Kristofferson A, Ahlstedt S, Pettersson E, Svärd P O
Int Arch Allergy Appl Immunol. 1977;55(1-6):13-22.
This communication presents a sensitive and discriminative method for detection of protein impurities in penicillin preparations. Antibodies against various penicilloyl derivatives of high avidities and specificities raised in rabbits were coupled to microcrystalline cellulose. The amount of penicilloyl antigen present in a sample was calculated from the relative uptake of a radioiodinated penicilloylated albumin competing with the sample for binding to the antipenicilloyl immunosorbent. As little as 0.048 pmol/ml of penicilloylated human serum albumin could be detected. The accuracy of the determination was within +/- 23% (p less than 0.05). The pronounced specificities against the penicillin side chains demonstrated by the various immunosorbents were not displayed by the antibodies in passive cutaneous anaphylaxis experiments in guinea pigs. Furthermore, the immunosorbents showed the same pattern of specificity against monomeric penicillins as for penicilloylated proteins, but the former were considerably less efficiently recorded. The relatively small quantities of protein impurities in penicillin preparations, however, necessitated a separation from penicillin prior to analyses with the RIA. This was accomplished by fractionation on Sephadex G-50 fine, ginving a recovery of 80-90% of 0.1-2.5 ppm of penicilloylated protein.
本文介绍了一种灵敏且有鉴别力的检测青霉素制剂中蛋白质杂质的方法。在兔体内产生的针对各种高亲和力和特异性的青霉噻唑衍生物的抗体与微晶纤维素偶联。样品中存在的青霉噻唑抗原量是根据与样品竞争结合抗青霉噻唑免疫吸附剂的放射性碘化青霉噻唑化白蛋白的相对摄取量计算得出的。低至0.048 pmol/ml的青霉噻唑化人血清白蛋白都能被检测到。测定的准确度在±23%以内(p<0.05)。各种免疫吸附剂对青霉素侧链表现出的明显特异性在豚鼠的被动皮肤过敏试验中未被抗体表现出来。此外,免疫吸附剂对单体青霉素的特异性模式与对青霉噻唑化蛋白质的相同,但前者的记录效率要低得多。然而,青霉素制剂中相对少量的蛋白质杂质在采用放射免疫分析(RIA)进行分析之前需要与青霉素分离。这通过在Sephadex G - 50细柱上进行分级分离来完成,0.1 - 2.5 ppm的青霉噻唑化蛋白质的回收率为80 - 90%。