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单位剂量包装中最适宜的储存方法及阿司匹林片剂颜色变化与分解速率的相关性。

The most appropriate storage method in unit-dose package and correlation between color change and decomposition rate of aspirin tablets.

机构信息

Department of Health Care and Sciences, Faculty of Pharmaceutical Sciences, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo 204-8588, Japan.

出版信息

Int J Pharm. 2010 Aug 30;396(1-2):105-10. doi: 10.1016/j.ijpharm.2010.06.031. Epub 2010 Jun 25.

Abstract

The most appropriate method to preserve Bufferin 81-mg tablets dispensed for unit-dose packaging in the hospital pharmacy was examined. The surface color change of the tablets was investigated over time by spectrophotometry, and the decomposition rate of aspirin was measured by high-performance liquid chromatography (HPLC). To overcome these, it was found that we can effectively prevent color changes and preserve the quality by maintaining the humidity as 55% or less, storage with drying agent in a plastic or aluminum pack. It was revealed that the color changes became greater and the decomposition rate became higher as time passed. Color changes markedly affect the patients' compliance, and are found to be a very important factor. It was considered that the clarity of the correlation between the color change and decomposition rate may contribute to a decrease in the number of tablets discarded before the expiration date.

摘要

我们考察了医院药房单位剂量包装的 Buffered 81mg 片剂的最佳保存方法。通过分光光度法研究了片剂随时间的表面颜色变化,并通过高效液相色谱法(HPLC)测量了阿司匹林的分解率。为了解决这些问题,我们发现可以通过将湿度保持在 55%或以下、在塑料或铝包装中加入干燥剂来有效防止变色并保持质量。结果表明,随着时间的推移,颜色变化和分解率都会增加。颜色变化明显影响患者的顺应性,是一个非常重要的因素。可以认为,颜色变化与分解率之间的相关性的明确程度可能有助于减少在过期日期之前丢弃的片剂数量。

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