安国八大祁药重金属镍的污染水平分析及出口贸易措施应对

Analysis on Pollution Level of Heavy Metal Nickel in Eight Major Chinese Medicines in Anguo and Measures to Deal with Export Trade

了解安国中药材及其特色品种八大祁药(菊花、紫菀、山药、北沙参、薏苡仁、荆芥穗、白芷、天花粉)的出口情况,并对八大祁药中的重金属镍(Ni)含量进行检测分析与评价,制定有效降低Ni含量的措施,旨为扩大安国八大祁药出口提供信息支持。使用Excel软件对近3a安国中药材及其八大祁药的出口数据进行统计;并实地采样八大祁药,采用湿法消解-石墨炉原子吸收法对其Ni含量进行测定,分别采用GB15196—2003的Ni含量限值(1mg/kg)和2015版《中国药典》第四部中重金属最大限量理论值公式对八大祁药中的Ni含量超限情况进行了评价。结果表明:2016年、2017年、2018年上半年安国中药材的出口总量分别为11853.27、12902.58、5633.07t,出口总额分别为7109.90万、7640.87万、3162.59万美元,主要出口到韩国、日本、德国和中国台湾,其中,八大祁药的总出口量分别为286.32、271.71、144.12t,山药、荆芥穗和白芷出口量一直较大,其他5种中药材2017年的出口量较2016年均有所增加。测定结果显示,八大祁药样品的Ni含量为0.2~2.2mg/kg。采用GB15196—2003的Ni含量限值1mg/kg进行超限评价时,荆芥穗、菊花和北沙参的Ni平均含量超过了1.0mg/kg,超限率也均相对较高;紫菀居于中等水平;其他4种中药材的Ni平均含量和超限率均相对较低,但紫菀、白芷和山药中存在Ni含量较高的样本,天花粉和薏苡仁相对安全。采用2015版《中国药典》第四部中的重金属最大理论限值为标准进行超限评价时,仅山药中有1个样本超过限值,其他药材均未超限。八大祁药在国际市场上有一定的需求,为了保证药材的安全性和有效性,防止重金属污染影响八大祁药的出口,提出了控制重金属含量的4项有效措施:从源头上控制中药材重金属含量;标准化采集、加工及储藏;建立科学合理的中药材重金属风险评估体系;创新监管技术,完善监管制度。

To understand the export situation of eight major Chinese herbal medicines(chrysanthemum,aster,yam, Radix glehniae, coix seed, Schizonepeta tenusfolia flower spikes, Angelica dahurica and Trichosanthes root) in Anguo,the content of heavy metal nickel(Ni) in those Chinese medicines were tested and analyzed,the effective measures to reduce Ni content were formulated to provide information support for expanding the export of these medicines. The Excel software was used to calculate the export data of Chinese herbal medicines and the eight major Chinese medicines of Anguo in recent 3 years. The eight major medicines were sampled in the field,and the Ni content was determined by the wet digestion-graphite furnace atomic absorption method. The Ni content limit(1 mg/kg) in GB15196-2003 and the theoretical formula of the maximum limit of heavy metals in the fourth edition of the Chinese Pharmacopoeia in 2015 were used to evaluate the over-limit of Ni content in the eight major Chinese medicines of Anguo. The results showed that the total exports of Chinese herbal medicines in Anguo in2016,2017,and the first half of 2018 were 11 853.27,12 902.58,and 5 633.07 t,respectively,and the total export value was 71.909,76.408 and 31.625 millions dollons,respectively. These Chinese herbal medicines were mainly exported to South Korea,Japan,Germany and Chinese Taiwan. The total export volume of the eight major Chinese medicines of Anguo were 286.32,271.71 and 144.12 t,respectively,among them,the export volumes of yam,Schizonepeta tenusfolia flower spikes and Angelica dahurica were always larger,and the export volume of the other five Chinese medicinal materials in 2017 was higher than that in 2016. The measurement results showed that the Ni content of the eight major medicines samples was 0.2-2.2 mg/kg. When the Ni content limit of 1 mg/kg of GB 15196-2003 was used to evaluate the over-limit, the average Ni content of Schizonepeta tenusfolia flower spikes,chrysanthemum and Radix Glehniae exceeded 1.0 mg/kg,and the over-limit rate was relatively higher.The average Ni content of the other five Chinese medicines did not exceed 1.0 mg/kg,and the over-limit rate was relatively low,but there were samples with high Ni content in aster,Angelica dahurica and yam,while Trichosanthes root and coix seed were relatively safe. When the maximum theoretical limit of heavy metals in the fourth part of 2015 edition of the Chinese Pharmacopoeia was used as the standard for the over-limit evaluation,only one sample of yam exceeded the limit,and the other medicinal materials were not exceeded. The eight major Chinese medicines of Anguo have certain needs in the international market. In order to ensure the safety and effectiveness of medicinal materials and prevent heavy metal pollution affecting the export,four effective measures to control the content of heavy metals were proposed:controlling the heavy metal content of Chinese medicinal materials from the source,standardizing collection,processing and storage,establishing scientific and reasonable heavy metal risk assessment system for Chinese herbal medicines,and innovating regulatory techniques and improving regulatory systems.was suitable for sowing after oil sunflower harvest,which could be a disaster relief variety sown after July 25 th.