宫炎平软胶囊制备工艺研究

Study on Preparation Technology of Gongyanping Soft Capsules

目的:研究宫炎平软胶囊制备工艺。方法:以没食子酸提取量为指标,采用正交试验优选提取工艺;以没食子酸保留率、浸膏得率为指标,采用单因素试验优选分离、纯化工艺;以没食子酸提取量和收得率为指标,采用单因素试验优选浓缩、干燥工艺;以药液的稳定性和流动性为指标,对辅料的用量进行筛选。结果:优选的制备工艺为取处方量药材,加10倍量水煎煮2次,每次2h,浓缩至相对密度为1.25(55～60℃),加乙醇至含醇量达50%,静置时间24h,减压干燥,辅料用量为处方总量的72.5%,蜂蜡与单硬脂酸甘油酯用量比为1:1(m/m),羟苯乙酯用量为处方总量的0.25%。结论:所选工艺合理、可行,可用于制备宫炎平软胶囊。

To study the preparation technology of Gongyanping soft capsules. METHODS ： The extraction technology was optimized by orthogonal test with extraction amount of gallic acid as index. The separation and purification technology was optimized by single factor test with retention rate of gallic acid and the yield of extract as index. Concentration and drying process was optimized by single factor test with the extraction amount and yield of gallic acid as index. The amount of excipients was selected using stability and fluxility of solution as index. RESULTS： Optimal preparation technology was as follows： adding 10-fold water, decocting two times, 2 h per time, concentrated into 1.25（55-60 .C ）, 50% ethanol, setting for 2：4 h, drying under reduced pressure, excipients accounting of 72.5%, ratio of beewax to glycerin monostearate of 1 ： 1 （m/m）, ethylparaben of 0.25%. CONCLUSION：The technology is reasonable and practicable, and it is suitable for the preparotion of Gongyanping soft capsules.