注射用甲氧异腈中二氧硫脲的稳定性研究

The study on stability of formamidinesulfinic acid in methoxy isobutyl isonitrile for injection

采用间接碘量法测定二氧硫脲（ＦＳＡ）的含量；进行ＦＳＡ的加速稳定性试验，考察湿度、强光对ＦＳＡ的影响，并结合药盒放射化学纯度的测定，推测注射用甲氧异睛（ＭＩＢＩ）的贮存有效期，提出保存药盒的理想条件。测得方法回收率为９８．０％－１０２．４％，ＦＳＡ的降解反应为一级反应，活化能为８４．５３ｋＪ／ｍｏｌ，药盒有效期为１３．７个月。

In order to explore the optimal store condition and calculate the shelf life of methoxy isobutyl isonitrile (MIBI) for injection. The stability of formamidinesulfinic acid (FSA) in methoxy isobutyl isonitrile(MIBI) for injection was studied. FSA is determined by indirect iodometry analysis. The recovery was 98.0%-102.4%. Temperature and light are the major influence factors. Acceleration test showed that the degradation reaction was a first-order reaction. The activation energy E was 84.53kJ/mol. It was estimated that the shelf life of MIBI for injection kept in refrigerator might be longer than 13.7 months.