| 齐秋焕,黄春华,王志娟,等.3型肺炎球菌结合物原液中游离多糖含量测定方法的建立[J].安徽医药,2025,29(7):1319-1323. |
| 3型肺炎球菌结合物原液中游离多糖含量测定方法的建立 |
| Establishment of determination method of free polysaccharide in the stock solution serotype 3 pneumococcal conjugate |
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| DOI：10.3969/j.issn.1009-6469.2025.07.011 |
| 中文关键词: 肺炎链球菌结合疫苗 多糖类 游离多糖 脱氧胆酸钠酸沉淀 含量测定 |
| 英文关键词: Pneumococcal conjugate vaccine Polysaccharides Free polysaccharide Sodium deoxycholate acid precipitation Assay |
| 基金项目:国家科技重大专项“重大新药创制”项目( 2018ZX09738006) |
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| 中文摘要: |
| 目的建立测定 3型肺炎球菌结合物原液中游离多糖含量的方法。方法 3型肺炎球菌结合物原液经脱氧胆酸钠酸沉淀处理后按照蒽酮硫酸法进行游离多糖含量测定。 2019年 4月至 2020年 12月使用不同盐酸浓度按照脱氧胆酸钠酸沉淀法处理样品，通过蛋白质去除率和多糖回收率，确定处理游离多糖时使用盐酸的最佳浓度。对建立的方法进行检测限、量限、准确度、精密度测定。结果 3型肺炎球菌结合物原液游离多糖处理的最佳盐酸浓度为 0.20 mol/L。该方法仅沉淀蛋定白质，而对游离多糖无影响。 3型肺炎球菌结合物原液中游离多糖检测限为 0.606 mg/L，定量限为 1.837 mg/L。3型肺炎球菌结合物原液准确度回收率为 94.0%~102.4%。重复性相对标准偏差( RSD)为 3.6%。中间精密度 RSD为 2.1%。6批 3型肺炎球菌结合物原液游离多糖含量测定结果均不高于 6.164 mg/L。结论采用脱氧胆酸钠酸沉淀法处理样品后按照蒽酮硫酸法进行游离多糖含量测定，具有良好的准确度、精密度，且方法稳定、易操作、结果可靠，可用于 3型肺炎球菌结合物原液中游离多糖含量测定。 |
| 英文摘要: |
| Objective To establish a method for the determination of free polysaccharide in stock solution serotype 3 pneumococcal conjugate.Methods The stock solution serotype 3 pneumococcal conjugate was treated with sodium deoxycholate acid precipitationmethod, and the content of free polysaccharide was detected by anthrone sulfuric acid method. During the period from April 2019 to De-cember 2020, the samples were treated with different concentrations of hydrochloric acid according to the sodium deoxycholate acidprecipitation method. The optimum concentration of hydrochloric acid was determined by protein removal rate and polysaccharide re-covery rate. The detection limit, quantitative limit, accuracy and precision of the established method were tested.Results The optimalconcentration of hydrochloric acid was 0.20 mol/L for the treatment of free polysaccharide from the stock solution serotype 3 pneumo-coccal conjugate. This method only precipitated proteins and had no effect on free polysaccharides. The detection limit of free polysac-charide in the stock solution serotype 3 pneumococcal conjugate was 0.606 mg/L and the limit of quantification was 1.837 mg/L. The ac-curacy recovery rate in the stock solution serotype 3 pneumococcal conjugate was between 94.0%-102.4%. The repeatability RSD was3.6%. The intermediate precision RSD was 2.1%. The content of free polysaccharide in 6 batches of the stock solution of serotype 3pneumococcal conjugate stock solution were not higher than 6.164 mg/L. Conclusion The sodium deoxycholate acid precipitationmethod is used to treat the sample and then the free polysaccharide content is detected according to the anthrone sulfuric acid method.It has good accuracy and precision, and the method is stable, easy to operate, and the result is reliable. It can be used for the detectionof free polysaccharide content in the stock solution serotype 3 pneumococcal conjugate. |
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