中国药品标准2024,Vol.25Issue(4) :405-408.DOI:10.19778/j.chp.2024.04.014

药用辅料海藻酸钠含量测定方法改进

Improvement on the determination method of sodium alginate pharmaceutical excipient

孔璇 吴燕 胡盼盼
中国药品标准2024,Vol.25Issue(4) :405-408.DOI:10.19778/j.chp.2024.04.014

药用辅料海藻酸钠含量测定方法改进

Improvement on the determination method of sodium alginate pharmaceutical excipient

孔璇 1吴燕 1胡盼盼2
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作者信息

  • 1. 天津市药品检验研究院,天津 300070
  • 2. 丹尼斯克生物科技(上海)有限公司,上海 200335
  • 折叠

摘要

目的:对USP收载的药用辅料海藻酸钠含量测定方法进行改进,以适用于我国市场上样品的含量测定.方法:对应高、低黏度海藻酸钠样品,分别采用酸-水和酸-异丙醇沉淀法进行前处理,再进行酸碱中和容量分析,以测定海藻酸钠的含量.结果:对前处理条件进行探索优化后,酸-水沉淀法和酸-异丙醇沉淀法分别在0.5~1.5 g样品量范围内与消耗氢氧化钠滴定液的体积呈良好的线性关系(R2=1.0000,0.9999),平均回收率分别为104.2%、101.9%,RSD分别为0.3%、0.2%(n=6).结论:改进的方法专属性强、准确度高、精密度好,便捷、成本低,可用于药用辅料海藻酸钠的含量测定.

Abstract

Objective:To improve the determination method of sodium alginate pharmaceutical excipient in the USP for the analysis of sodium alginate content in the Chinese market.Methods:High and low viscosity sodium alginate samples were subject to acid-water and acid-isopropanol precipitation methods,respectively,followed by acid-base neutralization capacity analysis to calculate the sodium alginate content in the sample.Results:The line-ar relations were good between sample weight and the volume of sodium hydroxide titrant consumed in the range of 0.5-1.5g(R2=1.000 0,0.999 9).For two precipitation methods,the average recovery rates were 104.2%with RSD value of 0.3%(n=6)and 101.9%with RSD value of 0.2%(n=6),respectively.Conclusion:The improved method has good specificity,accuracy and precision,which is convenient and low cost that can be performed in the assay of sodium alginate pharmaceutical excipient.

关键词

药用辅料/海藻酸钠/酸-水沉淀法/酸-异丙醇沉淀法/容量法/含量测定

Key words

pharmaceutical excipient/sodium alginate/acid-water precipitation/acid-isopropanol precipitation/volumetric analysis/content assay

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出版年

2024
中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
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