雷公藤贴剂中雷公藤内酯醇释放度的测定.pdf

现代药物与临床 Drugs Clinic 第 26 卷 第 5 期 2011 年 9 月 • 403 • 雷公藤贴剂中雷公藤内酯醇释放度的测定 * 钱丽萍，阙慧卿，林 绥 ，彭华毅，郭舜民 福建省医学科学研究院，福建 福州 350001 摘 要：目的 建立雷公藤贴剂中雷公藤内酯醇的释放度测定方法。方法 采用 HPLC 法测定雷公藤内酯醇，Ultimate 色谱 柱（250 mm ×4.6 mm ，5 μm ），流动相为乙腈–超纯水（3 ∶7 ），检测波长为218 nm ，体积流量为 1 mL/min，柱温为 35 ℃， 进样量为 20 μL 。采用《中国药典》释放度测定法第三法，释放介质为 50% 甲醇–生理盐水（1 ∶1）。结果 雷公藤内酯醇 在 6～96 μg/mL 线性关系良好（r=0.999 7 ），平均回收率为 98.27%，RSD 为 1.68%。雷公藤贴剂中雷公藤内酯醇的释放过程 符合 Higuchi 方程。结论 本法操作方便，重现性好，适合于雷公藤贴剂中雷公藤内酯醇的释放度测定。 关键词：雷公藤贴剂；雷公藤内酯醇；释放度；高效液相色谱 中图分类号：R286.02 文献标志码：A 文章编号：1674 - 5515(2011)05 - 0403 - 03 Release of triptolide in Leigongteng Adhesive Plaster QIAN Li-ping, QUE Hui-qing, LIN Sui, PENG Hua-yi, GUO Shun-min Fujian Institute of Medical Sciences, Fuzhou 350001, China Abstracts: Objective To establish an analysis method for determination of triptolide release in Leigongteng Adhesive Plaster. Methods HPLC method was used with Ultimate chromatographic column (250 mm×4.6 mm, 5 μm), acetonitrile-ultra pure water (3 ∶7) as mobile phase, detective wavelength 218 nm, flow rate 1.0 mL/min, column temperature 35 ℃, and injection volume 20 μL. Release was determined by Third Release Method in Chinese Pharmacopoia with the mixture of 50% methanol-physiological saline (1 ∶1) as media. Results The linear correlation of triptolide was good ranging from the concentrations of 6—96 μg/mL (r=0.999 7). The recovery rate of triptolide was 98.27% with RSD 1.68%. Triptolide release in Leigongteng Adhesive Plaster was in accordance with Higuchi equation. Conclusion The method is very convenient, reproducible, and suitable for determination of triptolide release in Leigongteng Adhesive Plaster . Key words: Leigongteng Adhesive Plaster; triptolide; release; HPLC 雷公藤内酯醇 （又名雷公藤甲素、雷公藤内酯） 释药情况进行了研究，为其外用剂型研究