基于药典算法的无公害中药材农残限量通用标准的RAM研究
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摘要
中药材农残及重金属超标严重危害人类健康及中医药产业的可持续发展,为提升中药材质量,建立无公害中药材及饮片农药最大残留限量(MRL)通用标准,从根源上保障临床用药安全。采用《中国药典》的农药最大残留计算公式(MRL=A×W/100M)计算出本标准MRL,与国内外现行标准及文献比较,通过RAND/UCLA合适度检测法(RAND/UCLA appropriateness method,RAM)形成专家咨询问卷并采用9分制的李克特量表(Likert scale)进行合适度分析,确定无公害中药材及饮片农药最大残留限量通用标准。结果表明:共计9位来自不同领域的专家分别就标准制定的必要性及206种农残限量进行了评分。206种农药进行RAND/UCLA合适度评分后分值均大于7,合适度为100%,专家意见达成了一致。采用RAND/UCLA(RAM)合适度检测法建立的无公害中药材质量标准达成了专家共识,形成的206种农药最大残留限量标准与CAC、欧盟、美国、韩国、日本、澳大利亚、新西兰及加拿大颁布相关标准进行了对比分析,结果表明,88.8%农药类型的MRL与国际标准规定的MRL范围一致,4.4%农药类型的MRL高于国际标准范围,6.8%农药类型的MRL低于国际标准范围。该标准的制定为规范无公害中药材的农药使用提供了依据。
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.
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.
引文
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