Analysis and health risk assessment, including recommendation of limits for heavy metals and harmful elements in Chinese patent medicines
10.16438/j.0513-4870.2020-0864
- VernacularTitle:中成药中重金属及有害元素残留分析、风险评估和限量制定建议
- Author:
Li-xing NIE
1
;
Xiu-yu QIAN
1
;
Qin-yue JIANG
2
;
Xiang LI
3
;
Jing LI
1
;
Tian-tian ZUO
1
;
Yan CHANG
1
;
Hong-yu JIN
1
;
Zhong DAI
1
;
Shuang-cheng MA
1
Author Information
1. National Institutes for Food and Drug Control, Beijing 100050, China
2. Beijing University of Chinese Medicine, Beijing 100029, China
3. Medical Supplies Center of the PLA General Hospital, Beijing 100048, China
- Publication Type:Research Article
- Keywords:
Chinese patent medicine;
heavy metal and harmful element;
harmful residue;
risk assessment;
limit;
national post-market drug surveillance
- From:
Acta Pharmaceutica Sinica
2020;55(11):2695-2701
- CountryChina
- Language:Chinese
-
Abstract:
Heavy metals and other harmful elements in traditional Chinese medicines inflict serious damage on public health. Therefore, risk assessment of Chinese raw materials has gained increasing attention. To date, few reports have been published on the health risk assessment of heavy metals and harmful elements in Chinese patent medicines. To gain a comprehensive understanding of heavy metals and other harmful elements in Chinese patent medicines and to establish proper limits, residual Pb, Cd, As, Hg, Cu and Cr in 15 054 samples of 295 drugs was analyzed with regard to distribution and variation between elements and dosage forms. In addition, in accord with procedures including hazard identification, hazard characterization, exposure assessment and risk characterization, basic procedures and specific parameters for risk assessment of heavy metals and harmful elements in Chinese patent medicines were clarified based on the health risk assessment of 14 787 samples and 276 drugs. A method and equation for establishing residual limits is proposed. The results show that content and target hazard quotients (THQs) of the investigated elements in all samples showed a skewed distribution approaching 0. Content of Pb, As, Cu, Hg, Cd or Cr in the samples exceeded 100 mg·kg-1 and the content of Pb, As, or Cu in individual samples exceeded 1 000 mg·kg-1. THQs of 586 samples and four drugs were above 1. We believe that the health risk of Hg, Pb and As in Chinese patent medicines with dosage forms of pill, capsule, tablet and powder, especially those in raw powder preparations, warrant concern.
