摘要
目的查找影响甘露醇注射液结晶的因素,并提出控制措施。方法通过分析产品的结晶及内在质量指标情况查找包装材料、质量指标对结晶的影响,并结合试验及生产经验,确定最佳的配制工艺。结果产品的包装形式、pH值、含量、不溶性微粒对甘露醇注射液结晶有直接的关系,通过优化产品的配制工艺可减少结晶的产生。
Objective To find the influencing factors for crystallization of Mannitol Injection and propose control measures. Methods To find the influence of packing material and quality guideline on crystallization by analyzing the crystallization of products and the situation of inner quality indices. The optimal preparation technology was determined by combining with experi- ments and production experience. Results The packaging,pH, content and insoluble panicles had direct relation to the crystalli- zation of Mannitol Injection, and the crystallization can be reduced by optimizing the preparation process.
出处
《齐鲁药事》
2012年第5期298-299,共2页
qilu pharmaceutical affairs
关键词
甘露醇注射液
结晶
影响因素
控制措施
Mannitol Injection
Crystallization
Influencing factors
Control measures
