| 林雀跃,黄清泉,滕爱君,马双成,谢培德,昝珂.基于国家药品评价性抽验的通草品种的质量及监管对策[J].中国药事,2019,33(12):1419-1423 |
| 基于国家药品评价性抽验的通草品种的质量及监管对策 |
| On Quality and Regulatory Countermeasures of Tetrapanacis Medulla Based on National Drug Sampling Inspection |
| 投稿时间：2019-04-13 |
| DOI：10.16153/j.1002-7777.2019.12.014 |
| 中文关键词: 通草 专项抽验 混淆品 非法增重 市场调研 质量分析 |
| 英文关键词: tetrapanacis medulla special sampling inspection adulterant illegal weight gain market investigation quality analysis |
| 基金项目:科技部国家科技重大专项（民口）课题重大新药创制“中药组分资源库及产业公共技术服务平台建设”（编号2018ZX09735-006） |
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| 中文摘要: |
| 目的：通过开展通草的国家药品评价性抽验，掌握全国范围的通草质量问题及对策，为该药材的监管提供技术支持，保障公众用药安全。方法：按照《中国药典》2015年版一部进行法定检验，针对存在的问题，进行探索性研究。结果：共抽验118批通草药材及饮片，按现行质量标准检验，合格86批，不合格32批，不合格项目为性状和总灰分；市场调研显示通草药材品种混乱，与抽样结果相符；针对通草非法增重问题，建立了补充检验方法。结论：超过四分之一的通草饮片质量存在问题，主要为品种混乱及非法增重。 |
| 英文摘要: |
| Objective: To find out the quality problems and countermeasures for Tetrapanacis medulla through national drug sampling inspection so as to provide technical support for the supervision of this medicinal material and ensure the safety of public medication. Methods: Statutory inspection was carried out according to the Chinese Pharmacopeia 2015 edition volume I. Furthermore, exploratory research was developed to solve the problems. Results: A total of 118 batches of Tetrapanacis medulla medicinal materials and decoction pieces collected nationwide underwent sampling inspection, of which 86 batches were qualified while 32 batches were unqualified according to the current quality standards. The unqualified items were traits and total ash. Market investigation showed that the varieties of the medicinal materials were chaotic, which was consistent with the results of the sampling inspection. A supplementary test method was established to solve the problem of illegal weight gain. Conclusion: Adulterants and illegal weight gain were found in more than one fourth of Tetrapanacis medulla decoction pieces. |
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