山楂内消丸质量标准提高探究.doc

山楂内消丸质量标准提高探究[摘要] 目的：提高山楂内消丸的质量标准。方法：采用TLC法对制剂中的香附、山楂进行定性鉴别；用RP-HPLC法对制剂中的橙皮苷进行含量测定。色谱柱：Agilent HC-C18 (4.6 mm ×150 mm, 5 μm)；流动相：乙腈-0.1 %磷酸水溶液(22∶78) ；检测波长：283 nm。结果：TLC法能对香附、山楂进行专属性定性分析；橙皮苷线性范围为0.051~0.510 μg ，平均回收率为97.65%。结论：本文所建立的质量控制方法可准确地进行定性和定量检测，方法可靠，重复性好，可有效控制山楂内消丸的质量。 [关键词] 山楂内消丸；TLC；HPLC；质量标准 [中图分类号]R927[文献标识码]A [文章编号]1673-7210（2007）11（c）-078-03 Studies on elevating quality standard of Shanzha Neixiao Pills YAN Yan1,2，RAO Yi1，3#，LUO Guo-an2#，WANG Yi-ming2，WEI Hui-zhen1,3 (1. Jiangxi University of Traditional Chinese Medicine, Nanchang330006, China;2. Research Center for Modernization of Traditional Chinese Herbal Medicines, Tsinghua University, Beijing 100084, China; 3. The National Pharmaceutical Engineering Center (NPEC) for Solid Preparation in Chinese Herbal Medicine,Nanchang330006, China) [Abstract] Objective:To elevate the method for quality control of Shanzha Neixiao Pills. Methods:TLC was used to identify Rhizoma Cyperi and Fructus Crataegi qualitatively; the content of total aurantiamarin in the preparation was determined by RP-HPLC.The samples were separated by Agilent HC-C18 (4. 6 mm ×150 mm, 5 μm) with the mobile phase consisting of acetonitrile-0.1% phosphoric acid (22∶78). The detective wavelength was set at 283 nm. Results:Rhizoma Cyperi and Fructus Crataegi could be identified by TLC. The linearity range of aurantiamarin was 0.051~0.510 μg，and the average recovery rate was 97.65%.Conclusion:The methods are reliable and reproducible and can be used for quality control of Shanzha Neixiao Pills. [Key words] Shanzha Neixiao Pills；TLC；HPLC；Quality standard 山楂内消丸由香附、山楂、陈皮、青皮等11味药材加工制成，具有开胃化滞，破气消食的功效，主要用于胃病患者倒饱吞酸，胸满气胀，肚腹疼痛，大便燥结等症状，在临床上已取得了良好的疗效。山楂内消丸原收载于《卫生部药品标准中药成方制剂》第15册[1]，现行标准只在性状和显微鉴别上对其进行了简单的质量控制，为了更准确地控制本品的内在质量，参考有关文献[2,3]进行了质量标准提高的研究工作，增加了对制剂中香附、山楂的薄层定性鉴别；同时用高效液相色谱法对制剂中橙皮苷进行了含量测定，为该制剂的质量标准提高提供了实验依据。 1 仪器与试药 1.1 仪器 岛津高效液相色谱系统(岛津SPD-M10A二极管阵列检测器，CLASS-VP色谱工作站)；昆山KQ-500E型超声仪(40 Hz)；MILLIPORE超纯水制备仪。 1.2 试药