HPLC法测定草乌甲素贴释放度

目的：建立草乌甲素贴的释放度测定方法，为评价和控制药品质量提供方法。方法：采用小杯碟法以纯化水为溶出介质，温度控制在（32±0．5）℃，转桨转速为50r·min^-1，用高效液相色谱法测定草乌甲素，色谱柱为luna C18（250mm×4．6mm，5μm）；流动相：0．2％三乙胺水溶液（用磷酸调节pH值至3．14-0．1）-乙腈（60：40）；流速：1mL·min^-1；‘检测波长260nm；柱温25℃。结果：本法线性范围为4．95～59．4mL·min^-1，r=0．9999；平均回收率为98．3％，RSD％为0．50％（n=9），对不同批次草乌甲素贴释放度进行测定，释放度参数差异无显著性意义（P〈0．05）。结论：本方法具有灵敏、准确、快速的优点，适用于草乌甲素贴的质量控制。

HPLC Determination of Release of Bulleyaconitine A Controlled Release Patches

Objective： To establish an HPLC method for the release of bullyaconitine A controlled release patches , and provide method for the evaluation and controlling of medicine quality. Method ： 6 patches were placed separately into small solution vessels filled with release medium of pure water, the temperature was maintained at 32℃ ± 0.5℃, paddles method was used at rotary speed of 50 r·min-1 The separation on the chromatography column of lunaC18 （250mm ×4. 6mm, 5μm） with acetonitrile-0. 2% triethylamine （adjusted to pH = 3. 1 ±0. 1 with phosphoric aicd ） （40： 60） as mobile phase at the flow - rate of 1.0mL ·min-1 The detective wavelength was 260 nm. The column temperature was 25℃. Result： The calibration curve was linear in the range of 0. 099μg- 1. 188μg, r = 1. 0000. The release of patches produced in different batches had no significatintly difference after detection. Conclusion ： The method is sensitive, accurately and quickly for the quality control of bullyaconitine A controlled release patches .