中外健康文摘
中外健康文摘
중외건강문적
WORLD HEALTH DIGEST
2012年
41期
422-423
,共2页
补肺胶囊%微生物限度检查%方法学验证%培养基稀释法
補肺膠囊%微生物限度檢查%方法學驗證%培養基稀釋法
보폐효낭%미생물한도검사%방법학험증%배양기희석법
BuFei capsules%microbial limit tests%method validation%medium dilution method
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.
目的建立補肺膠囊的微生物限度檢查方法.方法採用常規法、培養基稀釋法對補肺膠囊的細菌、黴菌及酵母菌計數測定進行加樣迴收率試驗.結果採用培養基稀釋法(1:10供試液,0.5ml/皿)能有效消除補肺膠囊的抑菌作用,使三箇批號樣品的金黃色葡萄毬菌的加樣迴收率均大于70%;採用常規法能使三箇批號樣品的大腸埃希菌、枯草芽孢桿菌、白色唸珠菌及黑麯黴的加樣迴收率均大于70%.結論因補肺膠囊對金黃色葡萄毬菌有較彊的抑製作用,所以其微生物限度檢查採用培養基稀釋法進行細菌計數;採用常規法進行黴菌和酵母菌計數;採用控製菌中大腸埃希菌的相應檢查法進行其控製菌的檢查.
목적건립보폐효낭적미생물한도검사방법.방법채용상규법、배양기희석법대보폐효낭적세균、매균급효모균계수측정진행가양회수솔시험.결과채용배양기희석법(1:10공시액,0.5ml/명)능유효소제보폐효낭적억균작용,사삼개비호양품적금황색포도구균적가양회수솔균대우70%;채용상규법능사삼개비호양품적대장애희균、고초아포간균、백색념주균급흑곡매적가양회수솔균대우70%.결론인보폐효낭대금황색포도구균유교강적억제작용,소이기미생물한도검사채용배양기희석법진행세균계수;채용상규법진행매균화효모균계수;채용공제균중대장애희균적상응검사법진행기공제균적검사.
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