Preparation of a novel formulaton of recombinant human interferon α-2b suppository and its studies on quality control and stability

Objective In order to provide a formulation of recombinant human interferon α-2b (rhIFNα-2b) suppository for clinical applications, a series experiments of its preparation, quality control and stability were carried out in this study. Methods Methods used for characterizations and stability were based on protocols published in China Pharmacopeia (Edition 2005). Results The appearance, melting time limit, microbial limit and biological activity for quality control were all to be in line with the standards published in China Pharmacopeia (Edition 2005). The stability study data showed that rhIFNα-2b suppository can be stored for 24 months at the temperature of 2–8 °C. Conclusion rhIFNα-2b suppository prepared above exhibit a high quality control and a very good stability.