正交实验法优选非诺贝特滴丸的处方工艺

Study on the Optimal Formulation and Preparation Process of Fenofibrate Dropping Pills by Orthogonal Design

目的:以水溶性高分子材料PEG 4000为主要基质,研究非诺贝特滴丸的最佳制血工艺条件。方法:以滴丸的成型率(%)为筛选指标,以滴丸滴制过程的滴速、冷却液面至滴头距离及滴头口径为考察因素,采用正交设计对非诺贝特滴丸的制血工艺进行优选。结果:非诺贝特滴丸的处方工艺,PEG 4000和泊洛沙姆(1:1),在滴制过程中的滴速为45d/min,滴头至冷却液面距离为5cm,滴头内径为5mm,按此优化条件制血的非诺贝特滴丸成型率最高。结论:初步确定了非诺贝特滴丸的处方组成及制血工艺,为提高非诺贝特滴丸制剂的进一步稳定性考察提供参考。

Objective：Using Water-soluble PEG4000 as the main matrix to optimize the formulation and preparation process of fcnotibratc dropping pills by orthogonal design.Methods：Water-soluble PEG4000 and Poloxamer 188 were used as the main matrix with rounding and finishing degree,the dropping rate,the diameter ratio of dropping tip and the distance with dropping tip and cooling liquid. Rcsults：The optimums was following：the matrix of PEG4000 and Poloxamer 188（1：1）.the distance with dropping tip and cooling liquid of 5cm,at the dropping rate of 45d/min and the diameter ratio of dropping tip of 5mm.Conclusion：This preparation of fenofibrate dropping pills was promising and deserved further study.