复方中药胰胆舒丸的质量标准探讨  

Quality Standard Discussion on Compound Chinese Medicine Yidanshu Concentrated Pill

作　　者：赵江红[1] 董文玲 刘伏先 王宪龄[4] 

机构地区：[1]河南省安阳市食品药品检验所,河南安阳455000 [2]安阳中智药业有限责任公司,河南安阳455001 [3]南京市建邺区妇幼保健所,江苏南京210004 [4]河南中医学院,河南郑州450008

出　　处：《中医学报》2011年第10期1174-1176,共3页Acta Chinese Medicine

摘　　要：目的:研究与修订胰胆舒丸的质量标准。方法:采用HPLC法,选用依利特kromasil C18色谱柱(4.6×200.0 mm,5μm);甲醇-0.1%磷酸溶液(8020)为流动相;流速1.0 mL/min,检测波长为254 nm。理论板数按大黄素峰计算应不低于3 000。结果:HPLC含量测定,表明大黄素在线性范围为6.375-127.500 mg/L,标准曲线近似过圆点,采用外标一点法定量;大黄素的回收率为97.99%,RSD=1.67%。结论:本方法可对胰胆舒丸的主要药味进行定量测定,能更有效的控制胰胆舒丸的质量。Objective：To study and revise quality standards of yidanshu concentrated pill.Methods：HPLC was applied,and the special kromasil C18 column chromatography（4.6×200 mm,5 muon m） was chosen;Methanol-0.1% phosphoric acid（8020） was used as mobile phase whose velocity was 1.0 ml/min and the detected wavelength was 254 nm.According to emodin peak,theoretical tower number should be no less than 3 000.Results：HPLC determination showed that content of emodin in linear ranged among 6.375-127.5 μg/mL.The standard curve approximately passed the dot and external standard one point method was applied to quantify.The recovery rate of emodin was 97.99%,RSD=1.67%.Conclusion：This method can be used to quantitatively determine the main herbs in yidanshu concentrated pill and ensure its quality effectively.

关 键 词：胰胆舒丸 质量标准 大黄素 高效液相色谱法 

分 类 号：R285.1[医药卫生—中药学]