| 苏晶,陶慕珂,陈晓虎,李青.远志质量问题及中药材产地加工探讨[J].中国药事,2018,32(11):1467-1472 |
| 远志质量问题及中药材产地加工探讨 |
| On Quality Problems of Polygalae Radix and Primary Processing of Traditional Chinese Medicinal Materials |
| 投稿时间：2018-07-13 |
| DOI：10.16153/j.1002-7777.2018.11.004 |
| 中文关键词: 中药材 远志 产地加工 质量监控 黄曲霉毒素 远志(口山)酮Ⅲ |
| 英文关键词: traditional Chinese medicinal materials Polygalae radix primary processing quality control aflatoxin Polygalaxanthone Ⅲ |
| 基金项目:国家十二五“重大新药创制”专项（编号2014ZX09304307-002），药品医疗器械审评审批制度改革子课题（中药）（编号ZG2016-2-06） |
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| 中文摘要: |
| 目的：总结2017年远志监督检验工作中发现的影响质量的主要问题，完善远志的质量标准，对其产地加工及贮藏提供建议。方法：基于远志（口山）酮Ⅲ的含量测定、制远志的甘草鉴别，分析检验过程中遇到的问题，探讨现行标准对质量控制的可行性。模拟产地加工及贮藏条件，研究远志易感染黄曲霉及黄曲霉毒素超标的原因。结果与结论：现行质量标准中远志（口山）酮Ⅲ含量测定不能准确定量，现有标准的含量限度偏高；制远志质量标准不能控制其是否依法炮制，中药饮片厂炮制过程中可能存在偷工减料；远志产地加工及贮藏过程中易感染黄曲霉，造成黄曲霉毒素超标。建议修订远志质量标准中远志（口山）酮Ⅲ含量测定项，增订蜜远志质量标准，完善制远志质量标准，发布远志产地加工及贮藏指导意见，以便更全面地控制远志药材质量。 |
| 英文摘要: |
| Objective: To summarize the major problems affecting the quality found in the supervision and inspection work of Polygalae radix in 2017, to improve its quality standards, and to provide suggestions for the primary processing and storage. Methods: Based on the determination of the content of Polygalaxanthone Ⅲ, identification of Radix Glycyrrhizae from processed Polygalae radix and the problems encountered in the process of analysis and inspection the feasibility of the current standards for quality control were discussed. The reasons for the susceptibility to Aspergillus flavus and aflatoxin exceeding the standards were analyzed by simulating the primary processing and storage conditions of Polygalae radix. Results and Conclusion: According to the current quality standards, the content of Polygalaxanthone Ⅲ could not be accurately determined and the content limit was too high. The quality standards of processed Polygalae radix could not control whether it was processed according to the standards. There might exist jerry-building and cutting of materials in the processing of Herbal Piece Factories. Polygalae radix was susceptible to Aspergillus flavus during primary processing and storage, causing aflatoxin to exceed the standards. It was suggested to revise the content of determination of Polygalaxanthone Ⅲ in the Polygalae radix quality standards, to increase the quality standards of honey baked Polygalae radix, to improve the quality standards of processed Polygalae radix, and to publish the guidance of primary processing and storage of Polygalae radix in order to more comprehensively control the quality of medicinal material of Polygalae radix. |
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