摘要
目的按照国家计划抽验要求,评价国内不同企业生产的注射用美罗培南的质量。方法按国家标准检验与探索性研究相结合,对抽验样品进行检验,对检验结果进行统计分析。结果共抽取样品115批次,按国家标准检验合格率99.1%,1批溶液的颜色不符合规定。探索性研究优化了现行标准有关物质检查方法,对主要杂质的来源与结构进行了研究;发现溶液的澄清度主要与样品的酸碱度和制剂规格有关;有关物质、色差值和聚合物均与碳酸钠含量呈显著正相关;美罗培南输液的配伍稳定性较差。结论目前国内注射用的美罗培南总体质量较好;现行标准有待进一步提高,建议现行标准修订有关物质检查方法,增加碳酸钠含量测定;建议企业优化处方配比,以提高产品质量。
Objective To evaluate the suitability of statutory standard and the quality condition of meropenem for injection of different domestic manufacturers. Methods Official method was used to test the samples combined with the exploratory research. Then the results were treated by using the statistical method to evaluate the quality of meropenem for injection. Results According to the statutory standards for the examination, the qualified rate of the 115 batches of samples was 99.1%. The unqualified items were the clarity and color of the solution. The method of related substances test was optimized. This paper also researched the structures and sources of major impurities. The clarity of the solution was related to the pH value and the specifications mostly. The content of the impurities, the color of the solution and the polymer were all correlated with the sodium carbonate content. The result of exploratory research also showed that the stability of the mixtures of meropenem for injection was not positive. Conclusion With the overall, the quality of meropenem for injection general at present is positive. The statutory standard needs to be improved such as related substances test and determination of sodium carbonate. In order to improve the quality of products, the manufacturers should optimize their formulations.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2017年第6期486-490,共5页
Chinese Journal of Antibiotics
关键词
注射用美罗培南
有关物质
评价性抽验
质量分析
Meropenem for injection
Related substances
Evaluative testing
Quality analysis
