中文摘要：

目的：制备青霉素类药物的致敏性杂质———青霉噻唑酸,并建立该杂质的定性和定量分析方法。方法：以青霉素钠为原料,采用碱水解的方法制备青霉噻唑酸;分别用理化检测法、质谱法和高效液相色谱法对青霉噻唑酸进行定性和定量分析。结果：经定性分析确证制备所得产物即为青霉噻唑酸;建立了青霉噻唑酸的HPLC色谱检测方法,精密度良好,制备所得青霉噻唑酸的含量在92%以上;并测定了不同批次以及同一批次不同放置时间的青霉素钠溶液中青霉噻唑酸杂质的含量,发现随着时间的推移,青霉素钠的含量迅速降低,而青霉噻唑酸的含量有所增加。结论：本文建立了青霉噻唑酸的定性和定量分析方法,为青霉素类药物中青霉噻唑酸杂质的分析奠定基础,为青霉素钠的质量控制提供依据;同时也为食品中抗生素残留的检测提供参考。

英文摘要：

Objective：To prepare the benzylpenicilloic acid from penicillin and establish the qualitative and quantitative determination methods for benzylpenicilloic acid.Methods：Benzylpenicilloic acid was prepared using penicillin sodium as raw material with alkaline solution.The qualitative and quantitative analysis of benzylpenicilloic acid was carried out using high performance liquid chromatography,mass spectrometry and physical chemical methods.Results：The prepared benzylpenicilloic acid was confirmed by qualitative analysis and the concentration of benzylpenicilloic acid was determined by high performance liquid chromatogramphy（above 92%）.Conclusion：The developed qualitative and quantitative analysis methods of benzylpenicilloic acid were simple and accurate,which provide a new idea for the quality control of penicillin sodium and the detection of antibiotic residue in food.