抗宫炎凝胶剂成型工艺研究

目的:研究抗宫炎凝胶剂的成型工艺,优化制备工艺。方法:对基质种类、辅料种类及用量进行筛选,优选最佳制备工艺路线,采用外观指标综合评分(满分6分)即以制剂的外观、涂布性、细腻性、粘稠性、稳定性为考核指标,用正交试验设计法筛选基质的组成,参照2010年版《中国药典(二部)》附录XC的体外溶出度试验,采用转篮法进行试验,测定君药广东紫珠中总黄酮溶出度为考核指标,制备抗宫炎凝胶剂。结果:以卡波姆940为基质,氢氧化钠为中和剂,甘油为保湿剂,氮酮为吸收促进剂,制备抗宫炎凝胶剂的工艺稳定可行。结论:抗宫炎凝胶剂制备方法简便易操作,质地均匀细腻有光泽,涂展性好,性质稳定,在常温时保持胶状,不干涸或液化,溶出度高,说明该成型工艺稳定可行。

Molding Technology Research of KangGongyan Gel

Objective:To study the forming process of KangGongyan gel and to optimize its preparation process.Methods:The matrix type and excipient type as well as their dosage were screened to select the optimal preparation process route. Using comprehensive score of appearance indicators (maximum score of 6), that is taking the appearance, spreading properties, fine and smooth, viscosity, stability of the preparations as performance indicators, to screen the matrix composition using orthogonal experimental design; The method of dissolution rate test in vitro in Appendix XC of Chinese Pharmacopoeia (2010 edition) was referred, and rotate basket method was used to carry out the experiment; The dissolution rate of total flavonoids in the monarch drug Guangdongzizhu was determined and taken as assessment indicator, to prepare KangGongyan gel.Results:The process of KangGongyan gel preparation was stable and feasible with Carbomer 904 as matrix, sodium hydroxide as neutralizer, glycerol as humectant, and azone as absorption enhancer.Conclusion:The preparation method of KangGongyan gel is simple and easy to operate; The texture is uniform, fine and smooth, glossy and spreading-well with stable quality, and it can maintain gel-like at normal temperature, not dry or liquidation, with high dissolution rate, indicating that the forming process is stable and feasible.