基于星点设计-响应面法优化双柏凝胶贴膏剂基质处方

Optimization of a Shuangbai gel ointment matrix formulation based on star point design-response surface methodology

目的优化双柏凝胶贴膏剂基质处方。方法2021年10月至2022年7月以感官评价、膜残留性、初黏力、持黏力为评价指标,采用星点设计-响应面法优化凝胶贴膏剂处方中甘氨酸铝、聚丙烯酸钠、甘油、聚乙烯吡咯烷酮的用量比例。结果凝胶贴膏剂最优基质处方,甘氨酸铝∶聚丙烯酸钠∶甘油∶聚乙烯吡咯烷酮为0.11∶2.33∶11.70∶1.93,所得凝胶贴膏剂涂展均匀、可反复揭贴10次以上、初黏力和持黏力符合要求。结论该方法稳定、可靠、准确,可用于双柏凝胶贴膏剂处方优化,具有借鉴意义。

Objective To optimize of the ointment matrix of a Shuangbai gel formulation.Methods From October 2021 to July 2022,the dosage ratios of aluminum glycinate,sodium polyacrylate,glycerol,and polyvinylpyrrolidone in the gel plaster were optimized by the star point design-response surface method using sensory evaluation,residual film,initial adhesion,and adhesion holding capacity as evaluation indices.Results The optimal matrix formulation of gel ointment was aluminum glycinate:sodium polyacrylate:glycero:polyvinylpyrrolidone(0.11∶2.33∶11.70∶1.93).The obtained gel ointment was spread evenly,and the process was repeated for more than 10 times to reveal the paste,the initial adhesive force and the holding adhesive force in line with the requirements.Conclusion This method is stable,reliable and accurate,and can be used for the optimization of the formulation of the Shuangbai gel ointment,which is highly important.