蒙药制剂琪素-25丸质量标准研究  

Study on the quality standard of Mongolian medicine preparation Qisu-25 pills

作　　者：王玮婷 谭谊萌 朱俊宣 邬国栋[1] 杨丹[1] 薄彧坤[1] 安明 WANG Weiting;TAN Yimeng;ZHU Junxuan;Wu Guodong;YANG Dan;BO Yukun;AN Ming(Baotou Medical College of Inner Mongolia University of Science and Technology,Baotou 014060,China)

机构地区：[1]内蒙古科技大学包头医学院,内蒙古包头014060

出　　处：《包头医学院学报》2022年第6期35-40,共6页Journal of Baotou Medical College

基　　金：内蒙古自治区科技创新引导项目(00120209);内蒙古自治区自然科学基金项目(2021MS08011);包头医学院“花蕾计划”研究项目(HL2021046)。

摘　　要：目的:建立蒙药制剂琪素-25丸的质量标准。方法:采用薄层色谱(thin layer chromatography,TLC)法对琪素-25丸中栀子和苘麻子进行定性鉴别;采用高效液相色谱(high performance liquid chromatography,HPLC)法测定琪素-25丸中栀子苷的含量。结果:TLC法结果显示,与对照品或对照药材色谱相比,供试品溶液在对应位置上显示相同颜色的、独特的清晰斑点或荧光斑点,且阴性溶液对样品无影响,专属性强。HPLC法结果显示,栀子苷峰面积在34.73~76.40μg/mL范围内呈线性,回归方程为y=30762x-92915(R^(2)=0.9991);平均回收率为104.7%,RSD为1.7%;琪素-25丸含栀子苷(C_(17)H_(24)O_(10))不得少于0.0520%。结论:本研究建立的方法专属性强、稳定、重复性好,可应用于建立蒙药制剂琪素-25丸质量标准。Objective:To establish the quality standard of Mongolian Medicine Qisu-25 Pills.Methods:Thin layer chromatography(TLC)method was used to qualitatively identify Gardenia jasminoides and Semen Abutili in Qisu-25 pills;high performance liquid chromatography(HPLC)method was used to determine the content of geniposide in Qisu-25 pills.Result:The results of TLC method showed that compared with the chromatogram of the control substance or the control medicinal material,the test solution showed unique clear spots or fluorescent spots of the same color on the corresponding position,and the negative solution had no effect on the sample,with strong specificity.The results of HPLC method showed that The peak area of geniposide is linear in the range of 34.73~76.40μg/mL,the regression equation was y=30762x-92915,(R^(2)=0.9991);the average recovery rate was 104.7%,and the RSD was 1.7%;The content of Geniposide in Qisu-25 pills shall not be less than 0.0520%.Conclusion:The method established in this study has strong specificity,stability and good repeatability,and can be applied to establish the quality standard of Qisu-25 pills.

关 键 词：琪素-25丸 质量标准 栀子 苘麻子 栀子苷 

分 类 号：R29[医药卫生—民族医学]