摘要
目的建立疫苗用氢氧化铝佐剂的质量标准。方法参照《欧洲药典》8.0和《中国药典》四部(2015版),选择5个实验室对6个厂家12批氢氧化铝佐剂样品同时进行17个理化项目的检测及分析,建立适合国内氢氧化铝佐剂的质量标准。结果初步建立了疫苗用氢氧化铝佐剂17项质量标准。经5个实验室检测,12批样品外观、溶解性能、鉴别试验、无菌、吸附率、硫酸盐含量、硝酸盐含量、铵盐含量、砷盐含量、铁盐含量、重金属含量、氯化钠含量、氯化物含量及细菌内毒素的结果均符合《欧洲药典》8. 0和《中国药典》四部(2015版)相关质量标准;而p H值、铝含量、沉降率检测结果不同厂家之间差异较大。结论建立了适合国内氢氧化铝佐剂的质量评价体系,为氢氧化铝佐剂的质量标准进入2015版《中国药典》增补版提供了方法细则和标准制定依据。
Objective To establish a quality standard for aluminum hydroxide adjuvant of vaccines. Methods Seventeen physicochemical parameters of twelve batches of aluminum hydroxide adjuvant from six manufacturers were determined according to the requirements in Europe Pharmacopoeia 8. 0 and Chinese Pharmacopoeia (Volume Ⅳ,2015 edition)by five laboratories,based on which a quality standard suitable for domestic aluminum hydroxide adjuvant was established. Results The quality standard consisting of seventeen items was established. The appearance,solubility, identity,sterility,adsorption rate as well as contents of sulphate,nitrate,smmonium salt,arsenic salt,ferric salt,heavy metal,sodium chloride,chloride and bacterial endotoxin of twelve batches of samples met the requirements in Europe Pharmacopoeia 8. 0 and Chinese Pharmacopoeia (Volume Ⅳ,2015 edition). However,the pH value,aluminum content and sedimentation rate of samples from various manufacturers were significantly different. Conclusion The quality evaluation system suitable for domestic aluminum hydroxide adjuvant was established,which provided a basis for inclusion of the requirements for aluminum hydroxide adjuvant into the supplement of Chinese Pharmacopoeia (2015 edition).
作者
肖詹蓉
张娜
潘殊男
杨溢尧
艾绪露
李彦涵
许文婷
孙宏亮
吴永林
杨明
XIAO Zhan-rong;ZHANG Na;PAN Shu-nan;YANG Yi-yao;AI Xu-lu;LI Yan-han;XU Wen-ting;SUN Hong-liang;WU Yong-lin;YANG Ming(National Vaccine & Serum Institute,Beijing 100176,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2019年第7期721-725,731,共6页
Chinese Journal of Biologicals
基金
国家“重大新药创制”科技重大专项资助项目(2018ZX09738003)
关键词
疫苗
氢氧化铝
佐剂
质量标准
Vaccine
Aluminum hydroxide
Adjuvant
Quality standard
