肠激安制剂质量标准研究  

Study on the quality standard of Changji′an Preparation

作　　者：闫雪[1] 唐洪梅[1] 李得堂[1] 何嘉仑[1] 

机构地区：[1]广州中医药大学第一附属医院,广州510405

出　　处：《西北药学杂志》2017年第4期411-415,共5页Northwest Pharmaceutical Journal

基　　金：国家自然科学基金项目(编号:81073160);广东省自然科学基金项目(编号:s2012010010539);广东省科技厅科技项目(编号:2010B030700065);广州市科技局重大科技生物专项(编号:2008AJE4101-6)

摘　　要：目的建立肠激安制剂的质量标准。方法采用TLC法对肠激安制剂中的延胡索、黄连、陈皮、枳壳、白芍和石榴皮进行定性鉴别;采用HPLC法测定肠激安制剂中芍药苷的含量,色谱柱:Luna C18(250mm×4.6mm,5μm);流动相:1mL·L-1磷酸水溶液-乙腈(85∶15);流速:1mL·min-1;检测波长:230nm;柱温:30℃。结果薄层色谱斑点清晰,不同成分阴性样品无干扰;芍药苷质量浓度在0.037 36~0.186 8mg·mL-1(r=0.999 9)范围内线性关系良好,精密度、重复性和稳定性的RSD值均小于3%,平均加样回收率为100.57%(RSD=2.81%,n=6)。结论所建立的标准专属性强、重复性好,可用于肠激安制剂的质量控制。Objective To establish the quality standards of Changji′an Preparation.Methods Qualitative identification of Corydalis rhizome,Coptidis rhizome,Citri reticulatae pericarpium,Autantii fructus,Paeoniae radix alba and Granati pericarpium in Changji′an Preparation were carried out by thin-layer chromatography（TLC）.The content of paeoniflorin was determined by HPLC method.With 1mL·L^-1 phosphoric acid solution-acetonitrile（85∶15）used for mobile phase,the Luna C18（250mm×4.6mm,5μm）column was adopted for the determination of paeoniflorin.The flow rate was 1 mL·min^-1 and the detection wavelength was set at 230 nm.The column temperature was maintained at 30℃.Results The TLC spots were clear and specific in good repeatability without interference from negative sample.The linear range of paeoniflorin was 0.037 36-0.186 8 mg·mL^-1（r=0.999 9）with average recoveries of 100.57%（RSD=2.81%,n=6）.The RSD of precision,repeatability,stability were all less than 3%.Conclusion The established method can be used for the quality control of Changji′an Preparation for its specific and good repeatability.

关 键 词：肠激安制剂 芍药苷 薄层鉴别 含量测定 质量标准 

分 类 号：R282[医药卫生—中药学]