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通过离心淘析将多尺寸药物悬浮液分离成窄分布。

Separation of multisized drug suspensions into narrow distributions by centrifugal elutriation.

作者信息

Howard S A, Mauger J W, Khwangsopha A, Lee P

出版信息

J Pharm Sci. 1978 May;67(5):673-5. doi: 10.1002/jps.2600670527.

Abstract

A centrifugal elutriator rotor was used to separate suspensions of micronized hydrocortisone acetate and prednisolone acetate. Up to five distinct particle fractions could beisolated from a single parent suspension, and reasonable reproducibility was exhibited between various elutriator runs. Arithmetic means and associated standard deivations, based on volume, were calculated for each isolated fraction. These data demonstrate the narrowness and uniqueness of each fraction. The particle-size data show an apparent log-normal distribution for each isolate. The uniqueness of each fraction also was demonstrated by dissolution experiments where Fraction 1, the smallest fraction of prednisolone acetate, dissolved much more rapidly than Fraction 4, the largest fraction. The substantial difference in dissolution behavior of these two fractions of prednisolone acetate powder was biopharmaceutically significant.

摘要

使用离心淘析转子分离微粉化醋酸氢化可的松和醋酸泼尼松龙的悬浮液。从单一母悬浮液中最多可分离出五个不同的颗粒级分,并且在不同的淘析运行之间表现出合理的重现性。基于体积,计算每个分离级分的算术平均值和相关标准偏差。这些数据证明了每个级分的狭窄范围和独特性。粒度数据显示每个分离物呈明显的对数正态分布。通过溶出实验也证明了每个级分的独特性,其中醋酸泼尼松龙的最小级分1比最大级分4溶解得快得多。这两个醋酸泼尼松龙粉末级分在溶出行为上的显著差异具有生物药学意义。

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