市售Furosemide錠劑品質調查

INVESTIGATION ON THE QUALITY OF DIURETIC TABLETS WITH FUROSEMIDE INGREDIENT OF MARKETED PRODUCTS

Furosemide作用於腎尿細管之全域，抑制鈉與氣之重吸收，而呈利尿作用，並被用於治療高血壓之輔藥，因本製劑廣為全省各大醫院與藥房普遍採用，為了解市售Furosemide製劑其Furosemide之含量遂於七十四年赴全省各地展開抽購調查工作。本次共抽購Furosemide錠劑97件，並依據英國藥典（BP1980版）之檢驗方法進行化驗。鑑別：含量測定中檢品溶液按紫外光吸收光度測定法，應在波長228nm及271nm處呈現最大吸收，含量測定：取20粒檢品並研成細粉，精確稱取相當於Furosemide 200mg之粉末置入500ml容量瓶中加0.1M氫氧化鈉溶液300ml，振搖10分鐘，再以0.1M氫氧化鈉溶液稀釋至500ml，混合均勻並過濾。取濾液5ml再以0.1M氫氧化鈉溶液稀釋至500ml，在波長271nm處測定其吸光度，以0.1M氫氧化鈉為空白對照液，以580為E值（即1％，1cnm時之比吸光度），計算出檢品所含C12 H11 C1 N2 O5之量。 The Bureau purchased 97 samples of Furosemide preparations (diuretics) from the drugstores in Taiwan area. The analytical results indicated that 13 cases, i.e., 13.4% of the examined samples violated the BP requirement-95-105%, while 4 case samples were in violation in accordance with the Chp III or USP XX requirement-90-110% of the labeled amount.