溫度、溼度及儲存老化對口服固體製劑之影響

Effect of Temperature, Humidity and Aging of Oral Solid Dosage Forms

李貫棠(Derek K. T. Lee) ； 王大鵬(Da-Peng Wang) ； 陳彰儀(Chang-Yi Chern)

《Journal of Medical Sciences》 20卷8期 (2000/10) Pp. 408-415

摘要

本研究之目的乃探討溫度、濕度及儲存老化對日服固體製劑物化性質之影響。本研究乃以本院（高雄榮民總醫院）之常用7種口服固體製劑於各種不同之儲存條件儲存後，分別測定其水分含量、崩散度及溶離度以了解口服固體製劑之物化性質與溫度、濕度及儲存老化間之關係。本研究結果顯示，Acetazolamide Tablets、Metronidazole Capsules及Nitrofurantoin Capsules等三種口服固體製劑受溫度、濕度及儲存老化之影響甚巨。

關鍵字

口服固體製劑 ； 溫度 ； 濕度 ； 儲存老化水分 ； 崩散度溶離度

並列摘要

It is generally recognized that aging of oral solid dosage forms can results in chemical and physical change, creating problems with stability and bioavailability. In this study, extensive studies of the effects of storage time, temperature and humidity on oral solid dosage forms properties such as moisture content, disintegration, and dissolution have been conducted with seven drugs. From the results, it may be concluded that storage at high temperature and humidity would have a strong influence on the physical-chemical properties of acetazolamide tablets, metronidazole capsules and nitrofurantoin capsules.

並列關鍵字

oral solid dosage forms ； temperature ； humidity ； aging ； moisture ； disintegration ； dissolution