盐酸奥昔布宁醇脂质体凝胶的制备及质量评价

Preparation and Quality Evaluation of Oxybutynin Hydrochloride Ethosomal Gel

目的 制备盐酸奥昔布宁醇脂质体凝胶剂,并评价体外经皮渗透性、pH、外观形态等方面的质量.方法 以羟丙基纤维素（HPC）为基质制备OXB醇脂质体凝胶;采用Franz透皮扩散实验仪考察醇脂质体凝胶和普通凝胶的经皮渗透性;高效液相色谱法测定其中主药含量,并评价其质量.结果 醇脂质体凝胶（4％ OXB）的累积渗透率是普通凝胶（10％ OXB）的3.9倍.盐酸奥昔布宁线性范围为10 ～1 000 μg/mL,平均回收率为99.58％.结论 制备的醇脂质体凝胶经皮渗透性高,质量稳定可控.

Objective To prepare oxybutynin（OXB） hydrochloride ethosomal gel and to perform the quality evaluation on the transdermal penetrability in vitro,pH and appearance shape.Methods Hydroxypropyl cellulose （HPC） was used as the base material to prepare OXB ethosomal gel; the Franz in vitro transdermal diffusion test was adopted to investigate the in vitro transdermal penetrability of the ethosomal gel and the common gel; the content of OXB hydrochloride was determined by high performance liquid chromatography （HPLC）,and its quality was evaluated.Results The cumulative permeation rate of the ethosomal gel（4% OXB） was 3.9 times of the common gel（10% OXB）.The linear range of OXB hydrochloride was 10-1 000 μg/mL,the average recovery rate was 99.58%.Conclusion The prepared OXB ethosomal gel has the high transdermal penetrability with stable and controllable quality.