市售指示藥品：眼用製劑／點眼液劑之品質調查案件彙整報告

Survey on the Quality of Ophthalmic OTC Preparation in Taiwan

10.6946/ASRNL.200309.0001

江盈盈(Ying-Ying Chiang)；陳玉盆(Yu-Pen Chen)；溫國慶(Kou-Ching Wen)

指示藥品 ； 眼用製劑 ； 點眼液劑 ； 含量測定 ； Ophthalmic OTC Preparation ； Assay

藥物食品檢驗局調查研究年報

21號（2003 / 09 / 01）

1 - 10

繁體中文

民國八十五年四月衛生署公告「指示藥品審查基準」共十大類，凡列屬指示藥品之查驗登記申請案，採書面審查，無須送驗，為了解廠商自行控管藥品品質之能力，衛生署於本局九十年度市售藥物食品化粧品衛生調查研究協調會中提出「指示藥品審查作業計畫」，指示九十年度之調查品項為眼用製劑及綜合感冒劑，本報告係本局於九十年五月至十一月間，委由各縣市衛生局就轄區內藥局（房）抽送眼用製劑檢體，共抽得檢體39件，因有重複抽樣情形，故實際抽驗產品之許可證僅26張，輸入19件，國產7件，分屬19個廠牌。依據各檢體之原廠檢驗規格進行檢體外觀、pH值、鑑別及含量測定等檢驗，結果均符合原廠規格。

The post-market survey was conducted to ascertain the quality of ophthalmic OTC preparation in Taiwan. Thirty-nine samples were sampled from the Pharmacies of seven cities and counties in Taiwan area during May to November in 2001. The test items including identification, pH value and assay were carried out according to the methods proposed by the manufacturers. The results showed that all samples meet their specifications.