| 许玮仪,于江泳,王莹,金红宇,孙磊,马双成.全国10种中药材品种中亚硫酸盐残留量的初步风险评估[J].中国药事,2019,33(5):513-518 |
| 全国10种中药材品种中亚硫酸盐残留量的初步风险评估 |
| Preliminary Risk Assessment of Sulfite Residues in Ten Kinds of Traditional Chinese Medicinal Materials |
| 投稿时间：2018-12-28 |
| DOI：10.16153/j.1002-7777.2019.05.004 |
| 中文关键词: 硫磺熏蒸 中药材及饮片 风险评估 限量标准 |
| 英文关键词: sulphur fumigation traditional Chinese medicinal materials and decoction pieces risk assessment limit standard |
| 基金项目:国家十二五"重大新药创制"专项-中药质量安全检测和风险控制技术平台（编号2014ZX09304307-002） |
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| 中文摘要: |
| 目的：统计全国市场上10种常用中药材及饮片品种的亚硫酸盐残留量，初步评估摄入的健康风险，对目前《中国药典》限量值提出建议标准。方法：在全国范围内，统计2013-2017年10种药材及饮片的二氧化硫残留量值，结合《中国药典》2015年版对服用剂量的规定，采用点评估的方法初步评估二氧化硫的暴露风险。结果：按各品种二氧化硫残留量平均值、中位值以及限量值计算，人群服用这10种药材及饮片二氧化硫暴露值低于国际食品法典食品添加剂专家委员会（JFCFA）规定的二氧化硫每日允许摄入量上限（0.7 mg·kg-1体重），风险系数HI小于1，风险可接受；但部分品种二氧化硫残留量最大值计算的HI大于1，具有一定的风险。结论：从整体水平看，人群单一摄入10种中药材及饮片暴露二氧化硫的健康风险较低；但对于二氧化硫残留量超标的样品，会有一定的健康风险。《中国药典》2015年版规定的二氧化硫残留限量标准基本合理，可以达到控制风险的目的。但本次评估仅局限于单一药材的摄入暴露，未计算累积暴露风险，因此，建议在产业技术不断进步的基础上，逐渐严格限量标准值，以降低安全风险。 |
| 英文摘要: |
| Objective:To assess sulfite residues in ten kinds of common traditional Chinese medicinal materials on the markets, to evaluate the health risk of the SO2 intake and to put forward standard recommendation for the current limit value stipulated in the Chinese Pharmacopoeia. Methods:SO2 residues in ten kinds of traditional Chinese medicinal materials and decoction pieces from 2013 to 2017 were collected from nationwide markets. In combination with the daily dosage stipulated in the Chinese Pharmacopoeia of 2015 edition, the point assessment method was used to evaluate the risk of SO2 exposure. Results:According to the average value, the median value and the limit value of SO2 residues, the SO2 exposure value from taking these ten kinds of traditional Chinese medicinal materials and decoction pieces was lower than the upper limit of SO2 for acceptable daily intake(0.7 mg·kg-1 body weight) stipulated by the Joint FAO/WHO Expert Committee on Food Additives(JECFA). The hazard index (HI) was less than 1, indicating that the risk was acceptable. But the maximum HI of SO2 residues in some kinds was greater than 1, indicating that the risk was unacceptable. Conclusion:On the whole, the health risk of the SO2 exposure by taking one of the ten kinds of traditional Chinese medicinal materials and decoction pieces is low. However, there exists some health risk in the samples with excessive SO2 residues. The limit standard for SO2 residues stipulated in the Chinese Pharmacopoeia of 2015 edition is basically reasonable and can achieve the purpose of controlling risks. However, this assessment is limited to the exposure of a single medicinal material, so the cumulative exposure risk is not calculated. Therefore, it is recommended that the standard value be gradually limited to reduce the safety risks with the continuous improvement of industrial technology. |
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