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。
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.
作者
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
Ren Qi;Fu Huizheng;Xu Yan;Shen Min;Wu Qiuping;Zhao Wen;Zhou Zhiqiang;Zheng Yingying;Luo Yuehua;Zhong Ruijian(Jiangxi Institute for Drug Control,Jiangxi Engineering Research Center for Drug and Medical Device Quality,Nanehang 330029,China)
出处
《中国药事》
CAS
2018年第11期1473-1482,共10页
Chinese Pharmaceutical Affairs
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
Atractylodes macrocephala
quality analysis
statutory standard testing
excessive sulfur
exploratory research
pesticide leftover