目的 通过三七伤药片的评价性抽验结果进行分析,对其质量现状进行评价。方法 依据标准检验中发现的问题,结合原药材的质量现状,从与药品真实性、有效性、安全性等方面进行探索性研究,对三七伤药片的质量状况进行全面分析与评价。结果 标准检验合格率为98.8%;探索性研究结果表明,部分企业可能存在投料不足、制法与标准不一致、染色、重金属及有害元素超标,过度辐照等问题。结论 三七伤药片总体质量状况较好,质量标准有待进一步提高。
Abstract
OBJECTIVE To evaluate the quality status of Sanqi Shangyao tablets. METHODS Based on the results of statutory inspection and exploratory research, the quality evaluation regarding authenticity, effectiveness, and safety, was carried out. RESULTS The qualified rate of inspection was 98.8%. Some problems, such as inconsistency of preparation process of standards and illegal dying, were discovered in some samples. CONCLUSION In general,the overall quality of Sanqi Shangyao tablets is good. Some deficiency in the quality standards deserves further concern.
关键词
三七伤药片 /
质量分析 /
国家评价性抽验
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Key words
Sanqi Shangyao tablet /
quality analysis /
national evaluation sampling
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中图分类号：
R917
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参考文献
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脚注
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基金
国家十二五“重大新药创制”专项(2014ZX09304307-002)
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