防风质量追溯探索性研究

摘要/Abstract

摘要： [摘要]目的：以外源性杂质监测及质控成分变化研究两条主线，从“基地-药材-饮片-中成药”各个环节，对中药防风全产业链的质量追溯进行探索性研究。方法：在“基地-药材”阶段，对种子的净度、千粒重、发芽率进行测定。采用ICP-MS及GC-MS/MS对土壤和灌溉用水中的重金属（铅、砷、汞）、农药残留（六六六、滴滴涕）进行监测。在“药材-饮片-中成药”阶段，通过对质控成分的定性（显微、薄层色谱、LC-MS）及定量（HPLC）分析来研究其质量传递规律。结果：“基地-药材”阶段，防风种子均可满足播种要求，土壤及药材的重金属（铅、砷、汞）均符合要求。土壤中农药残留符合要求，灌溉用水及药材均未检出农药残留。“药材-饮片-中成药”阶段，药材炮制成饮片的过程中，色原酮及香豆素类成分未发生丢失，能够实现化学成分的传递。3种防风通圣制剂因制备工艺不同，导致其主要化学成分有所差异。结论：在“基地-药材”阶段，重点关注外源性杂质引入，可以从源头降低药材的安全风险，提升药材质量。在“药材-饮片-中成药”阶段，重点关注药材炮制及制剂工艺的影响。通过质量传递规律研究，不仅可以实现对全产业链的追溯核查，也可以为工艺优化、制剂开发、质量控制、适应证研究等提供科学依据。

关键词: font-size:medium, ">防风；防风通圣制剂；质量追溯；外源性杂质；质控成分

Abstract: Objective：The systematic study was taking the monitoring of foreign matter and the variation of quality control components as two main lines， and throughout the whole industry chain of “planting base-Chinese crude drugs-prepared slices of Chinese crude drugs-Chinese patent preparations”. The exploratory research of quality traceability system of traditional Chinese medicine fangfeng was carried out. Methods：In the period of “planting base-Chinese crude drugs-Chinese patent preparations”， the evaluation methods of seed quality including purity， thousand seed weight and germination rate tests were performed. The residues of heavy metals (Pb， As， Hg) and pesticides (HCHs， DDTs) in agricultural soil and water were determined by ICP-MS and GC-MS/MS. In the period of “Chinese crude drugs-prepared slices of Chinese crude drugs-Chinese patent preparations”， the qualitative (microscopic， TLC， LC-MS) and quantitative (HPLC) methods were employed to explore the law of chemical components transfer. Results：The batches of tested seeds were in accordance with the request of seeding. The residues of heavy metals (Pb， As， Hg) in agricultural soil and Chinese crude drugs both met the criteria. The residues of pesticides in agricultural soil accorded with the requirements. The residues of pesticides in agricultural water and Chinese crude drugs were not detected. Furthermore， the chromone and coumarins were not lost during the process of prepared slices of Chinese crude drugs， and the main chemical components could be transferred. The main chemical components of three Fangfeng Tongsheng preparations differed a lot due to different manufacturing processes. Conclusion： In order to reduce the safety risk of Chinese crude drugs from the origin， it is important to focus on the introduction of foreign matter in the period of “planting base-Chinese crude drugs”. In the period of “Chinese crude drugs-prepared slices of Chinese crude drugs-Chinese patent preparations”， the impacts of processing and manufacturing procedure were highly investigated， which can not only make it possible to retrospect and verify the whole industry chain， but also provide scientific basis for process optimization， pharmaceutical preparation development， quality control and clinical research.

Key words: font-size:medium, ">Saposhnikoviae radix； Fangfeng tongsheng preparations； Quality traceability； Foreign matter； Quality control components

中图分类号:

R283
R288

陆松茂, 杨文宁, 吴清云, 刘洋, 孟千万, 周丹丹. 防风质量追溯探索性研究[J]. 中国医药导刊, 2019, 21(10): 623-629.

LU Songmao, YANG Wenning, WU Qingyun, LIU Yang, MENG Qianwan, ZHOU Dandan. Exploratory Research of Quality Traceability System of Saposhnikoviae Radix (Fangfeng)[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2019, 21(10): 623-629.

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