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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。
Objective: To study the forming process of anti-uterine inflammation gel and optimize the preparation process. Methods: The types of matrix, the types of excipients and the amount of screening were optimized, and the optimal preparation process was optimized. The appearance score, appearance, coatability, viscosity, viscosity and stability of the preparation were According to the in vitro dissolution test of appendix XC of 2010 edition of “Chinese Pharmacopoeia (two parts)”, the method of basket spinning was used to test the dissolution of total flavonoids Degrees of assessment indicators, preparation of anti-palace inflammation gel. Results: Using carbomer 940 as matrix, sodium hydroxide as neutralizer, glycerin as humectant and azone as absorption accelerator, the process of preparing anti-uterine inflammation gel was stable and feasible. Conclusion: The preparation method of anti-uterine gel is simple and easy to operate, the texture is fine and luster, the spreading is good, the property is stable, the gel remains at room temperature, does not dry up or liquefies, the dissolution rate is high, indicating that the molding process is stable and feasible .