银乐丸质量控制方法的研究  

Study on quality control Methods of Yinle Pills

作　　者：赵小伟[1] 吴剑坤[1] 王宏蕾[1] 李洋[1] 陈占功[1] Zhao Xiaowei;Wu Jiankun;Wang Honglei;Li Yang;Chen Zhangong(National Famous Traditional Chinese Medicine Expert Studio of Mao Kechen,Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing 100010,China)

机构地区：[1]毛克臣全国名老中医药专家传承工作室,首都医科大学附属北京中医医院,北京100010

出　　处：《首都食品与医药》2024年第4期157-160,共4页Capital Food Medicine

摘　　要：目的 建立银乐丸的质量控制方法,保障临床用药安全.方法 采用薄层色谱法定性鉴别丹参、首乌藤、当归、赤芍、白芍;采用高效液相色谱法测定丹酚酸B和丹参酮ⅡA的含量.结果 薄层色谱法检测结果斑点明显,阴性无干扰;丹酚酸B在0.1000-1.0000μg范围内线性关系良好(r=1.0000),回收率平均值为97.31%,RSD=1.68%;丹参酮ⅡA在0.0800-0.2800μg范围线性关系良好(r=0.9999),回收率平均值为99.06%,RSD=1.81%.结论 该实验建立的定性与定量方法能够有效控制银乐丸的质量.Objective Establish a quality control method for Yinle Pills to ensure the safety of clinical medication.Methods Radix salviae miltiorrhizae,Polygoni Multiflori Caulis,Radix Angelicae sinensis,Radix paeoniae rubra and Radix Paeoniae Alba were identified by TLC.Salvianolic acid B and tanshinone Ⅱ A in Salvia miltiorrhiza were determined by HPLC.Results TLC spots of Salvia miltiorrhiza,Caulis Polygoni Multiflori,Angelica sinensis,Radix paeoniae rubra and Radix Paeoniae Alba were clear,and negative control had no interference Salvianolic acid B showed a good linear relationship in the range of 0.1000-1.0000μg(r=1.0000),the average recovery was 97.31%,RSD=1.68%;tanshinone ⅡA showed a good linear relationship in the range of 0.0800-0.2800μg(r=0.9999),the average recovery was 99.06%,RSD=1.81%.Conclusion The qualitative and quantitative methods established in this experiment can effectively control the quality of Yinle pills.

关 键 词：银乐丸 薄层色谱法 高效液相色谱法 质量控制 

分 类 号：R927.11[医药卫生—药学]