Development of national standards for detection of Streptococcus pneumoniae serotype 12F,14,17F and 22F polysaccharide content
10.19778/j.chp.2025.04.007
- VernacularTitle:12F、14、17F和22F血清型肺炎链球菌多糖含量检测用国家标准品的研制
- Author:
Shanshan WANG
1
;
Qiong CHEN
1
;
Chune WANG
1
;
Yinghua XU
1
;
Qiang YE
1
Author Information
1. 中国食品药品检定研究院,卫健委生物技术产品检定方法及其标准化重点实验室,中国医学科学院创新疫苗质量评价与标准化研究创新单元,北京 102629
- Publication Type:Journal Article
- Keywords:
national standard;
pneumococcal polysaccharide;
quality control,stability
- From:
Drug Standards of China
2025;26(4):380-384
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop national standard materials for Streptococcus pneumoniae serotypes 12F,14,17F and 22F polysaccharides.Methods:According to the method recommended by the 2020 Chinese Pharmacopoeia,the relevant limit quality control of four different serotypes of polysaccharide candidate standards was conducted.The uniformity of subpackage and stability of the candidate standard products under different conditions were ana-lyzed.Furthermore,three laboratories were organized for collaborative calibration.Results:The results showed that the quality of serotypes 12F,14,17F and 22F polysaccharides candidate standards met the requirements of the quality standard of polysaccharide in the 2020 edition of the Chinese Pharmacopoeia.The RSD between polysaccha-ride content of different candidate standard samples were less than 5.0％,indicating that the uniformity of the poly-saccharide candidate standards was better.The results from stability analysis confirmed that the polysaccharide con-centration of serotypes 12F,14,17F and 22F polysaccharide candidate standard did not change significantly after being placed at 2-8 ℃,25 and 37℃for different times and after repeated freezing and thawing three times.Compared with the test results of each candidate standard product stored at-70 ℃ for a long time,the RSD were all within 5％.The collaborative results confirmed that the RSD of the polysaccharide content in different laborato-ries were less than 12％,of which assigned the concentration of four different serotype polysaccharide candidate standards.Conclusion:Serotypes 12F,14,17F and 22F polysaccharide standards have been developed,of which can be used for quality control of pneumococcal polysaccharide vaccines in the future.
