健阴栓微生物限度检查方法适用性试验及体外抑菌作用研究
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摘要
目的:进行健阴栓微生物限度检查方法适用性试验及体外抑菌作用研究,为该药临床应用提供参考。方法:参考《中华人民共和国药典:四部》(2015年版),对健阴栓进行微生物限度检查方法适用性试验,采用试管二倍稀释法和琼脂平板法,对大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、铜绿假单胞菌和白色念珠菌进行体外抑菌作用的研究,测定其最低抑菌浓度(MIC)与最低杀菌浓度(MBC)。结果:健阴栓的需氧菌总数可采用1∶10供试液按平皿法测定,霉菌及酵母菌总数计数可采用1∶10供试液以薄膜过滤法冲洗液500 ml/膜测定,控制菌采用常规法检验;体外抑菌作用试验结果显示,该药对大肠埃希菌和白色念珠菌无抑菌作用,对金黄色葡萄球菌的MIC和MBC分别为0.25和0.5 g/ml,对铜绿假单胞菌、枯草芽孢杆菌的MIC和MBC均为0.25 g/ml。结论:健阴栓有较强的抑菌作用。
OBJECTIVE: To conduct adaptability test and bacteriostasis in vitro of microbial limit test on Jianyin suppository, so as to provide reference for its clinical application. METHODS: By reference of Pharmacopoeia of the People's Republic of China(Volume Ⅳ,2015 Edition), adaptability test of microbial limit test on Jianyin suppository was conducted, bacteriostasis in vitro of Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa and Candida albicans were carried out by using tube double dilution method and agar-method to determine its minimum inhibitory concentration(MIC) and minimum bactericidal concentration(MBC). RESULTS: The number of aerobic bacteria of Jianyin suppository can be determined by plate method with 1∶10 test solution, the total number of mold and yeast can be determined by membrane-filter procedure with 1∶10 test solution of 500 ml/membrane, and the control bacteria was tested by routine method; results of bacteriostasis in vitro test showed that the drug had no bacteriostasis on E.coli and C.albicans, the MIC and MBC of this drug against S.aureus were respectively 0.25 g/ml and 0.5 g/ml, the MIC and MBC against P.aeruginosa and B.subtilis were both 0.25 g/ml. CONCLUSIONS: Jianyin suppository has strong bacteriostasis.
OBJECTIVE: To conduct adaptability test and bacteriostasis in vitro of microbial limit test on Jianyin suppository, so as to provide reference for its clinical application. METHODS: By reference of Pharmacopoeia of the People's Republic of China(Volume Ⅳ,2015 Edition), adaptability test of microbial limit test on Jianyin suppository was conducted, bacteriostasis in vitro of Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa and Candida albicans were carried out by using tube double dilution method and agar-method to determine its minimum inhibitory concentration(MIC) and minimum bactericidal concentration(MBC). RESULTS: The number of aerobic bacteria of Jianyin suppository can be determined by plate method with 1∶10 test solution, the total number of mold and yeast can be determined by membrane-filter procedure with 1∶10 test solution of 500 ml/membrane, and the control bacteria was tested by routine method; results of bacteriostasis in vitro test showed that the drug had no bacteriostasis on E.coli and C.albicans, the MIC and MBC of this drug against S.aureus were respectively 0.25 g/ml and 0.5 g/ml, the MIC and MBC against P.aeruginosa and B.subtilis were both 0.25 g/ml. CONCLUSIONS: Jianyin suppository has strong bacteriostasis.
引文
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[2] 马绪荣,苏德模.药品微生物学检验手册[M].北京:科学出版社,2000:198.
[3] 唐亮,刘翠艳,韩春杨,等.中药研究常用三种体外抑菌方法的比较[J].中国中医药科技,2011,18(5):419-420.
[4] 段如麟,陈解民.妇产科症状鉴别诊断学[M].北京:人民军医出版社,1995:76-96.
[5] 李汉浠,任赛赛,李勇,等.萘醌对常见菌的抗菌谱、最低抑菌浓度和最低杀菌浓度研究[J].时珍国医国药,2012,23(6):1422-1424.
[6] 刘鹏,马仕洪,戴翚,等.不同企业来源活血止痛胶囊微生物限度检查结果分析[J].中国药事,2012,26(10):1112-1114.
[7] 王德启.珍珠冰硼散微生物限度检查方法学验证[J].中国执业药师,2011,8(2):37-39.
[8] 胡君茹,姜华.小儿解热中空栓剂体外抑菌作用的研究[J].甘肃中医,2008,21(2):51-52.
[9] 曹晓云,郭艳娟.药品微生物限度检查方法学验证试验及其相关的技术问题[J].天津药学,2006,18(6):49-51.
[10] 特玉香,刘鹏,戴晕,等.黄连上清丸微生物限度检查方法验证浅析[J].药物分析杂志,2006,26(18):1674-1 678.
[11] 黄依玲.医院制剂微生物限度检查方法的重验证[J].中国现代药物应用,2013,7(9):3-4.
[12] 文玉辉,韩珍珍.11 种医院制剂微生物限度检查方法验证[J].临床医药实践,2015,24(10):763-765.
[13] 徐爱良,卢芳国,文宁,等.中药净坤液体外抗菌作用的研究[J].中国中医药信息杂志,2005,12(6):28-29.