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白术饮片质量分析报告
引用本文:任琦,付辉政,许妍,沈敏,邬秋萍,赵雯,周志强,郑盈莹,罗跃华,钟瑞建.白术饮片质量分析报告[J].中国药事,2018,32(11):1473-1482.
作者姓名:任琦  付辉政  许妍  沈敏  邬秋萍  赵雯  周志强  郑盈莹  罗跃华  钟瑞建
作者单位:江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029,江西省药品检验检测研究院, 江西省药品与医疗器械质量工程技术研究中心, 南昌 330029
摘    要:目的:评价白术饮片的总体质量状况。方法:采用法定标准检验与探索性研究相结合的方法对白术质量进行评价和分析。结果:共抽取248批次白术饮片,按法定标准检验,合格率为96.0%,不合格率为4.0%;不合格项目为二氧化硫残留量和色度,不合格原因为过度硫熏和炮制过度。按探索性研究方法检验,合格率为37.1%,不合格率高达62.9%,不合格原因主要是各产地白术一致性差、指标成分不达标、滥用植物生长调节剂、杀菌剂、杀虫剂农药以及重金属超标等。结论:综合法定检验和探索性研究结果,白术饮片总体质量状况评价为“一般”,建议对白术进行规范化种植,完善提高白术饮片现行质量标准,并加强监管。

关 键 词:白术  质量分析  法定检验  过度硫熏  探索性研究  农药残留
收稿时间:2018/7/13 0:00:00

Report of Quality Analysis on Prepared Slices of Atractylodes Macrocephala
Ren Qi,Fu Huizheng,Xu Yan,Shen Min,Wu Qiuping,Zhao Wen,Zhou Zhiqiang,Zheng Yingying,Luo Yuehua and Zhong Ruijian.Report of Quality Analysis on Prepared Slices of Atractylodes Macrocephala[J].Chinese Pharmaceutical Affairs,2018,32(11):1473-1482.
Authors:Ren Qi  Fu Huizheng  Xu Yan  Shen Min  Wu Qiuping  Zhao Wen  Zhou Zhiqiang  Zheng Yingying  Luo Yuehua and Zhong Ruijian
Institution:Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China,Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China,Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China,Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China,Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China,Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China,Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China,Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China,Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China and Jiangxi Institute for Drug Control, Jiangxi Engineering Research Center for Drug and Medical Device Quality, Nanchang 330029, China
Abstract:Objective: To evaluate the overall quality of prepared slices of Atractylodes macrocephala. Methods: The quality of Atractylodes macrocephala was evaluated and analyzed by statutory standard testing combined with exploratory research. Results: 248 batches of Atractylodes macrocephala were sampled. The qualified rate was 96.0% and the unqualified rate was 4.0% according to the legal standards. The unqualified items were sulfur dioxide residues and chromaticity, and the reasons for disqualification were excessive sulfur and overcooking. The qualified rate was 37.1% and the unqualified rate was as high as 62.9% according to exploratory research testing. The reasons for disqualification were mainly poor consistency of Atractylodes macrocephala in various places, substandard composition, abuse of regulators, fungicides, pesticides for plant growth and excessive heavy metals. Conclusion: Based on the results of statutory standard testing and exploratory research, the overall quality status of Atractylodes macrocephala was evaluated as average. Therefore, it is recommended to standardize the planting of Atractylodes macrocephala, improve the current quality standards of prepared slices of Atractylodes macrocephala, and strengthen supervision.
Keywords:Atractylodes macrocephala  quality analysis  statutory standard testing  excessive sulfur  exploratory research  pesticide leftover
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