消炎止痢灵片的质量标准研究  

Study on Quality Standard of Xiaoyanzhililing Tablets

作　　者：郭丽娟[1] 冯丹[2] 张庆英[1] 张树杰[2] 

机构地区：[1]黑龙江中医药大学,黑龙江哈尔滨150040 [2]黑龙江省药品检验所,黑龙江哈尔滨150001

出　　处：《中医药信息》2009年第3期25-28,共4页Information on Traditional Chinese Medicine

基　　金：国家药品标准提高行动计划

摘　　要：目的:建立消炎止痢灵片的质量标准。方法:采用TLC法对消炎止痢灵片中的苦参进行定性鉴别;采用HPLC法测定苦参碱、氧化苦参碱以及甲氧苄氨嘧啶的含量。结果:①方法专属性强。②在0.0845～1.0560μg范围内,苦参碱峰面积与进样量呈现良好的线性相关(r=0.9999),加样回收率为100.9%(RSD=2.3%);在0.0600～0.7500μg范围内,氧化苦参碱峰面积与进样量呈现良好的线性相关(r=0.9993),加样回收率为100.8%(RSD=2.4%)。③在1.03～12.91μg范围内甲氧苄氨嘧啶峰面积与进样量呈现良好的线性相关(r=1.0000),加样回收率为100.6%(RSD=0.93%)。结论:方法灵敏、准确,重现性好,可作为消炎止痢灵片的质量控制方法。Objective:To develop effective methods for Xiaoyanzhililing Tablets. Methods:TLC was performed to identify Sophora flavescens Ait.The Matrine and Oxymatrine of Sophora flavescens Ait.,and Trimethoprim were determined by HPLC. Results:①The identification study showed strong specificity.②The standard curve Matrine of by HPLC was linear in the range of 0.0845μg^1.0560μg,r=0.9999;The average recovery was 100.9%,and RSD was 2.3%; The standard curve of Oxymatrine by HPLC was linear in the range of 0.0600μg^0.7500μg,r=0.9993;The average recovery was 100.8%,and RSD was 2.4%;③The standard curve of Trimethoprim by HPLC was linear in the range of 1.03μg^12.91μg,r=1.0000;The average recovery was 100.6%,and RSD was 0.93%;Conclutions:The methods are sensitive,accurate and reproducible. It could be used in the quality control of Xiaoyanzhililing tablets.

关 键 词：消炎止痢灵片 苦参碱 氧化苦参碱 甲氧苄氨嘧啶 TLC HPLC 质量标准 

分 类 号：R286[医药卫生—中药学]