台灣地區市售BROMHEXINE HYDRO-CHLORIDE錠劑之含量調查

AN INVESTIGATION FOR THE ASSAY OF BROMHEXINE HYDROCHLORIDE TABLETS IN TAIWAN AREA

由於呼吸器系統疾病，常併隨有痰，故一般醫院、藥局經常以Bromhexine Hydrochloride成分之製劑做為調劑用藥，為了解此常用藥國產市售產品品質之概況故作此調查。本計劃於民國80年度由全省各縣市地區之藥局或藥房抽購Bromhexine Hydrochloride錠劑，其批號均不同亦不逾有效期限。共抽購國產30件。依據British Pharmacopeia上所載之分光光度法鑑別並制定其含量。茲簡述實驗方法如下：取Bromhexine Hydrochloride標準品及檢體中含Bromhexine Hydrochloride量各8mg，精確稱定，分置於100ml之容量瓶中，以O.1M鹽酸.甲醇溶液溶解並稀釋至刻度，分別供作標準品溶液及檢液。鑑別試驗則取標準品溶液及檢液於波長200-350nm間分別掃瞄，二者應有相同之紫外光吸收圖譜，並應於相同波長317±1nm處呈現最大吸收。含量測定則取標準品溶液及檢液，以0.1M鹽酸.甲醇溶液為空白試液，分別於317±1nm處測定其吸光度，依照下列公式計算檢品中所含Bromhexine Hydrochloride之含量。

In order to understand the quantity of Bromhexine Hydrochloride tablets, thirty samples were purchased from different counties and cities in Taiwan during August 1990 to June 1991. All of the samples were determined by the spectrophotometry method. The results showed that all the samples met the assay requirement of the government regulation (92.5%-107.5%)