展望微量热技术用于比较原研和仿制抗生素抑菌活性差异
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摘要
微量热技术是以测量细胞在代谢过程中能量变化规律为基础,通过细胞能量变化间接反应细胞活性,分析外界因素对其生长代谢影响的一种研究方法。微量热分析可以绘制生物体生长热谱图,通过建立数学模型,得到生长速率k,最大热功率Pm,传代时间tG及最小抑菌浓度(minimal inhibitory concentration, MIC)等热动力学参数。微量热技术是一项灵敏度高、测量准确的热分析技术,具有实时检测、在线分析、定量评估和动态描述等特点,已在生命科学领域得到了广泛的应用。本文主要讨论微量热技术在检测和比较原研与仿制抗生素药物中抑菌活性差异的应用可行性,为其在该领域的应用提供参考。
The microcalorimetry is a method used for recording of the heat produced by cells or bacterial populations over time. The change of the heat production indirectly reflects viability of cells or bacterial populations. Hence, microcalorimetric technique has increasingly been explored to study bacterial interactions with different factors in the medium culture. The process of bacterial growth can be monitored in real time by recording a graph of generated power over time. As a result, the power-time curves of bacteria can be continuously plotted in real time. It can provide abundant thermodynamic and kinetic parameters, such as the growth rate k, the generation time tG, the minimal inhibitory concentration(MIC), the maximum thermal power Pm, and so on. The aim of this study is to discuss the application of microcalorimetry to detect and compare anti-bacterial activity of original and generic antibiotics, providing information about the utilization of microcalorimetry in this field.
The microcalorimetry is a method used for recording of the heat produced by cells or bacterial populations over time. The change of the heat production indirectly reflects viability of cells or bacterial populations. Hence, microcalorimetric technique has increasingly been explored to study bacterial interactions with different factors in the medium culture. The process of bacterial growth can be monitored in real time by recording a graph of generated power over time. As a result, the power-time curves of bacteria can be continuously plotted in real time. It can provide abundant thermodynamic and kinetic parameters, such as the growth rate k, the generation time tG, the minimal inhibitory concentration(MIC), the maximum thermal power Pm, and so on. The aim of this study is to discuss the application of microcalorimetry to detect and compare anti-bacterial activity of original and generic antibiotics, providing information about the utilization of microcalorimetry in this field.
引文
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[2]胡昌勤.2015年版《中国药典》有关抗生素的增修订及其质量控制方向[J].中国药学杂志,2015,50:1764-1769.
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[10]Chang-Qin H U,Yin L H,Liang Y N.Physical and chemical characteristics of a new cefazolin sodium hydrate crystal[J].Acta Pharm Sin,2008,43:868-872.
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[18]Fujimura S,Watanabe A,Fuse K,et al.In vitro susceptibility of clinical isolates of methicillin-resistant Staphylococcus aureus(MRSA)to manufactured generic drugs compared with the brand vancomycin[J].Int J Antimicrob Agents,2008,31(4):391-392.
[19]World Health Organization.Marketing authorization of pharmaceutical products with special reference to multisource(generic)products:a manual for National Medicines Regulatory Authorities(NMRAs)[S].2nd edition.Geneva:World Health Organization.2011:142.
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[21]Ma J,Qi W T,Yang L N,et al.Microcalorimetric study on the growth and metabolism of microencapsulated microbial cell culture[J].J Microbiol Methods,2007,68:172-177.
[22]Braissant O,Wirz D,Gopfert B,et al.Biomedical use of isothermal microcalorimeters[J].Sensors(Basel),2010,10:9369-9383.
[23]Bonkat G,Braissant O,Widmer A F,et al.Rapid detection of urinary tract pathogens using microcalorimetry:Principle,technique and first results[J].BJU Int,2012,110:892-897.
[24]Kong W,Jin C,Xiao X,et al.Comparative study of effects of two bile acid derivatives on Staphylococcus aureus by multiple analytical methods[J].J Hazard Mater,2010,179:742-747.
[25]Gould J L.The quarterly review of biology[J].Q Rev Biol,1976,51(2):211-244.
[26]Wenzler T,Steinhuber A,Wittlin S,et al.Isothermal microcalorimetry,a new tool to monitor drug action against Trypanosoma brucei and Plasmodium falciparum[J].PLoSNegl Trop Dis,2012,6:e1668.
[27]孔维军,赵艳玲,山丽梅,等.微量热法研究板蓝根中四种有机酸对微生物生长代谢的影响[J].生物工程学报,2008,24(4):646-650.
[28]章从恩,王嘉毅,郝俊杰,等.微量量热法体外表征拉米夫定对肠道特征菌群的影响[J].药学学报,2013,48(10):1590-1594.
[29]Morgan T D,Beezer A E,Mitchell J C,e t a l.Amicrocalorimetric comparison of the anti-Streptococcus mutans efficacy of plant extracts and antimicrobial agents in oral hygiene formulations[J].J Appl Microbiol,2001,90:53-58.
[30]Kong W,Wang J,Xing X,et al.Screening for novel antibacterial agents based on the activities of compounds on metabolism of Escherichia coli:A microcalorimetric study[J].J Hazard Mater,2011,185:346-352.
[31]Qian P Y,Xu Y,Fusetani N.Natural products as antifouling compounds:recent progress and future perspectives[J].Biofouling,2010,26:223.
[32]Coates A R,Hu Y.Targeting non-multiplying organisms as a way to develop novel antimicrobials[J].Trends Pharmacol Sci,2008,29:143.
[33]Chunmei D,Jiabo W,Weijun K,et al.Investigation of antimicrobial activity of catechin on Escherichia coli growth by microcalorimetry[J].Environ Toxicol Pharmacol,2010,30:284-288.
[34]Kong W J,Zhao Y L,Xiao X H,et al.Investigation of the anti-fungal activity of coptisine on Candida albicans growth by microcalorimetry combined with principal component analysis[J].J Appl Microbiol,2009,107:1072-1080.
[35]Vogel H J,Schibli D J,Jing W,et al.Towards a structurefunction analysis of bovine lactoferricin and related tryptophan-and arginine-containing peptides[J].Biochem Cell Biol,2002,80:49-63.
[36]Wenzler T,Steinhuber A,Wittlin S,et al.Isothermal microcalorimetry,a new tool to monitor drug action against Trypanosoma brucei and Plasmodium falciparum[J].PLoSNeglect Trop Dis,2012,6:e1668.
[37]Garedew A,Schmolz E,Lamprecht I.Microbiological and calorimetric investigations on the antimicrobial actions of different propolis extracts:An in vitro approach[J].Thermochimica Acta,2004,422:115-124.
[38]Ah U,Wirz D,Daniels A U.Isothermal micro calorimetry-a new method for MIC determinations:Results for 12antibiotics and reference strains of E.coli and S.aureus[J].BMC Microbiology,2009,9:106.
[39]Braissant O,Wirz D,Gopfert B,et al.Use of isothermal microcalorimetry to monitor microbial activities[J].FEMSMicrobiol Lett,2010,303:1-8.
[2]胡昌勤.2015年版《中国药典》有关抗生素的增修订及其质量控制方向[J].中国药学杂志,2015,50:1764-1769.
[3]Davit B M,Nwakama P E,Buehler G J,et al.Comparing generic and innovator drugs:a review of 12 years of bioequivalence data from the United States Food and Drug Administration[J].Ann Pharmacother,2009,43:1583-1597.
[4]张崖冰,胡善联,彭颖,等.国内专利后原研药及其仿制药的现状研究[J].中国卫生经济,2013:21-23.
[5]Gauzit R,Lakdhari M.Generic antibiotic drugs:Is effectiveness guaranteed[J].Med Mal Infect,2012,42:141-148.
[6]Kanfer I,Skinner M F,Walker R B.Analysis of macrolide antibiotics[J].J Chromatogr A,1998,812:255-286.
[7]Feldsine P,Abeyta C,Andrews W H,et al.AOACinternational methods committee guidelines for validation of qualitative and quantitative food microbiological official methods of analysis[J].J AOAC Int,2002,85:1187-1200.
[8]Berg M J,Gross R A,Tomaszewski K J,et al.Generic substitution in the treatment of epilepsy:Case evidence of breakthrough seizures[J].Neurology,2008,71:525-530.
[9]Arnet I,Altermatt M,Roggo Y,et al.Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia[J].J Chemother,2015,27:337-342.
[10]Chang-Qin H U,Yin L H,Liang Y N.Physical and chemical characteristics of a new cefazolin sodium hydrate crystal[J].Acta Pharm Sin,2008,43:868-872.
[11]涂林,余方键,胡昌勤.国产注射用头孢曲松钠的质量现状[J].中国药事,2002,16:45-46.
[12]Hickey M B,Peterson M L,Manas E S,et al.Hydrates and solid-state reactivity:A survey ofβ-lactam antibiotics[J].JPharm Sci,2007,96:1090-1099.
[13]谢景文,王荣,贾正平,等.毛细管电泳测定头孢曲松钠对映体含量[J].中国药房,2002,13:43-44.
[14]Lambert P A,Conway B R.Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin[J].J Chemother,2003,15:357-368.
[15]Schito G C,Keenan M H.Predicting the clinical efficacy of generic formulations of ceftriaxone[J].J Chemother,2005,17(Suppl 2):33-40.
[16]Snyman J R,Schoeman H S,Grobusch M P,et al.Generic versus non-generic formulation of extended-release clarithromycin in patients with community-acquired respiratory tract infections:a prospective,randomized,comparative,investigator-blind,multicentre study[J].Clin Drug Invest,2009,29(4):265-274.
[17]Nightingale C H.A survey of the quality of generic clarithromycin products from 18 countries[J].Clin Drug Invest,2005,25(2):135-152.
[18]Fujimura S,Watanabe A,Fuse K,et al.In vitro susceptibility of clinical isolates of methicillin-resistant Staphylococcus aureus(MRSA)to manufactured generic drugs compared with the brand vancomycin[J].Int J Antimicrob Agents,2008,31(4):391-392.
[19]World Health Organization.Marketing authorization of pharmaceutical products with special reference to multisource(generic)products:a manual for National Medicines Regulatory Authorities(NMRAs)[S].2nd edition.Geneva:World Health Organization.2011:142.
[20]李婧,方小伟,张兴磊.抗生素药物质量分析方法研究进展[J].广东化工,2015,42(9):119-120.
[21]Ma J,Qi W T,Yang L N,et al.Microcalorimetric study on the growth and metabolism of microencapsulated microbial cell culture[J].J Microbiol Methods,2007,68:172-177.
[22]Braissant O,Wirz D,Gopfert B,et al.Biomedical use of isothermal microcalorimeters[J].Sensors(Basel),2010,10:9369-9383.
[23]Bonkat G,Braissant O,Widmer A F,et al.Rapid detection of urinary tract pathogens using microcalorimetry:Principle,technique and first results[J].BJU Int,2012,110:892-897.
[24]Kong W,Jin C,Xiao X,et al.Comparative study of effects of two bile acid derivatives on Staphylococcus aureus by multiple analytical methods[J].J Hazard Mater,2010,179:742-747.
[25]Gould J L.The quarterly review of biology[J].Q Rev Biol,1976,51(2):211-244.
[26]Wenzler T,Steinhuber A,Wittlin S,et al.Isothermal microcalorimetry,a new tool to monitor drug action against Trypanosoma brucei and Plasmodium falciparum[J].PLoSNegl Trop Dis,2012,6:e1668.
[27]孔维军,赵艳玲,山丽梅,等.微量热法研究板蓝根中四种有机酸对微生物生长代谢的影响[J].生物工程学报,2008,24(4):646-650.
[28]章从恩,王嘉毅,郝俊杰,等.微量量热法体外表征拉米夫定对肠道特征菌群的影响[J].药学学报,2013,48(10):1590-1594.
[29]Morgan T D,Beezer A E,Mitchell J C,e t a l.Amicrocalorimetric comparison of the anti-Streptococcus mutans efficacy of plant extracts and antimicrobial agents in oral hygiene formulations[J].J Appl Microbiol,2001,90:53-58.
[30]Kong W,Wang J,Xing X,et al.Screening for novel antibacterial agents based on the activities of compounds on metabolism of Escherichia coli:A microcalorimetric study[J].J Hazard Mater,2011,185:346-352.
[31]Qian P Y,Xu Y,Fusetani N.Natural products as antifouling compounds:recent progress and future perspectives[J].Biofouling,2010,26:223.
[32]Coates A R,Hu Y.Targeting non-multiplying organisms as a way to develop novel antimicrobials[J].Trends Pharmacol Sci,2008,29:143.
[33]Chunmei D,Jiabo W,Weijun K,et al.Investigation of antimicrobial activity of catechin on Escherichia coli growth by microcalorimetry[J].Environ Toxicol Pharmacol,2010,30:284-288.
[34]Kong W J,Zhao Y L,Xiao X H,et al.Investigation of the anti-fungal activity of coptisine on Candida albicans growth by microcalorimetry combined with principal component analysis[J].J Appl Microbiol,2009,107:1072-1080.
[35]Vogel H J,Schibli D J,Jing W,et al.Towards a structurefunction analysis of bovine lactoferricin and related tryptophan-and arginine-containing peptides[J].Biochem Cell Biol,2002,80:49-63.
[36]Wenzler T,Steinhuber A,Wittlin S,et al.Isothermal microcalorimetry,a new tool to monitor drug action against Trypanosoma brucei and Plasmodium falciparum[J].PLoSNeglect Trop Dis,2012,6:e1668.
[37]Garedew A,Schmolz E,Lamprecht I.Microbiological and calorimetric investigations on the antimicrobial actions of different propolis extracts:An in vitro approach[J].Thermochimica Acta,2004,422:115-124.
[38]Ah U,Wirz D,Daniels A U.Isothermal micro calorimetry-a new method for MIC determinations:Results for 12antibiotics and reference strains of E.coli and S.aureus[J].BMC Microbiology,2009,9:106.
[39]Braissant O,Wirz D,Gopfert B,et al.Use of isothermal microcalorimetry to monitor microbial activities[J].FEMSMicrobiol Lett,2010,303:1-8.