摘要
目的:建立一种新型胃癌治疗性疫苗的无菌检查方法。方法:依据《中国药典》2015年版三部要求,采用薄膜过滤法和吐温80溶解及梯度冲洗的方法进行无菌检查并进行方法适用性试验。结果与结论:通过方法适用性试验说明建立的无菌检查法适用于该疫苗的无菌检查,并对其他黏性供试品的无菌检查具有借鉴意义。
Objective： To establish a method for sterility test of a novel gastric cancer therapeutic vaccine. Methods： Membrane filtration method and the method of Tween 80 dissolution and gradient washing were used for sterility test and applicability test according to the relevant requirements of the Chinese Pharmacopoeia 2015 edition, volume III. Results and Conclusion： The applicability test showed that the established method was suitable for sterility test of this vaccine and of reference significance to that of other viscosity samples.
出处
《中国药事》
CAS
2018年第2期221-224,共4页
Chinese Pharmaceutical Affairs
关键词
胃癌治疗性疫苗
无菌检查
薄膜过滤
方法学验证
gastric cancer therapeutic vaccines
sterility test
membrane filtration
method validation
