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 Changchun 130118,China.
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 Beijing 100193,China.
Zhongguo Zhong Yao Za Zhi. 2019 Dec;44(23):5058-5064. doi: 10.19540/j.cnki.cjcmm.20191015.201.
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.
为进一步完善中药复方制剂的质量与安全评价标准,选取小柴胡汤复方制剂深入分析重金属污染水平,并对服用此类复方制剂情况下的潜在健康风险进行评估。本研究采用电感耦合等离子体质谱法(ICP-MS)测定不同小柴胡汤复方制剂中铜(Cu)、砷(As)、镉(Cd)、汞(Hg)和铅(Pb)的含量。此外,结合目标危害系数法和体外人工系统,对散剂、汤剂和颗粒剂这三种主要服用方式的生物可及性和健康风险水平进行了研究。结果表明,在国际标准组织设定的最大残留限量下,仅一批生药的汞含量超出最大残留限量八倍,然而,在水煎剂和颗粒剂中,重金属残留率降至2.02%(颗粒剂中的汞)-42.85%(颗粒剂中的镉)。所以,尽管生药中重金属污染严重,但重金属污染和健康风险可降至安全范围。此外,三种服用方式的THQ和CR值均低于各重金属非致癌和致癌风险的标准值。可见,即使生药中的重金属超标,使用小柴胡汤汤剂和颗粒剂仍可降低重金属对人体的危害。综上所述,本健康风险评估模型的建立可为完善其他含重金属的中药复方制剂的安全评价标准,以及进一步完善临床使用中其他不同毒性化合物的质量控制方法提供实验依据和参考价值。