南京师大学报（自然科学版）2026，Vol.49Issue(1)：5-14,10.DOI:10.3969/j.issn.1001-4616.2026.01.002
布立西坦口服溶液的处方工艺筛选及对有关物质的研究
Study on the Formulation Optimization and Related Substances of Brivaracetam Oral Solution
摘要
Abstract
Exploring the stability of brivaracetam oral solution,by examining the influence of formulation process on related substances in the solution.A method for related substances was established and validated.Scaling up the production of samples based on the optimized formulation composition and packaging form,and examining the stability of the product under high temperature and light conditions.The developed method for detecting related substances is feasible,achieving great separation of the active pharmacentical ingredient(API)and impurities.Controlling pH value of the product to 5.0-6.0 can effectively slow down the increase of related substances under high temperature;adding the API after the addition of anhydrous citric acid and sodium citrate can significantly reduce the level of related substances.This article developed a method for detecting related substances in brivaracetam oral solution and addressed the medication shortage for pediatric and elderly patients with epilepsy who have difficulty swallowing by optimizing the formulation process.关键词
药物分析/布立西坦口服溶液/癫痫/有关物质/处方工艺筛选Key words
pharmaceutical analysis/brivaracetam oral solution/epilepsy/the related substance/formulation optimization分类
医药卫生引用本文复制引用
孙慧,王娜,唐云,朱永强..布立西坦口服溶液的处方工艺筛选及对有关物质的研究[J].南京师大学报（自然科学版）,2026,49(1):5-14,10.基金项目
企业横向基金项目(FH542). （FH542）
