附子质量控制研究进展.PDFVIP

中国药事 2019年7月 第33卷 第7期 767 附子质量控制研究进展 * * 昝珂，过立农，马双成，刘杰，郑健 ，高妍 （中国食品药品检定研究院，北京 100050） 摘要 ：目的 对近年来附子的质量控制研究进展进行总结并提出相应建议，为有毒药材附子的质量控制 及其监管提供参考。方法：采用查阅国内外相关文献、质量标准、炮制规范，进行归纳分析，对附子的 质量研究进展进行综述。结果：附子的质量控制研究较多，药典标准基本能够起到控制其质量的作用。 但还存在着一些地方炮制规范制订时间较早，方法存在一定的缺陷；很多含附子的成药中缺少完善的质 控措施；附子饮片的质量参差不齐，缺少合理的质量分级标准；测定双酯型生物碱所需的乌头碱对照品 较难获得等问题。结论：附子的质量控制有一定进展，但仍有较多问题亟待解决以保障人民用药的安全 有效。 关键词： 附子；质量控制；毒性；研究进展 R28 R95 A 1002-7777(2019)07-0767-07 中图分类号： ； 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2019.07.008 Research Progress in Quality Control of Radix Aconiti Lateralis Praeparata * * Zan Ke, Guo Linong, Ma Shuangcheng, Liu Jie, Zheng Jian , Gao Yan (National Institutes for Food and Drug Control, Beijing 100050, China) Abstract Objective: To summarize research progress of quality control of Radix Aconiti Lateralis Praeparata (Fuzi) in recent years and put forward corresponding suggestions in order to provide references for quality control and regulation of the toxic medicinal materials. Methods: The relevant literatures about quality standards and processing specifications at home and abroad were summarized and analyzed. The research progress of quality control of Fuzi was reviewed. Results: There were many studies on quality control of Fuzi. Pharmacopoeia standards could basically control its quality. But there were still some problems, such as the early formulation of local processing standards, the shortcomings of methods, lack of perfect quality control measures in many patent medicines containing Fuzi, uneven quality of decoction pieces, lack of reasonable quality classification standards, and difficulty of obtaining reference substances for the determination of diesteralk