Plackett-Burman设计筛选及单因素实验优化冲和凝胶处方组成

Optimization of Chonghe gel formulation using Plackett-Burman design and single-factor design

[目的]优化冲和凝胶的处方。[方法]以黏度、芍药苷与蛇床子素稳定性为指标,通过Plackett-Burman设计筛选处方的主要影响因素。针对影响因素,采用单因素实验设计进一步优化冲和凝胶的处方。[结果]筛选实验表明,卡波姆、载药量、甘油、pH值为制剂黏度主要影响因素;pH值、亚硫酸氢钠为芍药苷稳定性的主要影响因素。通过对各因素优化,最终制剂处方为1.5%卡波姆981、12%甘油、0.175%亚硫酸氢钠、三乙醇胺调节pH值4.5~6.0,载药量20%~30%。[结论]经验证,优化的处方考察各项指标符合制剂要求。

[Objective] To choose the optimal formulation for the Chonghe gel prescription. [Methods] The viscosity of the preparation and the stability of paeoniflorin and osthole were served as evaluation criterions. The experiment would inspect the significance of influential factor of preparation by Plackett-Burman design. Then the prescription was further optimized for those factors. [Results] Plackett-Burman design tests showed that the amount of Carbomer, drug loading, glycerol, pH value were significant influencing factors on the formulation viscosity. The amount of sodium bisulfite, pH value were major influencing factors of stability of paeoniflorin. By further optimization of the various factors, the final prescription was optimized as follows ：carbomer 981 was 1.5%, glycerol was 12%, sodium bisulfite was 0.175%, pH value was at 4.5 to 6.0 adjusting by the triethanolamine, the amount of the drug loading was 20% to 30%. [Conclusion] The optimized formulation is proved to be reliable, stable and available for meeting the preparation requirements.