肝素钠微生物限度检查方法适用性研究

目的 建立肝素钠的微生物限度检查方法。方法 采用2015年版中国药典(四部)通则下方法，对肝素钠进行方法适用性试验，确定适宜的微生物限度检查方法。结果 计数方法采用薄膜过滤法，各试验菌比值均在0.5~2范围内，控制菌采用常规法，各阳性试验菌均检出，阴性对照均无菌生长。结论 所验证的肝素钠微生物限度检查方法是可行的。

Microbial limit suitability test method for heparin sodium#br#

Objective To establish a microbial limit test method for Heparin Sodium. Methods Employ the methods of microbial limit test for heparin sodium, which were described in Chinese Pharmacopeia (2015 Edition). Determine the suitable microbial limit test. Results The recovery efficiency of the test organism was from 0.5 to 2 by the membrane filtration method. Using a conventional method, every positive microorganism can be detected while the negative control can not grow in the control bacteria examination. Conclusion The validated method of microbial limit test for heparin sodium is