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析因设计在固体剂型制备中的构建与应用。

The construction and uses of factorial designs in the preparation of solid dosage forms.

作者信息

El-Banna H M, Boraie N, El-Shibini H A

出版信息

Pharmazie. 1981 Dec;36(12):819-23.

PMID:7330083
Abstract

The present experiments were factorially designed to study the effect of particle size (X3), at different levels of both temperature (X1) and time (X2), on the hardness and mechanical strength of sintered tablets. A 2 X 2 X 3 design was constructed for salicylamide tablets with X1, X2 and X3 at 2,2 and 3 levels respectively. For phenobarbital tablets, a 3 X 3 X 3 factorial experiment was run. On the basis of analysis of variance, empirical regression equations have been developed. Within the limits of the factors, it was found that the quadratic effect of X 2/3, on the average, was the most significant. The significance of the linear effects was in the following order: X3 greater than X1 greater than X2 in salicylamide tablets and X1 greater than X3 greater than X2 in phenobarbital tablets. A change of X3 from the high to the low or intermediate levels caused an increase in the mechanical properties of tablets. The only linear interaction was that of X1X3 for the hardness data of phenobarbital tablets, but it was of least significance among the other effects. Other quadratic main effects of X 2/1, X 2/2 and quadratic interaction effects of X 2/3X1 and X 2/1X2 were also found to be significant. The optimum values of the factors studied, that would maximize any given mechanical property, were located.

摘要

本实验采用析因设计,研究在不同温度(X1)和时间(X2)水平下,粒度(X3)对烧结片剂硬度和机械强度的影响。以水杨酰胺片剂构建了一个2×2×3设计,其中X1、X2和X3分别有2、2和3个水平。对于苯巴比妥片剂,进行了一个3×3×3析因实验。基于方差分析,建立了经验回归方程。在各因素范围内,发现平均而言,X2/3的二次效应最为显著。线性效应的显著性顺序如下:在水杨酰胺片剂中为X3>X1>X2,在苯巴比妥片剂中为X1>X3>X2。X3从高水平变为低水平或中间水平会导致片剂机械性能增加。唯一的线性交互作用是苯巴比妥片剂硬度数据的X1X3,但在其他效应中其显著性最低。还发现X2/1、X2/2的其他二次主效应以及X2/3X1和X2/1X2的二次交互效应也具有显著性。确定了所研究因素的最佳值,这些值可使任何给定的机械性能最大化。

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