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目的建立硫柳汞醇溶液的微生物限度检验方法。方法按《中国药典》2010年版规定,分别采用培养基稀释法、薄膜过滤法对样品进行微生物限度检查;根据5株阳性对照菌试验组、菌液组、供试品对照组的结果进行其方法学验证试验研究。结果硫柳汞醇溶液具有抑菌活性,培养基稀释法回收率<70.0%;薄膜过滤法各菌回收率>78.0%,能有效的去除其抑菌活性。结论用该法进行微生物限度检查,可以客观地反映药物中微生物的污染状况,以达到检测目的。
Objective To establish a microbial limit test of thimerosal solution. Methods According to “Chinese Pharmacopoeia” 2010 edition, respectively, using the medium dilution method, the membrane filtration method for microbial limit test; according to the five positive control bacteria test group, bacterial liquid group for the control group test results Study verification test research. Results The thimerosal solution had antibacterial activity, the recovery rate was less than 70.0% in medium dilution method and the recovery rate was 78.0%. The antibacterial activity of thimerosal was removed effectively. Conclusion The method of microbial limit test can objectively reflect the microbial contamination in the drug in order to achieve the purpose of testing.