巿售紫黴秦注射劑之力價及熱原調查研究

AN INVESTIGATION ON POTENCY AND PYROGEN OF GENTAMICIN INJECTION

紫黴素（Gentamicin），為一僅有注射劑型之抗生素，本局於民國74年8月至民國75年6月間自全省各縣市全面抽購紫黴素注射劑176件檢體（其中國產品128件，輸入品48件）。依1982日本抗生物質醫藥品基準解說所載圓筒平板法測定檢體之力價，並以LAL試劑 （Limulus Amebocyte Lysate test kits） 作熱原 （pyrogen） 測定，結果顯示有3件檢體力價超出合格範園（90～120%），判定不合格，不合格率1.7%，LAL試驗結果均呈陰性反應。

The stability of a drug is affected by many factors. The proparations of antibiotics for injection are specially uneasy to control their stability. The gentamicin is the only antibiotic which supplied as a product for injection. From August 1985 to June 1986. a large scale sumplicy of 176 gentamicin (including 128 homemade and 48 imported) was carried out in all counties and hsians of Taiwan. The potency of all samples was detected with cylinder method. The Limulus Amebocyte Lysate (LAL) test kit was also used to detect pyrogen substance residued inside samples. Collectively, there are 3 samples (about 1. 7%) over the ruled range of 90% to 120% on potency, However pyrogen substance was not detected in all samples.