目的:运用信息熵赋权法和星点设计-效应面法优选四妙勇安汤发酵物的片剂处方。方法:在单因素实验基础上,以颗粒成型率、流动性(cot值)为评价指标,确定以乳糖为填充剂,95%乙醇作为黏合剂,淀粉、聚维酮为崩解剂,硬脂酸镁为助流剂;以加醇量、助流剂使用量、乳糖和药粉的比例、淀粉与聚维酮的比例为影响因素,以吸湿率、弹性复原率、硬度和脆碎度作为响应指标,采用信息熵赋权法结合星点设计-效应面法优选四妙勇安汤发酵物的片剂处方。结果:四妙勇安汤发酵物的片剂最优处方工艺为乳糖和药粉的总量为15 g,95%乙醇的加入量为3.91 mL,助流剂的加入量为0.090 g,其中乳糖和药粉的比例为1.13∶1,淀粉与聚维酮的比例为2.13∶1。最优的处方工艺的综合评分的实验值与预测值的偏差为2.68%。结论:优选的处方工艺简单、稳定、可行,所得参数可为四妙勇安汤的进一步研究提供数据支撑,信息熵赋权法结合星点设计-效应面法为中药制剂工艺的多指标评价研究提供借鉴。
Objective: To optimize the tablet formulation of Simiao Yongan decoction, the information entropy theory and central composite design-response surface methodology were used in this study. Methods: Based on the single-factor experiment and the evaluation indicators including graininess and fluidity, the lactose, 95% ethyl alcohol, starch, povidone and magnesium stearate were s as the filler, adhesive, disintegrant and glidant, respectively. The amount of alcohol, glidant, ratio of lactose to powder, ratio of starch to povidone were set as influence factors, and moisture absorption, elastic recovery, hardness and brittleness were set as the response indicators, then tablet formulation of Simiao Yongan decoction was optimized with information entropy theory and central composite design-response surface methodology. Results: The optimal formulation of Simiao Yongan decoction was as follows: lactose and powder of 15 g, 95% ethanol of 3.91 mL, glidant of 0.090 g, ratio of lactose to powder of 1.13∶1, ratio of starch to povidone of 2.13∶1. The deviation between the experimental value and the predicted value for optimal formulation was 2.68%. Conclusion: The optimized formulation is simple, stable and feasible, and parameters obtained can provide data support for further study of Simiao Yongan decoction. The information entropy weighting method combined with central composite design-response surface methodology had provided a reference for the multi-indictors assessment for traditional Chinese medicine preparation.
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