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

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. Staphylococcus 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 antibacterial properties. Conclusion： The sterility test method for somatostatin for injection established in this study is scientific and reliable， 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.

Key words: Somatostatin for injection, Sterility test, Membrane filtration method, Method suitability test