建立雷公藤貼劑中雷公藤內(nèi)酯醇的釋放度測定方法。方法 采用HPLC法測定雷公藤內(nèi)酯醇，Ultimate色譜柱（250 mm×4.6 mm，5 μm），流動相為乙腈–超純水（3∶7），檢測波長為218 nm，體積流量為1 mL/min，柱溫為35 ℃，進樣量為20 μL。采用《中國藥典》釋放度測定法第三法，釋放介質(zhì)為50%甲醇–生理鹽水（1∶1）。結(jié)果 雷公藤內(nèi)酯醇在6～96 μg/mL線性關(guān)系良好（r=0.999 7），平均回收率為98.27%，RSD為1.68%。雷公藤貼劑中雷公藤內(nèi)酯醇的釋放過程符合Higuchi方程。結(jié)論 本法操作方便，重現(xiàn)性好，適合于雷公藤貼劑中雷公藤內(nèi)酯醇的釋放度測定。

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 .

福建省科技重大專項（2009YZ0001-1-3）；福建省醫(yī)學創(chuàng)新項目（2009—CX—16）