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作 者:李欣晴[1] 饶毅[2] 魏惠珍[2] 陈卓[3] 胡景婷[4] 刘玲[5]
机构地区:[1]赣州市人民医院,江西赣州341000 [2]中药固体制剂制造技术国家工程研究中心,江西南昌341000 [3]赣南医学院,江西赣州341000 [4]九江市解放军第171医院,江西九江332000 [5]江西省人民医院,江西南昌330006
出 处:《中国医院药学杂志》2015年第1期79-82,共4页Chinese Journal of Hospital Pharmacy
基 金:"重大新药创制"科技重大专项(编号:2009ZX09310-005)
摘 要:目的:建立四逆泡腾片HPLC特征图谱分析方法。方法:采用Hypersil ODS2C18(4.6 mm×250 mm,5μm)色谱柱,流动相:乙腈-0.05%磷酸水溶液梯度洗脱,流速1 ml·min-1,检测波长240 nm,柱温25℃。结果:本色谱条件下四逆泡腾片各成分得到较好的分离,经方法学验证,该方法具良好精密度、重复性和稳定性。采用中药色谱特征图谱相似度评价系统软件(2004A版)进行特征图谱分析,10批四逆泡腾片样品相似度均在0.88以上。结论:通过四逆泡腾片特征图谱建立,可对四逆泡腾片成品进行定性分析和质量控制。OBJECTIVE To establish the method of HPLC fingerprint analysis for Sini effervescent tablets. METHODS The separation was performed on a Hypersil ODS2 C18 column(4.6 mm× 250 mm,5 μm), eluted with the mobile phase consisted of acetonitrile-0.05% phosphoric acid at a flow rate of 1 ml·min-1, detection wavelength at 240 nm, and the column temperature at 25 ℃. RESULTS Different component of Sini effervescent tablets were well separated under these conditions. As confirmed by methodology, this method had good precision, reliability and stability. Similarity Evaluation System for Chromatographic Fingerprint of Chinese Materia Medica (Version 2004A) was used to perform fingerprint analysis, and the similarity of 10 batches of Sini effervescent tablets was all 〉 0.88. CONCLUSION By establishing fingerprints, qualitative analysis and quality control can be realized for the finished products of Sini effervescent tablets.
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