最新中国药科大学药物分析课件第六版第十六章药品质量控制中的现代分析方法与技术-PPT文档.ppt
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1、现代分析方法与技术,为药学的发展提供了适时而有效的手段与动力。,色谱及其联用技术: 药学研究分子水平。 手性分析: 毛细管电泳及手性色谱技术药物研究与质量控制提供了保障。 现代光谱技术: 药物结构鉴定, 微量杂质检定。,第一节 概况,Capillary electrophoresis,CE,Modern chromatogr & its application,药物现代色谱法及其应用,UPLC,UltraPerformance LC (UPLC ) technology starts with unique 1.7 m small-particle chemistries. Chromatog
2、raphers no longer need to choose between speed and resolutionwith UPLC you get both.,Mass spectroscopy MS Nuclear magnetic resonance spectrometry NMR X-ray diffraction method Near infrared spectrometry NIRS,现代光谱法及其应用,Modern spectroscopy & its application in pharmaceutical analysis,Hyphenated Techniq
3、ues in Chromatography,现代联用技术及其应用,HPLC-MS,CE-MS,第二节 液质联用技术与应用,2.1 离子化方式,2.2 离子分离与测定模式,Full-Scan Mass Spectrometry,Advantage Provides MW Information,Full-Scan MS of Buspirone,Buspirone (丁螺环酮) C21H31N5O2 MW = 385,(M+H)+,(M+Na)+,Single Ion Monitoring (SIM),Advantages Targeted Analyte Monitoring High Dut
4、y Cycle Simple,Disadvantages Can suffer from interferences Not as sensitive or selective as SRM (see below),Fixed m/z,Pass All,Pass All,Product Ion Scanning: A Tandem MS Method,Advantage Provides Structural Information,Disadvantage Low duty cycle,Fixed m/z,Pass All,Scanning,Product Ion Spectrum,Q3,Q
5、2,Q1,Product Ion Spectrum of Buspirone,(M+H)+,Precursor Ion Scanning,Advantage ID compounds producing specific fragment ion (e.g., PO3 for phosphopeptides),Disadvantage Low duty cycle,Fixed m/z,Pass All,Scanning,Precursor Ion Spectrum,Q3,Q2,Q1,Precursor Ion Scan Mode for Buspirone Metabolites,Precur
6、sor Ion Scan: Q3 set to m/z 122,Neutral Loss Scanning,Advantage Screen for compounds producing specific neutral loss (e.g., loss of 176 for glucuronide conjugates),Disadvantage Low duty cycle,Scanning,Pass All,Scanning,Neutral Loss Spectrum,Linked,Q3,Q2,Q1,Neutral Loss Scan of Buspirone Metabolites,
7、Neutral Loss Scan: Q1/Q3 difference set to 121 Da,Selected Reaction Monitoring (SRM),Advantages Targeted Analyte Monitoring High Duty Cycle “Simultaneous” Monitoring of Multiple Transitions,Disadvantage No “advanced” structural information,Q1,Q2,Q3,MS/MS Selectivity in Complex Matrices,息斯敏阿斯咪唑(astem
8、izole),Chlroamphenicol(氯霉素,CAP)残留测定 黄杨生物碱成分鉴定 苯甲酸利扎曲普坦人体药代动力学研究,2.3药物分析中的典型应用,C11H12Cl2N2O5 FMW=323.13,【类别】 酰胺醇类抗生素 【适应症】本品是治疗伤寒、副伤寒的首选药物,外用可治疗沙眼。因脑脊液浓度高,故常用于治疗细菌性脑膜炎和脑脓肿。此外,尚可外用治疗痤疮、酒糟鼻、脂溢性皮炎等。,被农业养殖滥用! 肉食品中严格检查。,2.3.1 Chlroamphenicol(氯霉素,CAP)残留测定,HPLC analysis was performed on the Finnigan Surveyo
9、r HPLC module with MS Pump and Autosampler Column: Thermo Hypersil Gold C18 (1002.1 mm, 5) Mobile Phase: A: Water; B: Acetonitrile Column Temperature: 40 oC Gradient Program: 0.25 mL/min Injection: 20 uL with loop,Operation Conditions for CAP,Q1 peak width and H-SRM experiment,Enabling the H-SRM exp
10、eriment Highly Selective Selected Reaction Monitoring (H-SRM) Reduces “isobaric” chemical noise Increases confidence of analysis & improved LOQ,CAP SRM Result: CAP Standard Q1 peak width = 0.7 Da,CAP,Peak Area Counts = 2.4E4,CAP SRM Result: Kidney Blank,CAP SRM Result: Kidney Spiked (0.5ng/g),CAP,No
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