复方茜草增色液质量标准研究

Establishment of quality control method for the compound Rubia cordifolia chromotropic solution

目的研究复方茜草增色液定性定量方法,建立其质量控制标准。方法采用薄层色谱(TLC)法对茜草、马齿苋、苏木、虎杖、独活进行定性鉴别。HPLC法测定制剂中羟基茜草素、大叶茜草素的含量,采用AgilentZORBAX-SBC18色谱柱(250mm×4.6mm,5μm),流动相为甲醇-乙腈-0.2%磷酸(25∶50∶25);流速:1.0ml/min;检测波长:250nm;柱温:30℃。结果TLC法能定性鉴别茜草、马齿苋、苏木、虎杖、独活。羟基茜草素、大叶茜草素分别在0.8~5.6μg/ml(r2=0.9999)、2~14μg/ml(r2=0.9999)范围内线性关系良好。平均加样回收率分别为101.09%(RSD为1.44%)、101.56%(RSD为1.59%)。结论该制剂制备方法简便易行,主要成分含量分析方法专属性好、重复性和准确度高,操作方便,该标准可作为本制剂的质量控制标准。

Objective To study the qualitative and quantitative method for the quality control of compound Rubia cordifolia chromotropic solution,so as to establish the quality control standard of the solution product. Methods The TLC method was used for qualitative identification of R. cordifolia L.,Portulaca oleracea L.,Caesalpinia sappan L.,Reynoutria japonica Houtt. and Heracleum hemsleyanum Diels. The content of purpurin and mollugin in the preparation was determined by HPLC. Agilent ZORBAX-SB C18 col? umn(250 mm ×4.6 mm,5 μm)was used. The mobile phase was methanol-acetonitrile-0.2% phosphoric acid(25∶50∶25);flow rate: 1.0 ml/min;detection wavelength:250 nm;column temperature:30℃. Results TLC could be used to identify R. cordifolia,P. olera? cea,C. sappan,R. japonica and H. hemsleyanum. The purpurin and mollugin showed a good linearity in the concentration range of 0.8- 5.6(r2=0.9999)and 2-14 μg/ml(r2=0.9999)in the HPLC analysis,respectively. The average recovery rate for purpurin and mollugin was 101.09%(RSD 1.44%)and 101.56%(RSD 1.59%),respectively. Conclusion The preparation of the solution products is sim? ple and convenient,and the established HPLC method for the quantitative determination of the main components in the compound preparations has a good specificity,high repeatability and high accuracy,which is also easily maneuverable. The present method can be used as the quality control standard for the preparation.