我国2013-2017年中药材及饮片硫熏情况调查以及二氧化硫残留量限度标准建议
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篇名: 我国2013-2017年中药材及饮片硫熏情况调查以及二氧化硫残留量限度标准建议
TITLE:
摘要: 目的:对我国中药材及饮片的硫熏现状进行调查,并提出对其二氧化硫残留量限度标准的建议。方法:收集来自全国27个省、直辖市、自治区的省/市级药品检验机构在2013-2017年期间的共374个中药材及饮片品种信息及二氧化硫残留量测定数据,并进行汇总分析。对样品数量≥10批的121个品种的二氧化硫残留量平均值、中位值、最大值、合格率、检出率等指标进行分类统计。结果:本次调查共涉及中药材及饮片374个品种,合计13 776批次样品,其二氧化硫含量平均值为242 mg/kg,中位值为27 mg/kg,最大值为8 782 mg/kg,总体合格率为79.7%。分类统计的结果显示,《中国药典》规定限度不得超过400 mg/kg的10个品种中,党参、天花粉、天冬、粉葛、牛膝等5个品种硫熏超标现象较严重,合格率均不到80%;样品数量≥30批的品种中,红花等16个品种不存在或极少存在滥用硫熏情况,土鳖虫等19个品种虽存在过度硫熏的情况但不严重,金银花等25个品种存在严重的过度硫熏情况;样品数量为10~29批的品种中,酸枣仁等33个品种不存在或极少存在滥用硫熏情况,菟丝子等8个品种虽存在过度硫熏的情况但不严重,瓜蒌皮等10个品种存在严重的过度硫熏情况。结论:对于不存在或极少存在过度硫熏的品种,建议单列名单,不需进行批批检测;对于存在硫熏现象及硫熏现象严重的品种,建议在2020版《中国药典》各品种项下增加二氧化硫残留限量项目,并将硫熏严重的品种限量规定为不得超过400 mg/kg,到2025年版《中国药典》则可将其限量要求降低至不得超过150 mg/kg;其他品种则保留2015年版《中国药典》(四部)通则0212“药材和饮片检定”中的“二氧化硫药材及饮片(矿物类除外)的二氧化硫残留量不得超过150 mg/kg”的规定。
ABSTRACT: OBJECTIVE: To investigate the status of sulfur fumigation of TCM and its decoction pieces, and to put forward the suggestions on limit standard of sulfur dioxide residue. METHODS: The information of 374 varieties of TCM and sulfur dioxide residue were collected from the provincial and municipal drug inspection institutions of 27 provinces,municipalities and autonomous regions in China during 2013-2017, and then summarized and analyzed. The average value,median value,maximum value,qualification rate and detection rate of sulfur dioxide residue of 121 varieties with the sample number ≥10 batches were classified and statistically analyzed. RESULTS: This investigation involved 374 varieties of TCM and its decoction pieces, and a total of 13 776 batches of samples. The average content of sulfur dioxide was 242 mg/kg,the median value was 27 mg/kg,and the maximum value was 8 782 mg/kg. The overall qualified rate was 79.7%. According to the results of classified statistics, among the 10 varieties whose limit shall not exceed 400 mg/kg,5 varieties,including Codonopsis pilosula, Radix Trichosanthis, Asparagus cochinchinensis, Pueraria lobata, Achyranthes bidentata, were seriously affected by sulfur fumigation,and the qualified rate was less than 80%. Among the varieties with the sample number≥30 batches, there was no or very little abuse of sulfur fumigation in 16 varieties, such as Carthamus tinctorius; 19 varieties, such as Eupolyphaga Steleophaga, had excessive sulfur fumigation, but it was not serious; 25 varieties,such as Lonicera japonica,had severe excessive sulfur fumigation. Among the varieties with the sample number of 10-29 batches,33 varieties including Ziziphus jujube seed had no or very little abuse of sulfur fumigation; 8 varieties including Cuscuta chinensis had excessive sulfur fumigation but were not serious; 10 varieties including Pericarpium Trichosanthis had serious excessive sulfur fumigation. CONCLUSIONS: For the varieties with no or very little excessive sulfur fumigation,it is recommended that batch testing should not be carried out and a single list should be made; for the varieties with sulfur fumigation or severe sulfur fumigation, it is suggested to increase the sulfur dioxide residue limit under all varieties in the 2020 edition of Chinese Pharmacopoeia, and set the limit for the varieties with severe sulfur fumigation to be no more than 400 mg/kg,while the limit for the 2025 edition of Chinese Pharmacopoeia can be reduced to no more than 150 mg/kg. Other varieties should retain the provisions of “sulfur dioxide residue of sulfur dioxide medicinal materials and decoction pieces (except for minerals) shall not exceed 150 mg/kg” in the general rules 0212 “for the identification of medicinal materials and decoction pieces” in the 2015 edition of Chinese Pharmacopoeia (part Ⅳ).
期刊: 2019年第30卷第24期
作者: 许玮仪,于江勇,金红宇,孙磊,马双成
AUTHORS: XU Weiyi,YU Jiangyong,JIN Hongyu,SUN Lei,MA Shuangcheng
关键字: 中药材;饮片;硫熏;二氧化硫;残留量;限度;标准
KEYWORDS: TCM; Decoction piece; Sulfur fumigation; Sulfur dioxide; Residues; Limit; Standard
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