补肺胶囊的微生物限度检查法的验证试验
蒋玲;韩云霞
【期刊名称】《中外健康文摘》 【年(卷),期】2012(000)041
【摘要】目的建立补肺胶囊的微生物限度检查方法.方法采用常规法、培养基稀释法对补肺胶囊的细菌、霉菌及酵母菌计数测定进行加样回收率试验.结果采用培养基稀释法(1：10供试液,0.5ml/皿)能有效消除补肺胶囊的抑菌作用,使三个批号样品的金黄色葡萄球菌的加样回收率均大于70%；采用常规法能使三个批号样品的大肠埃希菌、枯草芽孢杆菌、白色念珠菌及黑曲霉的加样回收率均大于70%.结论因补肺胶囊对金黄色葡萄球菌有较强的抑制作用,所以其微生物限度检查采用培养基稀释法进行细菌计数；采用常规法进行霉菌和酵母菌计数；采用控制菌中大肠埃希菌的相应检查法进行其控制菌的检查.%Objective: To establish the microbial limit test method for BuFei capsules. Methods: The conventional method was used for bacteria count and the medium dilution method was used for molds and yeast count by sample recovery test. Results: The medium dilution method (1:10 for the test solution, 0.5ml per plate) could effectively eliminate the inhibitory effect of the BuFei capsules, the recovery of Staphylococcus aureus were greater than 70% in three batch samples;the conventional method could make the recoveries of E. coli, Bacillus subtilis, Candida albicans and Aspergillus greater than 70% in three batch samples. Conclusions: Due to the BuFei capsule have strongly antibacterial effect on
Staphylococcus aureus ,so the medium dilution method was used for bacterial count and the conventional method was used for mold and yeast count; the conventional method was used for Control bacteria examination of E. coli 【总页数】2页(422-423)
【关键词】补肺胶囊;微生物限度检查;方法学验证;培养基稀释法 【作者】蒋玲;韩云霞
【作者单位】贵州贵阳中医学院第二附属医院药剂科 550001;贵州贵阳中医学院第二附属医院药剂科 550001 【正文语种】中文 【中图分类】R446.5 【文献来源】
https://www.zhangqiaokeyan.com/academic-journal-cn_chinese-foreign-health-digests_thesis/0201256297691.html 【相关文献】
1.伏立康唑胶囊微生物限度检查法及有效性验证试验研究 [J], 靳维 2.滇桂艾纳香胶囊微生物限度检查法验证研究 [J], 潘积常; 周凤娇 3.头孢拉定胶囊微生物限度检查法的验证分析 [J], 徐秋萍; 姚斌 4.罗红霉素胶囊微生物限度检查法的验证 [J], 李玉珍 5.痔疮胶囊微生物限度检查法验证研究 [J], 笪宁虞
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补肺胶囊的微生物限度检查法的验证试验
