三叉神经通络胶囊的质量标准研究  

Quality Standard of Sanchashenjing Tongluo Capsules

作　　者：黄海波[1] 顾洪双[1] 侯佳宁[2] 杨琳[1] 霍花[1] HUANG Hai-bo GU Hong-shuang HOU Jia-ning YANG Lin HUO Hua(The North Hospital, General Hospital of Shenyang Military Region, Shenyang 110031, China Outpatient Department of the Political Department of Shenyang Military Region,Shenyang 110013,China)

机构地区：[1]沈阳军区总医院北方医院,辽宁沈阳110031 [2]沈阳军区政治部门诊部,辽宁沈阳110013

出　　处：《解放军药学学报》2016年第4期329-331,共3页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项课题重点项目;No.14ZJZ09

摘　　要：目的提高并建立三叉神经通络胶囊的质量控制方法。方法采用TLC法对三叉神经通络胶囊中的川芎、天麻、蒲公英进行定性分析,采用HPLC法测定阿魏酸含量。色谱柱:Phenomenex Luna-C_(18)柱(250 mm×4.6 mm,5μm);流动相:1‰磷酸水-乙腈(80∶20);检测波长:316 nm;流速:1.0 ml·min^(-1);进样量:20μl。结果川芎、天麻、蒲公英的TLC鉴别中,供试品色谱在与对照药材色谱相应的位置上,显相同颜色的斑点,分离较好,阴性对照无干扰。阿魏酸的质量浓度在10.4~200.8μg·ml^(-1)范围内与其峰面积成良好线性关系(r=1.000);精密度、稳定性、重复性试验的RSD<3%;平均加样回收率为99.74%,RSD为1.84%(n=6)。结论该方法操作简单,灵敏度高,专属性强,重复性好,可作为三叉神经通络胶囊的质量控制方法。Objective To improve and establish a quality control method for Sanchashenjing Tongluo capsules. Methods Ligusticum chuanxiong hort,Gastrodia elata,Taraxacum mongolicum of the Sanchashenjing Tongluo capsules were qualitatively identified by TLC. The content of ferulic acid was determined by HPLC. The determination was performed on Phenomenex Luna C18 column with a mobile phase composed of 1‰ phosphoric acid-acetonitrile（ 80∶ 20,V / V）. The detection wavelength was 316 nm,the linear flow rate was 1. 0 ml·min-1and the sample size was 20 μl. Results TLC spots of ferulic acid were clear within the range of 10. 4- 200. 8 μg·ml-1（ r = 1）with an average recovery of 99. 74%（ RSD = 1. 84%,n = 6）. The RSD of precision,stability and reproducibility test was below 3%. Conclusion This method is simple,sensitive,specific and reproducible,which can be used for quality control of Sanchashenjing Tongluo capsules.

关 键 词：三叉神经通络胶囊 TLC HPLC 阿魏酸 质量标准 

分 类 号：R927.2[医药卫生—药学]