[1]孙 慧,王 娜,唐 云,等.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(01):5-14.[doi:10.3969/j.issn.1001-4616.2026.01.002]
　Sun Hui,Wang Na,Tang Yun,et al.Study on the Formulation Optimization and Related Substances of Brivaracetam Oral Solution[J].Journal of Nanjing Normal University(Natural Science Edition),2026,49(01):5-14.[doi:10.3969/j.issn.1001-4616.2026.01.002]
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布立西坦口服溶液的处方工艺筛选及对有关物质的研究()

《南京师大学报（自然科学版）》[ISSN:1001-4616/CN:32-1239/N]

卷:
49
期数:
2026年01期
页码:
5-14
栏目:
化学
出版日期:
2026-02-10

文章信息/Info

Title:
Study on the Formulation Optimization and Related Substances of Brivaracetam Oral Solution
文章编号:
1001-4616(2026)01-0005-10
作者:
孙 慧1; 王 娜2; 唐 云2; 朱永强1
(1.南京师范大学食品与制药工程学院,江苏 南京 210023)
(2.江苏正大丰海制药有限公司,江苏 南京 210033)
Author(s):
Sun Hui1; Wang Na2; Tang Yun2; Zhu Yongqiang1
(1.School of Food and Pharmaceutical Engineering,Nanjing Normal University,Nanjing 210023,China)
(2.Jiangsu Chia Tai Fenghai Pharmaceutical Co.,Ltd.,Nanjing 210033,China)
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
Keywords:
pharmaceutical analysis; brivaracetam oral solution; epilepsy; the related substance; formulation optimization
分类号:
R917
DOI:
10.3969/j.issn.1001-4616.2026.01.002
文献标志码:
A
摘要:
为考察布立西坦口服溶液的处方工艺对有关物质的影响,探究本品的稳定性. 本文建立有关物质的检查方法并进行方法学验证; 按拟定的处方工艺放大生产,考察成品在高温、光照条件下的稳定性. 结果显示,有关物质的检测方法可靠,原料药(active pharmacentical ingredient,API)和杂质实现良好的分离; 同时控制药液pH值在5.0～6.0范围内,能有效减缓其在高温下有关物质的增长; 无水枸橼酸在原料药之前加入,能显著降低药液有关物质的水平. 本文开发了布立西坦口服溶液有关物质的检查方法,并通过优化处方工艺,解决了儿童及吞咽困难的老人等癫痫患者用药短缺的问题.
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.

参考文献/References:

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备注/Memo

备注/Memo:
收稿日期:2024-11-21.
基金项目:企业横向基金项目(FH542).
通讯作者:朱永强,博士,教授,研究方向:分子靶向抗肿瘤药物设计及研究,计算机辅助药物设计,仿制药合成工艺产业化及晶型研究. E-mail:zhyqscu@hotmail.com
更新日期/Last Update: 2026-02-10