延胡索咀嚼片质量标准研究  

Study on quality standard of Corydalis Rhizoma Chewable Tablets

作　　者：姜黎[1] 赵森[1] 纪开一 邹明[1] 孙涌津[1] 徐保利 JIANG Li;ZHAO Sen;JI Kai-yi;ZOU Ming;SUN Yong-jin;XU Bao-li(Department of Pharmacy,Affiliated Zhongshan Hospital of Dalian University,Liaoning Province,Dalian,116001,China)

机构地区：[1]大连大学附属中山医院药剂科

出　　处：《中国当代医药》2019年第27期44-46,50,共4页China Modern Medicine

摘　　要：目的建立延胡索咀嚼片的薄层及高效液相测定方法。方法采用1%NaOH制备硅胶G板上,以正己烷-氯仿-甲醇(7.5:4:1)为展开剂,利用延胡索乙素对延胡索咀嚼片进行鉴别。采用反相高效液相色谱(RP-HPLC)进行测定,色谱柱为Hypersil BDS C18(5μm,4.6 mm×150 mm);流动相为甲醇-0.1%磷酸(用三乙胺调节pH至6.0)(60:40);检测波长为280 nm。结果延胡索咀嚼片薄层鉴别,置紫外灯(365 nm)下检视,在供试品色谱中,与对照品相同位置上,显相同颜色荧光斑点,阴性对照无此斑点。利用HPLC法对延胡索咀嚼片中的延胡索乙素进行测定,延胡索咀嚼片中延胡索乙素的线性范围为0.0832~0.4160μg,r=0.9997,平均回收率为99.94%(RSD=0.52%)。结论所建立的延胡索咀嚼片定性及定量质量控制方法,操作简单、重现性好、专属性高,可作为质量控制的方法。Objective To establish thin layer and high performance liquid phase determination methods for Corydalis Rhizoma Chewable Tablets.Methods The silica gel G plate was prepared with 1%NaOH,and the Corydalis Rhizoma Chewable Tablets were identified by tetrahydropalmatine,with n-hexane-chloroform-methanol(7.5:4:1)as the developing agent.It was determined by reversed phase high performance liquid chromatography(RP-HPLC).The column was Hypersil BDS C18(5μm,4.6 mm×150 mm),the mobile phase was methanol-0.1%phosphoric acid(pH adjusted to 6.0 with triethylamine)(60:40),and the detection wavelength was 280 nm.Results The thin layer of Corydalis Rhizoma Chewable Tablets was identified and placed under ultraviolet light(365 nm).In the chromatogram of the test sample,the same color fluorescent spot was displayed at the same position as the reference substance,and the negative control did not have this spot.The content of tetrahydropalmatine in the Corydalis Rhizoma Chewable Tablets was determined by HPLC.The linear range of tetrahydropalmatine was 0.0832-0.4160μg,r=0.9997,and the average recovery rate was 99.94%(RSD=0.52%).Conclusion The qualitative and quantitative quality control methods of the Corydalis Rhizoma Chewable Tablets are easy to operate with good reproducibility and high specificity,and can be used as quality control methods.

关 键 词：延胡索咀嚼片 延胡索乙素 薄层色谱 高效液相 

分 类 号：R282.1[医药卫生—中药学]