摘要
目的验证苯酚法检测b型流感嗜血杆菌荚膜多糖提取新工艺中Triton X-114残留含量的可行性,并建立Triton X-114在Hib荚膜多糖中残留含量的质量标准。方法参考2015版《中国药典》三部中检测Triton X-100及相关文献中的苯酚法,对其线性范围、准确性、精密性进行验证,对多批次荚膜多糖的残留含量及对应的安全性结果进行统计归纳。结果苯酚法可以应用于b型流感嗜血杆菌荚膜多糖中Triton X-114的残留量检测,其线性范围、准确性及精密性较好,经15批次荚膜多糖中数据统计,b型流感嗜血杆菌荚膜多糖中Triton X-114的残留含量标准建议定为<25.00mg/g荚膜多糖。结论苯酚法可以有效检测Triton X-114在b型流感嗜血杆菌荚膜多糖中的残留含量,本研究所制定质量标准可以保证产品的安全性。
Objective To verify the feasibility of phenol method to detect the residual content of Triton X-114 in the new process of extraction of capsular polysaccharide from haemophilus influenzae type b(Hib),and to establish the quality standard for the residual content of Triton X-114 in Hib capsular polysaccharide.Methods The linear range,accuracy and precision of phenol method to detect Triton X-100 were verified after the method was consulted from the reference to Pharmacopoeia of the People’s Republic of China(2015)VolumeⅢand the related literature,and the residual content of capsular polysaccharide in multiple batches and the corresponding safety results were statistically summarized.Results Being with good linear range,accuracy and precision,phenol method could be applied to the detection of the residual content of Triton X-114 in Hib capsular polysaccharide.According to the statistics of 15 batches of capsular polysaccharide,the residue standard of Triton X-114 in Hib capsular polysaccharide was recommended to be less than 25.00mg/g capsular polysaccharide.Conclusion Phenol method can effectively detect the residual content of Triton X-114 in Hib capsular polysaccharide.The quality standard worked out by this study can ensure the safety of the product.
作者
朱文勇
欧阳圣洁
代小虎
宋绍辉
寸怡娜
陈枫
廖国阳
ZHU Wenyong;OUYANG Shengjie;DAI Xiaohu;SONG Shaohui;CUN Yi'na;CHEN Feng LIAO(Guoyang Institute of Medical Biology,Chinese Academy of Medical Sciences,Yunnan,Kunming 650118,China)
出处
《中国医药科学》
2020年第11期6-9,22,共5页
China Medicine And Pharmacy
基金
中国医学科学院医学与健康科技创新工程协同创新团队项目(2016-I2M-3-026)。
