壳聚糖肛肠抗菌凝胶的无菌方法学验证

Validation of Aseptic Methodology for Chitosan Anorectal Antibacterial Gel

目的:尝试建立壳聚糖肛肠抗菌凝胶的无菌检查方法。方法:严格按照《中华人民共和国药典》(2020版)四部第1101条无菌检查方法,采用薄膜过滤法对壳聚糖肛肠抗菌凝胶进行无菌检查,并对建立的方法进行验证。结果:样品管无菌生长,六株阳性对照菌生长良好。结论:通过方法学验证说明建立的无菌检查法适用于壳聚糖肛肠抗菌凝胶的无菌检查,保证无菌检查方法的有效性。

Objective:To establish a sterility test method for chitosan anorectal antibacterial gel.Methods:According to the sterility test method of 2020 Edition of Pharmacopoeia of the People’s Republic of China,the sterility test of chitosan anorectal antibacterial gel was conducted by membrane filtration method and the methodology was verified.Results:The sample tubes grew aseptically and the six positive control strains grew well.Conclusion:Through methodological verification,it is proved that the established sterility test method is suitable for sterility test of chitosan anorectal antibacterial gel,so as to ensure the effectiveness of the sterility test method.