痛泻要方颗粒质量标准研究  

Study on Quality Standard of Tongxieyaofang Granules

作　　者：宋茹[1] 魏萍[2] 

机构地区：[1]武警部队药品仪器检验所,北京102613 [2]总后勤部卫生部药品仪器检验所,北京100166

出　　处：《解放军药学学报》2012年第2期154-156,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立控制痛泻要方颗粒的质量标准。方法采用TLC法对痛泻要方颗粒中白术、陈皮进行定性鉴别;采用HPLC法对痛泻要方颗粒中芍药苷进行定量分析。色谱条件:色谱柱为C18柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.1%磷酸溶液(14∶86),流速为0.8 ml/min,检测波长为230 nm。结果薄层斑点清晰,阴性对照无干扰;芍药苷对照品在13～130μg/ml范围内,进样量与峰面积呈良好线性关系,平均回收率为100.65%,RSD为0.52%(n=6)。结论本文方法简便可行,结果准确可靠,可作为该制剂的质量控制方法。Objective To establish a quality standard of Tongxieyaofang Granules.Methods Rhizome of largehead atractylodes and tangerine peel were identified by TLC.The content of paeoniflorin was determined by HPLC.The separation was performed on C18 column with acetonitrile-0.1% phosphoric acid（14 ∶ 86）as a mobile phase.The flow rate was 0.8 ml/min,and the detection wavelength was at 230 nm.Results The TLC spots that developed were fairly clear,and the blank test showed no interference.The control content of paeoniflorin was within the range of 13-130 μg/ml,and there was a fine linearship between the sample input and the peak area.The average recovery was 100.65%,RSD=0.52%（n=6）.Conclusion This method is simple,reliable,accurate and can be used for quality control of Tongxieyaofang Granules.

关 键 词：痛泻要方颗粒 质量标准 TLC HPLC 芍药苷 

分 类 号：R917[医药卫生—药物分析学]