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固体剂型制备中析因设计的构建与应用。第3部分。温度和时间对烧结片剂机械性能的影响。

The construction and uses of factorial designs in the preparation of solid dosage forms. Part 3. Effect of temperature and time on the mechanical properties of sintered tablets.

作者信息

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

出版信息

Pharmazie. 1981 Nov;36(11):772-5.

PMID:7323126
Abstract

The present and forecoming series of experiments illustrate the application of factorial design to the study of the sintering phenomena of pharmaceutical tablets. This part was concerned with the effect of temperature (X1) and time (X2) on the mechanical properties of sintered tablets. A 2 X 2 design was developed for salicylamide tablets with the two factors at two levels, and a 3 X 3 design for phenobarbital tablets with the two factors at three levels. Analysis of variance was used to determine the significant effects. Empirical regression equations were obtained which indicated that the hardness of sintered tablets was markedly improved by using the high level of X1 at the low level of X2 in phenobarbital tablets, and the high levels of both X1 and X2 in salicylamide tablets. The tablets tensile strength was a linear function of X1 and X2, but the interaction effect X1X2 was insignificant. Significant quadratic effects of X2/2 and/or X2/1 were also detected for the mechanical properties of phenobarbital tablets.

摘要

目前以及即将开展的一系列实验阐述了析因设计在药物片剂烧结现象研究中的应用。本部分关注温度(X1)和时间(X2)对烧结片剂机械性能的影响。针对水杨酰胺片剂,采用双因素两水平的2×2设计;针对苯巴比妥片剂,采用双因素三水平的3×3设计。运用方差分析来确定显著效应。得到了经验回归方程,结果表明,对于苯巴比妥片剂,在X2低水平时采用X1高水平可显著提高烧结片剂的硬度;对于水杨酰胺片剂,X1和X2均采用高水平可显著提高烧结片剂的硬度。片剂的拉伸强度是X1和X2的线性函数,但交互效应X1X2不显著。对于苯巴比妥片剂的机械性能,还检测到X2/2和/或X2/1的显著二次效应。

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