中药材西红花ISO国际标准研究

Study on ISO international standards for traditional Chinese medicine Croci Stigma(Xihonghua)

目的:制定西红花药材ISO国际标准,保证临床用药的质量和安全,促进中药西红花的国际贸易。方法:收集来自全球10个不同地区总计40批样品,参照2020年版《中国药典》及世界各国药典对西红花的收录情况,检测了药材的水分和挥发性物质、灰分、酸不溶性灰分,对药材粉末进行了薄层鉴别以及西红花苷、重金属和农药残留物的含量测定。结果:在薄层鉴别中,所有产地西红花色谱均与对照品色谱位置相同,且显相同颜色的荧光斑点;规定西红花药材的水分和挥发性物质含量在12.0%以下,总灰分含量在7.5%以下,酸不溶性灰分含量在1.0%以下,重金属铅、镉、砷、汞含量分别不得超过5.0 mg·kg^(-1)、0.3 mg·kg^(-1)、3.0 mg·kg^(-1)、0.2 mg·kg^(-1),农药残留物六氯环己烷、双对氯苯基三氯乙烷、狄氏剂残留量分别不得超过0.1 mg·kg^(-1),狄氏剂残留量不超过0.05 mg·kg^(-1),西红花苷-Ⅰ和西红花苷-Ⅱ总含量需大于10.0%。结论:全面考察规定了全球流通西红花药材的各项质量指标,推进中药材西红花国际标准制定,为西红花药材及相关产品在国际市场流通提供技术支撑和法律依据。

Objective:To establish ISO international standards for Xihonghua medicinal herbs,ensuring the quality and safety of clinical medication and promoting international trade of traditional Chinese medicine Xihonghua.Methods:A total of 40 batches of samples from 10 different regions worldwide were collected.Referring to the 2020 edition of the Chinese Pharmacopoeia and the inclusion of Xihonghua in pharmacopoeias of various countries,the moisture and volatile substances,ash content,acid-insoluble ash content,and the contents of crocin,heavy metals,and pesticide residues in the medicinal herbs were tested.Results:In thin layer chromatography identification,the chromatography of Xihonghua from all production areas appeared at corresponding positions to the reference chromatography,showing the same color fluorescence spots.The specified moisture and volatile substance content in Xihonghua was less than 12.0%,the total ash content was less than 7.5%,the acid-insoluble ash content was less than 1.0%.The content of heavy metals lead,cadmium,arsenic,and mercury was less than 5.0 mg·kg^(-1),0.3 mg·kg^(-1),3.0 mg·kg^(-1),and 0.2 mg·kg^(-1),respectively.Pesticide residues of hexachlorocyclohexane,dichlorodiphenyltrichloroethane was less than 0.1 mg·kg^(-1),and dieldrin was less than 0.05 mg·kg^(-1).The total content of saffron crocin-I and crocin-II shall not be less than 10.0%.Conclusion:A comprehensive assessment of various quality indicators of Xihonghua has been conducted,advancing the development of international standards for Xihonghua medicinal herbs.This initiative can provide technical support and legal foundation for Xihonghua and related products to enter the international market.