驻极体氟尿嘧啶凝胶贴剂的制备研究

目的 制备并优化驻极体氟尿嘧啶凝胶贴剂及考察贴剂的相关性质。方法 通过预实验筛选黏合剂和保湿剂,采用正交设计优化处方,用补偿法测量驻极体贴剂的电荷储存稳定性,用透皮扩散仪和HPLC仪研究药物的体外透皮作用。结果 贴剂基质的最佳配比为PAAS∶明胶∶PVA∶高岭土∶CMC-Na∶保湿剂=0.2∶0.7∶0.5∶0.7∶0.2∶12;制备的贴剂具有良好的电荷储存稳定性;驻极体和3%氮酮均能有效地促进药物释放,且两者有协同促渗作用。结论 按最佳条件制备了质量优良的驻极体氟尿嘧啶凝胶贴剂,该贴剂对皮肤无刺激性,且该贴剂的药物释放行为优于一般的凝胶贴剂。

The preparation of electret fluorouracil gel patch

Objective To study and optimize the preparation process and abserve the related properties of electret fluorouracil gel patch. Methods the adhesives and moistening agents were screened by preliminary experiment. The optimal matrix proportion in the blank gel patch was obtained with orthogonal design. The charge storage stability of the patch was studied by compensation method. The transdermal behaviors of the patch were evaluated by modified diffusion cell method and HPLC. Results The optimal matrix proportions of PAAS:gelatin:PVA:Kaolin:CMC-Na:moistening agents were 0.2:0.7:0.5:0.7:0.2:12.The patch had a good charge storage stability. All the electrets and 3% azone could enhance the cumulative penetration amount of drug and they had synergistic enhancing effect. Conclusion The qualified electret fluorouracil gel patch was prepared under the optimal process, which had no skin irritation and the behavior of transdermal delivery was better than that of the traditional gel patch.