臺灣地區市售紅黴素(Erythromycin)口服製劑之品質調查

Investigation on the Quality of Erythromycin Preparations in Taiwan Area

林王珊(Yuh-Shan Lin) ； 羅美顯(Mei-Shien Lo)

《藥物食品檢驗局調查研究年報》 5號 (1987/09) Pp. 97-99

https://doi.org/10.6946/ASRNL.198709.0097

摘要

為瞭解市售紅黴素(Erythromycin)口服製劑之品質，於民國74年4月間，由全省各縣市抽驗國產及進口之紅黴素口服製劑共300件，其中國產品260件，進口品40件，依據日本抗生物質醫藥品基準解說1982微生物檢定法測定其力價，檢驗結果發現國產紅黴素口服製劑中有68件未達其現定之90~120%之合格標準（中華藥典之合格標準亦為90~120%），不合格率為26.2%，進口品有l件未達合格標準，不合格率為2.5%。

並列摘要

In an attempt to understand the quality of erythromycin preparations in the market, 300 samples were collected from different countries and cities in Taiwan area in Apr, 1985. Among them, 260 samples were domestic products and 40 were imported. The potency of the drugs was analyzed by biological assay method described in Minimum Requirement of Antibiotics Products of Japan, 1982. The results showed that 68 domestic samples (i.e. 26.2%) and one imported sample (i.e. 2.5%) were failed to reach the potency requirement (90~120%).