| 简介 |
PROBLEM TO BE SOLVED : To provide a re-formulation of an α-type interferon solution product which maintains, for an extended storage period, high chemical stability, high physical stability, and a high biological activity of an α-type interferon in an aqueous solution formulation, and is used for preparing a solution formulation which does not contain a human-blood-derived product such as HSA (human serum albumin).
SOLUTION : The formulation is a stable aqueous formulation having a high biological α-type interferon activity, does not contain a human-blood-derived product, and contains the followings : (a) an α-type interferon of 0.1×106-100×106 IU/mL; (b) a buffer to maintain the pH in the range of 4.5-7.1; (c) a chelating agent in an effective quantity; (d) a sorbitan mono-9-octadecenoate poly(oxy-1, 2-ethanediyl) derivative in a quantity sufficient to stabilize an α-type interferon against the loss of the α-type interferon; (e) a tonicity agent in an effective quantity; (f) an antimicrobial preservative in an effective quantity; and (g) the water for injection in a quantity sufficient for preparing a solution containing the ingredients listed above.
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