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作 者:廖磊[1] 姚静[1] 黄林[1] 谭柯[1] 吕雪艳[1]
机构地区:[1]成都生物制品研究所有限责任公司,成都610023
出 处:《中国新药杂志》2012年第10期1119-1122,共4页Chinese Journal of New Drugs
基 金:国家科技支撑计划(2008BAI66B06)
摘 要:目的:挑选特定的9V型肺炎球菌精制多糖应用于9V型肺炎球菌多糖含量检测,探讨其作为标准多糖使用的可行性。方法:对选定批次的9V型肺炎球菌精制多糖进行单型多糖质量指标成分测定,并以其作为标准多糖进行准确度、精密度和线性研究。结果:批号为STD1213的9V型肺炎球菌精制多糖在半年内物理性状无变化,各质量指标均合格、良好、稳定。使用该多糖进行定量检测是准确的、精密的,线性良好。结论:此批精制多糖质量和稳定性均良好,具有作为9V型标准多糖使用的可能性。应用9V型标准多糖进行定量检测为进一步完善肺炎球菌多糖含量检测体系奠定了基础。Objective: To investigate the practicability of specific type 9V pneumococcal polysaccharide as a standard polysaccharide for detecting the concentrations of pneumococcal polysaccharides. Methods: The compo- nents of 9V polysaccharide were determined. Then three studies of accuracy, precision and linearity regression were performed. Results: The type 9V polysaccharide (lot number STD1213) had no changes in physical properties in half a year. Quality indexes were all qualified, favorable and stable. It was accurate, precise and good linear regression to use this type 9V polysaccharide for polysaccharide quantitative determination. Conclusion: The quality and stability of type 9V polysaccharide are satisfactory. It is quite possible to become standard substance for quantitative determination of polysaccharides. Application of type 9V polysaccharide standard substance provides a tool for quantitative polysaccharide determination.
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