PF-3084014_HNMR_24515_MedChemExpress
光度法测定依达拉奉注射液中抗氧剂焦亚硫酸钠的含量
文章编号：1004-3918（2010）11-1403-02光度法测定依达拉奉注射液中抗氧剂焦亚硫酸钠的含量梁艳利，张慧丽，吴拥军（郑州大学化学系，郑州450001）摘要：为建立测定依达拉奉注射液中抗氧剂焦亚硫酸钠的质量控制方法，利用二氧化硫能使酸性品红溶液褪色的性质，将供试液在室温放置25min ，采用比色法在549nm 波长处测定吸光度，用标准曲线法测定含量.结果显示无水亚硫酸钠在4．4～26．4μg /mL 范围内，吸光度的倒数与浓度呈良好的线性关系，复相关系数R 2＞0．99，平均加样回收率为94．9％，RSD 为3．0％.该法操作方便，结果准确可靠、可用于依达拉奉注射液中焦亚硫酸钠含量的测定.关键词：依达拉奉注射液；焦亚硫酸钠；比色法；含量测定中图分类号：O 657文献标识码：A依达拉奉（MC－971）是一种脑保护剂（自由基清除剂），其注射液中的抗氧剂焦亚硫酸钠氧化后的残留物亚硫酸盐可能会对人体造成损害，应对其加入量进行控制，以提高产品的安全性指标.亚硫酸盐在溶液中分解释放出的二氧化硫能使酸性品红溶液褪色，据此原理并参考复方氨基酸注射液（18AA－Ⅰ）[1]中焦亚硫酸钠的检查方法，建立了依达拉奉注射液中焦亚硫酸钠的含量测定方法.以前的相关质量标准中未对其进行质量控制，《中国药典》作为药用辅料收载了其含量测定方法[2]；有关依达拉奉注射液中焦亚硫酸钠的比色法含量测定方法国内外未见报道，本实验建立的含量测定方法可对抗氧化剂的加入量进行质量控制，完善质量标准.1仪器与试剂722s 可见分光光度仪（上海精密科学仪器有限公司），电子天平AL104（梅特勒托利多仪器（上海）有限公司）），依达拉奉注射液（河南某药业有限公司，批号20090817），酸性品红（天津市科密欧化学试剂开发中心），无水亚硫酸钠（上海硫酸厂），乙二胺四乙酸二钠（EDTA）（中国医药（集团）上海化学试剂公司），冰乙酸（天津市恒兴化学试剂制造有限公司），无水乙酸钠（天津市风船化学试剂科技有限公司），所用试剂均为分析纯.2方法和结果2．1酸性品红溶液的制备精密称取酸性品红0．085g ，加硫酸0．25mL ，加水溶解定容到1000mL （7d 内使用）.2．2醋酸盐缓冲液的制备称取醋酸钠136．1g ，EDTA 0．4g ，加入冰醋酸57mL ，加水溶解定容到1000mL .2．3亚硫酸钠对照溶液的制备精密称取无水亚硫酸钠0．110g ，用4×10－4g /mL 的EDTA 溶液溶解定容到250mL （临用新制）.2．4标准曲线的建立精密量取酸性品红溶液5mL ，共6份，分别置50mL 量瓶中，各加缓冲液约40mL ，分别精密加对照品溶液0．5，1．0，1．5，2．0，2．5，3．0mL ；用缓冲液稀释至刻度，摇匀，室温放置25min ，以缓冲溶液做空白，在549nm 波长处测定吸光度.以亚硫酸钠的浓度为横坐标，吸光度的倒数为纵坐标，做标准曲线并进行线性回归，得到回归方程Y ＝9．7271X ＋0．7723，R 2＝0．9987.多次试验的结果表明：亚硫酸钠在4．4～26．4μg /mL 范围内，吸收稿日期:2010-09-26作者简介:梁艳利（1986－），女，河南洛阳人，硕士研究生，主要研究方向为药物分析通信作者:吴拥军（1968－），男，河南郑州人，教授，博士，主要研究方向为药物分析.第28卷第11期2010年11月河南科学HENAN SCIENCE Vol.28No.11Nov.2010第28卷第11期河南科学光度的倒数与亚硫酸的浓度呈良好的线性关系.2．5重复性试验取同一批供试品，同法测定.分别测定6次亚硫酸钠含量，求得相对标准偏差（RSD ）为2．2％.2．6加样回收率试验精密称取无水亚硫酸钠对照品0．0661，0．1109，0．1553g ，分别置于250mL 的容量瓶中，用质量分数为0．04％的EDTA 溶液溶解并稀释至刻度，摇匀，作为对照品溶液.精密量取酸性品红溶液5mL ，共9份，分别置50mL 容量瓶中，各加醋酸盐缓冲液约40mL ，依次分别精密加对照品溶液1．5mL 和已知含量的供试品溶液1．5mL ，并用醋酸盐缓冲液稀释至刻度，摇匀，照含量测定项下操作，求得平均回收率为94．9％，RSD 为3．0％（n ＝9）.2．7焦亚硫酸钠的含量测定精密量取供试品溶液3mL ，同法测定，以对照品溶液吸光度的倒数与其浓度拟合标准曲线.根据标准曲线计算并将结果与0．754相乘，即得样品中焦亚硫酸钠的含量[1-3].此批次供试品的6次测定结果依次为：0．1849，0．1732，0．1822，0．1854，0．1804，0．1801mg /mL ；平均值为0．1810；RSD 2．3％.3讨论1）文献［4］的反应条件为28℃水浴15min ，吴小曼等[1]认为反应温度并不重要，关键是对照品溶液与供试品溶液同时平行操作即可.为便于操作，本研究将反应条件改为室温放置25min .2）文献［1］认为吸光度的对数与浓度的对数呈良好的线性关系，本实验经过比较后认为，按亚硫酸盐的浓度与吸光度的倒数拟合得到的标准曲线，其相关系数要优于双对数方式.3）文献［5］采用碱性品红－甲醛比色法测定亚硫酸盐，对照品为亚硫酸氢钠.考虑到对照品的稳定性影响，本文选用相对较稳定的无水亚硫酸钠作为对照品，其纯度可达97％以上.4）参阅的相关文献中，均采用缓冲溶液做比色法的空白，考虑到依达拉奉注射液处方中，其他物质对吸光度可能造成的影响，本研究对比了缓冲溶液空白和成相应比例的依达拉奉和缓冲溶液混合液的空白，结果相差不大，为简单起见，本文仍采用缓冲溶液做空白对照.参考文献:［1］吴小曼，纪宇．比色法测定复发氨基酸注射液（18AA－I ）中焦亚硫酸钠的含量［J ］．中国药品标准，2007，8（5）：38－40．［2］中国药典委员会.中国药典：二部［S ］．2005年版.北京：中国医药科技出版社，2005：914．［3］中国药典委员会.国家药品标准：新药转正标准（第27册）［S ］．北京：人民卫生出版社，2003（7）：102－103．［4］姚克荣，徐连连．影响复方氨基酸注射液中焦亚硫酸钠含量测定的因素［J ］．中国生化药物杂志，1997，18（3）：132－133．［5］谭仕轩．比色法测定复方氨基酸注射液中亚硫酸盐的含量［J ］．氨基酸和生物资源，2005，27（3）：63－65．Determination of Antioxygen Sodium Pyrosulfite in Edaravone Injectionby the Spectrophotometric MethodLiang Yanli ，Zhang Huili ，Wu Yongjun（Department of Chemistry ，Zhengzhou University ，Zhengzhou 450001，China ）Abstract ：To establish a spectrophotometric method for the assay of antioxidant sodium pyrosulfite in edaravone injection．Sulfur dioxide released from sodium pyrosulfite can fade fuchsin acid solution．The sample solution was determined at the wavelength of 549nm at room temperature for 25minutes．The amount of sodium pyrosulfite in sample was calculated by reference to a calibration curve obtained ，under the same condition ，for known amount of sodium sulfite．The results of experiments prove that s odium sulfite showed good linearity ，R 2was above 0．99，the linear range was from 4．4μg /mL to 26．4μg /mL．The average recovery was 94．4％with RSD 3．0％．The method is simple ，rapid and accurate ，suitable for the determination of sodium pyrosulfite in injection．Key words ：edaravone injection ；sodium pyrosulfite ；colorimetric method ；determination 1404--。
Gelucire-14-44-SDS-MedChemExpress
Inhibitors, Agonists, Screening LibrariesSafety Data Sheet Revision Date:Nov.-23-2018Print Date:Nov.-23-20181. PRODUCT AND COMPANY IDENTIFICATION1.1 Product identifierProduct name :Gelucire 14/44Catalog No. :HY-Y1892CAS No. :121548-04-71.2 Relevant identified uses of the substance or mixture and uses advised againstIdentified uses :Laboratory chemicals, manufacture of substances.1.3 Details of the supplier of the safety data sheetCompany:MedChemExpress USATel:609-228-6898Fax:609-228-5909E-mail:sales@1.4 Emergency telephone numberEmergency Phone #:609-228-68982. HAZARDS IDENTIFICATION2.1 Classification of the substance or mixtureNot a hazardous substance or mixture.2.2 GHS Label elements, including precautionary statementsNot a hazardous substance or mixture.2.3 Other hazardsNone.3. COMPOSITION/INFORMATION ON INGREDIENTS3.1 SubstancesSynonyms:NoneFormula:N/AMolecular Weight:N/ACAS No. :121548-04-74. FIRST AID MEASURES4.1 Description of first aid measuresEye contactRemove any contact lenses, locate eye-wash station, and flush eyes immediately with large amounts of water. Separate eyelids with fingers to ensure adequate flushing. Promptly call a physician.Skin contactRinse skin thoroughly with large amounts of water. Remove contaminated clothing and shoes and call a physician.InhalationImmediately relocate self or casualty to fresh air. If breathing is difficult, give cardiopulmonary resuscitation (CPR). Avoid mouth-to-mouth resuscitation.IngestionWash out mouth with water; Do NOT induce vomiting; call a physician.4.2 Most important symptoms and effects, both acute and delayedThe most important known symptoms and effects are described in the labelling (see section 2.2).4.3 Indication of any immediate medical attention and special treatment neededTreat symptomatically.5. FIRE FIGHTING MEASURES5.1 Extinguishing mediaSuitable extinguishing mediaUse water spray, dry chemical, foam, and carbon dioxide fire extinguisher.5.2 Special hazards arising from the substance or mixtureDuring combustion, may emit irritant fumes.5.3 Advice for firefightersWear self-contained breathing apparatus and protective clothing.6. ACCIDENTAL RELEASE MEASURES6.1 Personal precautions, protective equipment and emergency proceduresUse full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas.Refer to protective measures listed in sections 8.6.2 Environmental precautionsTry to prevent further leakage or spillage. Keep the product away from drains or water courses.6.3 Methods and materials for containment and cleaning upAbsorb solutions with finely-powdered liquid-binding material (diatomite, universal binders); Decontaminate surfaces and equipment by scrubbing with alcohol; Dispose of contaminated material according to Section 13.7. HANDLING AND STORAGE7.1 Precautions for safe handlingAvoid inhalation, contact with eyes and skin. Avoid dust and aerosol formation. Use only in areas with appropriate exhaust ventilation.7.2 Conditions for safe storage, including any incompatibilitiesKeep container tightly sealed in cool, well-ventilated area. Keep away from direct sunlight and sources of ignition.Recommended storage temperature:Pure form-20°C 3 years4°C 2 yearsIn solvent-80°C 6 months-20°C 1 monthShipping at room temperature if less than 2 weeks.7.3 Specific end use(s)No data available.8. EXPOSURE CONTROLS/PERSONAL PROTECTION8.1 Control parametersComponents with workplace control parametersThis product contains no substances with occupational exposure limit values.8.2 Exposure controlsEngineering controlsEnsure adequate ventilation. Provide accessible safety shower and eye wash station.Personal protective equipmentEye protection Safety goggles with side-shields.Hand protection Protective gloves.Skin and body protection Impervious clothing.Respiratory protection Suitable respirator.Environmental exposure controls Keep the product away from drains, water courses or the soil. Cleanspillages in a safe way as soon as possible.9. PHYSICAL AND CHEMICAL PROPERTIES9.1 Information on basic physical and chemical propertiesAppearance White to off-white (Oil)Odor No data availableOdor threshold No data availablepH No data availableMelting/freezing point No data availableBoiling point/range No data availableFlash point No data availableEvaporation rate No data availableFlammability (solid, gas)No data availableUpper/lower flammability or explosive limits No data availableVapor pressure No data availableVapor density No data availableRelative density No data availableWater Solubility No data availablePartition coefficient No data availableAuto-ignition temperature No data availableDecomposition temperature No data availableViscosity No data availableExplosive properties No data availableOxidizing properties No data available9.2 Other safety informationNo data available.10. STABILITY AND REACTIVITY10.1 ReactivityNo data available.10.2 Chemical stabilityStable under recommended storage conditions.10.3 Possibility of hazardous reactionsNo data available.10.4 Conditions to avoidNo data available.10.5 Incompatible materialsStrong acids/alkalis, strong oxidising/reducing agents.10.6 Hazardous decomposition productsUnder fire conditions, may decompose and emit toxic fumes.Other decomposition products - no data available.11.TOXICOLOGICAL INFORMATION11.1 Information on toxicological effectsAcute toxicityClassified based on available data. For more details, see section 2Skin corrosion/irritationClassified based on available data. For more details, see section 2Serious eye damage/irritationClassified based on available data. For more details, see section 2Respiratory or skin sensitizationClassified based on available data. For more details, see section 2Germ cell mutagenicityClassified based on available data. For more details, see section 2CarcinogenicityIARC: No component of this product present at a level equal to or greater than 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.ACGIH: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by ACGIH.NTP: No component of this product present at a level equal to or greater than 0.1% is identified as a anticipated or confirmed carcinogen by NTP.OSHA: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by OSHA.Reproductive toxicityClassified based on available data. For more details, see section 2Specific target organ toxicity - single exposureClassified based on available data. For more details, see section 2Specific target organ toxicity - repeated exposureClassified based on available data. For more details, see section 2Aspiration hazardClassified based on available data. For more details, see section 212. ECOLOGICAL INFORMATION12.1 ToxicityNo data available.12.2 Persistence and degradabilityNo data available.12.3 Bioaccumlative potentialNo data available.12.4 Mobility in soilNo data available.12.5 Results of PBT and vPvB assessmentPBT/vPvB assessment unavailable as chemical safety assessment not required or not conducted.12.6 Other adverse effectsNo data available.13. DISPOSAL CONSIDERATIONS13.1 Waste treatment methodsProductDispose substance in accordance with prevailing country, federal, state and local regulations.Contaminated packagingConduct recycling or disposal in accordance with prevailing country, federal, state and local regulations.14. TRANSPORT INFORMATIONDOT (US)This substance is considered to be non-hazardous for transport.IMDGThis substance is considered to be non-hazardous for transport.IATAThis substance is considered to be non-hazardous for transport.15. REGULATORY INFORMATIONSARA 302 Components:No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.SARA 313 Components:This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.SARA 311/312 Hazards:No SARA Hazards.Massachusetts Right To Know Components:No components are subject to the Massachusetts Right to Know Act.Pennsylvania Right To Know Components:No components are subject to the Pennsylvania Right to Know Act.New Jersey Right To Know Components:No components are subject to the New Jersey Right to Know Act.California Prop. 65 Components:This product does not contain any chemicals known to State of California to cause cancer, birth defects, or anyother reproductive harm.16. OTHER INFORMATIONCopyright 2018 MedChemExpress. The above information is correct to the best of our present knowledge but does not purport to be all inclusive and should be used only as a guide. The product is for research use only and for experienced personnel. It must only be handled by suitably qualified experienced scientists in appropriately equipped and authorized facilities. The burden of safe use of this material rests entirely with the user. MedChemExpress disclaims all liability for any damage resulting from handling or from contact with this product.Caution: Product has not been fully validated for medical applications. For research use only.Tel: 609-228-6898 Fax: 609-228-5909 E-mail: tech@Address: 1 Deer Park Dr, Suite Q, Monmouth Junction, NJ 08852, USA。
Calcipotriol_SDS_MedChemExpress
Inhibitors, Agonists, Screening LibrariesSafety Data Sheet Revision Date:Sep.-13-2017Print Date:Sep.-13-20171. PRODUCT AND COMPANY IDENTIFICATION1.1 Product identifierProduct name :CalcipotriolCatalog No. :HY-10001CAS No. :112965-21-61.2 Relevant identified uses of the substance or mixture and uses advised againstIdentified uses :Laboratory chemicals, manufacture of substances.1.3 Details of the supplier of the safety data sheetCompany:MedChemExpress USATel:609-228-6898Fax:609-228-5909E-mail:sales@1.4 Emergency telephone numberEmergency Phone #:609-228-68982. HAZARDS IDENTIFICATION2.1 Classification of the substance or mixtureNot a hazardous substance or mixture.2.2 GHS Label elements, including precautionary statementsNot a hazardous substance or mixture.2.3 Other hazardsNone.3. COMPOSITION/INFORMATION ON INGREDIENTS3.1 SubstancesSynonyms:MC 903; CalcipotrieneFormula:C27H40O3Molecular Weight:412.60CAS No. :112965-21-64. FIRST AID MEASURES4.1 Description of first aid measuresEye contactRemove any contact lenses, locate eye-wash station, and flush eyes immediately with large amounts of water. Separate eyelids with fingers to ensure adequate flushing. Promptly call a physician.Skin contactRinse skin thoroughly with large amounts of water. Remove contaminated clothing and shoes and call a physician.InhalationImmediately relocate self or casualty to fresh air. If breathing is difficult, give cardiopulmonary resuscitation (CPR). Avoid mouth-to-mouth resuscitation.IngestionWash out mouth with water; Do NOT induce vomiting; call a physician.4.2 Most important symptoms and effects, both acute and delayedThe most important known symptoms and effects are described in the labelling (see section 2.2).4.3 Indication of any immediate medical attention and special treatment neededTreat symptomatically.5. FIRE FIGHTING MEASURES5.1 Extinguishing mediaSuitable extinguishing mediaUse water spray, dry chemical, foam, and carbon dioxide fire extinguisher.5.2 Special hazards arising from the substance or mixtureDuring combustion, may emit irritant fumes.5.3 Advice for firefightersWear self-contained breathing apparatus and protective clothing.6. ACCIDENTAL RELEASE MEASURES6.1 Personal precautions, protective equipment and emergency proceduresUse full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas.Refer to protective measures listed in sections 8.6.2 Environmental precautionsTry to prevent further leakage or spillage. Keep the product away from drains or water courses.6.3 Methods and materials for containment and cleaning upAbsorb solutions with finely-powdered liquid-binding material (diatomite, universal binders); Decontaminate surfaces and equipment by scrubbing with alcohol; Dispose of contaminated material according to Section 13.7. HANDLING AND STORAGE7.1 Precautions for safe handlingAvoid inhalation, contact with eyes and skin. Avoid dust and aerosol formation. Use only in areas with appropriate exhaust ventilation.7.2 Conditions for safe storage, including any incompatibilitiesKeep container tightly sealed in cool, well-ventilated area. Keep away from direct sunlight and sources of ignition.Recommended storage temperature: 4°C, protect from light, stored under nitrogenShipping at room temperature if less than 2 weeks.7.3 Specific end use(s)No data available.8. EXPOSURE CONTROLS/PERSONAL PROTECTION8.1 Control parametersComponents with workplace control parametersThis product contains no substances with occupational exposure limit values.8.2 Exposure controlsEngineering controlsEnsure adequate ventilation. Provide accessible safety shower and eye wash station.Personal protective equipmentEye protection Safety goggles with side-shields.Hand protection Protective gloves.Skin and body protection Impervious clothing.Respiratory protection Suitable respirator.Environmental exposure controls Keep the product away from drains, water courses or the soil. Cleanspillages in a safe way as soon as possible.9. PHYSICAL AND CHEMICAL PROPERTIES9.1 Information on basic physical and chemical propertiesAppearance White to off-white (Solid)Odor No data availableOdor threshold No data availablepH No data availableMelting/freezing point No data availableBoiling point/range No data availableFlash point No data availableEvaporation rate No data availableFlammability (solid, gas)No data availableUpper/lower flammability or explosive limits No data availableVapor pressure No data availableVapor density No data availableRelative density No data availableWater Solubility No data availablePartition coefficient No data availableAuto-ignition temperature No data availableDecomposition temperature No data availableViscosity No data availableExplosive properties No data availableOxidizing properties No data available9.2 Other safety informationNo data available.10. STABILITY AND REACTIVITY10.1 ReactivityNo data available.10.2 Chemical stabilityStable under recommended storage conditions.10.3 Possibility of hazardous reactionsNo data available.10.4 Conditions to avoidNo data available.10.5 Incompatible materialsStrong acids/alkalis, strong oxidising/reducing agents.10.6 Hazardous decomposition productsUnder fire conditions, may decompose and emit toxic fumes.Other decomposition products - no data available.11.TOXICOLOGICAL INFORMATION11.1 Information on toxicological effectsAcute toxicityClassified based on available data. For more details, see section 2Skin corrosion/irritationClassified based on available data. For more details, see section 2Serious eye damage/irritationClassified based on available data. For more details, see section 2Respiratory or skin sensitizationClassified based on available data. For more details, see section 2Germ cell mutagenicityClassified based on available data. For more details, see section 2CarcinogenicityIARC: No component of this product present at a level equal to or greater than 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.ACGIH: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by ACGIH.NTP: No component of this product present at a level equal to or greater than 0.1% is identified as a anticipated or confirmed carcinogen by NTP.OSHA: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by OSHA.Reproductive toxicityClassified based on available data. For more details, see section 2Specific target organ toxicity - single exposureClassified based on available data. For more details, see section 2Specific target organ toxicity - repeated exposureClassified based on available data. For more details, see section 2Aspiration hazardClassified based on available data. For more details, see section 212. ECOLOGICAL INFORMATION12.1 ToxicityNo data available.12.2 Persistence and degradabilityNo data available.12.3 Bioaccumlative potentialNo data available.12.4 Mobility in soilNo data available.12.5 Results of PBT and vPvB assessmentPBT/vPvB assessment unavailable as chemical safety assessment not required or not conducted.12.6 Other adverse effectsNo data available.13. DISPOSAL CONSIDERATIONS13.1 Waste treatment methodsProductDispose substance in accordance with prevailing country, federal, state and local regulations.Contaminated packagingConduct recycling or disposal in accordance with prevailing country, federal, state and local regulations.14. TRANSPORT INFORMATIONDOT (US)This substance is considered to be non-hazardous for transport.IMDGThis substance is considered to be non-hazardous for transport.IATAThis substance is considered to be non-hazardous for transport.15. REGULATORY INFORMATIONSARA 302 Components:No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.SARA 313 Components:This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.SARA 311/312 Hazards:No SARA Hazards.Massachusetts Right To Know Components:No components are subject to the Massachusetts Right to Know Act.Pennsylvania Right To Know Components:No components are subject to the Pennsylvania Right to Know Act.New Jersey Right To Know Components:No components are subject to the New Jersey Right to Know Act.California Prop. 65 Components:This product does not contain any chemicals known to State of California to cause cancer, birth defects, or anyother reproductive harm.16. OTHER INFORMATIONCopyright 2017 MedChemExpress. The above information is correct to the best of our present knowledge but does not purport to be all inclusive and should be used only as a guide. The product is for research use only and for experienced personnel. It must only be handled by suitably qualified experienced scientists in appropriately equipped and authorized facilities. The burden of safe use of this material rests entirely with the user. MedChemExpress disclaims all liability for any damage resulting from handling or from contact with this product.Caution: Product has not been fully validated for medical applications. For research use only.Tel: 609-228-6898 Fax: 609-228-5909 E-mail: tech@Address: 1 Deer Park Dr, Suite Q, Monmouth Junction, NJ 08852, USA。
新型肿瘤标志物(PIVKAII)临床应用进展及评价
healthy liver
Chronic hepatitis
Cirrhosis
慢性炎症以及逐渐加深的肝脏损伤
Cancer (HCC)
Viral marker
Fibrosis marker
Tumor marker
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现有肝癌相关肿瘤标志物
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后又随之增加。血清甲胎蛋白的含量与异常凝血酶原水平基本不具相关性。
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Research design:
Song et al. (2002)
Tsai et al. (1997)
Tsai et al. (2003)
Hsia et al. (2007)
Hsia et al. (2007)
Cui et al. (2003)
Yoon et al. (2004)
Cutoff value 2.0 ng/ml
Sensitivity 51%
• Tumor-Derived Autoantibody (TAA)
Etc.
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Markers GPC3 GP73
TGF-β1
IGF-II IL-6 IL-10 GGT HCCR
References
Hippo et al. (2004)
Marrero et al. (2005)
超高效液相色谱-串联质谱法测定化妆品中15种N-亚硝胺化合物
第42 卷第 11 期2023 年11 月Vol.42 No.111469~1478分析测试学报FENXI CESHI XUEBAO（Journal of Instrumental Analysis）超高效液相色谱-串联质谱法测定化妆品中15种N-亚硝胺化合物汪毅1，梁文耀1，何国山1，陈张好2，周智明2，吴谦1，席绍峰1，谭建华1*（1．广州质量监督检测研究院，国家化妆品质量检验检测中心（广州），广东广州511447；2．广东省药品检验所，广东广州510663）摘要：采用超高效液相色谱-串联质谱（UPLC-MS/MS）建立了化妆品中15种痕量N-亚硝胺化合物的分析方法。
水剂样品以水或乙腈分组超声提取，膏霜乳液样品采用亚铁氰化钾-乙酸锌溶液沉淀大分子或者饱和氯化钠-乙腈盐析分组处理后，以Agilent Poroshell 120 SB-Aq（100 mm×3.0 mm，2.7 μm）色谱柱分离，经大气压化学电离源（APCI）电离，多反应监测模式检测，以同位素内标法定量。
结果表明，15种N-亚硝胺化合物在相应质量浓度范围内线性关系良好（r2＞0.995），检出限和定量下限分别为5~15 ng/g和15~45 ng/g。
水、乳、膏霜3种化妆品基质在25、50、100 ng/g加标水平下的平均回收率为88.0%~111%，相对标准偏差（RSD，n=6）为1.4%~9.8%。
该方法用于市售化妆品检测，发现13批次样品检出N-亚硝基二乙醇胺（NDELA），其中1批次超限量值。
方法的专属性强，灵敏度高，精密度好，解决了N-亚硝胺化合物稳定性差、易被干扰等问题，适用于化妆品中15种N-亚硝胺化合物的痕量测定。
关键词：N-亚硝胺化合物；化妆品；超高效液相色谱-串联质谱法（UPLC-MS/MS）；大气压化学电离源中图分类号：O657.63；O623.732文献标识码：A 文章编号：1004-4957（2023）11-1469-10 Determination of Fifteen N-nitrosamine Compounds in Cosmetics by Ultra Performance Liquid Chromatography-TandemMass SpectrometryWANG Yi1，LIANG Wen-yao1，HE Guo-shan1，CHEN Zhang-hao2，ZHOU Zhi-ming2，WU Qian1，XI Shao-feng1，TAN Jian-hua1*（1．Guangzhou Quality Supervision and Testing Institute，National Quality Supervision and Testing Center for Cosmetics（Guangzhou），Guangzhou 511447，China；2．Guangdong Institute for Drug Control，Guangzhou 510663）Abstract：An ultra performance liquid chromatography-tandem mass spectrometric（UPLC-MS/MS）method was established for detecting 15 trace N-nitrosamine compounds in cosmetics. The final estab⁃lished method involved ultrasonic extraction of cosmetics using water or acetonitrile for different com⁃pounds. The samples were treated with potassium ferrocyanide-zinc acetate solution for precipitating macromolecules or saturated sodium chloride-acetonitrile for salting out.An Agilent Poroshell 120 SB-Aq（100 mm × 3.0 mm，2.7 μm） chromatography column was used for separation，followed by atmospheric pressure chemical ionization（APCI） source and multiple reaction monitoring mode detec⁃tion in the isotope internal standard method for quantification. The result showed good linearity（r2> 0.995） for the 15 N-nitrosamine compounds in their respective concentration ranges，with detection and quantitation limits of 5-15 ng/g and 15-45 ng/g，respectively.The average recoveries for the three cosmetic matrices（aqueous，emulsion，cream） at spiked levels of 25，50，100 ng/g were be⁃tween 88.0% and 111%，with relative standard deviations（RSD，n=6） of 1.4%-9.8%. The method was applied to the detection of commercial cosmetics and N-nitrosodiethanolamine（NDELA） was de⁃tected in 13 batches，with one batch exceeding the limit. The strong specificity，high sensitivity，and good precision made the method could solve the problems of poor stability and easy interference ofdoi：10.19969/j.fxcsxb.23051602收稿日期：2023－05－16；修回日期：2023－06－10基金项目：广东省药品监督管理局化妆品风险评估重点实验室专项（2021ZDZ03）；广东省市场监督管理局科技项目（2022CZ06）∗通讯作者：谭建华，博士，正高级工程师，研究方向：色谱－质谱检测技术研究，E-mail：tanjianhua0734@第 42 卷分析测试学报N-nitrosamine compounds，and was suitable for the trace determination of 15 N-nitrosamine com⁃pounds in cosmetics.Key words：N-nitrosamine compounds；cosmetics；ultra performance liquid chromatography-tan⁃dem mass spectrometry（UPLC-MS/MS）；atmospheric pressure chemical ionization（APCI） sourceN-亚硝胺化合物是一类具有N-亚硝基结构的化合物，因取代基的不同，形成了种类繁多的同系物，目前已发现超过300种［1］。
染色及助剂环保标准--2009年要求
邻氨基偶氮甲苯
97-56-3
４氨基联苯
92-67-1
５硝基邻甲苯胺
99-55-8
邻氨基苯甲醚
90-04-0
联苯胺
92-87-5
对氯苯胺
106-47-8
４氯邻甲苯胺
95-69-2
２甲氧基５甲基苯胺
120-71-8
２，４二氨基苯甲醚
615-05-4
４，４二氨基二苯甲烷
2682-20-4
五氯化苯酚(PCP)
87-86-5
未检出
§64 LFGB B 82.02.8(RL=0.5)
四氯苯酚(TeCP)
25167-83-3
富马酸二甲酯
624-49-7
禁止使用
溶剂萃取/GC-MS
IV) Bisphenol-A (BPA)双酚A
化学物质
CAS编号
产品最高限量
(ppm)
检检法
4,4dihydroxy2,2diphenylpropane
80-05-7
未检出
GC-MS/
LC-MS
V)抗光敏性致癌的分散染料及其它染料
化学物质
CAS编号
产品最高限量
检测法
(ppm)
分散染料
未检出
DIN54231单位：
毫克/升（RL：5）
分散蓝1
2475-45-8
分散蓝3
2475-46-9
分散蓝7
4098-71-9
游离型:1
封闭型: 100
四甲基苯二甲基二异氰酸酯
(TMXDI)
2778-42-9
游离型:1
封闭型: 100
甲苯异氰酸酯
(TDI)
高效液相色谱-串联质谱法检测泮托拉唑钠原料药中的水合肼
·药物研发·高效液相色谱-串联质谱法检测泮托拉唑钠原料药中的水合肼赵会明 张振洋 樊华军［英格尔检测技术服务（上海）有限公司 上海 201100］摘要建立了泮托拉唑钠原料药中的基因毒性杂质水合肼的高效液相色谱-串联质谱（LC-MSMS）检测方法。
采用反相色谱，以水-乙腈（含0.1%甲酸）为流动相，梯度洗脱，流速0.5 mL/min，以ESI正离子多反应监测（MRM）模式进行质谱检测。
结果显示，水合肼的检测限和定量限可达到0.23、0.47 ng/mL，其在0.47~9.37 ng/mL浓度范围内线性关系良好（r=0.999 9），准确度试验中低、中、高浓度回收率均在81.6%~90.9%之间。
在3批次泮托拉唑钠原料药中均未检出水合肼。
关键词高效液相色谱-串联质谱法基因毒性杂质泮托拉唑钠水合肼痕量检测中图分类号：R917; O657 文献标志码：A 文章编号：1006-1533(2022)11-0072-04引用本文 赵会明, 张振洋, 樊华军. 高效液相色谱-串联质谱法检测泮托拉唑钠原料药中的水合肼[J]. 上海医药, 2022, 43(11): 72-75.Determination of hydrazine hydrate in pantoprazole sodium by high performance liquid chromatography-tandem mass spectrometryZHAO Huiming, ZHANG Zhenyang, FAN Huajun[ICAS Testing Technology Service (Shanghai) CO., LTD., Shanghai 201100, China]ABSTRACT To establish a high-performance liquid chromatography-tandem mass spectrometry (LC-MSMS) method for the determination of hydrazine hydrate in active pharmaceutical ingredient (API) pantoprazole sodium. HPLC was carried out by reverse chromatography using water-acetonitrile containing 0.1% formic acid as flow phase and gradient elution at a flow rate of 0.5 mL/min. Mass spectrometry was performed with multi-reaction monitoring (MRM) in positive ESI mode. The detection and quantitative limits of hydrazine hydrate reached 0.23, 0.47 ng/mL and hydrazine hydrate showed good linear relationship in the range of 0.47-9.37 ng/mL (r=0.999 9). The recoveries of samples at low, medium and high-level concentrations reached81.6% to 90.9% in the accuracy experiment. No hydrazine hydrate was detected in 3 batches of pantoprazole sodium.KEY WORDS HPLC-tandem mass spectrometry; genotoxic impurities; pantoprazole sodium; hydrazine hydrate; trace determination上消化道出血是近年的临床疾病中常见且多发的一种疾病，其临床表现为呕血、黑便等，如得不到及时有效治疗，可能引发失血性休克。
致病疫霉菌效应蛋白Pi05440毒性功能验证及寄主候选靶标筛选
核农学报2024，38（3）：0434~0442Journal of Nuclear Agricultural Sciences致病疫霉菌效应蛋白Pi05440毒性功能验证及寄主候选靶标筛选张蝶陈胜男赵迪王荟洁王洪洋 *刘晶 *（云南师范大学，云南省马铃薯生物学重点实验室，云南昆明650500）摘要：致病疫霉菌（Phytophthora infestans）侵染时会分泌大量效应蛋白进入寄主细胞，通过操纵寄主靶标抑制植物免疫反应。
为研究致病疫霉菌效应蛋白Pi05440的功能，本研究重点分析了Pi05440的蛋白特征、毒性功能及鉴定其寄主靶标；利用生物信息学数据库，预测Pi05440的保守结构域和信号肽。
构建pRI101-GFP-Pi05440表达载体用于Pi05440的亚细胞定位和毒性功能分析；同时，利用酵母双杂交技术对Pi05440的寄主靶标蛋白进行了筛选和鉴定。
结果表明，Pi05440基因全长969 bp，编码322个氨基酸。
结构预测结果显示Pi05440含有3个典型的KAZAL功能域。
亚细胞定位结果表明Pi05440定位在质膜和细胞间隙。
在本氏烟中瞬时表达该基因显著促进致病疫霉菌扩展。
通过酵母双杂交筛选，初步鉴定到3个Pi05440的候选靶标蛋白，分别为马铃薯过氧化氢酶12、马铃薯几丁质酶以及马铃薯MYB-like A蛋白。
本研究为探究致病疫霉菌效应蛋白Pi05440及其靶标蛋白如何调控植物免疫提供了重要线索。
关键词：致病疫霉菌；效应蛋白；亚细胞定位；酵母双杂交；靶标蛋白DOI：10.11869/j.issn.1000‑8551.2024.03.0434马铃薯（Solanum tuberosum）富含碳水化合物、维生素、矿物质和抗氧化物质等营养成分，对人类健康和可持续农业发展至关重要［1］。
然而，马铃薯生产过程中会面临许多病害的威胁，其中最为严重的是由致病疫霉菌（Phytophthora infestans）引起的晚疫病。
江苏省检验分类编码标准
通用名称标准编码（通用名称编码）血红蛋白测定(干化学法)40101001血红蛋白测定(Hb)40101002红细胞计数(RBC)40101003红细胞比积测定(HCT)40101004红细胞参数平均值测定40101005网织红细胞计数(Ret)(仪器法)40101006网织红细胞计数(Ret)(流式细胞仪法)40101007网织红细胞计数(Ret)(镜检法)40101008嗜碱性点彩红细胞计数40101009异常红细胞形态检查40101010红细胞沉降率测定(ESR)(仪器法)40101011红细胞沉降率测定(ESR)(手工法)40101012白细胞计数(WBC)40101013白细胞分类计数(DC)40101014单核细胞直接计数40101015异常白细胞形态检查40101016浓缩血恶性组织细胞检查40101017血小板计数40101018血细胞分析（血常规自动分析）40101019血细胞分析（五分类仪器检测法）40101020血细胞分析（手工法）40101021出血时间测定(BT)40101022出血时间测定（测定器法）40101023凝血时间测定(CT)40101024红斑狼疮细胞检查(LEC)40101025血浆渗量试验40101026外周血细胞形态学分析40101027尿常规检查40102001尿酸碱度测定40102002尿比重测定40102003尿渗透压检查40102004尿蛋白定性40102005尿蛋白定量(各种化学方法)40102006尿蛋白定量(免疫比浊法)40102007尿蛋白定量(干化学法)40102008尿蛋白定量(手工比色法)40102009尿本-周氏蛋白定性检查40102010尿肌红蛋白定性检查40102011尿血红蛋白定性检查40102012尿糖定性试验40102013尿糖定量测定40102014尿酮体定性试验40102015尿三胆检查40102016尿含铁血黄素定性试验40102017尿三氯化铁试验40102018尿乳糜定性检查40102019尿卟啉定性试验40102020尿黑色素测定40102021尿浓缩稀释试验40102022尿酚红排泄试验(PSP)40102023尿妊娠试验(乳胶凝集法、酶免法)40102024尿妊娠试验(单克隆金标法)40102025尿妊娠试验(金标法)40102026卵泡刺激素（LH）快速测定（金标法）40102027卵泡刺激素（LH）排卵预测40102028尿沉渣镜检40102029尿沉渣定量(仪器法)40102030尿沉渣定量(手工法)40102031尿液爱迪氏计数(Addis)40102032尿三杯试验40102033一小时尿沉渣计数40102034一小时尿细胞排泄率40102035尿沉渣白细胞分类40102036尿十二小时E/C值测定40102037尿中病毒感染细胞检查40102038尿中包涵体检查40102039尿酸化功能测定40102040尿红细胞位相(手工法)40102041尿红细胞位相(图象分析仪法)40102042尿液分析使用抗维生素C试剂条加收40102043尿碘快速测定(当场出检测结果)40102044尿液分析40102045尿液草酸定量分析(酶法)40102046尿液枸椽酸定量分析(酶法)40102047尿靛甙定量分析40102048粪便常规40103001粪便隐血试验(OB)(免疫法)40103002粪便隐血试验(OB)(单克隆金标法)40103003粪便隐血试验(OB)(化学法)40103004粪胆素检查40103005乳糖耐受试验40103006粪便乳糖不耐受测定40103007粪苏丹III染色检查40103008胸腹水常规检查40104001胸腹水常规检查40104002胸腹水特殊检查40104003脑脊液常规检查(CSF)40104004脑脊液常规检查(CSF)40104005精子质量和功能分析40104006精液酸性磷酸酶测定40104007精液果糖测定40104008精液α-葡萄糖苷酶测定40104009精子运动轨迹分析40104010精子顶体完整率检查40104011精子受精能力测定40104012精子结合抗体测定40104013精子畸形率测定40104014前列腺液常规检查40104015细菌性阴道炎检查40104016阴道分泌物胺测定40104017阴道分泌物检查40104018羊水结晶检查40104019胃液常规检查40104020十二指肠引流液及胆汁检查40104021痰液常规检查40104022各种穿刺液常规检查40104023精子顶体酶活性测定40104024骨髓涂片细胞学检验40201001骨髓有核细胞计数40201002骨髓巨核细胞计数40201003造血干细胞计数(流式细胞仪法)40201004造血干细胞计数(荧光显微镜法)40201005骨髓造血祖细胞培养40201006白血病免疫分型(荧光显微镜法)40201007白血病免疫分型(酶免法)40201008白血病免疫分型(流式细胞仪法)40201009骨髓特殊染色及酶组织化学染色检查40201010白血病抗原检测40201011白血病残留病灶检测40201012红细胞包涵体检查40202001血浆游离血红蛋白测定40202002白血病免疫分型(手工法、光度法)40202003白血病免疫分型(免疫法)40202004高铁血红素白蛋白过筛试验40202005红细胞自身溶血过筛试验40202006红细胞自身溶血及纠正试验40202007红细胞渗透脆性试验40202008红细胞孵育渗透脆性试验40202009热溶血试验40202010冷溶血试验40202011蔗糖溶血试验40202012血清酸化溶血试验(Ham)40202013酸化甘油溶血试验40202014微量补体溶血敏感试验40202015蛇毒因子溶血试验40202016高铁血红蛋白还原试验(MHB－RT)40202017葡萄糖6－磷酸脱氢酶荧光斑点试验40202018葡萄糖6－磷酸脱氢酶活性检测40202019变性珠蛋白小体检测(Heinz小体)4020202040202021红细胞谷胱甘肽(GSH)含量及其稳定性检测红细胞丙酮酸激酶测定(PK)40202022还原型血红蛋白溶解度测定40202023热盐水试验40202024红细胞滚动试验40202025红细胞镰变试验40202026血红蛋白电泳(进口仪器试剂凝胶法)40202027血红蛋白电泳40202028血红蛋白A2测定(HbA2)40202029抗碱血红蛋白测定(HbF)40202030胎儿血红蛋白(HbF)酸洗脱试验40202031血红蛋白H包涵体检测40202032不稳定血红蛋白测定40202033血红蛋白C试验40202034血红蛋白S溶解度试验4020203540202036直接抗人球蛋白试验(Coombs')卡式法(进口卡)直接抗人球蛋白试验40202037间接抗人球蛋白试验卡式法(进口卡)40202038间接抗人球蛋白试验(凝集法)40202039红细胞电泳测定40202040红细胞膜蛋白电泳测定40202041肽链裂解试验40202042新生儿溶血症筛查40202043红细胞九分图分析40202044红细胞游离原卟啉测定4020204540202046磷酸葡萄糖异构酶(GPI)测定(化学法,比色法,酶促法,ELISA法)40203001血小板相关免疫球蛋白(PAIg)测定(酶免法)40203002血小板相关免疫球蛋白(PAIg)测定(流式细胞血小板相关补体C3测定(PAC3)(酶免法)4020300340203004血小板相关补体C3测定(PAC3)(流式细胞仪法)40203005抗血小板膜糖蛋白自身抗体测定(酶免法)40203006抗血小板膜糖蛋白自身抗体测定(流式细胞仪血小板纤维蛋白原受体检测(FIBR)4020300740203008血小板膜α颗粒膜蛋白140测定(GMP-140)(酶)血小板膜α颗粒膜蛋白140测定(GMP-140)(流)40203009毛细血管脆性试验40203010阿斯匹林耐量试验(ATT)40203011血管性假性血友病因子(VWF)抗原测定40203012血浆内皮素测定(ET)(酶免法)40203013血浆内皮素测定(ET)(流式细胞仪法)40203014血小板粘附功能测定(PAdT)(酶免法)40203015血小板粘附功能测定(PAdT)(流式细胞仪法)40203016血小板聚集功能测定(PAgT)(酶免法)4020301740203018血小板聚集功能测定(PAdT)(电极法，比浊法)40203019血小板聚集功能测定(PAgT)(流式细胞仪法)瑞斯托霉素诱导血小板聚集测定4020302040203021血小板第3因子有效性测定(PF4)（放免法、酶)血小板第3因子有效性测定(PF3)（流式细胞仪)40203022血小板第4因子测定(PF4)40203023血小板寿命测定40203024血小板钙流测定40203025血浆β－血小板球蛋白测定40203026血块收缩试验4020302740203028血浆血栓烷B2测定(TXB3)（放免法、酶免法）血浆血栓烷B2测定(TXB2)（流式细胞仪法）40203029血浆凝血酶原时间测定(PT)(手工法)40203030血浆凝血酶原时间测定(PT)(电化学法)40203031凝血酶时间测定40203032复钙时间测定及其纠正试验(手工法)40203033复钙时间测定及其纠正试验(仪器法)40203034凝血酶原时间纠正试验(手工法)40203035凝血酶原时间纠正试验(仪器法)40203036凝血酶原消耗及纠正试验(手工法)40203037凝血酶原消耗及纠正试验(仪器法)4020303840203039白陶土部分凝血活酶时间测定(KPTT)(手工法)40203040白陶土部分凝血活酶时间测定(KPTT)(仪器法)40203041活化部分凝血活酶时间测定(APTT)(手工法)活化部分凝血活酶时间测定(APTT)40203042活化凝血时间测定（ACT）40203043简易凝血活酶生成试验(手工法)40203044简易凝血活酶生成试验(仪器法)40203045血浆蝰蛇毒时间测定40203046血浆蝰蛇毒磷脂时间测定40203047血浆纤维蛋白原测定(手工法)40203048纤维蛋白原测定40203049血浆凝血因子活性测定(手工法)40203050血浆凝血因子活性测定(仪器法)40203051血浆因子Ⅷ抑制物定性测定（手工法）40203052血浆因子Ⅷ抑制物定性测定（仪器法）40203053血浆因子XIII缺乏筛选试验40203054凝血酶时间测定(TT)（手工法）40203055凝血酶时间测定(TT)（仪器法）40203056甲苯胺蓝纠正试验40203057复钙交叉时间测定40203058瑞斯托霉素辅因子测定（VWF：ROOF）40203059优球蛋白溶解时间测定(ELT)40203060血浆鱼精蛋白副凝试验(3P)40203061连续血浆鱼精蛋白稀释试验40203062乙醇胶试验4020306340203064血浆纤溶酶原活性测定(PLGA)（手工法）40203065血浆纤溶酶原活性测定(PLGA)（仪器法）40203066血浆纤溶酶原抗原测定(PLGAg)（手工法）40203067血浆纤溶酶原抗原测定(PLGAg)（仪器法）血浆α2纤溶酶抑制物活性测定(α2－PIA)40203068血浆α2纤溶酶抑制物活性测定(α2－PIA)40203069血浆α2纤溶酶抑制物抗原测定(α2－PIAg)4020307040203071血浆α2纤溶酶抑制物抗原测定(α2－PIAg)40203072血浆抗凝血酶Ⅲ活性测定(AT－ⅢA)（手工法)40203073血浆抗凝血酶Ⅲ活性测定(AT－ⅢA)（仪器法)40203074血浆抗凝血酶Ⅲ抗原测定(AT－ⅢAg)（手工法)40203075血浆抗凝血酶Ⅲ抗原测定(AT－ⅢAg)（仪器法)凝血酶抗凝血酶Ⅲ复合物测定(TAT)40203076血浆肝素含量测定40203077血浆蛋白C活性测定(PC)40203078血浆蛋白C抗原测定(PCAg)40203079活化蛋白C抵抗试验(APCR)40203080血浆蛋白S测定(PS)40203081狼疮抗凝物质检测4020308240203083血浆组织纤溶酶原活化物活性检测(t-PAA)40203084血浆组织纤溶酶原活化物抗原检测(t-PAAg)血浆组织纤溶酶原活化物抑制物活性检测40203085血浆凝血酶调节蛋白抗原检测(TMAg)40203086血浆凝血酶调节蛋白活性检测(TMA)40203087血浆凝血酶原片段1+2检测(F1+2)4020308840203089血浆纤维蛋白肽Bβ1-42和BP15-42检测(FPBβ)血浆纤溶酶-抗纤溶酶复合物测定(PAP)40203090纤维蛋白(原)降解产物测定(FDP)（乳胶凝集)40203091纤维蛋白(原)降解产物测定(FDP)4020309240203093血浆D-二聚体测定(D-Dimer)（乳胶凝集法）血浆D-二聚体测定40203094α2-巨球蛋白测定(散射比浊法)40203095α2-巨球蛋白测定(单扩法、免疫法)4020309640203097人类白细胞抗原B27测定(HLA-B27)(细胞毒法)40203098人类白细胞抗原B27测定(HLA-B27)(流式细胞)体外血栓形成试验40203099红细胞流变特性检测40203100全血粘度测定40203101血浆粘度测定40203102血小板ATP释放试验40203103纤维蛋白肽A检测40203104肝素辅因子II活性测定40203105低分子肝素测定（LMWH)40203106血浆激肽释放酶原测定40203107血栓弹力图试验(TEG)40203108床旁快速全血凝血功能测定40203109血清总蛋白测定（化学法）40301001血清白蛋白测定（化学法）40301002血清总蛋白测定（干化学法）40301002血清白蛋白测定（干化学法）40301003血清粘蛋白测定40301003免疫固定电泳40301004血清蛋白电泳40301004血清前白蛋白测定（其他方法）40301005血清前白蛋白测定（免疫比浊法、化学发40301005血清转铁蛋白测定（其他方法）4030100640301006血清转铁蛋白测定（免疫比浊法、化学发血清铁蛋白测定(各种免疫学方法)40301007可溶性转铁蛋白受体测定4030100740301008脑脊液总蛋白测定(免疫比浊法、化学发光法)脑脊液总蛋白测定(干化学法)40301008脑脊液总蛋白测定(化学法)40301009脑脊液寡克隆电泳分析40301009脑脊液白蛋白测定40301010脑脊液IgG测定40301010尿胰蛋白酶原-2检测(金标法)40301011β2微球蛋白测定（化学发光法）40301011α1抗胰蛋白酶测定40301012α巨球蛋白测定4030101240301013超敏C反应蛋白测定（速率散射比浊法）超敏C反应蛋白测定40301013超敏C反应蛋白测定（散射比浊法）4030101440301014高敏感C-反应蛋白测定（免疫比浊终点法）血清淀粉样蛋白测定(SAA)40301015视黄醇结合蛋白测定40301015葡萄糖测定(干化学法)40302001葡萄糖测定（各种酶法、酶电极法）40302002糖化白蛋白测定(酶法,定量测定)40302003血清果糖胺测定40302004糖化血红蛋白测定（色谱法）40302005全血半乳糖测定40302006血清果糖测定40302007木糖测定40302008血清唾液酸测定40302009血浆乳酸测定40302010全血丙酮酸测定40302011血清总胆固醇测定（化学法、酶法）40303001血清总胆固醇测定（干化学法）40303002血清甘油三酯测定（化学法、酶法）40303003血清甘油三酯测定（干化学法）40303004血清磷脂测定(干化学法)4030300540303006血清高密度脂蛋白胆固醇测定（干化学法40303007血清高密度脂蛋白胆固醇测定（其他方法40303008血清低密度脂蛋白胆固醇测定（其他方法40303009血清低密度脂蛋白胆固醇测定（干化学法血清脂蛋白电泳分析（凝胶法）40303010血清脂蛋白电泳分析40303011血清载脂蛋白AⅠ测定（其他方法）40303012血清载脂蛋白AⅠ测定（免疫比浊法）40303013血清载脂蛋白AⅡ测定（其他方法）40303014血清载脂蛋白AⅡ测定（免疫比浊法）40303015血清载脂蛋白B测定（其他方法）40303016血清载脂蛋白B测定（免疫比浊法）40303017血清载脂蛋白CⅡ测定（其他方法）40303018血清载脂蛋白CⅡ测定（免疫比浊法）40303019血清载脂蛋白CⅢ测定（其他方法）40303020血清载脂蛋白CⅢ测定（免疫比浊法）40303021血清载脂蛋白E测定（其他方法）40303022血清载脂蛋白E测定（免疫比浊法）40303023血清载脂蛋白α测定（其他方法）40303024血清载脂蛋白α测定（免疫比浊法）40303025血清β-羟基丁酸测定（其他方法）40303026血清β-羟基丁酸测定（化学发光法）40303027血游离脂肪酸测定40303028甘油测定40303029载脂蛋白E基因分型40303030血酮体测定40303031游离脂肪酸测定40303032钾测定（干化学法）40304001钾测定（火焰分光光度法或离子选择电极)40304002钠测定(干化学法)4030400340304004钠测定（火焰分光光度法或离子选择电极)氯测定（干化学法）40304005氯测定（离子选择电极法、滴定法）40304006钙测定(干化学法)40304007钙测定（比色法、分光光度法、离子选择40304008无机磷测定（干化学法）40304009无机磷测定（比色法）40304010镁测定(干化学法)40304011镁测定（比色法、分光光度法、离子选择40304012铁测定(干化学法)4030401340304014铁测定（比色法、分光光度法、离子选择血清总铁结合力测定40304015全血铅测定（原子法）40304016全血铅测定（尿离子测定）40304017血清碳酸氢盐(HCO3)测定40304018血一氧化碳分析（比色法）40304019血一氧化碳分析（干化学法）40304020血一氧化氮分析40304021汞微量元素测定40304022血清总胆红素测定（干化学法）40305001血清总胆红素测定（化学法或酶促法）40305002血清直接胆红素测定（干化学法）4030500340305004血清直接胆红素测定（化学法或酶促法）血清间接胆红素测定（速率法）40305005血清间接胆红素测定（干化学法）40305006血清间接胆红素测定（手工法）40305007血清δ-胆红素测定40305008血清总胆汁酸测定（干化学法）4030500940305010血清总胆汁酸测定（化学法、比色法、酶)血浆氨测定（酶促法）40305011血浆氨测定（干化学法）40305012血清丙氨酸氨基转移酶测定（手工法）40305013血清丙氨酸氨基转移酶测定（速率法）4030501440305015血清丙氨酸氨基转移酶测定（干化学法）40305016血清天门冬氨酸氨基转移酶测定（手工法40305017血清天门冬氨酸氨基转移酶测定（速率法天冬酸氨基转移酶线粒体同功酶检测4030501840305019血清天门冬氨酸氨基转移酶测定（干化学血清γ-谷氨酰基转移酶测定（手工法）40305020血清γ-谷氨酰基转移酶测定（速率法）4030502140305022血清γ-谷氨酰基转移酶测定（干化学法）血清γ-谷氨酰基转移酶同工酶电泳40305023血清碱性磷酸酶测定（手工法）40305024血清碱性磷酸酶测定（速率法）40305025血清碱性磷酸酶测定(化学发光法)40305026血清碱性磷酸酶测定（干化学法）40305027血清碱性磷酸酶同工酶电泳分析（凝胶法40305028血清碱性磷酸酶同工酶电泳分析4030502940305030血清骨型碱性磷酸酶质量测定（化学发光血清胆碱脂酶测定（干化学法）40305031血清胆碱脂酶测定（速率法）40305032血清单胺氧化酶测定40305033血清5′核苷酸酶测定40305034血清α-L-岩藻糖苷酶测定40305035血清Ⅳ型胶原测定40305036血清Ⅲ型胶原测定40305037血清层粘连蛋白测定40305038血清纤维连接蛋白测定40305039血清透明质酸酶测定40305040腺苷脱氨酶测定40305041血清亮氨酰氨基肽酶测定40305042胆酸测定40305043谷氨酸脱氢酶测定40305044糖缺失性转铁蛋白(CDT)检测40305045吲哚菁绿肝脏储备功能试验(PDD)法40305046血清肌酸激酶测定（速率法）40306001血清肌酸激酶测定（化学发光法）40306002血清肌酸激酶测定（干化学法）40306003血清肌酸激酶-MB同工酶活性测定（金标法）4030600440306005血清肌酸激酶-MB同工酶活性测定（速率法）40306006血清肌酸激酶-MB同工酶活性测定（干化学法）血清肌酸激酶-MB同工酶质量测定40306007血清肌酸激酶同工酶电泳分析40306008脑脊液标本乳酸脱氢酶测定(速率法)40306009乳酸脱氢酶测定(干化学法)4030601040306011血清乳酸脱氢酶同工酶电泳分析（其他方40306012血清乳酸脱氢酶同工酶电泳分析（凝胶法血清α羟基丁酸脱氢酶测定（其他方法）40306013血清α羟基丁酸脱氢酶测定（速率法）40306014血清肌钙蛋白T测定（化学发光法）40306015血清肌钙蛋白T测定（金标法）40306016血清肌钙蛋白Ⅰ测定（化学发光法)40306017血清肌钙蛋白Ⅰ测定（金标法）40306018血清肌钙蛋白Ⅰ测定（荧光免疫法）4030601940306020血清肌红蛋白测定（化学发光法、蛋白芯)血清肌红蛋白测定（金标法)40306021血清肌红蛋白测定（荧光免疫法)40306022血清肌红蛋白测定（各种免疫学方法）40306023血同型半胱氨酸测定（化学发光法）40306024血同型半胱氨酸测定（各种免疫学方法）40306025B型钠尿肽（BNP）测定4030602640306027N端-前脑钠肽(NT-PROBNP)测定(金标法)B型钠尿肽前体（PRO-BNP）测定4030602840306029缺血修饰白蛋白(IMA)测定（化学酶法，筛查试验）脂肪酸结合蛋白测定(金标法)40306030人血浆脂蛋白相关磷脂酶A2(Lp-PLA2)测定40306031尿素测定（干化学法）40307001尿素测定（化学法、酶促动力学法）40307002肌酐测定（干化学法）40307003肌酐测定（酶促动力学法）40307004内生肌酐清除率试验40307005指甲肌酐测定40307006血清尿酸测定40307007尿微量白蛋白测定（化学发光法）40307008尿微量白蛋白测定(散射比浊法)40307009尿微量白蛋白测定（各种免疫学方法）40307010尿转铁蛋白测定（化学发光法）40307011尿转铁蛋白测定（各种免疫学方法）40307012尿α1微量球蛋白测定（化学发光法）40307013尿α1微量球蛋白测定（指各种免疫学方法）40307014β2微球蛋白测定（化学发光法）40307015β2微球蛋白测定（各种免疫学方法）40307016尿蛋白电泳分析（凝胶法）40307017尿蛋白电泳分析40307018尿N-酰-β-D-氨基葡萄糖苷酶测定40307019尿β-D-半乳糖苷酶测定40307020尿γ-谷氨酰转移酶测定40307021尿丙氨酰氨基肽酶40307022尿亮氨酰氨基肽酶40307023尿碱性磷酸酶测定40307024尿浓缩试验40307025酸负荷试验40307026碱负荷试验40307027尿碳酸氢盐(HCO3)测定40307028尿氨测定40307029尿可滴定酸测定40307030尿结石成份分析（化学法）40307031尿结石成份分析（红外光谱法）40307032尿尿酸测定40307033尿草酸测定40307034尿透明质酸酶测定40307035超氧化物歧化酶(SOD)测定40307036血清胱抑素(CystatinC)测定40307037α1微球蛋白测定(透射法)40307038α1微球蛋白测定(散射法)40307039血清酸性磷酸酶测定（干化学法）4030800140308002血清酸性磷酸酶测定（比色法、速率法）40308003血清酒石酸抑制酸性磷酸酶测定（干化学40308004血清酒石酸抑制酸性磷酸酶测定(ELISA法)40308005血清酒石酸抑制酸性磷酸酶测定（比色法)血清前列腺酸性磷酸酶质量测定40308006淀粉酶测定（干化学法）40308007淀粉酶测定（比色法、速率法）40308008血清淀粉酶同工酶电泳40308009血清脂肪酶测定（干化学法）40308010血清脂肪酶测定（比浊法）40308011血清血管紧张转化酶测定40308012血清骨钙素测定(化学发光法,定量测定)40308013血清骨钙素测定40308014醛缩酶测定40308015 25羟维生素D测定(ELISA法)40309001 25羟维生素D3测定(化学发光法)40309002 25羟维生素D测定40309003 25羟维生素D测定403090041，25双羟维生素D测定40309005叶酸测定（化学发光法）40309006血清维生素测定（化学发光法）40309007血清药物浓度测定（免疫学法）40309008血清药物浓度测定（器官移植排异药物浓40309009血清药物浓度测定（色谱法）40309010各类滥用药物筛查40309011血清各类氨基酸测定40309012血清乙醇测定40309013中枢神经特异蛋白(S100)测定4030901440310001血清促甲状腺激素测定（化学发光法、荧)40310002血清泌乳素测定（化学发光法、荧光免疫血清生长激素测定（化学发光法、荧光免)40310003血清促卵泡刺激素测定（化学发光法）4031000440310005血清促黄体生成素测定（化学血清促黄体40310006血清促肾上腺皮质激素测定（化学发光法血瘦素(HLT)(化学发光法)4031000740310008抗利尿激素测定（化学发光法、荧光免疫40310009降钙素测定（化学发光法、荧光免疫法）甲状旁腺激素测定（化学发光法）40310010血清甲状腺素(T4)测定（化学发光法）4031001140310012血清三碘甲状原氨酸(T3)测定（化学发光法）血清反T3测定（化学发光法、荧光免疫法）40310013血清反T3测定（各种免疫学方法）4031001440310015血清游离甲状腺素(FT4)测定（化学发光法）40310016血清游离甲状腺素(FT4)测定（化学发光法）40310017血清游离三碘甲状原氨酸(FT3)测定（化学发光法）40310018血清T3摄取实验（化学发光法、荧光免疫法）40310019血清甲状腺结合球蛋白测定（化学发光法性激素结合球蛋白(HSBG)(化学发光法)40310020促甲状腺素受体抗体测定（化学发光法）4031002140310022血浆皮质醇测定（化学发光法、荧光免疫40310023 24小时尿游离皮质醇测定（化学发光法）尿17-羟皮质类固醇测定（化学发光法）4031002440310025尿17-羟皮质类固醇测定（各种免疫学方法）40310026尿17-酮类固醇测定（化学发光法、色谱法）尿17-酮类固醇测定（各种免疫学方法）4031002740310028血清脱氢表雄酮及硫酸酯测定（化学发光40310029醛固酮测定（化学发光法、荧光免疫法）醛固酮测定（各种免疫学方法）40310030尿儿茶酚胺测定（色谱法）40310031尿儿茶酚胺测定（各种免疫学方法）40310032尿香草苦杏仁酸(VMA)测定（色谱法）4031003340310034尿香草苦杏仁酸(VMA)测定（各种免疫学方法）血浆肾素活性测定40310035血管紧张素Ⅰ测定40310036血管紧张素Ⅱ测定40310037促红细胞生成素测定(化学发光法)40310038睾酮测定（化学发光法、荧光免疫法）4031003940310040血清双氢睾酮测定（化学发光法、荧光免雄烯二酮测定4031004140310042 17α羟孕酮测定（化学发光法、荧光免疫法）雌酮测定（化学发光法、荧光免疫法）4031004340310044雌三醇测定（化学发光法、荧光免疫法）孕酮测定（化学发光法、荧光免疫法）4031004540310046血清人绒毛膜促性腺激素测定（化学发光40310047血清胰岛素测定（化学发光法、荧光免疫40310048血清胰高血糖测定（化学发光法、荧光免血清胰高血糖测定（各种免疫学方法）4031004940310050血清C肽测定（化学发光法、荧光免疫法）40310051C肽兴奋试验（化学发光法、荧光免疫法）40310052血清抗谷氨酸脱羧酶抗体测定（化学发光40310053血清抗谷氨酸脱羧酶抗体测定（各种免疫胃泌素测定（各种免疫学方法）40310054血浆前列腺素(PG)测定40310055血浆6-酮前列腺素F1α测定4031005640310057肾上腺素测定（化学发光法、荧光免疫法40310058去甲肾上腺素测定（化学发光法、荧光免去甲肾上腺素测定（各种免疫学方法）4031005940310060胆囊收缩素测定（化学发光法、荧光免疫胆囊收缩素测定（各种免疫学方法）4031006140310062心纳素测定（化学发光法、荧光免疫法）心纳素测定（各种免疫学方法）40310063环磷酸腺苷(cAMP)测定40310064环磷酸鸟苷(cGMP)测定40310065甲状腺球蛋白测定（发光法)40310066降钙素原检测40310067游离β-绒毛膜促性腺激素测定40310068类胰岛素生长因子-1测定(IGF)ELISA法4031006940310070胰岛素样生长因子结合蛋白-1 检测胶体金法40310071类胰岛素生长因子结合蛋白3(IGFBP-3)ELISA法胰岛素原定量测定(化学发光法)40310072妊娠相关血浆蛋白A测定40310073尿CTx测定40311001尿NTx测定40311002尿吡啶酚测定40311003尿脱氧吡啶酚测定4031100440311005I型胶原羧基末端肽(CTx)测定(化学发光法，定量测定) I型胶原羧基端前肽(PICP)测定4031100640311007I型胶原氨基末端肽(NTx)测定(化学发光法，定量测定) T淋巴细胞转化试验40401001红细胞花环试验40401002细胞膜表面免疫球蛋白测定(SmIg)40401003中性粒细胞趋化功能试验40401004硝基四氮唑蓝还原试验40401005白细胞粘附抑制试验40401006白细胞杀菌功能试验40401007白细胞吞噬功能试验40401008巨噬细胞吞噬功能试验40401009自然杀伤淋巴细胞功能试验40401010抗体依赖性细胞毒性试验40401011干扰素测定40401012各种白介素测定(各种免疫学方法)40401013各种白介素测定(化学发光法)40401014溶菌酶测定40401015抗淋巴细胞抗体试验40401016肥大细胞脱颗粒试验40401017B因子测定40401018总补体测定(CH3)40401019总补体测定(CH50)(免疫比浊法仪器定量)40401020总补体测定(CH50)40401021补体测定（C3、C4）40401022补体1抑制因子测定40401024C3裂解产物测定(C3SP)40401025免疫球蛋白IgA定量测定（散射比浊法）40401026免疫球蛋白IgA定量测定（各种免疫学方法）40401027冷球蛋白测定4040102840401029C－反应蛋白测定(CRP)（各种免疫学方法）C反应蛋白测定(CRP)金标法(定量)40401030C－反应蛋白测定(CRP)（散射比浊法）40401031纤维结合蛋白测定(Fn)4040103240401033轻链KAPPA、LAMBDA定量(K-LC，λ-LC)铜蓝蛋白测定（各种免疫学方法、单扩法40401034铜蓝蛋白测定（散射比浊法）40401035淋巴细胞免疫分析（免疫荧光法）40401036淋巴细胞免疫分析（流式细胞仪法）40401037活化淋巴细胞测定（流式细胞仪法）4040103840401039血细胞簇分化抗原（CD）系列检测（流式细胞)免疫球蛋白亚类定量测定(散射比浊法)40401040胎儿纤维连接蛋白检测(fFN检测)40401041系统性红斑狼疮因子试验(LEF)40402001抗核抗体测定(ANA)（ELISA法）4040200240402003抗核提取物抗体测定(抗ENA抗体)（免疫学法）40402004抗中性粒细胞胞浆抗体测定（ANCA）（免疫学法）40402005抗双链DNA测定(抗dsDNA)（免疫印迹法）40402006抗双链DNA测定(抗dsDNA)（ELISA法）40402007抗线粒体抗体测定(AMA)（免疫印迹法）40402008抗核膜糖蛋白(GP210)抗体检测(酶联免疫法)40402009抗核骨架蛋白抗体测定(amin)（免疫印迹法）抗核糖体抗体测定（免疫印迹法）40402010抗核糖体抗体测定（免疫学法）40402011抗核糖核蛋白抗体测定(免疫印迹法)40402012抗核糖核蛋白抗体测定（免疫学法）40402013抗染色体抗体测定（免疫印迹法）40402014抗染色体抗体测定（免疫学法）40402015抗血液细胞抗体测定40402016抗肝细胞特异性脂蛋白抗体测定40402017抗组织细胞抗体测定40402018抗心肌抗体测定（AHA）40402019抗心磷脂抗体测定(ACA)(ELISA法)4040202040402021抗甲状腺球蛋白抗体测定(TGAb)（化学发光法）40402022抗甲状腺微粒体抗体测定(TMAb)（化学发光法）40402023抗肾小球基底膜抗体测定(GBM)(酶联免疫法)抗肾小球基底膜抗体测定40402024抗脑组织抗体测定40402025抗腮腺管抗体测定40402026抗卵巢抗体测定40402027抗子宫内膜抗体测定(EMAb)40402028抗精子抗体测定40402029抗硬皮病抗体测定40402030抗胰岛素抗体测定（ELISA法）40402031抗胰岛素抗体测定(酶联免疫法)40402032抗胰岛素受体抗体测定40402033抗乙酰胆碱受体抗体测定40402034抗磷壁酸抗体测定40402035抗鞘磷脂抗体测定40402036抗白蛋白抗体测定40402037。