药用辅料聚乙二醇6000质量评价及质量研究

Quality evaluation and quality research of polyethylene glycol 6000

目的评价药用辅料聚乙二醇6000质量现状及存在的问题,对该品种国家标准修订提供参考依据,同时为药品监管提供技术支持。方法对国家抽检的样品进行全项检验,对检验结果进行统计分析;基于检验中发现的问题,同时围绕聚乙二醇6000的安全、有效等方面开展探索性研究,建立并完善检验方法,全面分析其质量现状。结果7家生产企业的36批次样品按照现行质量标准检验,有2批样品不合格,不合格率为5.6%,不合格项目为酸度。探索性研究检验不合格率为19.4%。结论药用辅料聚乙二醇6000整体质量状况一般,现行质量标准有待完善。

Objective To evaluate the quality status and existing problems of polyethylene glycol 6000,and provide a basis for the revision of national drug standards and technical support for drug supervision.Methods All of the samples by national sampling evaluation were tested,and the results were statistically analyzed.Moreover,based on the problems found in the tests,exploratory research works were carried out in the aspects of safety and effectiveness of the drug,and a number of detection methods were established to fully analyze the quality.Results Totally 36 batches of samples from 7 manufacturers were tested,and 2 batches were unqualified,the overall unqualified rate was 5.6%,and the unqualified item was acidity.According to the exploratory study,the overall unqualified rate was 19.4%.Conclusion At present,the quality of polyethylene glycol 6000 is just passable.It is recommended to improve the quality standards as soon as possible.