| 孔璇,张玉婷,吴燕,刘菁.药用辅料海藻酸钠含量测定的方法研究[J].中国药品标准,2023,24(1): |
| 药用辅料海藻酸钠含量测定的方法研究 |
| Investigate determination method of sodium alginate in pharmaceutical excipients |
| 投稿时间：2022-05-07 修订日期：2023-01-31 |
| DOI： |
| 中文关键词: 药用辅料 海藻酸钠 容量法 分光光度法 含量测定 |
| 英文关键词: pharmaceutical excipient sodium alginate volumetric method spectrophotometer content assay |
| 基金项目:国家药典委员会药品标准提高课题(编号：2019Y045) |
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| 中文摘要: |
| 目的 建立容量法和分光光度法测定药用辅料海藻酸钠的含量。方法 容量法将海藻酸钠与浓盐酸发生脱羧反应生成二氧化碳，经过量的氢氧化钠吸收，然后用盐酸滴定剩余的氢氧化钠，从而推算样品中海藻酸钠的含量；分光光度法将海藻酸钠与四硼酸钠-硫酸作用后，可与间羟基联苯反应形成紫红色化合物，通过吸光度与海藻酸钠质量的线性关系，计算得海藻酸钠的含量。结果 对容量法前处理条件进行探索优化后，平均加标回收率为96.4%，RSD为1.9%（n=6）；分光光度法平均回收率为101.9%，RAD为0.45%（n=2），两方法的样品含量测定结果一致。结论 两种方法准确度高、精密度、耐用性好，均可用于药用辅料海藻酸钠的含量测定。 |
| 英文摘要: |
| Objective To establish volumetric method and spectrophotometer for assay of sodium alginate in pharmaceutical excipients. Methods Volumetric method was adopted, sodium alginate decarboxylates with hydrochloric acid to produce carbon dioxide, which is absorbed by excessive sodium hydroxide, and then titrates the remaining sodium hydroxide with hydrochloric acid to calculate the sodium alginate content in the sample; sodium alginate reacts with sodium tetraborate to form a violet red compound with 3-phenylphenol in spectrophotometer, and calculates the sodium alginate content through a linear relationship between absorbance and sodium alginate quality. Results The average recovery rates were 96.4% with RSD values of 1.9% (n＝6) and 101.9% with RAD values of 0.45% (n＝2) of the two methods, the results were consistent. Conclusion The two methods have good accuracy, precision and durability, which can be performed in assay of sodium alginate in pharmaceutical excipients. |
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