舒肝安胶囊的质量标准研究  

Study on the Quality Standard of ShuGanAn Capsules

作　　者：陈松旺 翁一玲[2] 蔡葵 李煌[3] CHEN Song-wang;WENG Yi-ling;CAI Kui;LI Huang(Fujian Center for Drug Control and examination,Fuzhou 350001,China;The second Affiliated People’s Hospital of Fujian University of Traditional Chinese Medicine,Fuzhou 350001,China;Fujian University of Traditional Chinese Medicine,Fuzhou 350122,China)

机构地区：[1]福建省药品审核查验中心,福建福州350001 [2]福建中医药大学附属第二人民医院药学部,福建福州350001 [3]福建中医药大学,福建福州350122

出　　处：《海峡药学》2021年第11期74-77,共4页Strait Pharmaceutical Journal

摘　　要：目的建立舒肝安胶囊的质量标准。方法显微定性鉴别柴胡、甘草、白花蛇舌草;薄层色谱法(TLC)定性鉴别舒肝安胶囊中的白芍、赤芍、五味子;采用高效液相色谱法(HPLC)测定舒肝安胶囊中芍药苷的含量。结果显微鉴别特征清晰;TLC斑点清晰,阴性无干扰;HPLC测定芍药苷在线性范围(0.0032~0.017 mg·mL^(-1))内相关性良好(r=0.9997),平均回收率为99.6%,RSD<2%,能准确测定出样品中芍药苷含量。结论该方法重复性好,专属性强,可用舒肝安胶囊的质量控制。OBJECTIVE To establish the quality standard for Shuganan Capsules.METHODS Radix Bupleuri,Radix Liquiritiae and Oldenlandia Diffusa Roxb were identified qualitatively by Microscopic qualitative identification.Radix Paeoniae Alba,Radix Paeoniae Rubra,Schisandra chinensis were identified qualitatively by TLC in ShuGanAn capsule.The content of paeoniflorin was determined by High performance liquid chromatography(HPLC).RESULTS The Microscopic identification signature was clear,the TLC spots were clear without negative inference.The constituent of paeoniflorin by HPLC showed good linear relationships(r=0.9997)within their own ranges(0.0032-0.017 mg·mL^(-1))and the average recoveries were 99.6%,respectively with RSD less than 2%.CONCLUSION This reproducible and specific method can be used for the quality control of ShuGanAn Capsules.

关 键 词：舒肝安胶囊 定性鉴别 含量测定 

分 类 号：R927[医药卫生—药学]