中药材二氧化硫限量标准及残留现状探讨

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传统的硫磺熏蒸加工方法由于其经济简便、可操作性强,防霉防虫等特点被广泛应用于药材初加工和仓储等环节。但是过度硫磺熏蒸会造成药材化学成分发生量变或质变,甚至危害人体健康。调查发现,中药材硫磺熏蒸方式主要是待药材采收后直接熏蒸以快速干燥,或者在贮藏过程中将干药材润湿后再熏蒸以防霉防虫。比较二氧化硫限量标准发现,中药材二氧化硫限量标准要比食品中的限量标准严苛得多。基于现有限量标准,统计得到了35种中药材共计862批药材的二氧化硫残留情况,按照中国药典限量标准(150/400 mg·kg-1)计算得到平均超标率高达52.43%。若按照食品添加剂法典标准中蔬菜的限量值计算(500 mg/kg),则平均超标率降为29.47%。作者认为应正确看待硫磺熏蒸问题:二氧化硫属于低毒物质,相比于黄曲霉素等高毒物质来说,残留危害并不大,少量残留也不会增加中药材毒性;但硫熏可能会改变中药材化学成分含量,从而影响中药材质量;毒性物质的暴露危害与暴露周期、暴露频次、使用方法等综合因素有关。建议加强中药材二氧化硫限量标准研究,制定切实可行,既符合中药材用药特点,又能保障人民安全用药需要的中药材二氧化硫残留限量标准。 Traditional sulfur fumigation processing method because of its economy is simple, maneuverability, mildew and pest control and other characteristics are widely used in raw materials processing and warehousing and other sectors. However, excessive sulfur fumigation will cause the chemical composition of the amount of change or qualitative change, or even endanger human health. The survey found that Chinese herbal medicines sulfur fumigation method is mainly to be directly after fumigation medicinal herbs fumigation to dry quickly, or in the course of storage of dried herbs after wetting fumigation to prevent mildew. Comparison of sulfur dioxide limit standards found that Chinese herbal medicine sulfur dioxide limit standards than food standards are much more demanding. Based on the existing limited standards, a total of 862 Chinese herbal medicines were collected for determination of sulfur dioxide residues. According to the Chinese Pharmacopoeia (150/400 mg · kg-1), the average over-standard rate was 52.43%. If calculated according to the limit values ​​of vegetables in the Codex Standard for Food Additives (500 mg / kg), the average rate of over-standard drops to 29.47%. The authors believe that sulfur fumigation should be correctly considered: sulfur dioxide is a low-toxic substance, compared with other high toxic substances such as aflatoxin, the residue is not harmful, a small amount of residue will not increase the toxicity of Chinese herbal medicines; sulfur smoked may Changes in the chemical composition of Chinese herbal medicines, thus affecting the quality of Chinese herbal medicines; exposure to toxic hazards and exposure cycles, exposure frequency, methods of use and other comprehensive factors. Proposed to strengthen the study of Chinese herbal medicines sulfur dioxide limit standards, to develop practical, not only in line with the characteristics of traditional Chinese medicine medication, but also to ensure the safety of people’s needs Chinese herbal medicines sulfur dioxide residue limits.
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