市售 Ambroxol HCl 錠劑之品質調查

N INVESTIGATION OF THE QUALITY OF AMBROXOL HCL TABLETS IN THE TAIWAN AREA

Ambroxol HCl係為痰液溶解劑，具有增進黏液纖毛運動機轉及溶解分泌物的特性。該製劑市面上已有多種廠牌，本局為瞭解市售Ambroxol HCl錠劑之品質狀況，乃於民國82年度由全省各縣市抽購國產及進口Ambroxol HCl製劑35件，其中國產製劑32件（佔總件數91.4%），分屬13個不同廠商製造，進口製劑3件（佔總件數8.6%），由2個不同廠商輸入。參照原開發廠規格方法，進行重量差異、崩散度、鑑別及含量測定。結果有2件國產品含量測定不合格，不合格率5.7%。

In order to assess the quality of Ambroxol HCl tablets, thirty five samples were purchased throughout Taiwan area from Sep. 1992 to Mar, 1993. All of the samples were investigated for mean weight, weight uniformity, identity of drug, drug content, and disintegration. Samples were determined by the method described in the USP XXII and/or from the manufacturer. The results showed that most of the samples meet general testing except two samples from the assay were 93% less than the minimum declared value.