首页|基于中国药典与国际标准对西红花生产流通中质量评价方法的改良

基于中国药典与国际标准对西红花生产流通中质量评价方法的改良

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目的:比较中国药典的HPLC法和国际标准的色价法检测西红花中西红花苷的差异,建立更能普遍适用于生产流通中检测总西红花苷含量的方法.方法:采用HPLC-DAD-ESI-MSn对西红花440nm波长下的色谱峰进绗结构鉴定,在此基础上,以含量最高的西红花苷-Ⅰ为对照,建立UV法测定总西红花苷的含量;采用该方法对62批西红花样品进行分析.结果:440 nm波长下主要有4个色谱峰,均为西红花苷类成分,其他类成分在此波长无干扰,并且西红花苷-Ⅰ和Ⅱ相对含量最高.62批样品的测定结果与按中国药典测定的西红花苷-Ⅰ、Ⅱ总含量及参考国际标准测定的色价均有显著线性相关性.中国药典规定西红花苷-Ⅰ和Ⅱ总含量应在10％以上,相应西红花苷色价均在150以上.结论:对总西红花苷定量时,可以西红花苷-Ⅰ为对照,用UV法对其含量进行测定;并将UV法测定的色价大于150作为快速判定药材合格的标准,对色价小于100的样品可判为不合格品,色价为100～150间的样品需分别用国际标准与中国药典标准进行测定,以判别是否符合西红花药用标准或食品标准.该方法在中国药典与国际标准间架起了一个桥梁,为普遍用于西红花生产流通中的质量监控提供了参考.
Improvement of quality evaluation of Croci Stigma in the process of producing and distributing based on Chinese pharmacopoeia and ISO
Objective:To explore an efficient,convenient and feasible method for the contents determination of total crocins in Croci Stigma based on Chinese pharmacopoeia(ChP)-HPLC method and ISO-color value.Methods:Firstly,ESI-MSn was adopted to identify the peaks at the wavelength of 440 nm,and crocin-Ⅰwas used as the reference for UV method of content determination of total crocins from 62 batches of Croci Stigma.Results:The results showed all the peaks were crocins,without other peaks,and the contents of crocins-Ⅰand crocins-Ⅱwere the highest.There was a significant linear correlation between the contents of total crocins determined by UV,total contents of crocins-Ⅰand crocins-Ⅱdetermined by ChP-HPLC and the improved color value determined by ISO.ChP requires that total contents of crocinsand crocins-Ⅱshould be more than 10％,correspondingly the color value should be more than 150.Condusion:UV can be adopted for the content determination of total crocins,and crocin-Ⅰcan be used as the reference.In addition,when determining whether Croci Stigma is qualified,the color value above 150 can be used as the fast determination standard.When the color value is less than 100,the sample can be identified as unqualified.When the color value is in the range of 100-150,the sample should be identified by ChP—HPLC and ISO—color value to identify whether it meets the medicinal standards or intemational food standards.The presented method has been a bridge between Chp and ISO,and provides a reference for quality control of Croci Stigma in the process of producing and distributing.

Croci Stigmasaffronflavoring agentcrocinsChinese pharmacopoeiaISOquality evaluationHPLC methodcolor value methodmass spectrometryspectrophotometric method

周桂芬、留永咏、钱晓东、姚冲、吕圭源、陈素红

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浙江中医药大学,杭州310053

温州医科大学,温州325035

湖州市中心医院,湖州313003

西红花 藏红花 食用香料 西红花苷 中国药典 国际标准 质量评价 高效液相色谱法 色价法 质谱法 分光光度法

国家自然科学基金浙江省公益技术应用研究(分析测试)项目一般项目浙江省自然科学基金青年基金浙江省中医药科技计划科学研究基金优秀青年人才基金湖州市科技计划公益性一般项目

814030322014C370542015C33272LQ15H2800012015ZB1122015ZQ0332014GYB01

2016

10.16155/j.0254-1793.2016.05.14

药物分析杂志
中国药学会

药物分析杂志

CSTPCDCSCD北大核心
影响因子：1.039
ISSN：0254-1793
年,卷(期)：2016.36(5)
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