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Interferon(IFN) is a kind of high biological activity,multi-purpose protein;it has anti-viral,anti-tumor and immunomodulatory in the clinic,and it is used in a very wide range.However,IFN is already used in the form of injection,because it is short in vivo half-life,and the medication cycle is long.it has brought enormous inconvenient to the patient,its clinical practice has also received certain limit.In response to these circumstances,to develop long-lasting IFN could solve the problem.At present,IFN and its product carry on a great deal of research at home and abroad.Roche’s "PEGASYS" is a pegylated IFN,it can be maintained one week after injection.The long-lasting interferon in this subject is human serum albumin(HSA) fused to N-end of the target protein,as a result of the impact of the nature of human serum albumin,the biological activity of the protein drugs is maintained and its in vivo half-life is increased as well.In the rHSA-IFNα2βfusion protein research,we explored the basics in the pharmacy under the guidance of the protein made of small volume injections of drugs.We studied key factors for the stability of the preparation including pH,stabilizer (including sugars,amino acids,surfactants,metal chelating agents,etc.),formulation, preparation process,etc.An optimized preparation was therefore obtained by the screening of the factors.This preparation could ensure the stability during preservation and transportation,and it was also convenient for clinical application and acceptable for human body as well.This subject also studied rHSA-IFNα2βfusion protein injection preparation process,identified the preparation of aseptic filling technology.This subject studied the stability of rHSA-IFNα2βfusion protein injection,due to rHSA-IFNα2βfusion protein was protein drug,the high temperature could easily lead to protein inactivation,we could only do accelerated test at 37℃and conventional test at 4℃.The stability experimental results showed that rHSA-IFNα2βfusion protein injection remained stable at low temperatures,light had no effect while hot had effect on it,and it suggested that it should pay attention to low temperature in the storage process.We applied the method of modern pharmacology to study its allergic,hemolytic and irritation,to provide a scientific experimental basis for the safety of clinical drug.The innovation of this study was development of long-lasting interferonα2βpreparations for the first time.Studies had shown that prescription and process design was reasonable, quality is stable and controllable.Allergy test,hemolysis test and blood vessels irritation test proved that subcutaneous administration of this preparation was in line with national requirements,and the delivery of clinical was safe and reliable.The success of product research and promotion of the use,will bring huge social and economic benefits.
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