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固体剂型制备中析因设计的构建与应用。第1部分:泡腾乙酰水杨酸片

The construction and uses of factorial designs in the preparation of solid dosage forms. Part 1: Effervescent acetylsalicylic acid tablets.

作者信息

El-Banna H M, Minina S A

出版信息

Pharmazie. 1981 Jun;36(6):417-20.

PMID:7279987
Abstract

The construction and application of a fractional factorial design of the type N = 2(5-2) for the preparation of effervescent acetylsalicylic acid tablets by a new technique was demonstrated. This method involved direct compression of the tablet ingredients, dipping the tablets in a volatile mixed solvent system and subsequent removal of the solvent. With the help of a derived regression equation, the factors considered most likely to have a beneficial effect on tablet hardness were: the compression force, the percent of acetylsalicylic acid content/tablet, the particle size of tablet ingredients and the solvent ratio. The time of dipping was found to have an insignificant effect on tablet hardness. By following the path of the steepest ascent, effervescent acetylsalicylic acid tablets of remarkable hardness, friability and dissolution time were obtained. The optimum conditions for preparing these tablets were determined.

摘要

展示了一种N = 2(5 - 2)型分数析因设计在通过新技术制备泡腾乙酰水杨酸片方面的构建与应用。该方法包括直接压片成分,将片剂浸入挥发性混合溶剂系统并随后除去溶剂。借助推导的回归方程,认为最有可能对片剂硬度产生有益影响的因素为:压片力、每片乙酰水杨酸含量百分比、片剂成分的粒度以及溶剂比例。发现浸渍时间对片剂硬度影响不显著。通过沿最速上升路径操作,获得了具有显著硬度、脆碎度和溶出时间的泡腾乙酰水杨酸片。确定了制备这些片剂的最佳条件。

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