塞来昔布凝胶的制备与质量控制

The Preparation and Quality Control of Celecoxib Gel

目的制备塞来昔布凝胶并建立其质量控制方法。方法以卡波姆940为凝胶基质,以月桂氮酮和油酸为透皮吸收促进剂,用二甲亚砜作塞来昔布的溶媒,制备外用凝胶;采用高效液相色谱法测定主药含量。结果该法制得的凝胶均匀细腻,易涂布;建立的色谱方法能排除辅料对塞来昔布的干扰,塞来昔布在2.12~212.00μg.mL-1浓度范围内线性关系良好,平均回收率为100.29%,RSD=0.55%。结论塞来昔布凝胶的制备方法简单,制得的凝胶符合要求,质量控制方法可靠。

Objective To prepare celecoxib gel and to establish the method for its quality control. Methods The celecoxib gel for external use was prepared by using carbopol 940 as the base,laurocapram and oleic acid as skin penetration enhancer and DMSO as solvent for celecoxib and the drug content was determined by HPLC. Results The preparation was stabililty and without irritation.Celecoxib can be completely separated with a linear range of 2.12-212.00 μg·mL-1 and correlation coefficients of r=0.999 9.The average recovery was 100.29% with a RSD of 0.55 %. Conclusion The preparation technique is simple and feasible for the quality control.