汤光. 新编药物学[M].17版. 北京:人民卫生出版社, 2010: 97.
[2]	国家药典委员会.中华人民共和国药典2010年版二部[S].北京:化学工业出版社, 2010: 附录105.
[3]	尤启东. 药物化学[M].北京:化学工业出版社, 2005: 418.
[4]	梁月秋, 刘涛, 朱斌, 等. 应用于喹诺酮类药物无菌检查金属离子的初步筛选[J].药物分析杂志, 2009, 29(2): 334-336.
[5]	裴小龙, 黎隽, 杨晓莉, 等. 喹诺酮类药物无菌检查中Mg2+的应用研究[J].中国药业, 2011, 20(1): 28-29.
[6]	朱斌, 刘涛, 蒋受军, 等. Mg²⁺在药物无菌检查中的应用[J].中国现代应用药学, 2010, 27(11): 1031-1033.
[7]	张光华, 余立, 刘文杰. 硫酸锰在几种喹诺酮类药物无菌检查中的应用[J].中国药品标准, 2008, 9(1): 35-38.
[8]	陈莹, 邢轶华, 卓明, 等. 加替沙星滴眼液无菌检查方法的建立[J].天津药学, 2009, 21(4): 7-9.
[9]	王沁馨. 甲磺酸培氟沙星注射液无菌检查的方法学验证[J].中国药师, 2010, 13(9): 1361-1362.
[10]	柏大为. 乳酸左氧氟沙星氯化钠注射液的无菌检查方法学研究[J].海峡药学,2012, 24(11):29-31.
[11]	白丽娟. 乳酸左氧氟沙星氯化钠注射液的无菌检查方法学研究[J].科学与财富,2014(1):247.
[12]	江志杰, 刘文杰, 高春, 等. 左氧氟沙星注射液无菌检查方法验证[J].中国药品标准, 2008, 9(4): 245-247.
[13]	江志杰, 高春. 无菌检查中消除喹诺酮类药物抗菌活性的方法研究[J].中国药业, 2013, 22(15): 52-54.
[14]	裴小龙, 黎隽, 杨晓莉, 等. 盐酸左氧氟沙星氯化钠注射液无菌检查法Mg²⁺加入方法验证[J].西北药学杂志, 2010, 25(6): 446-447.

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Establishment and validation of sterility test of levofloxacin lactate and sodium chloride injection

doi: 10.3969/j.issn.1006-0111.2015.06.019

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