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美国FDA 规定药品中青霉素污染限量为每一单次注射剂中不得超过0.05IU;口服制剂每一单剂不得超过0.5IU。作者根据牛奶中β-内酰胺抗生素的快速酶测定法的方法,以市售成套酶试剂Penzym~(?) 研究药品中苄青霉素交叉污染的监测方法。Penzym~(?)试剂(Imp Biotechnol Ltd 产)是由分装在玻质小瓶的4种试剂组成。试剂1:D-丙氨酸-D-丙氨酸羧肽酶;试剂2:(乙酰基)_2 L-赖氨酸D-丙氨酸-D-丙氨酸和显色剂;试剂3:显色剂(以上均为干品,
The United States FDA provides that the limit of penicillin contamination in the drug shall not exceed 0.05 IU per single injection; the oral preparation shall not exceed 0.5 IU per single dose. According to the method of rapid enzymatic determination of β-lactam antibiotics in milk, the authors used a commercially available complete set of enzyme reagent Penzym ~ (?) To study the method for monitoring the cross-contamination of benzyl penicillin in medicines. The Penzym® reagent (produced by Imp Biotechnol Ltd) consists of four reagents dispensed in glass vials. Reagent 1: D-alanine-D-alanine carboxypeptidase; Reagent 2: (acetyl) _2 L-lysine D-alanine-D-alanine and developer; Reagent 3: Color developers (above are dry goods,