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基于国家药品抽检的川牛膝质量问题及建议

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  • NETL
  • NSTL
  • 万方数据
目的 基于2022年国家药品抽检工作，分析市场上不同厂家川牛膝质量差异，分析问题并提出建议，为川牛膝的质量监管及标准提高提供依据。方法 针对所抽取川牛膝样品按照相应标准进行检测，出具检验报告书。针对检验中所发现的质量问题、标准问题及前期调研发现的相关问题进行有针对性的探索性研究，进行质量评价分析，发现问题，提出建议。结果 共抽取川牛膝样品334批。标准检验，2批样品性状不合格，存在用麻牛膝充当川牛膝使用的情况，同时发现标准收载含量测定方法过于复杂，且限度过低。探索性研究，27批川牛膝检出麻牛膝特有成分牛膝皂苷Ⅰ，7批超出规定限度，存在麻牛膝混用的情况;270批川牛膝检出植物生长调节剂(多效唑)。114批重金属及有害元素镉(Cd)检测超出限度。最后提升了川牛膝质量标准、建立了补充检验方法、提出风险警示。结论 通过此次全国抽检发现川牛膝饮片和标准中的相关问题，提示需完善标准并加强川牛膝的质量监管。
Quality Analysis of Cyathulae Radix Based on National Drug Sampling and Testing and Some Suggestions
OBJECTIVE To analyze the quality differences of Cyathulae Radix from different manufacturers on the market based on national drug sampling and testing in 2022,then analyze the problems and put forward suggestions to provide basis for the quality supervision and standard improvement of Cyathulae Radix.METHODS Inspection was conducted according to corresponding stand-ards,inspection reports were issued,and then quality evaluation and analysis were conducted.At the same time,problems were found and suggestions were made based on targeted exploratory research on quality problems,standard problems and other related problems found in the inspection RESULTS A total of 334 batches of Cyathulae Radix samples were taken.According to the standard inspec-tion,two batches of samples were found to be substandard in character,and Cyathulae capitatae Radix was used as Cyathulae Radix.At the same time,it was found that the content determination methods in the standard were too complex,and the specified limit for con-tent determination was too low.In the exploratory study,the unique component achybidensaponin I was detected in 27 batches of Cya-thulae Radix and 7 batches exceeded the specified limit,which was mixed with Achyranthes bidentata.Plant growth regulator(paclobutrazol)was detected in 270 batches of Cyathulae capitatae Radix The detection of heavy metals and harmful elements cadmi-um(Cd)in 114 batches exceeded the limit.Finally,the quality standard of Cyathulae Radix was improved,the supplementary test method was established,and the risk warning was put forward.CONCLUSION Through the national sampling inspection,the rele-vant problems in the prepared slices and quality standards of Cyathulae Radix are found,suggesting that the quality standards should be improved and the quality supervision of Cyathulae Radix should be strengthened.

Cyathulae RadixCyathulae capitatae Radixnational drug sampling and testingquality analysispaclobutrazol

高必兴、齐景梁、李倩、耿昭、钟恋、高驰、邓曦、王颖、包小红、杨蕾、苟琰

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四川省药品检验研究院,国家药品监督管理局中成药质量评价重点实验室,成都 611731

川牛膝 麻牛膝 国家药品抽检 质量分析 多效性

四川省药品监督管理局科技计划项目资助国家药品监督管理局中国药品监管科学行动计划第二批重点项目资助四川省药品检验研究院院立项目资助

2021002NMPAJGKX-2023-0752024-KYYL-002

2024

10.11669/cpj.2024.03.012

中国药学杂志
中国药学会

中国药学杂志

CSTPCD北大核心
影响因子：0.957
ISSN：1001-2494
年,卷(期)：2024.59(3)
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