盐酸氯米帕明口腔崩解片的制备工艺

目的:采用正交试验筛选盐酸氯米帕明口腔崩解片的处方,并测定其溶出度。方法:以微晶纤维素、乳糖、羧甲基淀粉钠的用量以及羟丙纤维素的浓度为考查因素,以口腔崩解片的崩解时间(td)、润湿时间(t)和混悬稳定性(△A)为评价指标进行正交试验,确定最佳处方;对优化处方所制样品测定其溶出度。结果:优选工艺为微晶纤维素30%、乳糖30%、羧甲基淀粉钠0.75%、羟丙纤维素的浓度是1%,所制样品平均td为13.2 s,t为21.6 s,△A为0.001 2;30 min内药物溶出超75%。结论:盐酸氯米帕明口腔崩解片处方设计合理,可进一步开发。

Preparation Technology of Clomipramine Hydrochloride Orally Disintegrating Tablets

Objective ： To optimize the formulation of clomipramine hydrochloride orally disintegrating tablets by orthogonal experi- ment and to determine the dissolution. Method： The formulation of the tablets was optimized by orthogonal experiment based on four factors, those were the amount of microcrystalline cellulose, lactose, and sodium carboxymethl starch and the concentration of hydroxypropyl methyl cellulose,and 3 indices,those were disintegrating time （ td ） ,wetting time （t） and suspending stability （AA）. The dissolution of the tablets was determined by HPLC. Result： The optimum preparation technical conditions for the tablets were as follows ：the proportions of microcrystalline cellulose, lactose and the sodium carboxymethl starch and the concentration of hydroxypropyl cellulose was 30% ,30% ,0. 75% and 1% , respectively. The tablets disintegrated completely within 30s with mean td of 13.2 s, t of 21.6 s, and AA of 0. 001 2. Conclusion： The formula of the clomipramine hydrochloride orally disintegrating tablets is reasonable and valuable to be studied further.