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Objective In order to observe the effect of recombinant human granulocyte/macrophage colony-stimulating factor (rhGM-CSF) gel for external use on animal model of burn. Methods rhGM-CSF gel for external use was prepared, and its quality control and stability at different temperatures were investigated extensively based on methods describe in China Pharmacopeia (Edition 2005), including appearance, activity, pH, homogeneity and microbial limit. The rat model of burn was established with electric flatiron and treated with blank gel matrix, basic fibroblast growth factor (bFGF) spraying and rhGM-CSF gel for external use at high (15µg/cm) and low (7.5µg/cm2) doses, respectively. Evaluate the curative effect of rhGM-CSF gel for external use by observing the healing time, infection of burn surface and death rate of model rats. Results Formulations and preparation procedures for rhGM-CSF gel for external use was simple and easy to scale up. The stability results of rhGM-CSF gel for external use were 3 months at 37°C, 6 months at 25°C and 2 years at 4°C, respectively. The time for healing of burn surface of model rats treated with rhGM-CSF gel for external use at both high and low doses was significantly shorter than that treated with blank gel matrix. There was no infection and death in rats with burn. The time for hair growth after healing of burn surface of mice treated with rhGM-CSF gel for external use was significantly shorter than that with blank gel matrix. Conclusion The rhGM-CSF gel for external use showed a good quality control, a long-term stability and a curative effect on animal model of burn.

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.