注射用穿琥宁质量标准研究  

Study on Quality Standard for Potassium Sodium Dehydroandran Drographolide Succinate

作　　者：汤俊梅[1] 

机构地区：[1]健雄职业技术学院生物与化学工程系,江苏太仓215411

出　　处：《化工时刊》2014年第10期22-24,共3页Chemical Industry Times

摘　　要：对注射用穿琥宁进行质量标准研究。采用化学法、UV法和高效液相色谱法鉴别制剂中的穿琥宁,高效液相色谱法测定穿琥宁的含量。化学鉴别色差明显、UV鉴别清晰可见、HPLC鉴别分离度好,对应的空白及辅料均未见干扰;HPLC法测定结果显示色谱峰形好,分检离度好,杂质无干扰,穿琥宁浓度在39.89μg/mL^119.7μg/mL内呈良好的线性关系。建立的标准方法可靠﹑能准确的进行定性和定量检测,可用于注射用穿琥宁的质量控制。To establish the quality standard for potassium sodium dehydroandran drographolide succinate. Potas-sium sodium dehydroandran drographolide succinate were identified by chemical identification methods and Spectro-photometric method and HPLC method, their content were determined by HPLC. The three methods was sensitive and specific. A good linear relationship between peak area and concentrations were found at the range of 39. 89μg/mL-119. 7μg/mL for potassium sodium dehydroandran drographolide succinate. The method is reliable, accurate and spe-cific, and can be used for the quality of potassium sodium dehydroandran drographolide succinate.

关 键 词：注射用穿琥宁 质量标准 HPLC 

分 类 号：R927[医药卫生—药学] O657.72[理学—分析化学]