摘要
目的:探索硫普罗宁注射液处方组成及制备工艺。方法:以pH值、含量及有关物质为评价指标,对影响硫普罗宁注射液的稳定性因素分别进行研究,优选出其制备工艺。结果:筛选出了影响硫普罗宁注射液稳定性的因素并优化了制备工艺关键控制点。结论:根据筛选出的关键工艺控制点制定工艺能够制备出符合质量标准的硫普罗宁注射液。
Objective：Through studiedied on Tiopronin injection formulation composition and preparation process; Methods：By pH, content and related substances for evaluation of the factors affecting the Tiopronin injection were studied separately , preferably out of the preparation process;Results ： Screened out the factors that influence the stability tiopronin injection and optimized prepara- tion process critical control points; Conclusion： The formulation process according to filter out critical process control points can he prepared to meet quality standards tiopronin injection.
出处
《亚太传统医药》
2015年第3期32-33,共2页
Asia-Pacific Traditional Medicine
关键词
硫普罗宁注射液
处方组成
工艺控制
Tiopronin Injection
Prescription
Critical Process Control
