首页|基于HPLC研究柏子仁中黄曲霉毒素的污染状况与风险分析

基于HPLC研究柏子仁中黄曲霉毒素的污染状况与风险分析

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目的 基于HPLC研究柏子仁中4 种黄曲霉毒素的污染情况,并进行风险分析,评估柏子仁的用药安全.方法 采用Agilent Eclipse Plus C18(4.6×250 mm 5 μm)为色谱柱,柱后光化学衍生法检测,以甲醇∶乙腈∶水(35∶10∶55)为流动相,流速1.0 mL·min-1;柱温:40℃;荧光检测器检测.结果 黄曲霉毒素B1、B2、G1、G2 分别在0.35~20.8 μg·L-1、0.13~7.6 μg·L-1、0.36~21.6 μg·L-1、0.13~7.6 μg·L-1范围内呈良好的线性关系,黄曲霉毒素B1、B2、G1、G2 平均回收率分别为 90.6%、83.46%、87.84%、86.58%,相对偏差分别为 2.9%、3.6%、3.6%、4.7%.23 批柏子仁中有14 批检出黄曲霉毒素B1 和总量,残留量分别在 1~4 μg·kg-1 和 1~5 μg·kg-1 之间,均符合规定,但检出率高达61%,存在安全隐患.结论 该方法简单、准确、方便,能有效评价柏子仁中黄曲霉毒素的污染情况.警示柏子仁易受黄曲霉毒素的污染,需加强柏子仁监管力度和不定期的专项抽检,降低安全风险,以确保临床用药安全.
Analysis of Aflatoxins Contamination and Risk in Platycladi Semen Based on HPLC
OBJECTIVE To study the contamination situation of four aflatoxins(AFs)in Platycladi Semen based on HPLC,to analysis risk and to evaluate the drug safety of Platycladi Semen.METHODS The Agilent E-clipse Plus C18(250 mm×4.6 mm,5 μm)was used,and the mobile phase was methanol-acetonitrile-water(35∶10∶55)with gradient elution,at the flow rate of 1.0 mL·min-1.The column temperature was at40℃and the determi-nation was set at Fluorescence detector.RESULTS The linear ranges of AFB1,AFB2,AFG1 and AFG2 were(0.35-20.8)μg·L-1,(0.13-7.6)μg·L-1,(0.36-21.6)μg·L-1,(0.13-7.6)μg·L-1,respectively.The average recoveries of AFB1,AFB2,AFG1 and AFG2 were 90.6%,83.46%,87.84%and 86.58%,respectively,with RSDs of 2.9%,3.6%,3.6%and 4.7%.The contents of AFB1 and AFs in 23 batches of samples were(1-4)μg·kg-1 and(1-5)μg·kg-1,respectively,which were in line with regulations,but the detection rate was as high as 61%.The samples had potential risks.CONCLUSION The method is simple,accurate and convenient,and can ef-fectively evaluate the contamination of AFs in Platycladi Semen.It is warned that Platycladi Semen is vulnerable to aflatoxin pollution,and it is necessary to strengthen the supervision of Platycladi Semen and irregular special sampling test to reduce safety risks,so as to ensure the safety of clinical drug.

Platycladi SemenHPLCImmunoaffinity Column CleanupPost-Column Photochemical DerivatizationAflatoxins

王娟弟、李敏、张明童、李欣、郭晓霞、马潇、李冬华、刘蕊

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甘肃省药品检验研究院,甘肃兰州 730070

国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃兰州 730070

柏子仁 高效液相色谱 光化学衍生 黄曲霉毒素

兰州市科技计划国家中药材及饮片质量控制重点实验室项目国家中药材及饮片质量控制重点实验室项目甘肃省药品科研项目甘肃省药品科研项目中藏药检验检测技术工程实验室

2022-3-412022GSMPA-KL102023GSMPA-KL062022GSMPA00172022GSMPA00752021-ZZY-SFG-02

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(3)
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