摘要
目的探讨硫酸庆大霉素原料和注射液的的杂质控制策略。方法采用高效液相色谱法,分析硫酸庆大霉素原料和注射液的杂质谱,并比较其变化。结果硫酸庆大霉素原料和注射液性质稳定,破坏性实验和影响因素实验中均未产生新的杂质,原料杂质决定于菌株和发酵工艺,制剂过程中杂质谱无变化。结论通过对硫酸庆大霉素及其注射液杂质谱的研究,可以有目的的控制一些杂质,为质量控制提供参;同时可以分析其样品来源,为日常质量监督提供参考。
Objective To develop the impurity control strategy of sulfate gentamicin and sulfate gentamicin injection. Methods The HPLC method was used to analyze the impurities profiling changes of sulfate gentamicin and its injection. Results Sulfate gentamicin and sulfate gentamicin injection were stability. There was not degradation product in stress testing. The impurities of gentamicin raw material came from strain and fermentation technology and the manufacture craft made no contribution to preparation. Conclusion The study of the impurities profiling on the sulfate gentamicin and sulfate gentamicin injection is help to the impurites control and the quality monitoring.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2014年第7期513-519,共7页
Chinese Journal of Antibiotics