辅料的影响不好说清楚或者研究明白,通俗来讲就是处方好不好就是蛋白稳定不稳定或者是否形成新的杂质,也可以理解为相容性,但不会像化学那样看看是不是反应形成别的物质或者析出形成别的物质了。
总的大类辅料是证明很多年的,但是辅料的杂质情况会影响产品质量。
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这个文献里就降到辅料里某个杂质与胰岛素发生反应了,形成共价的一个东东。
In insulin products containing glycerol or mannitol, some (<1%) of desPheB1-N-oxaly-ValB2 insulin is formed at 5°C
after 24 months. Although this derivative has not previously been described in detail in the literature, it is a known derivative in human, beef, and pork insulin (27). The rate of formation of the derivative is correlated to the quality of the excipient both for human insulin and insulin aspart batches. Because the batches of excipient with high contents of reducing substances such as -hydroxy carbonyl compounds seem to enhance the formation of the derivative.
另外行业内都知道Tween 80的质量对蛋白稳定性影响很大。