應用自動分析儀建立Prednisolone，Digoxin，Digitoxin等錠劑之含量均一度試驗法

By Using an Autoanalyzer for the Content Uniformity Methods of Prednisolone, Digoxin and Digitoxin Tablets

林澄琴(Cheng-Chin Lin) ； 方燕嬌(Yann-Jiau Fang) ； 徐廷光(Ting-Guang Shyu) ； 孫慈悌(Tsi-Tee Suen)

《藥物食品檢驗局調查研究年報》 8號 (1990/09) Pp. 63-71

https://doi.org/10.6946/ASRNL.199009.0063

摘要

本局於77年度研訂以自動分析儀建立藥品之含量均一度試驗法。測試結果五種品目中有三種品目(Prednisolone，Digoxin，Digitoxin)之市售檢體效果良好。同日內與異日間試驗之CV值均小，顯示其再現性良好。建立之自動分析儀試驗法經實際市售檢體檢驗結果，較傳統方法之時效為短，為測定含量均一度之快速試驗法。

關鍵字

自動分析儀 ； 含量均一度 ； 同日內試驗 ； 異日間試驗 ； Prednisolone ； Digoxin ； digitoxin

並列摘要

In 1988, our laboratory tried to establish method for testing the drug content uniformity by using an autoanalyzer. Among five drugs, three (Prednisolone Tablets, Digoxin Tablets, Digitoxin Tablets) showed good results. Their reproducibility are good, this was supported by the small CV values during intra-day assay and inter-day assay. The established method were applied to test market samples. The results showed that experimental efficiency was highly enhanced by using the self-design autoanalyzer.