浅谈影响20%甘露醇注射液质量的因素及控制方法

Discussion of Factors of Influencing Quality of 20% Mannitol Injection and Its Control Method

目的:研究影响20%甘露醇可见异物检查合格率低、细菌内毒素检查阳性率等质量问题的因素。方法:通过对原辅料包材的控制,采用加大活性炭量、二次脱碳吸附等工艺改进,对生产操作中不溶性微粒的控制等,保证产品质量。结果:采取以上方法后,我公司生产的甘露醇未发生过结晶现象,可见异物检查合格率在98.5%以上,细菌内毒素检查100%合格。结论:经过长期实践证明,采用上述方法进行质量控制,产品安全、稳定,质量有了很大的提高。

Objective：Research factors influencing quality that make qualified rate of visible foreign matter test of 20% mannitol injection low and test result of bacterial endotoxin positive etc.Methods：by controlling packaging materials of raw material,increasing activated carbon quantity,improving technologies such as second decarburization adsorption and controlling insoluble particles in production to ensure product quality.Results：After adopting the above methods,mannitol injections produced our company don＇t undergo crystallization,qualified rate of visible foreign matter test is over 98.5%,test result ofbacterial endotoxin is 100% qualified.Conclusion：Long-term practice proves that carrying out quality control in the above methods,products are safe to use and have stable quality which is greatly improved.