盐酸坦洛新口崩片的制备工艺研究

目的:采用正交试验筛选盐酸坦洛新口崩片的处方,并测定其溶出度及进行稳定性考查。方法:以内崩解剂微晶纤维素的用量(A)、填充剂乳糖的用量(B)、外崩解剂交联羧甲基淀粉钠的用量(C)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(ΔA)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,并分别在不同条件下留样观察24个月。结果:优选工艺为A30%、B15%、C10%,所制样品平均td为(20.1±4.2)s,t为(24.2±2.1)s,ΔA为0.002 4;30s内药物基本溶出完全,观察期内样品外观和含量等未见明显变化。结论:所选处方制备的样品符合《中国药典》相关规定。

Preparation Technology of Tamsulosin Hydrochloride Orally Disintegrating Tablets

OBJECTIVE： To optimize the formulation of tamsulosin hydrochloride orally disintegrating tablets by orthogonal experiment and to determine its dissolution and stability. METHODS： The formulation of tablets was optimized by orthogonal experiment based on 3 factors： the proportions of microcrystalline cellulose（A）, lactose（B）, and the cross- link sodium starch glycolate（C） and 3 indexes： disintegrating time （td）, the wet time（t ） and the suspend stability（ΔA）. The dissolution of the tablets was determined and its stability in different condition was followed for 24 months. RESULTS： To optimum preparation technical conditions for the tablets were as follows： the proportions of A, B, and C were 30% , 15% and 10%, respectively. The tablets disintegrated completely within 30 s, with mean t d at （20.1±4.2） s, t （24.2 ±2.1） s, and AA 0.002 4. No obvious change was noted in appearance and content for the samples within 24 mouths. CONCLUSION： The tamsulosin hydrochloride orally disintegrating tablets were up to the standards of Chinese Pharmacopeia