妇痛宁颗粒质量标准研究

Establishment of quality standard for futongning granules

目的：建立妇痛宁颗粒质量标准。方法：采用薄层色谱法对方中赤芍、丹参、肉桂进行定性鉴别；采用高效液相色谱法对丹酚酸B进行含量测定。色谱柱为AgilentEclipsePlus-C18（100mm×4．6mm，3．5μm），流动相为甲醇-甲酸-水-乙腈（28：1：61：10），流速为1．0ml／min；柱温为25℃。结果：薄层色谱中的特征斑点明显，重现性好，无干扰；丹酚酸B在0．2584～155．04μg范围内线性关系良好（r=0．9999），平均回收率为99．43％，RSD为1．25％。结论：本法专属性强、准确、快速，可用于妇痛宁颗粒的质量控制。

Objective：To establish a quality standard for futongning granules. Methods ：Paeonia lactiflora, Salvia mihiorrhiza, Cin- namomum cassia were identificated by TLC and salvianolic acid B was determinated by HPLC. Parameters ： Agilent Eclipse Plus - Cis （4.6 mmx 100 mm,3.5 μm） was used stationary phase at a temperature of 25 ℃and methanol - formic acid - water - aceto- nitrile （28： 1： 61： 10） as mobile phase at a flow rate of 1.0 ml/min; detection wavelength was set at 286 um. Results：The components were completely identified and no interference spot was found on the plate by TLC. The concentration of salvianolic acid B showed a .good linearity with peak areas over 25.84 - 155.04 μg/ml, The average recovery was 99.43% with RSD of 1.25%. Conclusion：The TLC and HPLC methods established here are simple,reliable and stable, being suitable for the quality control of tutongning granules.