穿心莲内酯原料中有关物质和稳定性研究.PDF

现代药物与临床 Drugs Clinic 第 28 卷 第 4 期 2013 年 7 月 • 523 • 穿心莲内酯原料中有关物质和稳定性研究 胡向青，巴晓雨，郝 福，武 勇，周学刚 神威药业集团有限公司 河北省中药注射剂工程技术研究中心，河北 石家庄 051430 摘 要：目的 建立 RP-HPLC 法测定穿心莲内酯中有关物质，并对穿心莲内酯原料进行不同影响因素的稳定性考察，了解 影响其稳定性的具体因素。方法 采用反相高效液相色谱法，菲罗门 Gemini C18 色谱柱（250 mm ×4.6 mm ，5 μm ），检测波 长为 224 nm，柱温为 30 ℃，体积流量为 1.0 mL/min，流动相为乙腈–甲醇–水梯度洗脱。考察穿心莲内酯原料药在不同 pH 值、氧化、高温、高湿、强光照条件下的稳定性。结果 穿心莲内酯及其 3 个有关物质得到了很好地分离，所建立的有 关物质方法经验证，表明专属性、重复性及稳定性均良好。穿心莲内酯固体状态较为稳定；在溶液状态对氧化和 pH 3～5 条件较为稳定，在碱性介质、高温、光照条件下均不稳定。结论 该方法可以很好地用于穿心莲内酯的质量控制，穿心莲内 酯在溶液状态下总体稳定性较差，该结果为穿心莲内酯及其相关制剂研究提供一定参考。 关键词：穿心莲内酯；有关物质；稳定性；高效液相色谱 中图分类号：R927.1 文献标志码：A 文章编号：1674 - 5515(2013)04 - 0523 - 05 DOI: 10.7501/j.issn.1674-5515.2013.04.014 Related substances and their stability of andrographolide in raw materials HU Xiang-qing, BA Xiao-yu, HAO Fu, WU Yong, ZHOU Xue-gang Hebei Engineering Technology Research Center of Traditional Chinese Medicine Injection, Shineway Pharmaceutical Group Co. Ltd, Shijiazhuang 051430, China Abstract: Objective To establish a selective RP-HPLC method for the determination of related substances in andrographolide, and to investigate the stability of them affected by different factors. Methods RP-HPLC method was used on Phenomenex Gemini C 18 column (250 mm × 4.6 mm, 5 μm) at the temperature of 30 ℃. The mobile phases consisted of acetonitrile, methanol, and water. The flow rate was set at 1.0 mL/min and the UV detection was performed at 224 nm. This method was applied to evaluate the stability of andrographolide in solid and liquid forms by the following conditions: different pH values, oxidation, high temperature, high humidity, and strong light. Results The andrographolide and three related substances were separated. The developed method was further