[关键词]
[摘要]
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。
[Key word]
[Abstract]
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 .
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[基金项目]
福建省科技重大专项(2009YZ0001-1-3);福建省医学创新项目(2009—CX—16)