国产注射用比阿培南的质量分析与研究

Quality evaluation and analysis of domestic biapenem for injection

目的研究并综合评价国产注射用比阿培南的质量现状和存在的问题。方法采用法定标准对56批抽验样品进行了检验;并开展了杂质谱、胶塞相容性、复溶行为、晶型和微观晶体形态等探索性研究。结果法定检验结果显示56批注射用比阿培南合格率为100%。通过探索性研究发现现行的局颁标准YBH13252008不能有效控制聚合物杂质;建立了能同时控制有关物质和聚合物杂质的高效液相色谱系统,并对产品中含量大于0.02%的杂质和潜在的降解杂质进行了结构分析;发现国产品和原研产品的复溶行为和微观晶体形态存在显著差异,提示国内生产企业应对结晶工艺进行进一步研究。结论目前国产注射用比阿培南的产品质量符合现行标准要求。现行质量标准有待统一和提高。

Objective To evaluate the suitability of the statutory standards and the current quality of domestic biapenem for injection of different manufacturers.Methods The statutory standard methods combined with exploratory researches were used to evaluate the quality of the 56 samples,including the impurity profile,compatibility between rubber closures and drug,redissolution behaviors,crystal forms,and particle appearances studies.Results The statutory test showed 56 batches of samples were all qualified.The exploratory research results suggested that one of the current standards had defects in that polymer impurities had not been effectively separated and controlled.The impurity profile was established,and the structures and sources of the major impurities were confirmed.The domestic products were not consistent with the original drugs in redissolution behaviors and particle appearances,and an improvement was put forward to promote the quality of domestic biapenem.Conclusion At present,the quality of domestic biapenem for injection meets the requirement of the current statutory standards.The current statutory standards should be further improved.