磺胺醋酰钠滴眼液无菌检查方法验证

摘要

目的:验证磺胺醋酰钠滴眼液的无菌检查方法.方法:依据<中国药典>2010年版二部附录ⅪH无菌检查法,采用薄膜过滤法对磺胺醋酰钠滴眼液进行无菌检查方法研究.结果:供试品对照组和空白对照组均无菌落生长,试验组菌与阳性对照菌生长情况相似,均生长良好.结论:采用薄膜过滤法,用500 ml 0.9%无菌氯化钠注射液冲洗,可消除磺胺醋酰钠滴眼液的抑菌活性,使检验结果更准确可靠.%Objective: To verify the sterility test of Sulfacetamide Sodium Eye Drops. Methods: According to the Appendix of Chinese Pharmacopoeia 2010 Edition 2, membrane filtration method was used to study the test for sterility of Sulfacetamide Sodium Eye Drops. Results: The substance control group and control group were no colony growth, the growth of bacteria of test group and positive control were similar with each other, and were growing well. Conclusion: Using membrane filtration method, with 500 ml 0.9% sterile Sodium Chloride Injection flush, can eliminate samples of the antibacterial activity and make test results more accurate and reliable.