除湿丸的质量标准研究  

Study on Quality Standard of Chushi Pill

作　　者：曾祖平[1,2] 王宏[1,2] 钱珊[3] 彭冰[1,2] 韩旭阳[1,2] 车晓平[1] 何薇[1,2] 

机构地区：[1]首都医科大学附属北京中医医院 [2]北京市中医研究所,北京100010 [3]北京中医药大学东方学院中药系,2009级河北廊坊065001

出　　处：《中国药房》2015年第24期3395-3398,共4页China Pharmacy

基　　金：北京市中医研究所苗圃科研项目(No.MP-2013-01)

摘　　要：目的：为建立除湿丸的质量标准提供参考。方法：采用显微鉴别法、薄层色谱（TLC）法对方中牡丹皮、白鲜皮、当归、茜草、栀子进行定性鉴别;采用高效液相色谱法测定丹皮酚、黄芩苷的含量。色谱柱为Kromasil 100-5 C18,流动相为甲醇-水-磷酸（47∶53∶0.2,V/V/V）,流速为1.0 ml/min,检测波长为280 nm,柱温为25℃,进样量为10μl。结果：显微鉴别中,白鲜皮、牡丹皮的显微特征明显,其他药材无干扰;TLC鉴别中,当归、茜草、栀子的特征斑点清晰,阴性对照无干扰。丹皮酚、黄芩苷进样量分别在0.106 24~2.124 8、0.059 04~1.180 8μg范围内与峰面积呈良好的线性关系（r=0.999 9、0.999 9）;精密度、稳定性、重复性试验的RSD均≤2.06%;平均加样回收率分别为101.56%、100.16%,RSD分别为1.68%、1.13%（n=9）。结论：该方法操作简便、结果准确、重现性好,可作为除湿丸的质量控制标准。OBJECTIVE： To establish the quality standard of Chushi pill. METHODS： Microscopic identification and TLC were adopted for the qualitative identification of Cortex moutan, C. dictamni, Angelica sinensis, Rubia cordifolia and Gardeniae fructus in Chushi pill; HPLC was performed to determine the contents of paeonol and baicalin. It was performed on column of Kromasil 100-5 C18 with mobile phase of methanol-water-phosphoric acid （47 ： 53 ： 0.2, V/V/V） at the flow rate of 1.0 ml/min, the detection wavelength was 280 nm, the temperature was 25 ℃ and the volume was 10 μl. RESULTS： The microscopic identification showed microscopic characteristics of C. moutan and C. dictamni, and characteristics of A. sinensis, R. cordifolia and G. fructus were identified by TLC; the linear range of paeonol was 0.106 24-2.124 8 μg （r=0.999 9） and baicalin was 0.059 04-1.180 8 μg （r=0.999 9） ; RSDs of precision, stability and reproducibility tests were no more than 2.06% ; average recoveries were respectively 101.56% （RSD=1.68% ,n=9） and 100.16% （RSD=1.13% ,n=9）. CONCLUSIONS： The method is simple, accurate and reproducible, and can be used for the quantity control of Chushi pill.

关 键 词：除湿丸 薄层色谱法 高效液相色谱法 丹皮酚 黄芩苷 质量标准 显微鉴别 

分 类 号：R284.1[医药卫生—中药学] R927.2[医药卫生—中医学]