摘要
目的：采用正交试验筛选布南色林口崩片的处方，并测定其溶出度。方法：以内崩解剂微晶纤维素的用量、填充剂乳糖的用量、外崩解剂交联羧甲基淀粉钠的用量为考查因素，以口崩片的崩解时间（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15％、交联羧甲基淀粉钠10％，所制样品平均td为19．8s，t为20．1s，△A为0．0016；30s内药物基本溶出完全。结论：所选处方制备的样品符合《中国药典》相关规定。
Objective： To optimize the formulation of blonanserin orally disintegrating tablets by orthogonal experiment and to determine its dissolution. Methods： The formulation of tablets was optimized by orthogonal experiment based on three factors： the proportions of microcrystalline cellulose, lactose, and the cross-linksodium starch glycolate and 3 indexes： disintegrating time （td）, the wet time（t） and the suspend stability（△ A）.The dissolution of the tablets was determined by HPLC. Results： To optimum preparation technical conditions for the tablets were as follows：the proportions of mierocrystalline cellulose, lactose, and the cross-linksodium starch glycolate were30%,15% and 10% respectively. The tablets disintegrated completely within30s, with meantdat 19.8s, t 20.1s, and △ A 0.0016. Conclusions： The blonanserin orally disintegrating tablets were up to the standards of Chinese Pharmacopeia.
