活血止痛丸质量标准研究  

Study on Quality Standard of Huoxue Zhitong Pills

作　　者：陶思宇 张永萍 陈晓兰 徐帮会 刘纯纯 刘政岑 TAO Siyu;ZHANG Yongping;CHEN Xiaolan;XU Banghui;LIU Chunchun;LIU Zhengcen(Guizhou University of Traditional Chinese Medicine,Guiyang 550025,China)

机构地区：[1]贵州中医药大学,贵阳550025

出　　处：《吉林中医药》2020年第5期667-670,共4页Jilin Journal of Chinese Medicine

基　　金：国家苗药工程技术研究中心项目(2014FU125Q09);贵州省国内一流建设学科项目(中药学)(GNYL〔2017〕008号);贵州省高层次创新型人才“百层次”人才项目(黔科合平台人才〔2015〕4030号);贵州省普通高等学校中药民族药(苗药)新剂型新制剂工程研究中心项目(黔教合KY字〔2014〕22号);贵州省普通高等学校中药民族药制剂重点实验室项目(黔教合KY字〔2016〕005号)。

摘　　要：目的建立活血止痛丸的质量标准。方法采用薄层色谱法(TLC)对处方中赤芍、西红花、木香3种中药进行定性鉴别,且分别对其进行耐用性考察,对鉴别方法进行方法学考察;以ZORBAX SB-C18(250 mm×4.6 mm,550)为固定相,0.1%磷酸-乙腈(79:21)为流动相,检测波长为286 nm,流速为1.2 mL/min,用高效液相色谱法测定制剂中丹酚酸B的含量。结果通过TLC检识,供试品和各对照药材通过点板显示,阴性无干扰,专属性强,耐用性好;丹酚酸B含量测定中在0.038~0.084 mg/mL范围内峰面积与丹酚酸B对照品溶液浓度的线性关系良好(r=0.9998),精密度、稳定性、重复性试验的RSD均小于2.0%,其平均加样回收率为102.2%(n=9),RSD%为0.98%,3批活血止痛丸中丹酚酸B的平均含量是3.232 mg/g。结论该方法简便、准确,重现性好,为活血止痛丸的质量标准控制提供了试验依据。Objective To establish the quality standard of Huoxue Zhitong pills.Methods Three traditional Chinese medicines of red peony,saff ron,common aucklandia root were qualitatively identifi ed by thin-layer chromatography,and their durability was investigated.The method of identifi cation was used to examine the method.ZORBAX SBC18(250 mm×4.6 mm,5μm)is the stationary phase,0.1%phosphoric acid-acetonitrile(79:21)is the mobile phase,the detection wavelength is 286 nm,the fl ow rate is 1.2 mL/min,and the preparation is determined by high performance liquid chromatography.The content of the medium phenolic acid B.Results The unfolding eff ect in TLC was better.The spots in the chromatogram of the test samples showed the same color spots at the corresponding positions of the corresponding medicinal materials.The negative interference-free,specificity and durability were strong.The content of salvianolic acid B was determined.The linear relationship between the peak area of 0.038-0.084 mg/mL and the concentration of salvianolic acid B reference solution was good(r=0.9998),and the RSD of precision,stability and repeatability test were less than 2.0%.The rate was 102.2%(n=9),and the RSD%was 0.98%.The average content of salvianolic acid B in the three batches of Huoxue Zhitong pills was 3.232 mg/g.Conclusion This method is simple,accurate and reproducible, and provides a test basis for the quality standard control of Huoxue Zhitong pill.

关 键 词：活血止痛丸 薄层鉴别法 高效液相色谱法 丹酚酸B 质量标准 

分 类 号：R285.5[医药卫生—中药学]