無菌填充產品之滅菌檢查

THE STERILITY TEST OF ASEPTIC FILLING PREPARATIONS

依藥典規定眼用製劑應為無菌的，但若因其製造、分裝、運送或保存之不當，以致受到微生物污染時，對於消費者將造成種種程度的傷害，而嚴重者可能有失明之處。本局有鑑於此，遂於民國78年2月間在全省各地藥局（房）抽購眼用製劑檢體100件，其中國產者有50件，進口者有50件，分別以U.S.P.XXII所載之密閉式微孔濾膜法及直接接種法進行其滅菌檢查。檢驗結果為陽性者有四件，佔抽購總件數4%，且均為國產製劑；其結果為陽性者濾膜法及直接法兩者均為陽性，陰性者則兩法亦均為陰性。若再依製劑種類區分，則在檢體100件中眼藥水有48件，陽性者2件，佔總件數之4.1%。隱形眼鏡用液52件中陽性者有2件，佔3.8%。所有陽性檢體再以USP XXI中之Microbial Limit Test方法試驗是否存有大腸桿菌、綠膿桿菌、沙門氏菌或金黃色葡萄球菌，結果均呈陰性。

One hundred ophthalmic preparations collected from different city of Taiwan on February 1989. Among these samples, 52 samples were contact lens solution, 48 samples were eye drop. The sterility test was operated by closed membrane filtration and directed transfer method of U.S.P XXI. 2 contact lens solutions were positive (3.8%). 2 eye drops were positive (4.1%). The positive samples were made in Taiwan.