Luo Lu, Dong Lin-Lin, Li Meng-Zhi, Liang Yi-Chuan, Wei Guang-Fei, Zhang Yun-Yi, Qian Zhong-Zhi, Chen Shi-Lin
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
Chinese Pharmacopoeia Commission Beijing 100061, China.
Zhongguo Zhong Yao Za Zhi. 2019 Jun;44(11):2197-2207. doi: 10.19540/j.cnki.cjcmm.20190514.101.
The excessive pesticide residues and heavy metals in traditional Chinese medicine seriously endanger human health and the sustainable development of Chinese medicine industry. In order to improve the quality of traditional Chinese medicine and establish a general standard for maximum residue limits(MRL) of pesticides in pollution-free traditional Chinese medicine and decoction pieces, and to ensure the safety of clinical medication from its origin, MRLs were calculated based on the formula(MRL=A×W/100M) from Chinese Pharmacopeia, comparing it with the current Chinese and international standards as well as literature review, the RAND/UCLA appropriateness method(RAM) was applied to determine the categories and MRLs of pesticides in pollution-free traditional Chinese medicine and decoction pieces. Two questionnaires were drafted for expert panel and appropriateness analysis was carried out with the 9-point Likert scale to determine the general standard for MRLs of pollution-free traditional Chinese medicine and decoction pieces. The results showed that a total of nine experts from different fields scored the necessity of standard-setting and 206 pesticide residue limits respectively. The appropriateness scores of 206 pesticides were greater than 7, and appropriateness rate was 100%, which signifies that the expert panel has reached consensus. In summary, based on the RAM, the general standard for maximum residue limits of pesticides in pollution-free Chinese medicines and decoction pieces has reached an expert consensus. Comparing with the MRLs of medicinal plants and plant-sourced food from CAC, Europe Union, the United States, South Korea, Japan, Australia, New Zealand and Canada, 206 MRLs from this general standard share 88.8% in common, 4.4% of which is higher and 6.8% lower than those international standards. This has provided a basis for standardizing the use of pesticides in pollution-free traditional Chinese medicine.
中药材中过量的农药残留和重金属严重危害人体健康及中医药产业的可持续发展。为提高中药材质量，建立无公害中药材及饮片农药最大残留限量（MRL）的通用标准，从源头保障临床用药安全，依据《中国药典》公式（MRL = A×W/100M）计算MRL，并与现行中国及国际标准以及文献进行比较，应用RAND/UCLA适宜性方法（RAM）确定无公害中药材及饮片农药的种类和MRL。针对专家小组起草两份问卷，采用9级李克特量表进行适宜性分析，以确定无公害中药材及饮片MRL的通用标准。结果显示，来自不同领域的9位专家分别对标准制定的必要性和206种农药残留限量进行评分。206种农药的适宜性得分均大于7，适宜率为100%，表明专家小组已达成共识。综上所述，基于RAM，无公害中药材及饮片农药最大残留限量的通用标准已达成专家共识。与食品法典委员会（CAC）、欧盟、美国、韩国、日本、澳大利亚、新西兰和加拿大的药用植物及植物源食品的MRL相比，该通用标准的206个MRL有88.8%相同，其中4.4%高于国际标准，6.8%低于国际标准。这为规范无公害中药材农药使用提供了依据。
