《中国药典》鹿衔草质量标准修订的研究  

Quality Standards of Pyrolae Herba in Chinese Pharmacopoeia

作　　者：孔亚萍 段吉平 赵振霞 刘永利 KONG Ya-ping;DUAN Ji-ping;ZHAO Zhen-xia;LIU Yong-li(Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research,Hebei Institute for Drug and Medical Device Control,Shijiazhuang 050227,China)

机构地区：[1]河北省药品医疗器械检验研究院河北省中药质量评价与标准研究重点实验室,河北石家庄050227

出　　处：《中国现代中药》2023年第6期1259-1265,共7页Modern Chinese Medicine

基　　金：河北省重点研发计划项目(22372503D)。

摘　　要：目的:针对《中华人民共和国药典》(以下简称《中国药典》)2020年版中鹿衔草药材标准存在的问题和局限性,对其质量标准进行改进和完善,为《中国药典》 2020年版鹿衔草药材质量标准的修订提供参考。方法:采用显微鉴别法与薄层色谱法对鹿衔草的鉴别项进行研究,增加了粉末显微鉴别,修订了薄层鉴别中的薄层板和展开剂;增加了鹿衔草质量标准中有关杂质的检查项;采用高效液相色谱法对鹿衔草中的水晶兰苷含量测定方法进行了改进,修订了供试品溶液制备方法。通过直观分析和主成分分析(PCA)对14批鹿衔草样品部分检验项目的测定结果进行分析与评价。结果:粉末显微鉴别法使标准控制更为完善;与原标准的薄层鉴别项比较,新建方法通用性好,斑点清晰;建立的含量测定方法准确、简便、快速、重复性好,对不同仪器和不同色谱柱的适应性好;直观分析和PCA的结果均显示杂质是影响鹿衔草质量的重要因素。结论:增加和修订的检测项目简便可行、重复性好,可用于鹿衔草药材的质量控制。Objective:To supply scientific evidence for revising the quality standards of Pyrolae Herba in Chinese Pharmacopoeia(ChP,2020 edition)in view of the problems and limitations.Methods:Microscopic identification and thinlayer chromatography(TLC)were employed to revise the identification method of Pyrolae Herba.The microscopic identification of powder and impurity inspection were added to the quality standard of Pyrolae Herba.The thin-layer plate and developer in TLC were revised.The method for determining monotropein content was improved by high performance liquid chromatography(HPLC),especially the preparation of the sample liquid.The intuitive analysis and principal component analysis(PCA)were employed to analyze and evaluate the determination results for the 14 batches of Pyrolae Herba.Results:The powder microscopic identification improves the standard control.Compared with the original method in ChP 2020,the newly established method demonstrates better universality and clearer spots.The established determination method is simple,rapid,and highly accurate,with good reproducibility and good adaptability to different instruments and chromatographic columns.The results of intuitive analysis and PCA show that impurity is the majorfactor affecting the quality of Pyrolae Herba.Conclusion:The testing items added and revised in this study have feasibility and repeatability and can be applied for the quality control of Pyrolae Herba.

关 键 词：鹿衔草 质量标准 显微鉴别 薄层色谱法 高效液相色谱法 杂质 水晶兰苷 

分 类 号：R282[医药卫生—中药学]