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

机译:新型重组人干扰素α-2b栓剂配方的制备及其质量控制和稳定性的研究

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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.
机译:目的为提供重组人干扰素α-2b(rhIFNα-2b)栓剂的临床应用,对其制备,质量控制和稳定性进行了一系列实验。方法用于表征和稳定性的方法是基于《中国药典》(2005版)中发布的规程。结果质量控制的外观,融化时限,微生物限度和生物学活性均符合《中国药典》(2005年版)发布的标准。稳定性研究数据表明,rhIFNα-2b栓剂可在2–8°C的温度下保存24个月。结论以上制备的rhIFNα-2b栓剂具有良好的质量控制和非常好的稳定性。

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