Yomota C, Tagashira Y, Miyazaki T, Okada S
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 1997(115):140-3.
The content of A-21 desamido insulin (A-21 DI) and B-3 desamido insulin (B-3 DI) in human insulin preparations was measured by new RP-HPLC method using a neutral eluent (pH 6.5). Sometimes the content of B-3 DI in human insulin preparations was about two times larger than that of A-21 DI. In particular, in the case of neutral insulin injection, the content of B-3 DI has increased remarkably as the increase of total desamido content. The content of B-3 DI obtained by the new RP-HPLC method will open the new aspect of the impurity test for insulin preparations.
采用中性洗脱液（pH 6.5）的新型反相高效液相色谱法（RP-HPLC）测定了人胰岛素制剂中A-21脱酰胺胰岛素（A-21 DI）和B-3脱酰胺胰岛素（B-3 DI）的含量。有时人胰岛素制剂中B-3 DI的含量约为A-21 DI的两倍。特别是在中性胰岛素注射液的情况下，B-3 DI的含量随着总脱酰胺含量的增加而显著增加。通过新型RP-HPLC法获得的B-3 DI含量将为胰岛素制剂的杂质检测开辟新的方向。
