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作 者:赵新霞[1] 王倩雯[2] 牛坡[3] 聂桂华[1]
机构地区:[1]河南省食品药品检验所,河南郑州450003 [2]中山大学药学院,广东广州510006 [3]河南省人民医院,河南郑州450003
出 处:《药物评价研究》2013年第2期111-113,共3页Drug Evaluation Research
摘 要:目的建立有效、简便的方法对腋臭粉及含汞制剂进行微生物限度检查。方法通过加入中和剂硫代乙醇酸钠来中和氧化汞,以达到破坏供试品抑菌活性的目的。细菌数测定采用离心沉淀-中和-薄膜过滤法,霉菌和酵母菌数测定以及控制菌检查采用中和-培养基稀释法。结果细菌、霉菌和酵母菌计数方法验证实验中,实验组和稀释剂对照组的菌回收率均不低于70%,控制菌检查结果符合要求。结论该方法有效、简便,可行性强,可作为腋臭粉及含汞制剂的微生物限度检查方法。Objective To establish an effective method for the microbiological limit test of Yexiu Powder and mercury containing preparations. Methods Sodium thioglycollate was used to neutralize mercuric oxide so that the antibacterial activity in the test was destroyed. Centrifugal sedimentation-neutralization-membrane filtration method was used for the validation test of bacteria count, and neutralization-medium dilution method was used for the validation test of mold and yeast count and control bacteria inspection. Results In the validation tests of bacterial, mold and yeast count, the microbial recovery rates were not less than 70% both in test group and in diluted control group. In the tests of specified microbial species, the results met the standard. Conclusion The method is effective and feasible, which could be used for the microbiological limit test for Yexiu Powder and mercury containing preparations.
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