注射用穿琥宁质量标准研究

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。

Study on Quality Standard for Potassium Sodium Dehydroandran Drographolide Succinate

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.