市售隱形眼鏡清洗、保存液之品質調查   全文下載

An Investigation of the Quality of Contact Lens Solutions in Taiwan Area

為了解市售隱形眼鏡清洗、保存液之品質，本局委請臺北市政府衛生局及高雄市政府衛生局，於民國八十七年九月至八十八年一月間，至轄區各藥局（房）及隱形眼鏡店抽取隱形眼鏡清洗、保存液檢體，共計38件。經參照廠商原申請查驗登記時檢附之檢驗規格及方法進行外觀、pH值、滲透壓、主成分鑑別、含量測定試驗，並依據USP23之方法，以密閉式微孔濾膜法進行滅菌檢查。測試結果，不合格者l件，佔總件數之2.6%。不合格之檢體為輸入品，不合格之項目為滲透壓試驗。有關標示事項之檢視，所有檢體均尚符合藥事法之相關規定。概括而官，市售隱形眼鏡清洗、保存液之品質尚可。本調查係本局之比較檢驗，曾於八十八年五月四日發布新聞在案。

38 contact lens solutions were collected from Taiwan markets during a period from September 1998 to January 1999 by Health Department of Taipei City Government and Kaohsiung City Government. Appearance、pH、osmolarity、identification and assay tests were performed by using the methods submitted by manufacturers during the pre-market approval application procedures. Sterility tests were conducted by using membrane filtration method described in USP23.It was found that only one imported sample failed to meet the acceptable criteria. Labeling of samples all complied with the regulatory requirements.