北京生物医学工程

羟丁基壳聚糖护创敷料无菌检查方法的建立

Establishment of the sterility test method for hydroxybutyl chitosanprotective dressings

作者：张娟李梦玉刘思敏岳卫华

单位：北京市医疗器械检验所（北京101111）

关键词：羟丁基壳聚糖护创敷料; 无菌检查；薄膜过滤法；抑菌性；方法适用性检查

分类号：R318

出版年·卷·期（页码）：2020·39·2（165-168）

摘要：

目的建立羟丁基壳聚糖护创敷料的无菌检查方法，为该类产品的无菌检查提供参考依据。方法根据《中国药典》2015年版无菌检查法（四部通则1101）相关要求，采用薄膜过滤法进行方法适用性检查，以2~8 ℃的0.1%蛋白胨水作为稀释液和冲洗液，将样品溶解并将供试液全部过滤后，用2~8 ℃的0.1%蛋白胨水冲洗滤膜，冲洗量为500 mL（每膜每次冲洗量不超过100 mL），培养基用量为100 mL。结果与对照组相比，实验组中药典规定的6种阳性菌株均生长良好，说明该测试品的该检验量在该检验条件下抑菌作用已被有效消除。结论所建立的方法能用于羟丁基壳聚糖护创敷料的无菌检查。

Objective To establish a sterility test method for hydroxybutyl chitosan protective dressings and provide reference for such kind of products. Methods According to the relevant requirements in the 2015 version of Chinese Pharmacopoeia(General Rule 1101, Volume IV), the method applicability test was carried out by membrane filtration method and used 2-8℃ 0.1% sterile peptone solution as dilute solution and rinse solution. After the sample was dissolved and the testing liquid was filtrated , we used 2-8℃ 0.1% sterile peptone solution to rinse the membrane with the rinsing amount of 500 mL per membrane (no more than 100 mL per membrane each time), and the medium dosage was 100 mL. Results In comparison with the control group, six kinds of positive control test strains required by Chinese Pharmacopoeia (2015 Version) grew well in the experimental groups, indicating that the antimicrobial activity of hydroxybutyl chitosan could be eliminated effectively. Conclusions The method can be used in the sterility test for hydroxybutyl chitosan protective dressings.

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