巿售Acetaminophen複方製劑品質調查

SURVEY ON THE QUALITY OF COMMERCIAL COMPOUND ACETAMINOPHEN PREPARATIONS

Acetaminophen 為一種非固醇類抗炎藥物（N on-steroidal Anti-inflamma tory Drugs, NSAID），因具有強力的解熱、止痛作用，且副作用較低，故為解熱止痛劑中最常使用的非 Pyrin 系藥物，舉凡綜合感冒劑、解熱退燒劑、一般止痛劑等均常加入，有時亦與肌肉鬆抽劑、鎮靜、鎮痙等劑合用。目前市售含 acetaminophen 的處方及品牌不勝枚舉，鑑於 GMP 制度尚未完全推行至各廠，在品管上良莠不齊，本局曾於七十五年度對市售 acetaminophen 單方製劑之品質作一全面調查，但對於含 acetaminophen 之複方製劑，其品牌與種類更為複雜，且與其他藥物共同配方，其品質良窳影響藥效更為顯著，本局遂再於七十五年初進行此項重點調查計劃。

To survey the quality of commercial compound acetaminophen preparations, we purchased 57 samples randomly from drugstores in Taiwan area during 1986. All samples were qualitatively and quantitatively analyzed by using a High-Performance Liquid Chromatographic (HPLC) method. They were also subjected to 'General Tests' specified in Ch. P. III. The results indicated that all samples passed the General Tests. As for assay, three of them failed to meet the regulation requirement-90.0 to 110.0% of the labelled amount.