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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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药品微生物检验替代方法国内外研究进展

Progress on alternative microbiological methods for pharmaceuticals

分类号:R917
出版年·卷·期(页码):2020,40 (4):577-582
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

快速微生物检测技术可提高检测效率和自动化程度,并为药品微生物检验的数据可靠性提供新思路,同时部分技术能够利用其即时监控的特点改进药品生产过程控制方式。各国药典及相关组织很早就开始研究和规范药品微生物检验替代方法验证的内容,并且不断地完善。本文总结了快速微生物检测技术作为药品微生物检验替代方法的技术原理和近些年的研究应用进展,并介绍了国内外相关法规指南的变化。

-----英文摘要:---------------------------------------------------------------------------------------

Rapid microbiological methods are able to enhance detection efficiency and automation,and provide new ideas for data integrity during drug microbiological examination. At the same time,some of them are expected to improve the control mode of drug manufacturing based on their characteristics of real-time monitoring. The pharmacopoeias in various countries and relevant organizations had already studied and standardized the contents of validation for alternative microbiological methods in pharmaceutical industry for long time,and have been constantly improving. The principle of rapid microbiological method as an alternative method for pharmaceutical microbial testing and its application progress in recent years is reviewed in this paper,and the changes of relevant global regulations and guidelines are also introduced.

-----参考文献:---------------------------------------------------------------------------------------
[1] 董芹,臧恒昌,刘爱华,等.过程分析技术在制药领域的应用及对我国制药行业的启示[J].中国药学杂志,2010,45(12):881 DONG Q,ZAN HC,LIU AH,et al.Application of process analytical technology in the pharmaceutical field and enlightenment on china's pharmaceutical industry[J].Chin Pharm J,2010,45(12):881
[2] Center for Drag Evaluation and Research,Center for Veterinary Medicine,Office of Regulatory Committee.Guidance for Industry:PAT-A framework for innovative pharmaceutical development,manufacturing,and quality assurance[EB/OL].(2004-12-14)[2019-03-26].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatorylnformation/Guidances/ucm070305.pdf
[3] 洪小栩,冯震,许华玉,等.分子生物学技术用于药品质量控制国家标准核酸数据库的建设规划研究[J].中国医药工业杂志,2016,47(5):651 HONG XX,FENG Z,XU HY,et al.Program of national standard nucleotide sequence database used in quality control of pharmaceutical products by molecular biology technology[J].Chin J Pharm,2016,47(5):651
[4] 许华玉,张志芬,王平.生产过程分析技术中所提倡使用的快速微生物检查法的作用[J].中国药品标准,2005,6(3):79 XU HY,ZHANG ZF,WANG P.The role of rapid microbiological methods with in the process analytical technology initiative[J].Drug Stand China,2005,6(3):79
[5] CUNDELL AM.Microbial testing in support of aseptic processing[J].Pharm Technol,2004,28:56
[6] SHINTANI H.Rapid assay of bioburden,endotoxin and other contamination[J].J Chromatogr Sep Tech,2013,4(8):2
[7] VERDONK GP,WILLEMSE MJ,HOEFS SG,et al.The Most Probable Limit of Detection(MPL) for rapid microbiological methods[J].J Microbiol Methods,2010,82(3):193
[8] 郝京京,颜喜亚,赵谦,等.微生物检验替代法的验证概述[J].中国药品标准,2007,8(2):9 HAO JJ,YAN XY,ZHAO Q,et al.Introduction of validation of alternative microbiological methods[J].Drug Stand China,2007,8(2):9
[9] 魏树源,杨京生,陈晓琦,等.三磷酸腺苷生物发光快速微生物检测法在疫苗中间品无菌试验中的应用[J].中国生物制品学杂志,2010,23(10):1120 WEI SY,YANG JS,CHEN XQ,et al.Application of rapid determination of microorganisms by ATP bioluminescence assay to sterility test of intermediate product of vaccine[J].Chin J Biol,2010,23(10):1120
[10] MICHAEL J.The implementation of rapid microbiological methods[J].Eur Pharm Rev,2010,6:27
[11] 高誉珊,郑丰杰,李鑫,等.基于微量量热法的寒热中药对大肠杆菌生长热谱曲线的影响[J].云南中医学院学报,2014,37(2):10 GAO YS,ZHENG FJ,LI X,et al.Effect of traditional Chinese medicine with cold and heat on the growth of Escherichia coli by microcalorimetry[J].J Yunnan Univ Tradit Chin Med,2014,37(2):10
[12] PARVEEN S,KAUR S,DAVID SAW,et al.Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products[J].Vaccine,2011,29(45):8012
[13] KHUU H,STOCK F,MCGANN M,et al.Comparison of automated culture systems with a CFR/USP-compliant method for sterility testing of cell-therapy products[J].Cytotherapy,2004,6(3):183
[14] LUIS J,NARENDRA R,JOSEPH A,et al.Validation of the BacT/alert? 3D system for rapid sterility testing of biopharmaceutical samples[J].PDA J Pharm Sci Technol,2012,66(1):38
[15] KAISER SJ,MUTTERS NT,BACKHAUS J,et al.Sterility testing of injectable products:evaluation of the growth based BacT/ALERT? 3DTM Dual T culture system[J].PDA J Pharm Sci Technol,2016,70(6):568
[16] KIELPINSKI G,PRINZI S,DUGUID J,et al.Roadmap to approval:use of an automated sterility test method as a lot release test for Carticel,autologous cultured chondrocytes[J].Cytotherapy,2005,7(6):531
[17] MURRAY L,MCGOWAN N,FLEMING J,et al.Use of the BacT/alert? system for rapid detection of microbial contamination in a pilot study using pancreatic islet cell products[J].J Clin Microbiol,2014,52(10):3769
[18] MIYASHITA N,TANAKA M,GOTODA R,et al.New approach for setting a management criterion in microbiological monitoring using rapid microbiological methods[J].Biol Pharm Bull,2015,38(11):1714
[19] BRUECKNER D,KR?HENBüHL S,ZUBER U,et al.An alternative sterility assessment for parenteral drug products using isothermal microcalorimetry[J].J Appl Microbiol,2017,123(3):773
[20] 安云庆,李玉兰,程松高,等.用生物发光测定法取代现行卡介苗活菌计数法的实验研究[J].首都医学院学报,1988,9(3):189 AN YQ,LI YL,CHENG SG,et al.Experimental research on ultilization of bioluminescent technique to substitute the viability count of current BCG vaccine[J].J Cap Inst Med,1988,9(3):189
[21] 王知坚,李珏.厄多司坦胶囊菌落计数替代方法的验证[J].药物分析杂志,2011,31(11):2146 WANG ZJ,LI J.Validation of alternative methods for colony count of erdosteine capsules[J].Chin J Pharm Anal,2011,31(11):2146
[22] 王知坚,李珏.大肠杆菌测试片在吡拉西坦片大肠埃希菌检查中的应用[J].中国现代应用药学,2011,28(11):1032 WANG ZJ,LI J.Application of E.coil count plate in E.coil test of piracetam tablets[J].Chin J Mod Appl Pharm,2011,28(11):1032
[23] 王鲁华,刘婷婷,卢京光,等.Petrifilm测试片法在药品微生物检验中的应用研究[J].药物分析杂志,2012,32(12):2267 WANG LH,LIU TT,LU JG,et al.Application of petrifilm paper disk method in drug microbioassay[J].Chin J Pharm Anal,2012,32(12):2267
[24] 李珏,王知坚,郑小玲.Bactalert? 3D微生物检测系统作为无菌检查替代方法可行性的探讨[J].中国现代应用药学,2015,32(4):474 LI J,WANG ZJ,ZHENG XL.Discussion on feasibility of alternative sterility test of Bactert? 3D microbial detection system[J].Chin J Mod Appl Pharm,2015,32(4):474
[25] 郜丹,任永申,鄢丹,等.基于生物热动力学的注射剂无菌检查新方法研究[J].药学学报,2014,49(3):385 GAO D,REN YS,YAN D,et al.A novel method for testing sterility of injections based on biothermodynamics[J].Acta Pharm Sin,2014,49(3):385
[26] 任永申,张萍,吕宏宇,等.基于微量量热法的无菌制剂快速无菌检查方法研究[J].第三军医大学学报,2015,37(20):2047 REN YS,ZHANG P,Lü HY,et al.Rapid detection of microbial contamination of sterile preparation based on microcalorimetry[J].Acta Acad Med Mil Tert,2015,37(20):2047
[27] 范一灵,王伟霞,闻宏量,等.等量微热技术快速评价头孢曲松钠的体外抑菌效果[J].药物分析杂志,2019,39(4):722 FANG YL,WANG WX,WEN HL,et al.Rapid antibacterial activity test of ceftriaxone sodium in vitro by isothermal microcalorimetry[J].Chin J Pharm Anal,2019,39(4):722
[28] EP 9.0. 5.1.6 Alternative Methods for Control of Microbiological Quality[S].2017:580
[29] SMITH R,von TRESS M,TUBB C,et al.Evaluation of the ScanRDI(R) as a rapid alternative to the pharmacopoeial sterility test method:comparison of the limits of detection[J].PDA J Pharm Sci Technol,2010,64(4):356
[30] SANDLE T,LEAVY C,JINDAL H,et al.Application of rapid microbiological methods for the risk assessment of controlled biopharmaceutical environments[J].J Appl Microbiol,2014,116(6):1495
[31] 顾珉,许丹,顾炳仁.荧光染色计数法在制药用水微生物限度检查替代应用初探[J].中国药品标准,2017,18(4):298 GU M,XU D,GU BR.A tentative exploration on fluorescence staining counting method as the alternative method of microbial limit test for the pharmaceutical water[J].Drug Stand China,2017,18(4):298
[32] ZHENG XL,XIONG ZQ,WU JQ.The use of a simple flow cytometry method for rapid detection of spores in probiotic Bacillus licheniformis-containing tablets[J].Food Sci Biotechnol,2017,26(1):167
[33] 王银环,钱凌,董芳华,等.流式细胞术和平板计数法用于地衣芽孢杆菌活菌制剂检测的比较研究[J].中国现代应用药学,2018,35(3):352 WANG YH,QIAN L,DONG FH,et al.Comparative research on the detection of viable organism preparation of Bacillus licheniformis between flow cytometry and plate counting method[J].Chin J Mod Appl Pharm,2018,35(3):352
[34] 张国林,景荣先.微生物快速鉴定、分型技术在食药源性微生物检测中的应用[J].中国现代应用药学,2014,31(11):1412 ZHANG GL,JING RX.Application of microorganism identification and genotyping techniques in microbial contamination detection in food and drug quality control[J].Chin J Mod Appl Pharm,2014,31(11):1412
[35] 周爽,钱文静.傅里叶变换红外光谱对药品中沙门菌的鉴别[J].中国药品标准,2014,15(5):348 ZHOU S,QIAN WJ.Classification and cluster analysis of Salmonella spp.by FT-IR[J].Drug Stand China,2014,15(5):348
[36] 裴琳,胡昌勤,马仕洪,等.FTIR法用于药品检出菌与药品微生物检验洁净室环境菌的相关性考察[J].药学学报,2007,42(11):1189 PEI L,HU CQ,MA SH,et al.Correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test investigated by FTIR[J].Acta Pharm Sin,2007,42(11):1189
[37] 范一灵,房蕊,蒋波,等.微生物鉴定分型技术应用于医药企业微生物污染调查[J].中国医药工业杂志,2010,41(11):810 FANG YL,FANG R,JIANG B,et al.Application of identification and characterization methods for microbial contamination survey in pharmaceutical industry[J].Chin J Pharm,2010,41(11):810
[38] 范一灵,蒋波,房蕊,等.药品无菌检查中微生物污染的鉴定和污染溯源分析[J].药物分析杂志,2011,31(6):1067 FANG YL,JIANG B,FANG R,et al.Identification and characterization of bacterial contaminations isolated from drug sterility test[J].Chin J Pharm Anal,2011,31(6):1067
[39] 池王胄,宋庭,周芳芳,等.微生物鉴定技术在无菌药品生产企业中的应用[J].中国医药导刊,2012,14(1):169 CHI WZ,SONG T,ZHOU FF,et al.Application of microbe technology in the industry of sterile medicine[J].Chin J Med Guide,2012,14(1):169
[40] 房蕊,蒋波,范一灵,等.ITS序列分析在药品微生物检验中真菌鉴定与控制中的应用研究[J].药物分析杂志,2011,31(2):302 FANG R,JIANG B,FANG YL,et al.Application of ITS sequences in identification and control of fungi in pharmaceutical microbial test[J].Chin J Pharm Anal,2011,31(2):302
[41] 郑小玲,杨丹燕,李珏,等.现代菌种鉴定技术在药品控制菌检查中的比较[J].中国卫生检验杂志,2015,25(5):658 ZHENG XL,YANG DY,LI J,et al.Comparison of modern strain identification technologies in drug control bacteria test[J].Chin J Health Lab Technol,2015,25(5):658
[42] 郑小玲,王征南,王知坚,等.药品微生物检测实验室环境菌库的建立[J].中国现代应用药学,2015,32(7):847 ZHENG XL,WANG ZN,WANG ZJ,et al.Establishment of the environmentally microbial library in the drug sterility testing laboratory[J].Chin J Mod Appl Pharm,2015,32(7):847
[43] 郑小玲,王知坚,李珏,等.多种测序技术在药品检测环境微生物鉴定分析中的应用研究[J].药物分析杂志,2016,36(1):46 ZHENG XL,WANG ZJ,LI J,et al.Application of a variety of sequencing technology in the identification of environmental microorganisms[J].Chin J Pharm Anal,2016,36(1):46
[44] FYKSE EM,TJ?RNHAGE T,HUMPPI T,et al.Identification of airborne bacteria by 16S rDNA sequencing,MALDI-TOF MS and the MIDI microbial identification system[J].Aerobiologia,2015,31(3):271
[45] USP 41-NF 36.1223 Validation of Alternative Microbiological Test Methods[S].2018:1756

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