| 乳酸左氧氟沙星氯化钠注射液无菌检查方法的建立及验证 |
| 投稿时间：2014-03-29 修订日期：2014-09-01 点此下载全文 |
| 引用本文：刘栋,汤长明,郝哲.乳酸左氧氟沙星氯化钠注射液无菌检查方法的建立及验证[J].药学实践杂志,2015,33(6):552~554 |
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| 中文摘要: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 ml,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。 |
| 中文关键词:乳酸左氧氟沙星 注射液 无菌检查 |
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| Establishment and validation of sterility test of levofloxacin lactate and sodium chloride injection |
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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. |
| keywords:levofloxacin lactate injection sterility test |
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