目的:优选金荞麦多酚分散片的处方并对其溶出度进行考察。方法:以崩解时间为指标,采用单因素试验法优选填充剂和崩解剂种类,采用正交设计优选各辅料的用量。以表儿茶素和原花青素为指标对金荞麦多酚分散片的溶出度进行考察。结果:处方组成为主药34.2%,交联聚乙烯吡咯烷酮15.0%,微晶纤维素50.0%,硬脂酸镁0.8%,该处方压片后崩解时间小于3 min,表儿茶素和原花青素在3 min内溶出率均达85%以上,原花青素在5 min内、表儿茶素在10 min内溶出率达100%。结论:此处方工艺配比所制备的金荞麦多酚分散片溶散迅速,溶出特性较好。

Objective:To optimize the formulation of Jinqiaomai(rhizoma fagopyri dibotryis) polyphenol dispersible tablets and to study its dissolvability. Methods:In terms of disintegration time the types of filler and disintegrant were optimized by single factor experiment and the dosage of the excipients was optimized by orthogonal test. The dissolvability of rhizoma fagopyri dibotryis polyphenol dispersible tablets was investigated by using epicatechin and procyanidins as the indicators. Results:The optimized formulation was composed of the extract powder 34.2%,microcrystalling cellulose 50%,polyvinylpolyrrolidone 15%,magnesium stearate 0.8%. The disintegration time of the optimized formulation was less than 3 minutes,the dissolvability of epicatechin and procyanidins in 3 minutes was more than 85%,the dissolvability of procyanidins reached100% in 5 minutes,and the dissolvability of epicatechin in 10 minutes reached 100%. Conclusion:This rhizoma fagopyri dibotryis dispersible tablets with the optimized formulation dissolves quickly with good dissolvability.