低内毒素蔗糖微生物限度检查方法的适用性试验

目的 建立低内毒素蔗糖微生物限度检查方法，并对检查方法进行验证。方法 根据《中国药典》2015年版四部通则1105非无菌产品微生物限度检查：微生物计数法；通则1106非无菌产品微生物限度检查：控制菌检查法；通则1107非无菌药品微生物限度标准；对检查方法进行适用性试验，通过确立的方法对供试品进行微生物限度检查。结果 各试验菌的计数回收比值均在0.5~2.0之间，控制菌生长良好，供试品微生物限度检查符合2015年版《中国药典》规定。结论 该方法有效可行，可用于低内毒素蔗糖的微生物限度检查。

Applicability test of the microbial limit test for low endotoxin sucrose

Abstract Objective To establish a microbial limit test method of low endotoxin sucrose, and carry out the verification of this methodology. Methods According to the general rules 1105 microbiological examination of non-sterile products: Microbial enumeration tests, the general rules 1106 microbiological examination of non-sterile products: Tests for specified microorganisms and the general rules 1107 microbiological examination standards of non-sterile products in the appendices volume Ⅳof Chinese Pharmacopeia (edition 2015), the inspection method was examined by the suitability test. It makes suitability test for inspection method. In addition, the samples were examined by means of the established method. Results Recoveries of trial bacteria were between 0.5 to 2.0, and the controlled bacteria grew well. The samples could pass the validation test of Chinese Pharmacopoeia 2015 version. Conclusion It was proved that this method was effective and feasible, and it could be used in microbial limit test of low endotoxin