目的:制备黄花倒水莲口腔速崩片并考察其体外溶出行为.方法:采用粉末直接压片制备速崩片.以崩解时限为评价指标,通过单因素及正交试验对处方中填充剂甘露醇与崩解剂微晶纤维素用量比、药材浸膏加入量、润滑剂硬脂酸镁加入量等影响因素进行考察.通过体外溶出度试验(以水为溶出介质,桨法)对优化后处方所制速崩片的溶出效果(以远志皂苷元为对照品)进行评价.结果:最优处方为药材浸膏加入量15%、甘露醇与微晶纤维素用量比1.5:1、硬脂酸镁加入量1.0%;所制片剂崩解时限为(31±4)s、硬度为(3.4±0.2)kg、脆碎度为(0.23±0.07)%(RSD均小于0.11%,n=3);5 min内总皂苷累积溶出度达到90%以上,溶出参数T50=0.84 min、Td=1.77 min.结论:制备的黄花倒水莲口腔速崩片在水溶液中可快速崩解和溶出.%OBJECTIVE:To prepare Polygala fallax rapidly disintegrating oral tablets and investigate its in vitro dissolution. METHODS:The rapidly disintegrating tablets was prepared by direct powder compression method. Using disintegration time as in-dex,the ratio of stuffing bulking agent mannitol to disintegrating agent microcrystalline cellulose,the amount of drug extract,the amount of lubricant magnesium stearate and other influential factors were investigated by single factor test and orthogonal test. The drug dissolution effect of prepared tablet(using senegenin as substance control)was evaluated by in vitro dissolution test(using wa-ter as dissolution medium,paddle method). RESULTS:The optimal formulation was that the amount of drug extract was 15%;the ratio of mannitol to microcrystalline cellulose was 1.5:1;the amount of magnesium stearate was 1.0%. The disintegration time of prepared tablet was(31±4)s;tablet hardness was(3.4±0.2)kg;tablet friability was(0.23±0.07)%(RSD<0.11%,n=3). Ac-cumulative dissolution rate of total saponins was more than 90% within 5 min. The dissolution parameters T50 was equal to 0.84 min and Td was equal to 1.77 min. CONCLUSIONS:Polygala fallax rapidly disintegrating oral tablets will dissolve quickly and dis-integrate rapidly in aqueous solution.
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