通脉降浊颗粒质量标准研究  

Quality Standard of Tongmai Jiangzhuo Granules

作　　者：张贺廷 李磊 杨永 王洪强 丁小凡 ZHANG Heting;LI Lei;YANG Yong;WANG Hongqiang;DING Xiaofan(Fuyang Hospital of TCM,Fuyang,Anhui,China 236025;School of Pharmacy,Anhui University of Chinese Medicine,Hefei,Anhui,China 230012;Fuyang Institutes for Food and Drug Control,Fuyang,Anhui,China 236069)

机构地区：[1]安徽省阜阳市中医医院,安徽阜阳236025 [2]安徽中医药大学药学院,安徽合肥230012 [3]安徽省阜阳市食品药品检验检测中心,安徽阜阳236069

出　　处：《中国药业》2023年第13期91-95,共5页China Pharmaceuticals

基　　金：安徽省阜阳市卫生健康委员会科研课题[FY2019-078]。

摘　　要：目的建立通脉降浊颗粒的质量标准。方法采用薄层色谱法对制剂中丹参、决明子、姜黄进行定性鉴别;采用高效液相色谱法测定丹参主要成分丹酚酸B的含量,色谱柱为Thermo Scientific Hypersil GOLD C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(23∶77,V/V),流速为1.0 mL/min,柱温为30℃,检测波长为286 nm,进样量为10μL。结果丹参、决明子、姜黄的薄层色谱斑点清晰,阴性对照无干扰。丹酚酸B进样量在0.08125~2.60000μg范围内与峰面积积分值线性关系良好(r=0.9999,n=6);精密度、稳定性、重复性试验的RSD均小于2%;平均加样回收率为99.10%,RSD为1.45%(n=6)。结论该方法可用于通脉降浊颗粒的质量控制。Objective To establish the quality standard of Tongmai Jiangzhuo Granules.Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Salviae Miltiorrhizae Radix et Rhizoma,Cassiae Semen and Curcumae Longae Rhizoma in Tongmai Jiangzhuo Granules.High-performance liquid chromatography(HPLC)method was used for the content determination of the main component salvianolic acid B in Salviae Miltiorrhizae Radix et Rhizoma,the chromatographic column was Thermo Scientific Hypersil GOLD C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(23∶77,V/V),the flow rate was 1.0 mL/min,the column temperature was 30℃,the detection wavelength was 286 nm,and the injection volume was 10μL.Results The TLC spots of Salviae Miltiorrhizae Radix et Rhizoma,Cassiae Semen and Curcumae Longae Rhizoma were clear,and the negative control had no interference.The linear range of salvianolic acid B was 0.08125-2.60000μg(r=0.9999,n=6).The RSDs of precision,stability,and repeatability tests were all lower than 2%.The average recovery of salvianolic acid B was 99.10%with an RSD of 1.45%(n=6).Conclusion The method can be used for the quality control of Tongmai Jiangzhuo Granules.

关 键 词：通脉降浊颗粒 薄层色谱法 高效液相色谱法 丹酚酸B 质量标准 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0