Study On The Quality And Stability Of Iron-protein Succinylate

Iron-protein succinylate is an iron supplement which was invented in 1980s by the ITALFARMACO in Italy. It first appeared in Italy in 1987, then spreaded to more than 20 countries, including Spain, Portugal, Greece, Argentina, South Korea and so on. After the successful development of iron-protein succinylate and oral solution in our group, this article focused on the study on the quality and stability of iron-protein succinylate,.Firstly, the synthesis of iron-protein succinylate was birdfly introduced. Casein was chosen as the raw material and was succinylated to increase binding positon for iron ions,then iron-protein succinylate was prepared through complexing with iron ions. Next, the quality of iron-protein succinylate was studied. Using HPLC and UV-VIS, the content of succinic acid and free iron in our product was checked. Both the trace metals and iron were determinated by AAS. We also studied the stability of our product, and found that it is quite stable in normal condition.After screening the prescription of iron-protein succinylate oral solution, we studied the quality of the oral solution, such as the normal physical and chemical properties. HPLC method was estabilished for the determination of methyl para-hydroxybenzoate and the propyl para-hydroxybenzoate.After testing the preparation's stability, it was confirmed that the prescription and the preparing craft are good. As the oral solution is unstable under high temperature, it should be stored in a cool place.Those results will be useful and essential for the application of new medicine.