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目的:采用自身降解物质作为定量指标,表征碳青霉烯类药物的降解程度,用以考察此类药物的稳定性和指针性杂质共性。方法:以美罗培南、亚胺培南和比阿培南为例,进行加速稳定性试验,寻找具有代表性的指针性杂质,并考察药物自身降解程度与指针性杂质之间的量值关系,用以作为稳定性表征指标。结果:HPLC法分析得到的美罗培南、亚胺培南和比阿培南主成分含量降低1.0%时的警戒线分别为:187,261,84。通过LC-MS确证指针性杂质结构为开环水解物。结论:通过对碳青霉烯类药物稳定性考察,依据指针性杂质表征降解程度。
OBJECTIVE: To characterize the degradation degree of carbapenems by using its own degradation substance as a quantitative index to investigate the stability of these drugs and the commonality of the finger-like impurities. Methods: Taking meropenem, imipenem and biapenem as an example, the accelerated stability test was carried out to find out the representative target impurities, and to investigate the relationship between the degree of drug degradation and the target impurities. Used as a stability indicator. Results: The alert lines for meropenem, imipenem and biapenem, respectively, with the 1.0% reduction of main components were 187,261,84. The structure of the finger-like impurity was confirmed by LC-MS to be a ring-opened hydrolyzate. Conclusion: The stability of carbapenems was investigated, and the degree of degradation was characterized according to the index of impurities.