盐酸奥昔布宁贴剂的制备及质量评价

Preparation of Oxybutynin Transdermal Patch and Quality Evaluation in vitro

目的制备盐酸奥昔布宁透皮贴剂,并对其质量进行评价。方法以丙烯酸树脂为基质材料,制备奥昔布宁贴剂,采用.HPLC法测定贴剂中药物含量;采用改良Franz扩散池法,考察贴剂的经皮渗透速率;采用《中国药典》附录法考察贴剂的体外释放行为和黏附性能。结果奥昔布宁贴剂体外72 h释药可达85%以上,其透皮稳态流量为8.01μg·(cm^2·h)^(-1),并可维持3~4 d的零级透皮速率,初黏力钢球号在16~18之间,持黏力在30~35 min之间。结论自制盐酸奥昔布宁贴剂基本达到国外上市药品质量标准。

Objective To prepare the oxybutynin transdermal patch and to study its quality. Methods The oxybutynin patch was prepared using polymethyl methacrylate as the vehicle. An HPLC method was established to determine the concentration of oxybutynin in vitro. Oxybutynin across the mouse skin was studied with Franz diffusion cell. Adhesion properties were evaluated by means of creep resistance test and rolling ball test. Results The cumulative release of oxybutynin from the patch was over 85%. The permeation kinetics of oxybutynin across the mouse skin showed a zero-order pattern. The J of the patch was 8.01 μg ·（ cm^2·h） ^-1. The peel adhesion and creep resistance were equal to No. 18 steel ball and 30 min repectively. Conclusion The prepared oxybutynin transdermal patch shows as good quality as foreign ones.