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目的:优选复方苯巴比妥颗粒的最佳处方。方法:用正交设计法,以每包颗粒的重量(A)、稀释剂(B)、粘合剂(C)为因素,按L_9(3~4)设计实验,以颗粒吸湿性和苯巴比妥溶出度为评价指标,进行综合评分。结果:影响因素顺序为A>B>C,其中A、B对颗粒质量影响有显著意义。最佳处方为A_1B_3C_3,即以乳糖为稀释剂、5%的羟丙甲纤维素为粘合剂、每包颗粒重3g。结论:优选的处方、工艺可行,制成的颗粒符合《中国药典》(2005年版)规定。
Objective: To optimize the prescription of compound phenobarbital granules. Methods: Using orthogonal design method, taking the weight of each pellet (A), diluent (B) and binder (C) as the factors and designing experiments according to L_9 (3-4) Ratio of dissolution as the evaluation index, a comprehensive score. Results: The order of influencing factors was A> B> C, among which A and B had significant effects on the particle quality. The best prescription for the A_1B_3C_3, that is, lactose as a diluent, 5% hypromellose binder, each bag weight 3g. Conclusion: The preferred prescription and technique are feasible. The granules made are in accordance with the requirements of Chinese Pharmacopoeia (2005 edition).