疫苗用氢氧化铝佐剂质量标准的初步建立
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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).
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).
引文
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[7]LI H Y,HAN Y J,ZENG R H.A study of enhancement immunopathogenesis effects of adjuvant Al(OH)3and CpG 2216to respiratory syncytial virus vaccine[J].Curr Immunol,2016,37(1):50-54.(in Chinese)李宏勇,韩艳娟,曾瑞红.佐剂Al(OH)3和CpG 2216对福尔马林灭活呼吸道合胞病毒疫苗免疫增强的作用研究[J].现代免疫学,2016,37(1):50-54.
[8]TANG Z H,ZHANG L,LUO Y,et al.Development of internal quality control standard for aluminum hydroxide adjuvant[J].Chin J Biologicals,2014,27:1625-1627.(in Chinese)唐朝辉,张莉,罗勇,等.氢氧化铝佐剂内控质量标准的建立[J].中国生物制品学杂志,2014,27:1625-1627.
[9]LI D J,HE W,ZHANG R,et al.Optimization of procedure for preparation of aluminium hydroxide adjuvant[J].Chin JBio-logicals,2010,23(10):1135-1137.(in Chinese)李德娟,何巍,张睿,等.氢氧化铝佐剂配制工艺的优化[J].中国生物制品学杂志,2010,23(10):1135-1137.
[10]Directorate for the Quality of Medicines&Health Care of the Council of Europe.The European Pharmacopoceia 8.0[S].France:Strasbourg Cedex,2013:1664E.
[11]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Repubic of China(VolⅣ)[S].Beijing:China Med Sci Press,2015.(in Chinese)国家药典委员会.中华人民共和国药典四部[S].北京:中国医药科技出版社,2015.
[2]YUE Z,ZHAO Y X,WANG H.Properties and advance in research of aluminium adjuvant[J].Chin J Biologicals,2016,29(12):1349-1354.(in Chinese)岳卓,赵玉秀,王辉.铝佐剂的特性及其研究进展[J].中国生物制品学杂志,2016,29(12):1349-1354.
[3]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Repubic of China(VolⅢ)[S].Beijing:China Med Sci Press,2015.(in Chinese)国家药典委员会.中华人民共和国药典(三部)[S].北京:中国医药科技出版社,2015.
[4]JIANG W W,LIANG J L,GAO N,et al.Immunogenicity of a candidate diphtheria,tetanus,acellular pertussis and Sabin strain inactivated poliovirus combined vaccine in a mouse model[J].Chin J Vac Immun,2018,24(5):559-564.(in Chinese)江文文,梁疆莉,高娜,等.候选无细胞百白破-Sabin株灭活脊髓灰质炎联合疫苗免疫小鼠的效果研究[J].2018,24(5):559-564.
[5]LI H Z,ZHENG H W,YANG X L,et al.Immunogenicity of diphtheria,tetanus,accellular pertussis,hepatitis B and inactivated poliovirus(Sabin strain)combined vaccine[J].Chin JBiologicals,2016,29(5):449-454.(in Chinese)李洪哲,郑惠文,杨晓蕾,等.吸附无细胞百日咳-白喉-破伤风-乙型肝炎-Sabin株灭活脊髓灰质炎联合疫苗免疫原性分析[J].中国生物制品学杂志,2016,29(5):449-454.
[6]ZHAO C Y,HUANG W J.Progress on physico-chemical properties of aluminum adjuvant and quality control of related adsorbed antigen preparation[J].Prog in Microbiol Immunol,2018,46(5):86-90.(in Chinese)赵晨燕,黄维金.铝佐剂理化特性及其吸附抗原后产物的质量控制研究进展[J].微生物学免疫学进展,2018,46(5):86-90.
[7]LI H Y,HAN Y J,ZENG R H.A study of enhancement immunopathogenesis effects of adjuvant Al(OH)3and CpG 2216to respiratory syncytial virus vaccine[J].Curr Immunol,2016,37(1):50-54.(in Chinese)李宏勇,韩艳娟,曾瑞红.佐剂Al(OH)3和CpG 2216对福尔马林灭活呼吸道合胞病毒疫苗免疫增强的作用研究[J].现代免疫学,2016,37(1):50-54.
[8]TANG Z H,ZHANG L,LUO Y,et al.Development of internal quality control standard for aluminum hydroxide adjuvant[J].Chin J Biologicals,2014,27:1625-1627.(in Chinese)唐朝辉,张莉,罗勇,等.氢氧化铝佐剂内控质量标准的建立[J].中国生物制品学杂志,2014,27:1625-1627.
[9]LI D J,HE W,ZHANG R,et al.Optimization of procedure for preparation of aluminium hydroxide adjuvant[J].Chin JBio-logicals,2010,23(10):1135-1137.(in Chinese)李德娟,何巍,张睿,等.氢氧化铝佐剂配制工艺的优化[J].中国生物制品学杂志,2010,23(10):1135-1137.
[10]Directorate for the Quality of Medicines&Health Care of the Council of Europe.The European Pharmacopoceia 8.0[S].France:Strasbourg Cedex,2013:1664E.
[11]Chinese Pharmacopoeia Commission.Pharmacopoeia of People's Repubic of China(VolⅣ)[S].Beijing:China Med Sci Press,2015.(in Chinese)国家药典委员会.中华人民共和国药典四部[S].北京:中国医药科技出版社,2015.
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