市售Vancomycin、Amikacin注射劑之力價調查   全文下載

An Investigation of the Potency of Vancomycin and Amikacin in the Taiwan Area

本計畫於八十五年七月至八十六年六月，由台灣地區各縣市衛生局代為抽樣國產及進口Vancomycin、Amikacin共71件。包括Vancomycin 19件（皆為進口產品），Amikacin 52件（國產39件、進口13件）。依據日本抗生物質醫藥品基準解說1993年版上所載之微生物法測定其力價，結果均符合公定書之合格標準(90~120%)，合格率100%。

During a period from July 1996 to June 1997, Vancomycin and Amikacin injection samples were randomly taken from different hospitals/clinics of Taiwan by members of the Bureau of Health. The samples were analysed to understand the potency of Vancomycin and Amikacin products. These samples consisted of nineteen Vancomycin injections, all imported, and fifty-two Amikacin injections, of which thirty-nine were domestic products and thirteen were imported products.All the samples were determined by the Cylinder-Plate method as described in the Minimum Requirements for Antibiotic Products of Japan.The results showed that all samples met the potency requirement of the government regulation (90%-120%).