壮药清解雾化液质量标准研究  

Quality Standard of Qingjie Atomized Liquid

作　　者：莫小林[1] 伍小燕[1] 龚敏阳[1] 陈晓明[1] 韦振源[1] Mo Xiaolin Wu Xiaoyan Gong Minyang Chen Xiaoming Wei Zhenyuan(First Affiliated Hospital of Guangxi Traditional Chinese Medicine University, Nanning, Guangxi, China 53002)

机构地区：[1]广西中医药大学第一附属医院,广西南宁530023

出　　处：《中国药业》2017年第10期27-30,共4页China Pharmaceuticals

基　　金：广西壮族自治区卫生厅中医药科技专项制剂类课题资助项目和医院制剂遴选课题[GZYZ1104];全国中药特色技术传承人才培训项目[J20164811007]

摘　　要：目的建立清解雾化液的质量标准。方法采用薄层色谱法(TLC)对清解雾化液中的桑叶、一点红、岗梅根进行定性鉴定。采用高效液相色谱(HPLC)法测定清解雾化液中芦丁的含量,色谱柱为Discovery C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸溶液(35∶65),检测波长为356 nm,流速为1.0 mL/min,柱温为35℃。结果桑叶、一点红、岗梅根薄层色谱斑点清晰,阴性对照无干扰;芦丁质量浓度在2~20μg/mL范围内与峰面积线性关系良好,r=0.999 6,平均回收率为99.92%,RSD为0.99%(n=6)。结论该方法操作简单、专属性和重复性良好,可作为该制剂的质量控制方法。Objective To establish the quality standard of Qingjie Atomized Liquid. Methods The Morus Alba, Emilia Sonchifolia and Radix llicis Asprellae in the Qingjie Atomized Liquid were identified by thin layer chromatography（TLC）. The content of rutin in the Qingjie Atomized Liquid was determined by high performance liquid chromatography（HPLC）. The column was Discovery C18 column （250 mm ×4.6 mm,5 μm） with mobile phase of methanol-0. 1% phosphoric acid solution（35：65）,the detection wavelength was 356 nm,the flow rate was 1.0 mL/min,the column temperature was 35 ℃. Results The TLC spots of Morus Alba, Emilia Sonchifolia and Radix llicis Asprellae were clear and showed negative control without interference. The concentration of rutin is linear in the range of 2-20 g/mL and had a good linear relationship with the peak area, r=0. 999 6, the average recovery was 99.92%, RSD was 0.99% （n = 6）. Conclusion The method is simple, specific and reproducible ,which can be used for the quality control of Qingjie Atomized Liquid.

关 键 词：清解雾化液 质量标准 薄层色谱法 高效液相色谱法 芦丁 

分 类 号：R284.1[医药卫生—中药学]