氨基酸输液中抗氧剂亚硫酸盐的控制与测定
氨基酸输液,,氨基酸输液；抗氧剂；亚硫酸氢钠；含量测定；氧化还原-分光光度法；安全性,1仪器、试剂与试药,2实验方法与结果,3结果与讨论,参考文献
摘 要 验证了氨基酸中抗氧剂亚硫酸盐的含量测定方法。在保证质量稳定的前提下，最大限度地控制抗氧剂亚硫酸氢钠的用量，对提高使用氨基酸输液的安全性具有积极的临床意义。实验结果表明：用氧化还原-分光光度法测定氨基酸输液中的亚硫酸氢钠的含量是可行的，平均回收率为98.90%。RSD为0.17%(n=6)，供试液中NaHSO3含量在0～63.4 μg/mL时，线性方程：y=1.864+6.147x,r=0.9985。关键词 氨基酸输液；抗氧剂；亚硫酸氢钠；含量测定；氧化还原-分光光度法；安全性
Control and determination of antioxidant In amino acid injection
HU Rongrong
(Guangzhou Qiaoguang Pharmaceutical Factory,Guangzhou,Guangdong 510140)
Abstract A method for the determination of antioxidant sodium hydrogen sulfite in amino acid injection was verified. The result showed that the oxidationreduction and spectrophotometry method was practicable. The average recovery was 98.90%.RSD was 0.17%(n=6). The linear range of sodium hydrogen sulfite(NaHSO3)was0～63.4 μg/mL,the linear equation was y=1.864+6.147x with r=0.9985.
Key words amino acid injection;antioxidant;sodium hydrogen sulfite;assay,oxidationreduction and spectrophotometry;safety
我国目前大部分的氨基酸输液生产厂基于工艺上的原因及设备条件的限制 ......
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