沉香中沉香四醇的测量不确定度评估
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摘要
目的:建立HPLC定量分析沉香药材中沉香四醇含量的测量不确定度的评定方法,找出影响不确定度的因素,为沉香药材质量控制提供科学依据。方法:用HPLC方法测定沉香四醇的含量,并根据《测量不确定度评定与表示》(JJF1059.1-2012)中的规定评估其不确定度,通过统计分析,量化不确定分量,最终确定测量结果的扩展不确定度和置信水平。结果:5批沉香药材中沉香四醇含量测定的不确定度评估结果为(2.80±0.45),(5.13±0.82),(13.86±2.21),(74.86±11.87),(125.71±19.94)g·L~(-1)。发现测量不确定度的主要影响因素有沉香样品的均匀性、称量、配制浓度及高效液相色谱仪性能4个类型,通过严格按照四分法取样沉香样品、确保称量介质保持干燥、正确或规范使用玻璃器皿和精密仪器、可有效减少样品痕量分析的误差。结论:该方法可用于HPLC法测定沉香药材中沉香四醇含量的不确定度分析,方法简便,测量结果不确定度纳入标准制定,有利于标准痕量更加合理,对沉香药材痕量分析方法的建立和质量标准的制定具有重要意义。
Objective: To find out the impacting factors on uncertainty by establishing a HPLC method for a quantitative analysis of agarotetrol,in order to provide the evidence for quality control of traditional Chinese medicinal materials of Aquilariae Lignum Resinatum. Method: Agarotetrol in Aquilariae Lignum Resinatum was determined by HPLC, and the uncertainty was evaluated according to JJF1059. 01-2012. The uncertainty components were quantified through a statistical analysis,and extended uncertainty and confidence level were finally determined. Result: The uncertainty evaluation results for the content determination of agarotetrol from five samples was( 2. 80 ± 0. 45),( 5. 13 ± 0. 82),( 13. 86 ± 2. 21),( 74. 86 ± 11. 87),( 125. 71 ± 19. 94) g·L~(-1).Sample homogeneity,weighing,compound concentration and HPLC property were the major factors to measure the uncertainty. The error of sample trace analysis could be reduced by quartering samples,drying weighing medium and correctly or regularly using glassware and precision instruments. Conclusion: The method can be used for uncertainty analysis of content of agarotetrol in Aquilariae Lignum Resinatum,which makes the standard trace amount more rational and significant to establish uncertainty analysis methods and quality standard for Chinese medicinal materials of Aquilariae Lignum Resinatum.
Objective: To find out the impacting factors on uncertainty by establishing a HPLC method for a quantitative analysis of agarotetrol,in order to provide the evidence for quality control of traditional Chinese medicinal materials of Aquilariae Lignum Resinatum. Method: Agarotetrol in Aquilariae Lignum Resinatum was determined by HPLC, and the uncertainty was evaluated according to JJF1059. 01-2012. The uncertainty components were quantified through a statistical analysis,and extended uncertainty and confidence level were finally determined. Result: The uncertainty evaluation results for the content determination of agarotetrol from five samples was( 2. 80 ± 0. 45),( 5. 13 ± 0. 82),( 13. 86 ± 2. 21),( 74. 86 ± 11. 87),( 125. 71 ± 19. 94) g·L~(-1).Sample homogeneity,weighing,compound concentration and HPLC property were the major factors to measure the uncertainty. The error of sample trace analysis could be reduced by quartering samples,drying weighing medium and correctly or regularly using glassware and precision instruments. Conclusion: The method can be used for uncertainty analysis of content of agarotetrol in Aquilariae Lignum Resinatum,which makes the standard trace amount more rational and significant to establish uncertainty analysis methods and quality standard for Chinese medicinal materials of Aquilariae Lignum Resinatum.
引文
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[13]张公信,周学进,李晓芬,等.三七总皂苷含量测定不确定度的评估[J].中国农学通报,2011,27(25):235-239.
[14]周政政,郭永辉,杨德智,等.苦杏仁苷纯度标准物质研制和纯度标准值及不确定度分析方法研究[J].医药导报,2013,32(4):504-510.
[15]刘淑聪,张宝喜,杨世颖,等.虎杖中虎杖苷和白藜芦醇含量标准值与不确定度评估分析方法研究[J].中国药业,2013,22(18):33-36.
[16]王磊,姚令文,程显隆,等.甘遂中大戟二烯醇HPLC定量方法的测量不确定度评定[J].中国药事,2015,29(2):147-152.
[17]张丽,周政政,杨德智,等.HPLC法对天麻素纯度标准物质的定值与不确定度研究[J].中国药师,2014,17(6):925-928.
[18]郭永辉,姜建国,闫凯,等.两种方法测定比沙可啶纯度及不确定度评定[J].中国药房,2014,25(41):3916-3918.
[19]饶毅,夏川川,周海滨,等.高效液相色谱法测定白芍总苷的不确定度分析[J].中国实验方剂学杂志,2011,17(19):89-93.
[20]陈华,马仕洪,张河战.高效液相色谱法测定伪麻黄碱含量的不确定分析[J].药物分析杂志,2005,25(2):201-204.
[21]陶松,刘旭海,刘玲,等.HPLC测定补肾口服液中淫羊藿苷的不确定分析[J].中国实验方剂学杂志,2012,18(13):111-114.
[22]寇光,刘玲,陶松,等.HPLC测定桉叶止咳糖浆中盐酸麻黄碱的不确定评价[J].中国实验方剂学杂志,2013,19(17):41-43.
[23]刘永利,李冬梅,冯丽,等.复方丹参片含量测定的不确定度分析[J].药物分析杂志,2007,27(11):1800-1802.
[24]凌霄,解斐,吴敬德.HPLC法测定降糖宁胶囊中格列本脲含量的不确定度分析[J].山东大学学报:医学版,2009,47(11):124-127.
[25]左登平,何亚琼,汪正宇.HPLC法测定罗红霉素分散片含量的测量不确定度分析[J].中国药房,2010,32(21):3067-3069.
[26]王玮.HPLC法测定头孢克肟胶囊含量的不确定的评价[J].安徽医药,2010,14(11):1284-1285.
[27]张红梅,张广宏,姜潇.HPLC法测定妥布霉素地塞米松眼膏中妥布霉素含量的不确定度分析[J].中国抗生素杂志,2013,38(10):3-6.
[28]陆明,范国荣,汪杨,等.测量不确定度在药品检测领域的研究进展[J].中国药事,2013,27(5):485-492.
[29]顾志荣,金岩,师富贵.不确定度评定在中药质量控制中的应用研究进展[J].亚太传统医药,2014,10(4):79-81.
[2]田燕泽,秘效媛,朴香兰.沉香的化学成分、药理活性与临床应用研究进展[J].中央民族大学学报:自然科学版,2010,19(1):77-81.
[3]黄俊卿,魏建和,张争,等.沉香结香方法的历史记载、现代研究及通体结香技术[J].中国中药杂志,2013,38(3):302-306.
[4]林焕泽,李红念,梅全喜.沉香叶与沉香药材抗炎作用的对比研究[J].中华中医药学刊,2013,31(3):548-549.
[5]安娜贝拉,陈颖,许敏,等.沉香的质量评价及药理活性研究进展[J].中国野生植物资源,2014,33(2):1-5.
[6]李红念,梅全喜,林焕泽,等.沉香叶与沉香药材镇痛作用的对比研究[J].时珍国医国药,2012,23(8):1958-1959.
[7]吴秀荣,李红念,梅全喜,等.沉香叶与沉香药材平喘作用的对比研究[J].今日药学,2013,23(6):346-347.
[8]Takemoto H,Ito M,Shiraki T.Sedative effects of vapor inhalation of agarwood oil and spikenard extract and identification of their active components[J].J Nat Med,2008,62(1):41-46.
[9]国家药典委员会.中华人民共和国药典.一部[M].北京:中国医药科技出版社,2015:185.
[10]国家质量技术监督局计量司组.测量不确定度评定与表示指南[M].北京:中国计量出版社,2001.
[11]Ellison S R,Rosslein M,Williams A,et al.Eurachem/CITAC Guide CG4.Quantifying Measurement Uncertainty in Analytical Measurement[M].3rd edition.London:UK National Measurement System,2012.
[12]胡坪,罗国安,赵中振,等.人参中人参皂苷HPLC定量方法的测量不确定度的评定[J].药学学报,2005,40(1):49-53.
[13]张公信,周学进,李晓芬,等.三七总皂苷含量测定不确定度的评估[J].中国农学通报,2011,27(25):235-239.
[14]周政政,郭永辉,杨德智,等.苦杏仁苷纯度标准物质研制和纯度标准值及不确定度分析方法研究[J].医药导报,2013,32(4):504-510.
[15]刘淑聪,张宝喜,杨世颖,等.虎杖中虎杖苷和白藜芦醇含量标准值与不确定度评估分析方法研究[J].中国药业,2013,22(18):33-36.
[16]王磊,姚令文,程显隆,等.甘遂中大戟二烯醇HPLC定量方法的测量不确定度评定[J].中国药事,2015,29(2):147-152.
[17]张丽,周政政,杨德智,等.HPLC法对天麻素纯度标准物质的定值与不确定度研究[J].中国药师,2014,17(6):925-928.
[18]郭永辉,姜建国,闫凯,等.两种方法测定比沙可啶纯度及不确定度评定[J].中国药房,2014,25(41):3916-3918.
[19]饶毅,夏川川,周海滨,等.高效液相色谱法测定白芍总苷的不确定度分析[J].中国实验方剂学杂志,2011,17(19):89-93.
[20]陈华,马仕洪,张河战.高效液相色谱法测定伪麻黄碱含量的不确定分析[J].药物分析杂志,2005,25(2):201-204.
[21]陶松,刘旭海,刘玲,等.HPLC测定补肾口服液中淫羊藿苷的不确定分析[J].中国实验方剂学杂志,2012,18(13):111-114.
[22]寇光,刘玲,陶松,等.HPLC测定桉叶止咳糖浆中盐酸麻黄碱的不确定评价[J].中国实验方剂学杂志,2013,19(17):41-43.
[23]刘永利,李冬梅,冯丽,等.复方丹参片含量测定的不确定度分析[J].药物分析杂志,2007,27(11):1800-1802.
[24]凌霄,解斐,吴敬德.HPLC法测定降糖宁胶囊中格列本脲含量的不确定度分析[J].山东大学学报:医学版,2009,47(11):124-127.
[25]左登平,何亚琼,汪正宇.HPLC法测定罗红霉素分散片含量的测量不确定度分析[J].中国药房,2010,32(21):3067-3069.
[26]王玮.HPLC法测定头孢克肟胶囊含量的不确定的评价[J].安徽医药,2010,14(11):1284-1285.
[27]张红梅,张广宏,姜潇.HPLC法测定妥布霉素地塞米松眼膏中妥布霉素含量的不确定度分析[J].中国抗生素杂志,2013,38(10):3-6.
[28]陆明,范国荣,汪杨,等.测量不确定度在药品检测领域的研究进展[J].中国药事,2013,27(5):485-492.
[29]顾志荣,金岩,师富贵.不确定度评定在中药质量控制中的应用研究进展[J].亚太传统医药,2014,10(4):79-81.