附子和附片质量标准研究  

Study on Quality Standard of Fuzi and Fupian

作　　者：聂黎行 张聿梅 鲁静 肖新月 马双成 林瑞超 

机构地区：[1]中闫药品生物制品检定所,北京100050

出　　处：《中国药学杂志》2010年第15期1182-1186,共5页Chinese Pharmaceutical Journal

基　　金：“十一五”国家科技支撑计划重点项目资助课题(2006BAI14B01)

摘　　要：目的采用薄层色谱法和高效液相色谱法建立附子和附片的质量控制方法。方法采用薄层色谱法分别对附子中的双酯型生物碱和附片中的单酯型生物碱进行鉴别。采用高效液相色谱法同时对附子中的单酯型生物碱和双酯型生物碱进行限量检查和含量测定、对附片中的双酯型生物碱和单酯型生物碱进行限量检查和含量测定。结果 TLC鉴别方法分离良好、斑点清晰;6种乌头碱类成分的HPLC限量检查和含量测定方法在5～100μg.mL-1内线性关系良好,检出限在1μg.mL-1,平均回收率均在95%～105%之间。结论本方法专属性强、结果准确、耐用性好,可更好地控制附子和附片的质量。OBJECTIVE To establish quality standard of Fuzi and Fupian by TLC and HPLC method.METHODS Diester aconitium alkaloids in Fuzi and monoester aconitium alkaloids in Fupian were identified by TLC method.The limit examination of monoester aconitium alkaloids and determination of diester aconitium alkaloids in Fuzi were carried out by HPLC method simultaneously.The limit examination of diester aconitium alkaloids and determination of monoester aconitium alkaloids in Fupian were carried out by HPLC method simultaneously.RESULTS Clear spots were obtained with good separation in TLC identification.For 6 aconitium alkaloids,calibration curves were linear in the range of 5-100 μg·mL-1,the limits of detection were 1 μg·mL-1 and recoveries were between 95%-105%.CONCLUSION The proposed method is exclusive,accurate and applicable for control of Fuzi and Fupian quality.

关 键 词：附子 附片 薄层鉴别 限量检查 含量测定 

分 类 号：R917[医药卫生—药物分析学]