心可舒胶囊检测方法的研究  

Investigation on determination methods for Xinkeshu Capsules

作　　者：杨献玲[1] 姜泽 赵凯鑫 徐多多[2] 王海洋[1,2] YANG Xianling;JIANG Ze;ZHAO Kaixin;XU Duoduo;WANG Haiyang(Jilin Institute for Drug Control,Changchun 130033,China;Changchun University of Chinese Medicine,Changchun 130117,China)

机构地区：[1]吉林省药品检验所,长春130033 [2]长春中医药大学,长春130117

出　　处：《中国药品标准》2020年第6期550-554,共5页Drug Standards of China

摘　　要：目的:建立心可舒胶囊的检测方法。方法:采用TLC法对山楂、木香、丹参和三七进行定性鉴别;采用HPLC法测定葛根中葛根素的含量,色谱柱为Diamonsil C18(4.6 mm×250 mm,5μm),流动相为甲醇-水(25∶75),流速为0.8 mL·min^-1,检测波长为250 nm。结果:山楂、木香、丹参和三七TLC图斑点清晰,专属性强,阴性对照无干扰。葛根素进样量在0.089~0.267μg(r=1.0000)范围内线性关系良好;平均回收率(n=6)为98.73%,RSD为0.33%;3批样品中葛根素含量分别为21.40 mg·g^-1、23.44 mg·g^-1、20.67 mg·g^-1。结论:本研究所建立的方法简便可靠,重复性好,适用于心可舒胶囊的质量控制。Objective:To establish the determination methods for Xinkeshu Capsules.Methods:Crataegi Fructus,Aucklandiae Radix,Salviae Miltiorrhizae Radix and Notoginseng Radix et Rhizoma were identified by TLC.The content of puerarin in Radix Puerariae Lobatae was determined by HPLC.The test was performed in a Diamonsil C 18 column(4.6 mm×250 mm,5μm)under the isocratic elution of methanol-water(25∶75).The flow rate was 0.8 mL·min^-1,and the detection wavelength was 250 nm.Results:The TLC chromatograms of Crataegi Fructus,Aucklandiae Radix,Salviae Miltiorrhizae Radix and Notoginseng Radix et Rhizoma had the clear and specific spots without the interference negative of control.The linear range of puerarin fell into 0.089-0.267μg(r=1.0000).The average recovery was 98.73%with RSD as 0.33%(n=6).The contents of 3 batches of samples were 21.40 mg·g^-1,23.44 mg·g^-1 and 20.67 mg·g-1,respectively.Conclusion:The established methods are simple,reliable and repeatable.They are applicable to quality control of Xinkeshu Capsules.

关 键 词：心可舒胶囊 质量标准 丹参 三七 山楂 木香 葛根 原儿茶醛 人参皂苷 三七皂苷 熊果酸 葛根素 

分 类 号：R921.2[医药卫生—药学]