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为评价注射用A群链球菌制剂(OK432)中是否含有青霉素过敏性杂质-青霉噻唑蛋白,利用SephadexG-10凝胶色谱法首先除去制剂中的游离青霉素,以消除其对免疫学测定的影响;并将酶联免疫吸附法和被动皮肤过敏试验联用,从体外、体内两方面证明注射用A群链球菌制剂中含有青霉座哩蛋白。通过对注射用A群链球菌制剂中青霉噻唑蛋白在SephadexG-10凝胶色谱中色谱行为的分析,发现用凝胶色谱法考察样品中青霉噻唑蛋白的含量较免疫学方法更快捷、简便,可用于常规质量控制。
To assess whether penicillin-sensitive penicillin-allergic impurities (OK432) are included in injectable A-streptococcal preparations (Peniclothiazole), Sephadex G-10 gel chromatography was used to first remove free penicillin from the formulation to eliminate its effect on immunological assays ; And enzyme-linked immunosorbent assay and passive skin allergy test combined with both in vitro and in vivo proved that A streptococcal injection formulations containing penicillin pemphigus. Through the analysis of the chromatographic behavior of penicillin zolmitin in Sephadex G-10 gel in group A streptococcal preparation, it was found that the content of penicillin zolmitin in the sample by gel chromatography was faster and easier than the immunological method , Can be used for routine quality control.