目的 了解目前吸附破伤风疫苗效价测定采用的方法、最新的研究进展及其发展趋势。方法 主要以中国、欧洲、英国、日本和印度药典、WHO百白破疫苗质量控制指南、美国采用的方法及国内外该领域的文献为依据,进行归纳、总结和分析。结果与结论 吸附破伤风疫苗效价测定方法在不久的将来可能以完全体外检测代替体内检测,进行相关方面的研究已经成为当务之急。
Abstract
Objective To get the present information of potency assay Methods of adsorbed tetanus vaccine, latest research and developmental trend.Methods Induction, summary and analyses were used, mainly according to the Chinese Pharmacopoeia, European Pharmacopoeia, British Pharmacopoeia, Japanese Pharmacopoeia, Indian Pharmacopoeia, the manual for quality control of diphtheria, tetanus, and pertussis vaccines, adopted Methods of FDA and literatures in the field. Results and Conclusion In the near future, complete in vitro potency assay Methods of adsorbed tetanus vaccine can be used instead of in vivo assay, so it is important and urgent that related research should be made in China.
关键词
吸附破伤风疫苗 /
效价 /
测定方法比较 /
发展趋势分析
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Key words
adsorbed tetanus vaccine /
potency /
assay method comparison /
developmental trend analyses
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中图分类号：
Q813
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