Lysozyme製劑效價之品質調查

AN INVESTIGATION ON POTENCY OF LYSOZYME PREPARATIONS IN TAIWAN AREA

為了解目前市售 Lysozyme 製劑之品質概況，於74年7月～75年6月再作此調查，其結果並與73年之調查結果作一比較。由全省21縣市之藥局、藥房、醫院及診所抽購含 Lysozyme 錠劑、顆粒、膠囊等之製劑，包括輸入及國產各廠牌，均不同批號（由於其時未規定標示有效期限及製造日期，故僅19件標示），每批各抽15粒（顆，或顆粒型30g），總計167件。參照日本藥局方外醫藥品成份規格1982之方法，以 Lysozyme standard [日本國立衛生試驗所標準品，1mg of Lysozyme Standard contains 1.0mg Lysozyme （potency）, control 835]為標準品，並以 Micrococcus lysodeikticus 為基質，利用分光光度計（640nm）測定法測其效價。

In order to understand the quality of Lysozyme preparation in Taiwan Area, 167 Lysozyme preparations were gathered randomly from different countries and cities of Taiwan. Among which, 133 samples were domestic and 34 imported, and the potency was analyzed quantitatively by spectrophotomet Method, using Micrococcus lysodeikticus as substrate. In this test, only 140 samples (Ca, 83.8%), Included of 108 (Ca. 81.2%) in domestric samples and 32 (94.1%) in imported samples were met the 90~ 125% potency requirement of the government regulation.