72年度臺灣地區市售眼用藥製劑之醫藥品粒子及金屬性粒子品質調查

THE QUALITY INVESTIGATION ON DRUG AND METAL PARTICLES OF MARKET-PURCHASED OPHTHALMIC OINTMENT IN TAIWAN AREA IN 1983

眼用藥膏製劑中所含醫藥品粒子及金屬性粒子之大小、多寡與眼粘膜之刺激性有關。為了解其品質並提供施政參考，抽樣台灣地區市售檢體共50件，依美國藥典第20版（USP.XX）及日本藥局方第10版（J.PX）規定之方法予以檢驗。結果顯示：醫藥品粒子超過75cm以上者4件，金屬性粒子超過規定者有2件。不符合規定者佔抽驗總數之12％。 The size and quantity of drug and metal particles contained in ophthalmic ointment is related to the eye-muco-membrane irritation. A total 50 cases of sample for inspecting their quality condition as a reference of governmental administration were sampled at random from pharmacy in Taiwan area. The USPXX and JPX standard methods were performed to analyse the samples. The result of inspection revealed that 4 cases contained drug particles size larger than 75 u and 2 cases failed to meet the standard of metal particle content in ointment. Twelve % of the total cases were out of the pharmaceutical order.