OBJECTIVE: To establish sterility test of Sodium carboxymethyl glucan biological amino colloid. METHODS: Membrane filtration method was adopted to inspect the growth of Staphylococcus aureus, Escherichia coli, Bacillus subtilis, Clos-tridium sporogenes, Candida albicans, Aspergillus niger; inhibition effect of sample on test bacteria {Clostridium sporogenes, Candida albicans) was eliminated by heating flushing fluid and validated. RESULTS: Sodium carboxymethyl glucan biological amino colloid showed the highest bacteriostasic activity on Clostridium sporogenes. 0.1% sterile peptone wash solution 500 mL/film which were heated to 45℃ could eliminate the bacteriostasic activity of sample, and test bacteria in validation test grow well. CONCLUSION: This method can be used for sterility test of Sodium carboxymethyl glucan biological amino colloid, and sterility test results are accurate and reliable.%目的:建立羧氨基葡聚多糖钠生物胶体液的无菌检查方法.方法:采用薄膜过滤法,对样品中金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌、黑曲霉生长情况进行考察;对受抑制的试验菌(生孢梭菌、白色念珠菌)采用加热冲洗液的方法消除样品对其的抑制作用并进行验证.结果:羧氨基葡聚多糖钠生物胶体液对生孢梭菌的抑菌作用最强;采用加热至45℃的0.1%无菌蛋白胨水溶液500mL(每膜)冲洗可消除其抑菌作用,验证试验中试验菌生长良好.结论:所建立的方法可用于羧氨基葡聚多糖钠生物胶体液的无菌检查,且结果准确、可靠.
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