盐酸氨溴索凝胶膏剂的制备及体外透皮研究

发布时间：2018-08-03 09:37

【摘要】：目的:制备盐酸氨溴索凝胶膏剂,并研究其体外透皮特性。方法:以聚乙烯醇、甘氨酸铝、聚丙烯酸钠等基质制备盐酸氨溴索凝胶膏剂。在单因素考察基础上,采用Box-Behnken响应面法,以外观性状、初黏力、持黏力、剥离强度的综合评分为指标优化处方中聚乙烯醇、甘氨酸铝、聚丙烯酸钠的用量,并进行验证试验。通过改良Franz扩散池法考察所制凝胶膏剂的体外透皮特性。结果:最优处方为聚丙烯酸钠2.35 g、甘氨酸铝0.1 g、聚乙烯醇1.0 g;所制3批凝胶膏剂的综合评分分别为9.4、9.5、9.7,与预测值比较的相对误差分别为2.08%、1.04%、1.04%;24 h内盐酸氨溴索的体外透皮速率为9.472μg/(cm~2·h),符合零级动力学模型(r=0.994)。结论:凝胶膏剂处方合理,具有较好的透皮特性,透皮行为符合零级动力学过程。
[Abstract]:Objective: to prepare ambroxol hydrochloride gel paste and study its transdermal properties in vitro. Methods: ambroxol hydrochloride gel paste was prepared by polyvinyl alcohol, aluminum glycine and sodium polyacrylate. On the basis of single factor investigation, the Box-Behnken response surface method was used to optimize the dosage of polyvinyl alcohol, aluminum glycine and sodium polyacrylate with the comprehensive score of appearance, initial viscosity, adhesion and peeling strength as the index, and the verification test was carried out. The in vitro transdermal properties of the gel paste were investigated by modified Franz diffusion cell method. Results: the optimum prescription was sodium polyacrylate 2.35 g, aluminum glycine 0.1 g and polyvinyl alcohol 1.0 g. The comprehensive scores of the three batches of gel plaster were 9.4%, 9.5% and 9.7%, respectively. The relative error of comparison with the predicted value was 2.08% 1.04% and 1.04%, respectively. The in vitro penetration of ambroxol hydrochloride was obtained within 24 hours. The skin rate was 9.472 渭 g / (cm~2 h),) in accordance with the zero order kinetic model (r _ (0.994). Conclusion: the formulation of gel paste is reasonable and has good transdermal properties. The transdermal behavior accords with zero order kinetic process.
【作者单位】：第三军医大学第一附属医院药剂科;
【分类号】：R943

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