摘要
目的:为注射用缓释微球制剂的质量研究和质控方法提供一定的参考。方法:全球现有多家企业生产注射用醋酸亮丙瑞林缓释微球,其工艺、质量评价体系多不相同,本文根据多年对该品种检验及标准研究的结果,概述了不同生产工艺及质量评价体系下注射用醋酸亮丙瑞林缓释微球的质量状况,并对关键质量参数进行了对比和分析。结果:注射用醋酸亮丙瑞林缓释微球质量基本稳定,不同企业产品间存在质量差异。结论:注射用醋酸亮丙瑞林缓释微球现行质量标准可对其质量进行有效评估,但尚需进一步完善。
Objective:To provide a reference of quality research and quality control of sustained released microspheres for injection. Methods:The process and quality evaluation system of euprorelin acetate sustained release microspheres for injection from global different manufactures is different. Based on the results of testing and research on the species for many years,this paper summarized the quality status of leuprorelin acetate microspheres for injection under different production processes and quality evaluation system. The key quality parameters(particle size and distribution,pH,residual organic solvents,dissolution,related substances,assay) are compared and analyzed. Results:The quality of leuprorelin acetate microspheres for injection imported is stable,and there are quality differences among products from different manufactures. Conclusion:.The existing quality system of leuprorelin acetate microspheres for injection can be used to evaluate their quality effectively,but further improvement is needed.
作者
孙悦
唐素芳
王卫
李娅男
张瑜
SUN Yue;TANG Su-fang;WANG Wei;LI Ya-nan;ZHANG Yu(Tianjin Institule of Drug Control,Tianjin 300070,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2020年第6期964-970,共7页
Chinese Journal of Pharmaceutical Analysis
基金
“十三五”国家重大新药创制专项(2017ZX09101001-007)资助。
关键词
醋酸亮丙瑞林
注射用缓释微球
工艺制法
质量回顾分析
关键质量参数
leuprorelin acetate
sustained release microspheres for injection
production process
quality evaluation and review
key quality parameters
