益气醒脑饮的质量标准改进研究.docVIP

益气醒脑饮的质量标准改进研究 夏天一束畅 孙渺 高守红 陈万生 张凤 上海长征医院药学部 : 目的提升上海长征医院院内制剂益气醒脑饮的质量标准。方法 采用薄层色谱法 (TLC)分别对黄茂、川瓠 枳实、石菖蒲、丹参、红花6味药材进行定性鉴别，采 用高效液相色谱法(I1PLC)对黄罠、川尊、丹参屮的主要成分毛蕊异黄酮葡萄糖 昔、原儿茶酸、丹酚酸B进行定量检测。结果在TLC色谱中，供试品色谱在与 对照药材色谱相应的位置上，显示相同颜色的斑点，分离度良好，阴性对照无 干扰。毛蕊异黄酮葡萄糖昔、原儿茶酸和丹酚酸B分别在质量浓度为 3. 3(/32. 24gg/ml、1. 1445. 76曲/ml和6. 34252. 60眩/ml范围内与峰面积呈现良好 的线性关系;重复性好(RSD〈1?93%),屮间精密度佳(RSD〈1.65%),准确度分 别为 101.47% (RSD=2. 14%)、98. 26% (RSD二2. 64%)、99. 39% (RSD二 1. 62%),供 试品溶液在24 h内稳定(RSD1.69%) o结论 该方法简便易行、准确可靠，可 为益气醒脑饮质量标准的建立提供依据。 关键词: 益气醒脑饮;薄层色谱;高效液相色谱;质量标准; ：夏天一，女，博士，研究方向：临床药学 ：张凤，女，大学，主管药师，研究方向：临床药学, E~mai1:fengzhai yun. com ：2017-01-12 基金：上海市科学技术委员会科研计划项目 Quality improvement of Yiqi Xingnao Oral Liquid XIA Tian-yi SHU Chang SUN Miao GAO Shou-hong CHEN Wan-sheng ZHANG Feng Department of Pharmacy, Changzheng Hospital of Second Military Medical University; Abstract： OBJECTIVE To improve the quality standard of Yiqi Xingnao Oral Liquid macle in Shanghai Changzheng Hospital. METHODS Thin layer chromatography (TLC) was applied for the qualitative identification of Astragali Radix, Chuanxiong Rhizoma, Aurantii Fructus Tmmaturus, Acori Tatarinowii Rhizoma, Salviac M订tioirhizac Radix ct Rhizom and Carthami Flos. High performance liquid chromatography (HPLC) was applied for the quantitative analysis of calycosin-7-glucoside, protocatechuate and salvianolic acid B. RESULTS In TLC analysis, the test samples showed the same color spots as the control drugs in the same positions, and no interference was observed from the negativc control. Calycosin-7-glucoside, protocatechuate and salvianolic acid B indicated good linearity in ranges of 3. 30 - 132. 00 l^g/ml, 1. 14 - 45. 60 l^g/ml and 6. 30 - 252. 00 l^g/ml, respectively. Good reproducibility (RSD1. 93%) , intermediate precision (RSD1. 65%) , stability within 24 h (RSD1. 69%) were achieved. Accuracy was 101.47% (RSD=2. 14%) , 98. 26% (RSD=2. 64%) , 99. 39% (RSD=1. 62%) for the 3 compounds, respec ti vely. CONCLUSION The met hod is feasible and