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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: To evaluate the main and objective indexes of the desorbed orally disintegrating tablets by fuzzy comprehensive evaluation, optimize the prescription of the orally disintegrating tablets, and provide references for the improvement of compliance of the related preparations. Methods: The prescriptions of desiccant tablets were optimized by star point design method. Three kinds of disintegrant microcrystalline cellulose (MCC), low-substituted hydroxypropyl cellulose (L-HPC), cross-linked polyvinylpyrrolidone (PVPP) and flavoring agent (sucralose + malic acid) were used as independent variables. In the process of optimization, fuzzy comprehensive evaluation was used to evaluate the subjective indexes (acidity, sweetness, gritty degree) and objective indexes (Disintegration time limit). Results: The optimum prescription was 2 g of clear-cut and taste-masking powder, 1.472 g of MCC, 0.398 g of L-HPC, 0.252 g of PVPP, 0.301 g of flavor and 0.06 g of lubricant. The prepared orally disintegrating tablets have good sweet and sour taste, no gritty feeling, the disintegration time is 48.8 s, the average of the total score of 4.48 and the predicted value of 4.51 are very small. Conclusion: The fuzzy comprehensive evaluation method can evaluate the main objective index and objective index of the orally disintegrating tablet simultaneously. The results obtained are accurate and reproducible.