心肝宝胶囊的质量标准研究  

Quality standard of Xinganbao capsule

作　　者：周亚楠 刘永利 赵春杰[1] ZHOU Yanan;LIU Yongli;ZHAO Chunjie(College of pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China;Heibei institute for Drug Control, Shifiazhuang 050011, China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]河北省药品检验研究院,河北石家庄050011

出　　处：《沈阳药科大学学报》2018年第6期453-459,共7页Journal of Shenyang Pharmaceutical University

摘　　要：目的完善和提高心肝宝胶囊的质量标准。方法 TLC法对麦角甾醇进行定性鉴别,分别用HPLC法测定5种核苷成分及HPLC-异硫氰酸苯酯(benzyl isothiocyanate,PITC)柱前衍生法测定17种氨基酸含量。结果薄层色谱斑点清晰,分离好,阴性无干扰。尿嘧啶、鸟苷、尿苷、腺嘌呤和腺苷5种核苷成分质量浓度与峰面积呈良好的线性关系;精密度,稳定性,重现性均符合方法学测定要求;回收率RSD均小于3%。17种氨基酸质量浓度与峰面积呈良好的线性关系,回收率在95%~105%内,RSD均小于3%。结论所建立的分析方法可有效地控制心肝宝胶囊的质量。Objective To develop and improve the quality standard for Xinganbao capsule. Methods TLC was used for the qualitative identification of ergosterin. HPLC was adopted in the quantitative content determination of 5 nucleosides and HPLC-PITC in the quantitative content determination 17 kinds of amino acids. Results The TLC spot was clear,well separated and negdtive control without interference. The calibration curves of the 5 nucleosides（ uracile,guanosine,uridine,adenine and adenosine） have good linear relationship in the ranges of the tested concentrations＇,precision,stability and repeatability according to the requirements of the methodology determination. The recoveries were 99. 8%,98. 9%,98. 0%,97. 5%,95. 7% respectively. All of the RSD were below3. 0%. The 17 kinds of amino acxids in a certain range,the concentration had good linear relationship with the peak area. There average recoveries were from 95% to105%,and RSD was less than 3%. Conclusion The developed method is simple,sensitive,reliable and accurate. It can effectively control the quality of Xinganbao capsul

关 键 词：心肝宝胶囊 TLC HPLC 核苷 氨基酸 质量控制 

分 类 号：R917[医药卫生—药物分析学]