国内外破伤风相关疫苗的质量参数比较

董国霞,田霖,谭亚军,侯启明,马霄*

中国药学杂志 ›› 2015, Vol. 50 ›› Issue (8) : 714-717.

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PDF(533 KB)
中国药学杂志 ›› 2015, Vol. 50 ›› Issue (8) : 714-717. DOI: 10.11669/cpj.2015.08.013
论著

国内外破伤风相关疫苗的质量参数比较

  • 董国霞,田霖,谭亚军,侯启明,马霄*
作者信息 +

Comparison of Quality Parameters of Domestic and Imported Tetanus-based Combined Vaccines

  • DONG Guo-xia, TIAN Lin, TAN Ya-jun, HOU Qi-ming, MA Xiao*
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文章历史 +

摘要

目的 了解基础免疫阶段在我国市场上主要使用的国内外破伤风相关疫苗的关键质量参数及其水平。方法 以国内外各厂家分别生产的10批次产品为依据,对其质量数据进行统计、分析和比较。结果 国产产品和进口产品各有其优势所在,同时也均有需进一步提升的空间。结论 期望更多国内外疫苗厂家能针对自身产品特点,进一步提高产品质量,在未来制造出更安全、有效且使用便捷的新型疫苗。

Abstract

OBJECTIVE To investigate the situation of the key quality parameters of the main domestic and imported tetanus-based combined vaccines used in the basic immunization phase in our country.METHODS The quality parameters of 50 batches of vaccine products which were manufactured respectively by domestic and foreign manufacturers were analyzed and compared.RESULTS AND CONCLUSION Domestic and imported tetanus-based combined vaccine products have different advantages and the quality and these products may be improved further in some respects. It is suggested that more domestic and foreign vaccine manufacturers improve the product quality based on the characteristics of their own products to provide safer and more effective vaccines that can also more convenient for use in the future.

关键词

破伤风相关疫苗 / 质量参数 / 比较

Key words

tetanus-based combination vaccines / quality parameter / comparison

引用本文

导出引用
董国霞,田霖,谭亚军,侯启明,马霄*. 国内外破伤风相关疫苗的质量参数比较[J]. 中国药学杂志, 2015, 50(8): 714-717 https://doi.org/10.11669/cpj.2015.08.013
DONG Guo-xia, TIAN Lin, TAN Ya-jun, HOU Qi-ming, MA Xiao*. Comparison of Quality Parameters of Domestic and Imported Tetanus-based Combined Vaccines[J]. Chinese Pharmaceutical Journal, 2015, 50(8): 714-717 https://doi.org/10.11669/cpj.2015.08.013
中图分类号: R927   

参考文献

[1] Ch. P(2010)Vol Ⅲ(中国药典2010年版.三部). 2010:67-68,notice Ⅺ. [2] WANG D S, ZHAO H, DONG S L. The adverse reaction review of tetanus toxoid.Prog Microbiol Immunol(微生物学免疫学进展),1995,23(3):179-183.[3] SCHIJNS V E, LAVELLE E C. Trends in vaccine adjuvants. Expert Rev Vaccines,2011,10(4):539-550.[4] FREDERIKSENMS, TOFTE H. Immunisation with aluminium-containing vaccine of a child with itching nodule following previous vaccination. Vaccine, 2004,23(1):1-2.[5] BORDET A L, MICHENET P, COHEN C, et al. Post-vaccination granuloma due to aluminium hydroxide. Ann Pathol, 2001,21(2):149-152.[6] BAYLOR N W, EGAN W, RICHMAN P. Aluminum salts in vaccines--US perspective. Vaccine, 2002,20(suppl 3):18-23.[7] VAN′T VEEN A J. Vaccines without thiomersal:Why so necessary,Why so long coming. Drugs, 2001,61(5):565-572.[8] ABERER W, REITER E, ZIEGLER V, et al. The importance of including thimerosal, an increasingly frequent allergen in Europe, in standard screening series for allergic contact dermatitis. Am J Contact Dermat,1991,2(2):110-112.[9] WHO. Guidelines on regulatory expectations related to the elimination,reduction or replacement of thiomersal in vaccines. WHO TRS, NO. 926, 2004.[10] Committee for Proprietary Medicinal Products. Points to consider on the reduction, eliminationor substitution of thiomersal in vaccines. CPMP/BWP/2517/00,2001.[11] GEIER D A, JORDAN S K, GEIER M R. The relative toxicity of compounds used as preservatives in vaccines and biologics. Med Sci Monit, 2010, 16(5):21-27.

基金

中国食品药品检定研究院中青年发展研究基金资助(2013NB3)
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