α-干扰素是一抗病毒蛋白质,由人体白细胞在病毒感染时自然产生,在体外生产α-干扰素时,则以相似方式较大规模诱生细胞。由于其稳定性差,在分离、纯化和制备生产过程中均有可能降低其生物活性,为此,在设计和大量制备其注射剂型时首先需要考虑给药途径中的剂量体积、注射速度和辅料类型等等因素。由于干扰素的分析试验大多在水性体系中进行,故要求产品使用水溶性辅料。若采用非水溶性辅料,则在分析测定前需预先将干扰素小心抽提到水性体系中。为了确保产品在使用期内溶液的pH 值恒定,应加入适当的缓冲液。因α-干扰素是机体内自然产生的一种蛋白质,可选用pKa 在6～8的缓冲液,如磷酸盐缓冲液。所采用的缓冲液应可生物配伍、无毒,且不干扰试验方法。此外在注射剂型的处方设计中,常加有一些附加剂,如 Alpha-interferon is an antiviral protein that is naturally produced by human leukocytes when they are infected by the virus. When alpha interferon is produced in vitro, the cells are induced on a larger scale in a similar manner. Because of its poor stability, it is possible to reduce its bioactivity in the process of separation, purification and preparation. Therefore, when designing and mass-producing its injection dosage form, it is necessary to consider the dose volume, the injection speed and the type of the excipients And so on. Since the majority of interferon assays are conducted in aqueous systems, the product is required to use water-soluble excipients. If using water-insoluble excipients, the interferon should be carefully extracted into the aqueous system before analysis and determination. To ensure that the pH of the solution remains constant over the lifetime of the product, appropriate buffers should be added. Because α-interferon is a naturally occurring protein in the body, the choice of pKa in 6 to 8 buffer, such as phosphate buffer. The buffer used should be bio-compatible, non-toxic, and does not interfere with the test method. In addition to the formulation of injection formulations, often with some additives, such as