RP-HPLC法测定姜黄素温敏凝胶的含量及体外释放度

目的:建立姜黄素温敏凝胶中姜黄素的含量测定方法并研究其体外释放行为。方法:以泊洛沙姆407、泊洛沙姆188为基质制备姜黄素温敏凝胶;采用反相高效液相色谱(RP-HPLC)法测定姜黄素温敏凝胶的含量和体外释放度,色谱柱为Kromasil C18(250mm×4.6mm,5μm),流动相为乙腈-2%冰醋酸溶液(58∶42),检测波长为430nm。结果:回归方程为A=113.2c+82.177(r=0.9993),姜黄素检测浓度在4～128μg·mL-1范围内与峰面积积分值线性关系良好,平均回收率为(100.23±0.75)%,低、中、高浓度标准品溶液日内精密度的RSD分别为1.99%、1.86%、1.96%,日间精密度的RSD分别为1.04%、1.74%、1.98%。样品于120h在释放介质中的累积释放率为(81.54±1.07)%,药物释放遵循Higuchi方程释放动力学模型。结论:本方法准确、可靠,可用于姜黄素温敏凝胶中姜黄素的含量测定。姜黄素温敏凝胶具有一定的缓释作用。

Determination of the Content and in Vitro Release Rate of Curcumin Thermosensitive Hydrogels by RP-HPLC

OBJECTIVE ： To establish the method for the content determination of curcumin in Curcumin thermosensitive hydrogels, and to study in vitro release rate of it. METHODS： Curcumin thermosensitive hydrogels were prepared using poloxamer 407 and poloxamer 188 as bases. The content and the in vitro release rate of Curcumin thermosensitive hydrogels were determined by RP-HPLC on Kromasil Ct8（250 mm×4.6 mm, 5 μm） column with acetonitrile and 2% acetic acid （58：42） as mobile phase. The detection wavelength was set at 430 nm. RESULTS： Regression equation was A = 113.2c＋82.177 （r=0.999 3）. The linear range of curcumin was 4-128 μg·mL^-1 with an average recovery of （100.23 ± 0.75）%. RSDs of intra-day were 1.99%, 1.86% and 1.96%, and RSDs of inter-day were 1.04%, 1.74% and 1.98%. The accumulative release rate reached （81.54± 1.07）% within 120 h, and drug release followed Higuchi equation release kinetic model. CONCLUSION： The method is accurate and reliable and it can be used for the content determination of curcumin in Curcumin thermosensitive gel. Curcumin thermosensitive hydrogels have sustained-release effect.