重组人干扰素a-2b栓的质量研究和稳定性研究

目的本次试验研究的目的是将重组人干扰素α-2b制备成通过直肠局部给药达到全身作用的栓剂。方法应用脂肪酸甘油酯suppcioreBM为基质，以Triton X-100为促吸收剂，制备重组人干扰素α-2b栓。以稳定性为指标，考察重组人干扰素α-2b栓的处方。结果用此方法制备的重组人干扰素α-2b栓稳定性强，在2～8℃条件下可保存24个月。结论重组人干扰素α-2b栓的应用可增强患者的顺应性，在临床中应用性强。

Study on Quality Control and Stability of Recombinant Human Interferon a-2b Suppository

OBJECTIVE In order to provide a formulation of recombinant interferon α-2b suppository for clinical application, a systemic studies of its quality control and stabity was carried out. METHODS Methods used for quality control and stability studies were based on protocols published in China Pharmacopeia 2005. RESULTS For quality control, the apperance, melting time limit, microbal limit and biogical activity were all to be in line with the standards published in China Pharmacopeia 2005. The stability study data showed that recombinant interferon α-2b suppository can be stored for 24 months at the temperaure of 2-8℃. CONCLUSION Recombinant interferon α-2b suppository prepared above exhibit a high quality control and very good stabity.