平安丸的质量控制研究  

Quality Standard of Ping-An Pill

作　　者：邱琳[1] 刘莹[1] 张媛媛[1] 李婉怡[1] 

机构地区：[1]北京同仁堂股份有限公司科学研究所,北京100079

出　　处：《世界科学技术-中医药现代化》2015年第9期1883-1889,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家药典委员会提高国家药品标准行动计划(GF2013-4-01):平安丸部颁标准提高;负责人:邱琳

摘　　要：目的:提高和完善平安丸的质量标准。方法:采用薄层色谱法对处方中母丁香、枳实进行了薄层色谱鉴别;采用高效液相色谱法对处方中木香的有效成分木香烃内酯、去氢木香烃内酯进行了含量测定。结果:薄层色谱斑点清晰、分离度好,阴性无干扰;木香烃内酯、去氢木香烃内酯进样量分别在0.103 4-1.033 5μg(r=0.999 9),0.110 1-1.100 5μg(r=0.999 7)范围内线性关系良好,平均回收率(n=6)分别为95.1%、98.6%,RSD分别为2.62%、2.84%。结论:本研究中的定性及定量方法简便准确、专属性强,能有效控制平安丸的质量。This study was aimed to revise and improve the quality standard of Ping-An（PA） Pill. Fructus Caryophylli and Fructus Aurantii Immaturus were identified by TLC. The content of costunolide and dehydrocostunolide were determined by HPLC. The results showed that there were clear spots, good degree of separation, and no negative interference in the TLC identification. The calibration curve of costunolide and dehydrocostunolide were linear at the range of 0.103 4-1.033 5 μg（r = 0.999 9） and 0.110 1-1.100 5 μg（r = 0.999 7）. The average recoveries were 95.1%（RSD = 2.62%, n = 6） and 98.6%（RSD = 2.84%, n = 6）, respectively. It was concluded that the method was convenient and accurate with strong specificity in the quality and quantity control of PA pill, which can be used in the quality control of PA pill.

关 键 词：平安丸 质量控制木香烃内酯 去氢木香烃内酯 薄层色谱 高效液相色谱 

分 类 号：R286[医药卫生—中药学]