紫草软膏质量标准研究.PDFVIP

·738 · 国际中医中药杂志2018年8月第40卷第8期 Int J Trad Chin Med, August 2018, Vol. 40, No.8 ·实验与方药 · 紫草软膏质量标准研究 师桂英 任志银 蒋莹 路平 【摘要】 目的 建立紫草软膏的质量标准。方法 采用 HPLC 法同时测定制剂中左旋紫草素及 β,β’- 二甲基丙烯酰阿卡宁的含量，色谱柱为 Inertsil ODS-3 C18 柱(4.6 mm ×250 mm, 5 μm)；流动相为 0.05% 甲酸水溶液-乙腈(30 ∶70)，流速为 1.0 ml/min，检测波长275 nm ，柱温25 ℃。结果 左旋紫草素、β,β’- 二甲基丙烯酰阿卡宁分别在 0.04～0.81 μg (r ＝0.999 5)、0.41～10.36 μg (r ＝0.999 2)范围内线性良好，两 者的平均回收率分别为 103.32%、101.80%，RSD 分别为 1.96%、2.11% 。结论 质量标准方法简便、准 确，专属性强，可用于紫草软膏的质量控制。 【关键词】 紫草；紫草素；β,β’-二甲基丙烯酰阿卡宁；色谱法，高压液相；质量控制 Study on the quality control of Zicao ointment Shi Guiying, Ren Zhiyin, Jiang Ying, Lu Ping. Pharmacy Department of Beijing Rectum Hospital, Beijing 100120, China Corresponding author: Shi Guiying, Email:765660091@ 【Abstract 】 Objective Study on the improvement of quality standard for Zicao ointment. Methods The content of shikonin and β,β’-dimethylacrylshikonin was determined by high performance liquid chromatogram (HPLC). The column was Inertsil ODS-3 C18 column (4.6 mm×250 mm, 5 μm). The mobile phase comprising of acetonitrile-0.05% formic acid solution (70:30). The flow rate was 1.0 ml/min, the detection wavelength was 275 nm, and the column temperature was 25 ℃ . Results The linear range of shikonin and β,β’-dimethylacrylshikonin were 0.04-0.81 μg (r=0.999 5) and 0.41-10.36 μg (r=0.999 2). The average recovery were 103.32% and 101.80%, the RSD were 1.96% and 2.11%. Conclusions The method is simple, accurate and sensitive to control the quality of Zicao ointment. 【Key words 】 Radix arnebiae ; Shikonin; β,β’-Dimethylacrylshikonin; Chromatography, high pressure liquid; Quality control 紫草软膏是本院的传统中药制剂(制剂文号： 目前紫草软膏的质量标准主要为鉴别试验。 京药制字 ，已申报注册二十余年，临