七十六年度台灣地區巿售之紅黴素(Erythromycin)口服製劑品質調查

INVESTIGATION ON THE QUALITY OF ERYTHROMYCIN PREPARATIONS IN TAIWAN AREA

紅黴素口服製劑在國內臨床上目前仍為廣泛應用之藥品，故本類製劑品質的良窳實著關係治病之療效，鑑于民國七十四年間，本局曾進行本項製劑之抽驗調查，檢驗結果在300件檢體中，其力價符合中華藥典第三版所規定之合格範圍（90-120%）者，計221件，合格率僅77.0%，其後並透過各縣市衛生局追蹤抽驗的結果，不合格率仍偏高。故本局為瞭解一年來各廠商之品質管制是否有所改進，於民國七十五年間仍針對本項製劑同前方式再次前往全省各縣市抽購檢體299件，並依同前次檢驗之方法──日本抗生物質醫藥品基準解說1982之微生物檢定法，檢驗其力價。檢驗結果發現其達合格範圍者294件，合格率高達98.3%，顯示市售品質已有大幅度的進步（見圖一）。同時也彰顯出藥廠在這一年來於產品之品質管制上已有具體之績效。

In order to understand the quatlity of erythromycin preparations in the market, 300 samples have been collected in 1985. However, 23.0% of the samples were lower than the regulation requirements Again, 299 Samples (249 domestic pharmaceutical products; 50 imported pharmaceutical products) of erythromycin preparations were purchased from various locations of domestic market in 1986 and were examined for potency by microbiological method. It was found that 98.0% of the domestic pharmaceutical products and 100% of the imported pharmaceutical products met the potency requirement of Ch. P. III (90-120%). Thus, anly 1.7% of the samples failed to reach the potency requirement in 1986. The results indicated that the quality of marketing erythromycin Perparations has been improved a lot.