基于供试液多维使用的炎可宁丸鉴别优化研究  

Study on the Identification Optimization of Yankening Pills Based on Multidimensional Use of Test Solution

作　　者：罗晖明 聂平 丁野 程雪清 余彬彬 LUO Huiming;NIE Ping;DING Ye;CHENG Xueqing;YU Binbin(Hunan Institute for Drug Control(Hunan Pharmaceutical Excipients Testing and Inspection Center),Changsha Hunan 410001,China;Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Changsha Hunan 410001,China;Hinye Pharmaceutical Co.,Ltd.,Changsha Hunan 410331,China)

机构地区：[1]湖南省药品检验研究院(湖南药用辅料检验检测中心),湖南长沙410001 [2]湖南省药品质量评价工程技术研究中心,湖南长沙410001 [3]天地恒一制药股份有限公司,湖南长沙410331

出　　处：《药品评价》2021年第16期977-979,共3页Drug Evaluation

基　　金：国家药典委员会药品标准制修订研究课题(2019Z093);湖南创新性省份建设专项课题(2020JJ9031)。

摘　　要：目的:优化、建立炎可宁丸的薄层鉴别方法。方法:基于供试液多维使用,对炎可宁丸目前执行标准中黄柏、大黄的鉴别进行优化,并新增黄连、黄芩、板蓝根的薄层鉴别方法。结果:对目前执行标准的鉴别进行了整体优化,仅仅只取样一次,共用大部分供试液制备步骤,实现黄柏、黄连、黄芩、大黄的薄层色谱鉴别;而且新增以靛玉红为对照的板蓝根的鉴别。优化后的方法减少了样品的用量,简化了供试液的制备步骤,降低了检验的成本,提升了检验的效率。薄层色谱图斑点清晰,分离良好,阴性没有产生干扰。结论:本法专属性强,重复性好,减少了检验用量、降低了检验成本,提升了检验效率,较好地优化了炎可宁丸的薄层色谱鉴别。Objective:To optimize and establish the TLC(thin-layer chromatography)identification method of Yankening Pills.Methods:Based on the multi-dimensional use of the test solution,the identification of the current standard of phellodendri chinensis cortex and rhei radix et rhizoma was optimized,and the thin-layer identification methods of coptidis rhizome,scutellariae radix and isatidis radix were added.Results:The identification of the current standard is optimized.The TLC identification of phellodendri chinensis cortex,coptidis rhizome,scutellariae radix and isatidis radix was realized by sampling only once and sharing most of the preparation steps of the test solution.The identification of Isatidis radix was added.the optimized method reduces the sample consumption,simplifies the preparation of test solution,reduces the test cost and improves the test efficiency.The spots in TLC were clear,the separation was good and negative without interference.Conclusion:The method has the advantages of specificity and good repeatability,can reduce the test dosage and the test cost,improve the test efficiency and optimize the TLC identifi-cation of Yankening pills.

关 键 词：炎可宁丸 主成分分析 薄层色谱法 供试液多维使用 板蓝根 

分 类 号：R286.0[医药卫生—中药学]