市售衛生套針孔試驗及含局部麻醉劑之品質調查   全文下載

Pin-hole Testing and the Assessment of Adulteration with Local Anesthetics in Condoms Distributed in Taiwan Market

本計畫於民國八十七年九月至八十七年十二月間，委託台灣省各縣市及北高兩市衛生局至轄區之藥局（房）及超級商店抽驗市售衛生套檢體計125件，依據八十三年九月二十六日修定之中國國家標準CNS 13245乳膠製衛生套檢驗法進行針孔試驗方法試驗，本次調查採用行政院衛生署87.09.01衛署藥字第87049812號公告「乳膠製衛生套檢驗案件之抽樣計畫及判定基準」之新規定判定之；另以薄層層析方法檢驗是否攙加局部麻醉劑，檢驗結果：針孔試驗有5件不合格（4.0%），均為輸入產品，而全部抽驗檢體中，有1件檢出（0.8%）含局部麻醉劑Benzocaine，亦為輸入產品。本調查係本局之比較檢驗，曾於八十八年五月十八日發布新聞在案。

In order to ascertain the quality of local distribution of condoms, 125 samples were purchased from drugstores and super market in different counties and cities in Taiwan, during the 1999 fiscal year.The pin-hole test was carried out following the methods listed in CNS No.13245. The results showed that 5 samples (4.0%) failed to meet the requirement mentioned above. These 5 samples were all imported products.Thin Layer Chromatography (T.L.C method) was further applied to analyse the adulteration with local anesthetics including Benzocaine, Cocaine HCl, Lidoccaine HCl, Procaine HCl, Tetracaine HCl and Dibucaine HCl.The test results indicated that one sample was adulterated with local anesthetics (Benzocaine), Which was also an imported product.