九十九年抗生素製劑之品質監測

Quality Survey of Antibiotic Preparations in Taiwan

連淑華(Shu-Hwa Lian) ； 李珮玲(Pei-Ling Lee) ； 葉美伶(Mei-Ling Yeh) ； 王德原(Der-Yuan Wang)

《食品藥物研究年報》 2期 (2011/12) Pp. 261-269

https://doi.org/10.6945/ARFDR.201112.0263

摘要

為保障民眾使用藥物之安全及有效性，本計畫持續監測台灣地區上市之抗生素製劑品質狀況，並以風險評估為原則，選定頭孢匹拉腙鈉（Cefoperazone sodium）、塞普沙辛（Ciprofloxacin）及立汎黴素（Rifampin）相關製劑，作為99年度監測之品項，監測檢體係委託各地方衛生局逕至轄區醫療院所和藥廠（包含代理商）進行抽樣，再依據中華藥典第六版（Ch. P. VI）、美國藥典第32版（USP 32）及原廠之檢驗規格進行全項檢驗，檢驗項目包括外觀檢查、單位劑量均一度（重量差異試驗）、含水量、溶離度、力價試驗、細菌內毒素試驗等。本計畫於99年1月至12月間，已抽樣Cefoperazone sodium 8件、Ciprofloxacin 68件及Rifampin 64件，共計140件檢體。檢驗結果137件符合規定，3件Rifampin膠囊不符合規定（不合格率為2.1%），其中2件為含量測定不符藥典規定，另1件外觀與衛生署原核准不符。不合格之產品均函請轄區衛生局進行相關之行政處理，並由本局派員查廠和輔導。

關鍵字

頭孢匹拉苁腙鈉月宗（Cefoperazone sodium） ； 塞普沙辛（Ciprofloxacin） ； 立汎黴素（Rifampin）

並列摘要

The aim of this study was to investigate the quality of antibiotics used in Taiwan included cefoperazone sodium injections, ciprofloxacin tablets, ophthalmic solution, otic suspension and injections, rifampin capsules and tablets to ensure the drug safety. All these samples were collected by the local health authorities from hospitals, clinics, manufacturers and importers in various counties from January to December, 2010. Totally, 140 samples were evaluated by the analytical methods described in the Chinese Pharmacopoeia VI, the US Pharmacopeia 32 and the original manufactures. The results showed 3 samples (2.1%) of Rifampin capsules did not meet the requirements of pharmacopeia and government regulations. Among them, the appearance of one Rifampin capsule differed from the original regulation and the others failed to meet the potency regulations. The follow-up treatments of unqualified products were continuously tracked by the local health authorities.

並列關鍵字

cefoperazone sodium ； ciprofloxacin ； rifampin