复方附子口服液质量标准的研究  

Quality standard for Compound Aconite Oral Solution

作　　者：徐小芳[1] 陈文婷[2] 刘敏[1] 朱春黎[1] 康园超 王新宏[2] 安叡[2] 

机构地区：[1]上海市第二人民医院药剂科,上海200011 [2]上海中医药大学,上海201203

出　　处：《中成药》2016年第4期815-819,共5页Chinese Traditional Patent Medicine

基　　金：上海市黄浦区科学技术委员会2013年黄浦区卫生系统科研项目(HKW201313)

摘　　要：目的建立复方附子口服液（黄芪、盐附子、党参和麦冬）的质量标准。方法 TLC法定性鉴别黄芪、盐附子、党参和麦冬,HPLC-CAD法测定黄芪甲苷和麦冬皂苷D的含有量。结果在TLC色谱图中,4种药材的斑点清晰,分离度好,阴性无干扰。黄芪甲苷在0.670～6.70μg的线性范围内线性关系良好（r=0.999 8）,加样回收率为97.56%（RSD=1.6%）;麦冬皂苷D在0.138 8～1.388μg的线性范围内线性关系良好（r=0.999 7）,加样回收率为96.79%（RSD=1.9%）。结论该方法准确可靠,专属性好,可用于复方附子口服液的质量控制。AIM To establish a quality standard for Compound Aconite Oral Solution（ Astragali Radix,salted aconite lateral root,Codonopsis Radix and Ophiopogonis Radix）. METHODS TLC was used for the qualitative identification of Astragali Radix,salted aconite lateral root,Codonopsis Radix and Ophiopogonis Radix. HPLC-CAD was applied to determining the contents of astragaloside and ophiopogonin D. RESULTS The TLC spots of four medicinal materials were clear and well separated without the interference of negative samples. The linear relationship of astragaloside was good within the range of 0. 670- 6. 70 μg（ r = 0. 999 8）,whose recovery rate was97. 56%（ RSD = 1. 6%）. Ophiopogonin D displayed a good linear relationship within the range of 0. 138 8-1. 388 μg（ r = 0. 999 7）,whose recovery rate was 96. 79%（ RSD = 1. 9%）. CONCLUSION This method is accurate and reliable with strong specificity,which can be used for the quality control of Compound Aconite Oral Solution.

关 键 词：复方附子口服液 黄芪 盐附子 党参 麦冬 黄芪甲苷 麦冬皂苷D TLC HPLC-CAD 

分 类 号：R927.2[医药卫生—药学]