中国药物评价2025，Vol.42Issue(4)：285-289,5.
注射用生长抑素无菌检查方法适用性研究
Applicability of the Sterility Test Method on Somatostatin for Injection
摘要
Abstract
Objective:To establish a sterility test method for somatostatin for injection,to address the differences in testing methods among different manufacturers,and to improve the reliability,accuracy and efficiency of the test.Methods:According to the sterility test method(General Chapter 1101)in the Chinese Pharmacopoeia 2020 Edition,the membrane filtration method was used to conduct the method suitability study on 12 batches of somatostatin for injection with the specification of 3 mg from different manufacturers.Staphylococ-cus aureus,Escherichia coli,Clostridium perfringens,Bacillus subtilis,Candida albicans and Aspergillus niger were used as test strains.The rest group,positive control group and negative control group were established respectively to verify the applicability of the method.Results:Through systematic comparison of existing methods and method suitability testing across 12 enterprises,the optimized protocol was finalized.Test samples were dissolved in buffered sodium chloride-peptone solution pH 7.0,followed by membrane filtration without subsequent rinsing.Method suitability tests demonstrated that all six standard bacterial strains exhibited robust growth in both the test group and positive control group,while negative controls showed no microbial growth.None of the samples from all enterprises showed an-tibacterial properties.Conclusion:The sterility test method for somatostatin for injection established in this study is scientific and relia-ble,which solves the problem of inconsistent methods among enterprises,provides a standardized basis for drug quality control.It can also serves as a good reference for the sterility test methods of other polypeptide hormone drugs.关键词
注射用生长抑素/无菌检查法/薄膜过滤法/方法适用性试验Key words
Somatostatin for injection/Sterility test/Membrane filtration method/Method suitability test分类
医药卫生引用本文复制引用
钟燕飞,赖珊,张帆..注射用生长抑素无菌检查方法适用性研究[J].中国药物评价,2025,42(4):285-289,5.基金项目
广东省医学科学技术研究基金项目(B2021335) （B2021335）
广东省医学科学技术研究基金项目(B2022192) （B2022192）
