模糊综合评价法在清降口腔崩解片处方优化中的应用

Application of Fuzzy Comprehensive Evaluation Method in Formulation Optimization of Qingjiang Orally Disintegrating Tablets

目的:采用模糊综合评价法对清降口腔崩解片的主、客观指标同时评价,优化清降口腔崩解片处方,为相关制剂服药顺应性的改善提供参考。方法:采用星点设计法优化清降口腔崩解片的处方,设定3种崩解剂微晶纤维素(MCC),低取代羟丙基纤维素(L-HPC),交联聚乙烯吡咯烷酮(PVPP)和矫味剂(三氯蔗糖+苹果酸)的用量为自变量,在优化过程中,应用模糊综合评价法同时评价该制剂的主观指标(酸甜度、沙砾感程度)和客观指标(崩解时限)。结果:最优处方为清降掩味粉末2 g,MCC 1.472 g,L-HPC 0.398 g,PVPP 0.252 g,矫味剂0.301 g,润滑剂0.06 g。制备的清降口腔崩解片酸甜适口,无沙砾感,崩解时限48.8 s,总评分平均值4.48与预测值4.51的偏差很小。结论:模糊综合评价法可同时评价清降口腔崩解片的主、客观指标,所得结果准确性高、重复性好。

Objective： Fuzzy comprehensive evaluation method was used to evaluate subjective and objective indexes of Qingjiang orally disintegrating tablets at the same time for optimization of its formulation. Method： In order to optimize the amount of disintegrants and flavoring agent, central composite design was used, and the subjective indexes （degree of sweet and sour, gravel sense） and objective index （ disintegration time） of Qingjiang orally disintegrating tablets were evaluated at the same time. Result： Optimal formulation of Qingjiang orally disintegrating tablets was Qingjiang taste-masking powder of 2 g, microcrystalline cellulose （MCC） of 1. 472 g, low-substituted hydroxypropyl cellulose （L-HPC） of 0. 398 g, crospolyvinylpyrrolidone （PVPP） of 0. 252 g, flavoring agent of 0. 301 g, lubricant of 0. 06 g. Qingjiang orally disintegrating tablets had a good favor without gravel sense, disintegration time was only 48.8 s. Conclusion： Fuzzy comprehensive evaluation method can evaluate the subjective repeatability.