均匀设计试验筛选阿替洛尔分散片的处方

目的：筛选阿替洛尔分散片处方。方法：制备阿替洛尔分散片并考察其质量，以微晶纤维素（MCC）、羧甲基纤维素钠（CMS—Na）、硬脂酸镁的用量和乙醇的质量浓度为考察因素，以阿替洛尔分散片30min的体外累积溶出度为指标，采用均匀设计试验筛选处方，验证处方并比较市售普通片和自制分散片45min内的体外累积溶出度。结果：成功制备了阿替洛尔分散片，质量符合分散片的要求。最佳分散片处方为45．0％MCC、7．0％CMS．Na、1．00％硬脂酸镁、40％乙醇溶液，验证试验结果表明处方设计合理。以最优处方制备的阿替洛尔分散片在30min的体外累积溶出度为91．78％，分散片的体外累积溶出度（93．4±0．9）％]高于市售普通片（89．0±1．2）％]。结论：研制的阿替洛尔分散片处方合理、工艺简单可行。

Formulation Screening of Atenolol Dispersible Tablets by Uniform Design Experiment

OBJECTIVE： To screen the formulation of Atenolol dispersible tablets. METHODS： Atenolol dispersible tablets were prepared and investigated in quality. The formulation of the tablet was screened by uniform design with 30 min accumulative dissolution rate as index using the amount of MCC, CMS-Na and magnesium stearate and the concentration of ethanol as factors. The formulation was validated and accumulative concentration of the tablet within 45 min were compared between commercial tab- let and self-made tablet. RESULTS： Atenolol dispersible tablets were prepared successfully, and the quality of the tablets was in line with the requirements. The optimal formulation was as follows： 45.0%MCC, 7.0%CMS-Na, 1.00%magnesium stearate and 40% ethanol. Results of validation test showed that the formulation design was rational. Accumulative dissolution rate of optimized Atenolol dispersed tablets was 91.78% within 30 rain in vitro. Accumulative dissolution rate of the dispersible tablet （93.4 ± 0.9） % ] was faster than the conventional tablet （89.0 ± 1.2 ） % ]. CONCLUSIONS ： The prepared Atenolol dispersible tablet is rea- sonable in formulation and feasible in technology.