软肝丸质量标准提高研究  

Quality Standard Improvement of Ruangan Wan

作　　者：王锦[1] 何世荣 李之兴 杨松[1] 

机构地区：[1]沈阳军区联勤部药品仪器检验所,辽宁沈阳110026 [2]沈阳军区联勤部门诊部,辽宁沈阳110003

出　　处：《解放军药学学报》2017年第4期333-336,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项面上课题,No.14ZJZ19-2

摘　　要：目的研究软肝丸质量控制方法,以提高其质量标准。方法在原标准的基础上增加了软肝丸中木香、板蓝根、妇贞子的薄层鉴别,改进了丹参、枳壳的薄层色谱条件;采用HPLC法对芍药苷进行含量测定。结果 TLC法鉴别专属性强;HPLC法测得芍药苷在114.0~1026.4ng(r=0.9997)线性关系良好,平均回收率为99.62%,RSD为1.38%(n=6)。结论本方法操作简单,结果准确,灵敏度高,重复性好;该质量标准可有效地控制软肝丸的质量。Objective To study quality control methods of Ruangan wan in order to improve the qual- ity standard.Methods TLC identification of Radix Aucklandiae, Isatis tinctoria and Fructus Ligustri Lucidi was added based on the original standard, the TLC conditions of Salviae Miltiorrhizae Radix et Rhizoma and Fructus aurantll were improved,and paeoniflorin content was determined by HPLC.Results The TLC iden tification was highly specific and the spots were clear.The linear range of paeoniflorin was 2114.0--1026.4 ng（ r =0.9997）.The average recovery of paeoniflorin was 99.62% with an RSD of 1.38%（ n =6）.Conclu- sion This method is easy to operate with accurate results, high sinsitivity and good reproducibility. This quality standard can effectively control the quality of Ruangan wan.

关 键 词：软肝丸 质量标准 TLC HPLC 芍药苷 

分 类 号：R917[医药卫生—药物分析学]