中国中药杂志

2019, v.44(23) 5058-5064

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小柴胡复方制剂中重金属残留污染分析及其健康风险评估
Safety evaluation of heavy metals contaminated Xiaochaihu Tang using health risk assessment model

李歆悦;孔丹丹;王蓉;骆骄阳;杨世海;杨美华;
LI Xin-yue;KONG Dan-dan;WANG Rong;LUO Jiao-yang;YANG Shi-hai;YANG Mei-hua;College of Traditional Chinese Medicine,Jilin Agricultural University;Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine,Ministry of Education,Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences & Peking Union Medical College;

摘要(Abstract):

为进一步完善中药材复方制剂的质量及安全评价标准,以小柴胡复方制剂为研究对象,深入了解重金属在其不同制剂类型中的污染水平及残留情况,并对服用该药材潜在的健康风险进行评估。该文采用电感耦合等离子体质谱(ICP-MS)法测定小柴胡复方制剂中铜(Cu),砷(As),镉(Cd),汞(Hg),铅(Pb)的含量,基于不同服药方式及人体消化模型分别制备小柴胡汤水煎剂与颗粒剂,测定水煎液、颗粒剂与原粉入药3种模式下的重金属的生物可及率,结合靶标危害系数法评估其健康风险等级。结果表明:在国际重金属限量标准下,仅1个批次原药材中Hg超标8倍,但经水煎与颗粒制备工艺后,重金属残留量明显降低,且重金属残留率降低至2. 02%(颗粒剂Hg)~42. 85%(颗粒剂Cd)。3种入药方式下THQ与CR均低于各重金属的非致癌与致癌风险标准值,可见:即使原药材中重金属超标,使用小柴胡汤剂和颗粒剂也可以一定程度上降低重金属对人体造成危害。因此,不同剂型的发展和使用可以减少重金属对人体健康造成的威胁,提高了中药材使用的安全性。以上研究结果进一步表明:该健康风险评估模型的建立对弥补及完善其他中药复方制剂在临床用药中的安全评价标准,提高其质量控制方法给出了实验基础及借鉴价值。
In order to further improve the quality and safety evaluation standards of traditional Chinese medicine compound preparation,Xiaochaihu Tang compound preparations were selected to analyze the pollution level of heavy metals deeply,and the potential health risks were evaluated under taking such kind of compound preparations. In this study,the contents of copper( Cu),arsenic( As),cadmium( Cd),mercury( Hg),and lead( Pb) in different Xiaochaihu Tang compound preparations were determinated by the method of inductively coupled plasma mass spectrometry( ICP-MS). Moreover,combined with target hazard coefficient method and in vitro artificial system,the bioaccessibility and health risk level was investigated in three main consumption ways including powder,decoction and granule. The result was showed that,under the maximum residual limit set by International Standard Organization,only one batch of raw herb was eight times exceeded the Hg MRL,however,in water decoctions and granules,the heavy metal residue rate was reduced to 2. 02%( Hg in granules)-42. 85%( Cd in granules). So,the heavy metal pollutions and health risks can be reduced to safe region in spite of the serious pollution in raw herbs. Besides,the THQ and CR values of the three consumption methods were lower than the standard values of non-carcinogenic and carcinogenic risks of each heavy metal. It can be seen that even if the heavy metals in the raw herbs exceed the standard,the use of Xiaochaihu Tang decoction and granules can reduce the harm of heavy metals to the human body. Above all,the establishment of this health risk assessment model can be provided experimental basis and reference value for improving the safety evaluation standard of other heavy metals contained traditional Chinese medicine( TCM) compound preparations,and further improving the quality control methods of other different toxic compounds in clinical use.

关键词(KeyWords): 小柴胡汤;复方制剂;ICP-MS;重金属及有害元素;服药方式;健康风险等级评估
Xiaochaihu Tang;compound preparation;ICP-MS;heavy metals and toxic elements;consumption method;health risk assessment

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(81903797);; 中国医学科学院协同创新项目(2017-I2M-1-013,2016-I2M-3-010);; 协和青年基金资助和中央高校基本科研业务费专项资金(3332018201);; 国家重点研发计划项目(2018YFF0214202)

作者(Author): 李歆悦;孔丹丹;王蓉;骆骄阳;杨世海;杨美华;
LI Xin-yue;KONG Dan-dan;WANG Rong;LUO Jiao-yang;YANG Shi-hai;YANG Mei-hua;College of Traditional Chinese Medicine,Jilin Agricultural University;Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine,Ministry of Education,Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences & Peking Union Medical College;

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