在药物安全性评价中组织学技术流程的探讨
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摘要
药物安全性评价中毒性病理学评价是最重要的一个步骤,而毒性病理学评价作为药物安全性评价体系中重要的一环,用以确定损伤靶器官、靶组织的形态及程度变化,评价受试药物是否具有毒性并判断其能否推向临床的重要指标。对组织学技术进行质量控制与评估则是确保毒性病理诊断准确性及一致性的重要前提。该文对组织学技术流程进行叙述并探讨流程中相关影响因素。
The evaluation of toxicological pathology is the most important step in the evaluation of drug safety, which is an important part of system in drug safety evaluation. It is used to identify the changes in morphology and degree of target organs and target tissues, to evaluate whether the drugs are toxic and judge they can be enter the clinic or not. The quality control and evaluation of histological techniques is an important prerequisite to ensure the accuracy and consistency of the diagnosis of toxicological pathology. This paper describes the process of histological techniques and discusses the related factors in the process.
The evaluation of toxicological pathology is the most important step in the evaluation of drug safety, which is an important part of system in drug safety evaluation. It is used to identify the changes in morphology and degree of target organs and target tissues, to evaluate whether the drugs are toxic and judge they can be enter the clinic or not. The quality control and evaluation of histological techniques is an important prerequisite to ensure the accuracy and consistency of the diagnosis of toxicological pathology. This paper describes the process of histological techniques and discusses the related factors in the process.
引文
[1]董延生.药物安全性评价毒性病理平台的规范化建设与实践[D].北京:中国人民解放军军事医学科学院,2012.
[2]王和枚,董延生,韩刚,等.GLP条件下毒性病理学的规范化建设与实践[J].中国药理学与毒理学杂志,2013(3):455-456.
[3]英永,王韶艳,屈卉锦,等.浅谈药物安全性评价中病理技术质量控制与评估[J].药学研究,2011,30(4):234-235.
[4]Wallace Hayes A,Kruger C L.Hayes'Principles and Methods of Toxicology[M].6th ed.Boca Raton:CRC Press.2014:572-593.
[5]Kim Y M,Paik S G.Induction of expression of inducible nitric oxide synthase by Taxol in murine macrophage cells[J].Biochem Biophys Res Commun,2005,326(2):410-416.
[6]Bregman C L,Adler R R,Morton D G,et al.Recommended tissue list for histopathologic examination in repeat-dose toxicity and carcinogenicity studies:a proposal of the Society of Toxicologic Pathology(STP)[J].Toxicol Pathol,2003,31(2):252-253.
[7]胡春燕.FDA、OECD及CFDA指导原则关于药物临床前毒理病理学研究的要求[C]//中国毒理学会毒性病理学专业委员会会员代表大会会议.2015.
[8]药物重复给药毒性研究技术指导原则[S].国家食品药品监督管理总局,2014.
[9]赵阿红,宋一民,尹玉慧,等.病理组织脱水的质量控制与管理[J].医疗卫生装备,2009,30(3):111-112.
[10]Stowell R E.Effect on tissue volume of various methods of fixation,dehydration,and embedding[J].Stain Technol,2009,16(2):67-83.
[11]刘瑾,袁怀志.自动组织脱水机乙醇浓度变化对组织脱水的影响及采取对策的探讨[J].重庆医学,2017,46(6):829-831.
[12]Luna L G.Histopathologic methods and color atlas of special stains and tissue artifacts[J]Histopathologic Methods and Color Atlas of Special Stains and Tissue Artifacts,1992.
[13]Goldberg M S,Wetherington S J,Susa J S,et al.Characterization of tissue and slide artifacts from automated embedding systems[J].Am J Dermatopathol,2015,37(11):846-849.
[14]屈哲,林志,吕建军,等.影响药物毒性神经病理学评价质量的主要因素[J].药物评价研究,2017,40(9):1348-1354.
[15]郑翔,毕文杰.以四氢呋喃为脱水剂的石蜡显微制片经验及优势分析[J].解剖学杂志,2014,37(4):560-562.
[16]Carson F L.Histotechnology:a self-instructional text[M].1990.
[17]Jones M L.Histotechnology:A self instructional text[J].J Histotechnol,2015(3):97.
[18]Feldman A T,Dapson R W.The Chemistry of Fixation and Staining:I.Basic Concepts[J].J Histotechnol,2013,3(4):132-135.
[19]Nancy.苏木素的种类及其配制法、伊红染液的配制法-常规石蜡切片制作[EB/OL].(2010-08-09)[2018-03-04]http://www.microimage.com.cn/xwjs/2010/0809/article_4995.html.
[20]Akita M,Kaneko K.An improved alum hematoxylin method with application of Mayer's hemalum for staining of elastic fibers[J].Stain Technology,1981,56(5):327-328.
[21]Rastogi V.Comparison of Alum Hematoxylin-Harri's,Mayer's and Ehrlich[M].LAP LAMBERT Academic Publishing,2012.
[22]章克萍,龙飞,周莹.组织染色剂伊红Y的化学性质及改良配制法探讨[J].南昌大学学报:医学版,2007,47(1):92.
[23]王伯.病理学技术[M].北京:人民卫生出版社,2000.
[24]马峰,刘仲祥.病理技术HE染色用于病理诊断中的价值分析[J].中国实验诊断学,2015(12):2103-2104.
[25]梁英杰.临床病理学技术[M].北京:人民卫生出版社,2011.
[26]高颖,吕艳萍.病理技术质量控制常见的问题与方法对策研究[J].中国医药指南,2013(27):583-584.
[2]王和枚,董延生,韩刚,等.GLP条件下毒性病理学的规范化建设与实践[J].中国药理学与毒理学杂志,2013(3):455-456.
[3]英永,王韶艳,屈卉锦,等.浅谈药物安全性评价中病理技术质量控制与评估[J].药学研究,2011,30(4):234-235.
[4]Wallace Hayes A,Kruger C L.Hayes'Principles and Methods of Toxicology[M].6th ed.Boca Raton:CRC Press.2014:572-593.
[5]Kim Y M,Paik S G.Induction of expression of inducible nitric oxide synthase by Taxol in murine macrophage cells[J].Biochem Biophys Res Commun,2005,326(2):410-416.
[6]Bregman C L,Adler R R,Morton D G,et al.Recommended tissue list for histopathologic examination in repeat-dose toxicity and carcinogenicity studies:a proposal of the Society of Toxicologic Pathology(STP)[J].Toxicol Pathol,2003,31(2):252-253.
[7]胡春燕.FDA、OECD及CFDA指导原则关于药物临床前毒理病理学研究的要求[C]//中国毒理学会毒性病理学专业委员会会员代表大会会议.2015.
[8]药物重复给药毒性研究技术指导原则[S].国家食品药品监督管理总局,2014.
[9]赵阿红,宋一民,尹玉慧,等.病理组织脱水的质量控制与管理[J].医疗卫生装备,2009,30(3):111-112.
[10]Stowell R E.Effect on tissue volume of various methods of fixation,dehydration,and embedding[J].Stain Technol,2009,16(2):67-83.
[11]刘瑾,袁怀志.自动组织脱水机乙醇浓度变化对组织脱水的影响及采取对策的探讨[J].重庆医学,2017,46(6):829-831.
[12]Luna L G.Histopathologic methods and color atlas of special stains and tissue artifacts[J]Histopathologic Methods and Color Atlas of Special Stains and Tissue Artifacts,1992.
[13]Goldberg M S,Wetherington S J,Susa J S,et al.Characterization of tissue and slide artifacts from automated embedding systems[J].Am J Dermatopathol,2015,37(11):846-849.
[14]屈哲,林志,吕建军,等.影响药物毒性神经病理学评价质量的主要因素[J].药物评价研究,2017,40(9):1348-1354.
[15]郑翔,毕文杰.以四氢呋喃为脱水剂的石蜡显微制片经验及优势分析[J].解剖学杂志,2014,37(4):560-562.
[16]Carson F L.Histotechnology:a self-instructional text[M].1990.
[17]Jones M L.Histotechnology:A self instructional text[J].J Histotechnol,2015(3):97.
[18]Feldman A T,Dapson R W.The Chemistry of Fixation and Staining:I.Basic Concepts[J].J Histotechnol,2013,3(4):132-135.
[19]Nancy.苏木素的种类及其配制法、伊红染液的配制法-常规石蜡切片制作[EB/OL].(2010-08-09)[2018-03-04]http://www.microimage.com.cn/xwjs/2010/0809/article_4995.html.
[20]Akita M,Kaneko K.An improved alum hematoxylin method with application of Mayer's hemalum for staining of elastic fibers[J].Stain Technology,1981,56(5):327-328.
[21]Rastogi V.Comparison of Alum Hematoxylin-Harri's,Mayer's and Ehrlich[M].LAP LAMBERT Academic Publishing,2012.
[22]章克萍,龙飞,周莹.组织染色剂伊红Y的化学性质及改良配制法探讨[J].南昌大学学报:医学版,2007,47(1):92.
[23]王伯.病理学技术[M].北京:人民卫生出版社,2000.
[24]马峰,刘仲祥.病理技术HE染色用于病理诊断中的价值分析[J].中国实验诊断学,2015(12):2103-2104.
[25]梁英杰.临床病理学技术[M].北京:人民卫生出版社,2011.
[26]高颖,吕艳萍.病理技术质量控制常见的问题与方法对策研究[J].中国医药指南,2013(27):583-584.