温胃理气止痛颗粒质量标准研究  

Study on Quality Standard of Wenweiliqizhitong Granules

作　　者：陈换平 张广春[2] 陈明明[2] 王东[1] 白雷[1] 刘东春[1] 

机构地区：[1]沈阳药科大学中药学院,辽宁沈阳110016 [2]中国人民解放军沈阳军区联勤部药品仪器检验所,辽宁沈阳110026

出　　处：《现代中药研究与实践》2016年第1期48-50,共3页Research and Practice on Chinese Medicines

基　　金：军队医疗机构制剂标准提高科研专项课题(14ZJZ13-3)

摘　　要：目的建立温胃理气止痛颗粒的质量标准。方法采用薄层色谱法对处方中的厚朴、延胡索进行定性鉴别,采用高效液相色谱法测定延胡索乙素的含量。色谱柱为Welchrom C18（4.6 mm×250 mm,5μm）,流动相为乙腈-0.1%磷酸溶液（三乙胺调p H值至6.0）（40：60）,柱温为30℃,流速为1.0 ml/min,检测波长为280 nm。结果该薄层色谱法斑点清晰,分离度好,阴性对照无干扰;延胡索乙素在1~80μg/ml范围内呈良好的线性关系（r=0.999 9）,平均回收率为96.93%,RSD为2.06%（n=6）。结论该方法操作简便、准确可靠、专属性强、重复性好,可用于温胃理气止痛颗粒的质量控制。Objective To establish the quality standard for Wenweiliqizhitong granules. Methods Magnolia officinalis Cortex and Corydalis Rhizoma in the granules were identified by TLC. The content of tetrahydropalmatine was determined by HPLC. A Welchrom CI8（4.6 mm×250 mm, 5μm）was used with the mobile phase consisting of acetonitrile - 0.1% phosphoric acid（adjusting pH to 6.0 with triethylamin） （40 ： 60） at the column temperature of 30℃. The flow rate was 1.0 ml/min and the detection wavelength was 280 nm. Results The method of TLC had good resolution with clear spots and without interference from negative control. The good linearity was obtained within the range of 1 - 80 μg/ml （r = 0.999 9） for tetrahydropalmatine and the average recovery was 96.93% （RSD = 2.06%, n = 6）. Conclusion The established method is simple, accurate and sensitive, and can be applied in the quality control of Wenweiliqizhitong granules.

关 键 词：温胃理气止痛颗粒 薄层色谱法 高效液相色谱法 延胡索乙素 质量标准 

分 类 号：R927.1[医药卫生—药学]