市售隱形眼鏡消毒藥水之品質調查

INVESTIGATION ON THE QUALITY OF MARKETED CONTACT LENS SOLUTIONS

近年來國內戴隱形眼鏡者越來越多，隱形眼鏡各種消毒藥水之使用益形普循，報章會報導市面上有不少劣質產品充斥，造成許多戴隱形眼鏡者眼紅症狀（red eye syndrome）或受細菌感染而有損健康之後虞。為瞭解其品質，於75年元月間自全省各隱形眼鏡行抽購隱形眼鏡藥水共計66件檢體，進行滅菌檢查、防腐抗菌作用、滲透壓、標示防腐劑成分之鑑別及含量測定等試驗。其中滅菌檢查陽性者，再進行微生物限度試驗。滅菌檢查、微生物限度及防腐抗菌作用試驗係依 USPXXI 之Sterility Tests, Microbial Limit Test 及 Antimicrobial Preservatives-Effectiveness 方法進行檢驗；滲透壓則使用 Osmometer （Fiske Associates U.S.A, Model os）測定，Chlorhexidine Gluconate 及Thimerosal 之鑑別及含量測定分別應用 Sodium hypobromide colorimetric method 及 Dithizone colorimetric method 檢驗結果如表一，不符藥品標誌規定，如：未標示成分、廠牌、批號及許可證字號者，其所佔之比例均相當高。標示防腐劑成分及含量與檢出結果不相符者共9件，其中標示成分未檢出者1件，超過標示含量120%者4件，低於標示量80%者4件。滲透壓超過 289 ±50 mOsm 範圍者5件（不包含清潔液）。滅菌檢查陽性者6件中，經微生物限度試驗結果，檢體每ml中含有生菌數在一萬個CFU以上者有5件，其中綠膿桿菌陽性者有二件（見表二）。防腐抗菌作用不適者達15件（22.7%），其原因為：已受微生物汙染，未含防腐劑或其含量過低。

In order to understand the quality of marketed contact lens solutions, we purchased 66 samples of disinfecting, soaking, cleaning and storage solutions in Taiwan area on January 1986. The items examined included：(1) Identification and assay of labelled preservatives (2) Osmolarity (3) Sterility test (4) Antimicrobial-Preservative Effectiveness The results showed 9 samples do not meet the 80～120% of labelled content, 5 samples (not including cleansing solutions) fail to meet of 289±50 mOsm of osmotic pressure, 6 samples are sterility test positive and 15 samples don't meet the requirement of antimicrobial-preservative effectiveness in USPXXI.