目的 通过国家药品评价性抽检工作,比较市场上不同厂家生产的制川乌样品的质量,分析存在的问题并提出建议,为制川乌的标准提高和市场监管提供基础数据。方法 从全国28个省级行政区抽取制川乌样品,按照2015年版《中国药典》(一部)制川乌项下的性状和薄层鉴别对制川乌开展常规检验工作,出具检验报告,分析目前制川乌饮片的市场情况。针对检验中反映的情况,结合探索性研究对64家企业生产的107批制川乌质量进行评价,发现问题并开展相应检测方法研究。结果 本次抽检的制川乌样品共计107批,其中3批样品性状不合格,存在用附子当做制川乌使用的情况。结论 通过全国抽检发现制川乌饮片和标准中的问题,结合标准提高工作完善制川乌检验标准。
Abstract
OBJECTIVE To conduct quality evaluation of Aconiti Radix Cocta by analyzing the RESULTS in national drug sampling and testing, analyze the quality differences among different companies, and put forward suggestions for the improvement of quality standards and market supervision on Aconiti Radix Cocta. METHODS According to the current statutory standard of Aconiti Radix Cocta in Chinese Pharmacopoeia (2015 edition) Volume Ⅰ, quality inspection and data analysis were carried out to evaluate the quality of Aconiti Radix Cocta which were sampled from 28 provinces in China. Moreover, other METHODS were used in exploratory study for solving the problems found in the inspection base on the 107 batches of samples came from 64 companies. RESULTS A total of 107 batches of samples were tested and three batches failed to satisfy the standard. The three batches of samples could be Fuzi. CONCLUSION Through the drug sampling and testing in China, the problems in the inspection standard of Aconiti Radix Cocta are found. The inspection standard of Aconiti Radix Cocta needs to be further improved combined with the improvement of the standard.
关键词
制川乌 /
国家药品评价性抽检 /
质量分析 /
标准提高 /
强阳离子吸附树脂固相萃取
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Key words
Aconiti Radix Cocta /
national drug sampling and testing /
quality evaluation /
national drug standard improvement /
SCX-SPE
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中图分类号:
R284
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脚注
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基金
国家药典委员会2020国家药品标准提高-制川乌制草乌标准提高研究项目资助(2020Z008)
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