目的 基于2018年国家药品抽验中药原粉制剂专项工作,探讨中药原粉制剂的质量现状。方法 分析清胃黄连丸、健脾丸、启脾丸、益母丸、上清丸、人参归脾丸、牛黄清胃丸等7个中药原粉制剂的现行标准。建立掺伪、染色、二氧化硫、农药残留、黄曲霉毒素、重金属及有害元素、辐照等检查项目,揭示安全隐患。建立全处方鉴别方法,对样品投料真实性进行评价。结果 2018年抽验涉及的原粉制剂现行标准比较简单,难以全面控制药品质量。未按规定投料,掺伪,铅、砷、汞残留是目前中药原粉制剂存在的主要问题。仅个别样品发现了染色、农药残留或黄曲霉毒素残留。二氧化硫在中药原粉制剂中残留风险低。大部分厂家采用辐照灭菌。结论 建议提高中药原粉制剂标准,实现全处方鉴别,并将重金属及有害元素纳入考察项目。生产企业应加强原料的质量控制,重视掺伪和有害残留风险。国家药品抽验专项工作能够揭示同类品种的共性问题,是药品监管的有力手段。
Abstract
OBJECTIVE To discuss the quality status of TCM raw powder preparations based on TCM raw powder preparation special project of national post-market drug surveillance in 2018. METHODS The statutory standards of seven TCM raw powder preparations, including Qingwei Huanglian pills, Jianpi pills, Qipi pills, Shangqing pills, Renshen Guipi pills, Yimu pills and Niuhuang Qingwei pills, were analyzed. The test methods for adulteration, dyeing, sulfur dioxide, pesticide residues, aflatoxins, heavy metals and harmful elements and irradiation were established to reveal the safety risk. Whole-ingredient identification methods were developed to evaluate the authenticity of the drug. RESULTS =The statutory standards of the TCM raw powder preparations tested in national post market surveillance in 2018 are simple and inadequate to comprehensively control the quality of the drugs. Unqualified feeding, adulteration, and contamination with Pb, As and Hg were the main problems currently. Dyeing, aflatoxins and pesticide residues were found in very few samples. Contamination risk of sulfur dioxide was low in TCM raw powder preparations. Most manufacturers adopted irradiation for sterilization. CONCLUSION The standards of TCM raw powder preparations should be improved to realize whole-ingredient identification. And heavy metals and harmful elements should be investigated. The manufacturers should enhance quality control of the raw material and pay attention to the risk of adulteration and harmful residues. Special project of national post-market surveillance can reveal common problems of similar drugs, which is a powerful measure for drug regulation.
关键词
中药原粉制剂 /
国家药品抽验 /
质量现状 /
掺伪 /
染色 /
二氧化硫 /
农药残留 /
黄曲霉毒素 /
重金属及有害元素 /
辐照 /
全处方鉴别
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Key words
TCM raw powder preparation /
national post-market drug surveillance /
quality status /
adulteration /
dyeing /
sulfur dioxide /
pesticide residue /
aflatoxin /
heavy metals and harmful element /
irradiation /
whole-ingredient identification
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中图分类号：
R917
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参考文献
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脚注
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基金
国家自然科学基金项目资助(81303194);中国食品药品检定研究院学科带头人培养基金项目资助(2017X1)
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