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厚朴药材专项抽验情况分析与研究
引用本文:曲佳,陈卓,王静,牛辰瑾,郑新元.厚朴药材专项抽验情况分析与研究[J].中国药事,2018,32(10):1362-1372.
作者姓名:曲佳  陈卓  王静  牛辰瑾  郑新元
作者单位:天津市药品检验研究院, 天津 300070,天津市药品检验研究院, 天津 300070,天津市药品检验研究院, 天津 300070,天津市药品检验研究院, 天津 300070,天津市药品检验研究院, 天津 300070
摘    要:目的:通过分析176批厚朴饮片及其炮制品的国家评价性抽验结果,对其质量现状进行评价。方法:按照厚朴现行法定标准检验中出现的问题,建立了真伪鉴别、有效性、安全性方面的探索性研究,对厚朴饮片及其炮制品的质量状况进行了全面的分析与评价。结果:法定标准检验合格率为95.5%;探索性研究方法检验合格率为88.8%。不合格的主要原因有含量、掺伪及炮制品辅料等。结论:厚朴饮片及其炮制品质量现状较好,但检验标准仍需进一步完善。

关 键 词:厚朴饮片及其炮制品  国家评价性抽验  质量分析  法定标准  探索性研究
收稿时间:2017/5/10 0:00:00

On National Evaluation Sampling Test of Magnolia Officinalis
Qu Ji,Chen Zhuo,Wang Jing,Niu Chenjin and Zheng Xinyuan.On National Evaluation Sampling Test of Magnolia Officinalis[J].Chinese Pharmaceutical Affairs,2018,32(10):1362-1372.
Authors:Qu Ji  Chen Zhuo  Wang Jing  Niu Chenjin and Zheng Xinyuan
Institution:Tianjin Institute for Drug Control, Tianjin 300070, China,Tianjin Institute for Drug Control, Tianjin 300070, China,Tianjin Institute for Drug Control, Tianjin 300070, China,Tianjin Institute for Drug Control, Tianjin 300070, China and Tianjin Institute for Drug Control, Tianjin 300070, China
Abstract:Objective: To evaluate the current quality of magnolia officinalis by analyzing the results of national evaluation sampling test of 176 batches of magnolia officinalis pieces and its processed products. Methods: According to the existing problems in the current statutory standard test of Magnolia officinalis, an exploratory study of the authenticity identification, effectiveness and safety was established. The quality of magnolia officinalis pieces and its processed products were analyzed and evaluated comprehensively. Results: The qualified rate of the statutory standard was 95.5%, and the qualified rate of the exploratory study method was 88.8%. The main reasons for nonconformity included content, adulteration and excipient of processed products. Conclusion: The current quality of magnolia pieces and its processed products is better, but the test standards still need to be further improved.
Keywords:magnolia officinalis pieces and its processed products  national evaluation sampling test  quality analysis  statutory standard  exploratory study
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