Stabilized albumin preparaions

Abstract

This invention provides albumin preparations with safety and without any risk of side effects, which are free from viruses or contaminating proteins and can be stably stored over a long time while showing neither changes in appearance nor decrease in content. <??>There are provided a stabilized albumin preparation produced by uniformly mixing a medium-chain fatty acid or a salt thereof and a sulfur-containing amino acid or a derivative thereof with an aqueous albumin solution (e.g., a buffer such as phosphate buffer which can be administered as pharmaceutical preparations, injection water, or a physiological saline) and dissolving them therein, and then processing the mixture solution into a formulation suitable for parenteral administration such as an intravenous fluid preparation or an injectable solution, and a stabilization method for an albumin preparation.

Description

technical field The present invention relates to an albumin preparation with extremely excellent stability. Further, in detail, it relates to albumin preparations such as fractionated human serum albumin, genetically recombinant human serum albumin, etc., which are excellent in stability and safety. Background technique Albumin preparations are drugs for improving the state of illness by supplementing acute hypoalbuminemia and chronic hypoalbuminemia that is difficult to manage. Specifically, it is widely used to improve the correction of circulating plasma volume during hemorrhagic and traumatic shock or various diseases such as edema, liver cirrhosis, and nephrotic syndrome, and is an indispensable medicine for modern medicine (Peter T.Jr., The Plasma Proteins, Academic Press, New York, 133-81(1975)., Rosenorer VM., Rothschild MA., Albumin Structure, Function and Uses, (1977)). Conventionally, human serum albumin preparations have been produced by fractionating blood c...

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Problems solved by technology

For low-temperature sterilization, N-acetyl tryptophan, sodium octanoate (Ballou GA., Boyer PD., Luck JM., Lum FG., J.Biol.Chem., 153, 589-605 (1944), Scatchard G, Strong LE., Hughes WL. Jr., AshWorth JN., Sparrow AH., J Clin. Invest., 24, 571-679 (1945), Boyer PD., Lum FG., Ballou GA ., Luch JM., Rice RG., J.Biol.Chem., 162, 181-198 (1946)), however, N-acetyl tryptophan has the problem of side effects such as brain diseases

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