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.
作者
杨献玲
姜泽
赵凯鑫
徐多多
王海洋
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)
出处
《中国药品标准》
CAS
2020年第6期550-554,共5页
Drug Standards of China
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
Xinkeshu Capsules
specification
Salviae Miltiorrhizae Radix
Notoginseng Radix et Rhizoma
Crataegi Fructus
Aucklandiae Radix
Puerariae Lobatae Radix
Protocatechuic Aldehyde
Ginsenoside
Notoginsenoside
Ursolic Acid
Puerarin