交联透明质酸钠微生物限度检查方法验证

Validation of microbial limit test method for cross-linked sodium hyaluronate

目的:建立合适的交联透明质酸钠微生物限度检查方法及控制菌检查方法,并进行方法学验证研究。方法:在前期摸索的提高稀释倍数方法的基础上,依据《中国药典》2015版采用滤纸过滤加薄膜过滤法对交联透明质酸钠进行微生物限度检测。结果:需氧菌总数、霉菌和酵母菌总数检查试验中5种测试菌的回收率均在0.5~2.0之间,符合规定。结论 :该检查方法操作方便,结果准确可靠,适用于交联透明质酸钠的微生物限度检测。

Objective:To establish a microbial limit detection method for cross-linked sodium hyaluronate and verify the methodology to ensure its applicability.Methods:According to the 2015 edition of the Chinese Pharmacopoeia,the total number of aerobic bacteria,molds and yeasts in cross-linked sodium hyaluronate was tested by membrane filtration method.Results:The recovery rates of the five test microoganims were in the range of 0.5 to 2.0,which were in compliance with the regulations.Conclusion:The method is accurate,reliable,easy to be operated and suitable for the detection of microbial limit of cross-linked sodium hyaluronate.