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目的：观察聚异丁烯、液体石蜡、增粘剂和月桂氮艹卓酮同时作为压敏胶和药库层时，其组成对吲哚美辛贴剂特性的影响。方法：运用正交设计实验研究处方基质组成对药物透皮释放和胶层物理参数的影响，用改进的Ｆｒａｎｚ 体外释药装置研究离体鼠皮的透皮规律，建立高效液相色谱法测定了药物的透皮累积释放量和制剂含量。结果：实验发现基质组成中增粘剂和液体石蜡是决定药物渗透系数和剥离强度的主要因素，低相对分子质量聚异丁烯和增粘剂对初粘力影响最大，增粘剂对拉力强度有显著作用；在优选的处方基础上，找到月桂氮艹卓酮的理想浓度约为５ ％ ；各项指标均符合橡皮胶的国家标准；测定方法可靠。结论：组分中增粘剂对贴剂粘附性的影响最大，５ ％ 月桂氮艹卓酮对药物渗透系数的作用显著。
OBJECTIVE: To observe the effect of the composition of polyisobutylene, liquid paraffin, tackifier and azinolone on the characteristics of indomethacin patch when used as pressure-sensitive adhesive and drug reservoir. Methods: The effects of prescription matrix composition on the drug transdermal delivery and the physical parameters of the adhesive layer were studied by orthogonal design experiments. The transdermal law of the in vitro rat skin was studied by the modified Franz in vitro release device. The establishment of high performance liquid chromatography Drug transdermal cumulative release and formulation content. Results: Tackifier and liquid paraffin were the main factors determining the permeability coefficient and peel strength of the matrix. The effect of low molecular weight polyisobutylene and tackifier on the initial tack was greatest, and the tackifier had a significant effect on the tensile strength The optimal concentration of laurocapram was found to be about 5% on the basis of the preferred prescription. All indexes met the national standards of rubber gum and the determination method was reliable. Conclusion: Tackifier has the most effect on the adhesiveness of the patch, and the effect of 5% lauroxonil on the drug permeability coefficient is significant.