市售Reserpine, Methyltestosterone, Nitroglycerine, Ergonovine Maleate及Methylergonovine Maleate單一製劑之含量均一度品質調查

Investigation on the Content Uniformity of Reserpine, Methyltestosterone, Nitroglycerine, Ergonovine Maleate, and Methylergonovine Maleate in Taiwan Area

林澄琴(Cheng-Chin Lin) ； 方燕嬌(Yann-Jiau Fang) ； 徐廷光(Ting-Guang Shyu) ； 張柏林(Ber-Lin Chang)

《藥物食品檢驗局調查研究年報》 9號 (1991/09) Pp. 36-47

https://doi.org/10.6946/ASRNL.199109.0036

摘要

本報告係應用自動分析儀(Autoanalyzer)，分析Reserpine, Methyltestosterone, Nitroglycerine, Erogonovine Maleate, Methylergonovine Maleate，等藥品之含量均一度試驗。經多次測試結果，建立上述五種品目快速，準確且再現性良好之試驗方法。應用此法針對市售檢品共96件之含量均一度進行檢驗，其合格率各為：100%, 90%, 48%, 90%, 100%，其中以Nitroglycerine錠劑之合格率最低。

並列摘要

This report describes the application of autoanalyzerfor testing drug content uniformity. The drugs testedincluded Reserpine, Methyltestosterone, Nitroglycerine, Ergonovine Maleate, and Methylergonovine. After severaltests, we have established five fast, accurate, and reproducible methods. These methods were applied to test ninety-six market samples. The percent of samples past the tests were 100% for Reserpine tablets, 90% for Methyltestosterone tablets and capsules, 48% for Nitroglycerine tablets, 90% for Ergonovine maleate tablets, and 100% for Methylergonovine Maleate tablets. The percent of Nitroglycerine tablets past the test was the lowest among the five drugs.