二丁二仙合剂质量标准的建立  

Study on the Quality Standardfor Erdingerxian Mixture

作　　者：顾小燕[1] 卢燕萍 陈敏[1] 年华[1] 朱全刚 

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海200437 [2]上海市皮肤病医院药剂科

出　　处：《中国药师》2018年第2期331-333,共3页China Pharmacist

基　　金：上海市进一步加快中医药事业发展三年行动计划项目(2014~2016年)(编号:ZY3-JSFC-2-2018)

摘　　要：目的:建立二丁二仙合剂质量标准。方法:采用TLC法对二丁二仙合剂中紫花地丁、黄柏进行定性鉴别;用HPLC法对制剂中淫羊藿苷、仙茅苷进行含量测定。结果:定性鉴别分离度较好,专属性强;淫羊藿苷的含量测定线性范围为5.77~184.50μg·ml^(-1)(r=0.999 9),平均回收率为96.55%(RSD=1.14%,n=9);仙茅苷的含量测定线性范围为12.36~395.50μg·ml^(-1)(r=1.000 0),平均回收率为100.58%(RSD=2.92%,n=9)。结论:所建立方法准确可靠、灵敏度高、专属性强,可用于二丁二仙合剂的质量控制。Objective： To establish the quality standard for Erdingerxian mixture. Methods： Herba Violae and Cortex Phellodendri in Erdingerxian mixture were identified by TLC. Icariin and curculigoside were determined by HPLC. Results： The characteristic identification by TLC was distinct and highly specific. The linear range of icariin was 5. 77^（-1）84. 50μg·ml^（-1）（ r = 0. 999 9）,and the average recovery was 96. 55%（ RSD = 1. 14%,n = 9）. The linear range of curculigoside was 12. 36-395. 50 μg·ml^（-1）（ r = 1. 000 0）,and the average recovery was 100. 58%（ RSD = 2. 92%,n = 9）. Conclusion： The method is reliable,accurate,sensitive and specific,which can be used for the quality control of Erdingerxian mixture.

关 键 词：二丁二仙合剂 质量标准 淫羊藿苷 仙茅苷 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]