高溶胀交联纤维素类产品微生物限度检测方法学建立和验证  

Establishment and validation of microbial limit of detection methodology for highly soluble cross-linked cellulose-based products

作　　者：陈雄伟 佘超民 刘鹤宁 CHEN Xiongwei;SHE Chaomin;LIU Hening(Imeik Technology Development Co.,Ltd,Beijing 101204,China)

机构地区：[1]爱美客技术发展股份有限公司,北京101204

出　　处：《安徽医药》2025年第4期677-682,共6页Anhui Medical and Pharmaceutical Journal

摘　　要：目的开发一种适用于无法通过常规方法对其内部微生物负载进行检测的高溶胀交联纤维素及其衍生物微生物限度的检测方法,同时对该方法适用性进行验证。方法利用纤维素酶对高溶胀交联羧甲基纤维素钠进行酶解,再结合薄膜过滤法对纤维素微生物限度进行检测,该研究从2023年4月开始,于2023年7月完成。结果细菌、霉菌及酵母菌薄膜过滤法检查,回收率在50%~200%。控制菌用薄膜过滤法进行验证,该方法适用。结论该方法可用于高溶胀交联羧甲基纤维素钠的微生物限度的检测中,方法准确可行,可重复性高。Objective To develop a method for the detection of the microbial limit of highly soluble cellulose and its derivatives that cannot be detected by conventional methods for their internal microbial load,and also to validate the applicability of the method.Methods Enzymatic digestion of highly soluble cross-linked carboxymethyl cellulose using cellulase was combined with membrane filtration for the detection of cellulose microbial limits.This study started in April 2023 and the test was completed in July 2023.Results Bacteria,molds and yeasts were examined by membrane filtration with recoveries in the range between 50%and 200%.Control bacteria were verified by membrane filtration method,this method is applicable.Conclusion The method can be used in the detection of microbial limit of highly soluble cross-linked carboxymethyl cellulose in an accurate and feasible way with high reproducibility.

关 键 词：微生物限度检查 纤维素 平衡溶胀 交联剂 方法学验证 薄膜过滤法 

分 类 号：TS2[轻工技术与工程—食品科学与工程]