一般的な血清アルブミン（高分子）

一般的な血清アルブミン（高分子） 化学特性,用途語,生産方法

• 化学的特性

  The USP 32 describes albumin human as a sterile nonpyrogenic preparation of serum albumin obtained from healthy human donors. It is available as a solution containing 4, 5, 20, or 25 g of serum albumin in 100mL of solution, with not less than 96% of the total protein content as albumin. The solution contains no added antimicrobial preservative but may contain sodium acetyltryptophanate with or without sodium caprylate as a stablizing agent.
  The PhEur 6.0 similarly describes albumin solution as an aqueous solution of protein obtained from human plasma; see Section 13. It is available as a concentrated solution containing 150–250 g/L of total protein or as an isotonic solution containing 35–50 g/L of total protein. Not less than 95% of the total protein content is albumin. A suitable stabilizer against the effects of heat, such as sodium caprylate (sodium octanoate) or N-acetyltryptophan or a combination of these two at a suitable concentration, may be added, but no antimicrobial preservative is added.
  Aqueous albumin solutions are slightly viscous and range in color from almost colorless to amber depending upon the protein concentration. In the solid state, albumin appears as brownish amorphous lumps, scales, or powder.

• 調製方法

  Albumin human (USP 32) Albumin human is a sterile nonpyrogenic preparation of serum albumin that is obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The source material is tested for the absence of hepatitis B surface antigen. It is made by a process that yields a product safe for intravenous use.
  Human albumin solution (PhEur 6.0) Human albumin solution is an aqueous solution of protein obtained from plasma. Separation of the albumin is carried out under controlled conditions so that the final product contains not less than 95% albumin. Human albumin solution is prepared as a concentrated solution containing 150–250 g/L of total protein or as an isotonic solution containing 35–50 g/L of total protein. A suitable stabilizer against the effects of heat such as sodium caprylate (sodium octanoate) or N-acetyltryptophan or a combination of these two at a suitable concentration, may be added, but no antimicrobial preservative is added at any stage during preparation. The solution is passed through a bacteriaretentive filter and distributed aseptically into sterile containers, which are then closed so as to prevent contamination. The solution in its final container is heated to 60±1.08℃ and maintained at this temperature for not less than 10 hours. The containers are then incubated at 30–328℃ for not less than 14 days or at 20–258℃ for not less than 4 weeks and examined visually for evidence of microbial contamination.

• 応用例（製薬）

  Albumin is primarily used as an excipient in parenteral pharmaceutical formulations, where it is used as a stabilizing agent for formulations containing proteins and enzymes.Albumin has also been used to prepare microspheres and microcapsules for experimental drug-delivery systems.
  As a stabilizing agent, albumin has been employed in protein formulations at concentrations as low as 0.003%, although concentrations of 1–5% are commonly used. Albumin has also been used as a cosolvent for parenteral drugs, as a cryoprotectant during lyophilization, and to prevent adsorption of other proteins to surfaces.
  Therapeutically, albumin solutions have been used parenterally for plasma volume replacement and to treat severe acute albumin loss. However, the benefits of using albumin in such applications in critically ill patients has been questioned.

• 安全性

  Albumin occurs naturally in the body, comprising about 60% of all the plasma proteins. As an excipient, albumin is used primarily in parenteral formulations and is generally regarded as an essentially nontoxic and nonirritant material. Adverse reactions to albumin infusion rarely occur but include nausea, vomiting, increased salivation, chills, and febrile reactions. Urticaria and skin rash have been reported. Allergic reactions, including anaphylactic shock, can occur. Albumin infusions are contraindicated in patients with severe anemia or cardiac failure. Albumin solutions with aluminum content of less than 200 mg/L should be used in dialysis patients and premature infants.
  LD₅₀ (monkey, IV): >12.5 g/kg
  LD₅₀ (rat, IV): >12.5 g/kg

• 貯蔵

  Albumin is a protein and is therefore susceptible to chemical degradation and denaturation by exposure to extremes of pH, high salt concentrations, heat, enzymes, organic solvents, and other chemical agents.
  Albumin solutions should be protected from light and stored at a temperature of 2–258℃ or as indicated on the label.

• 規制状況(Regulatory Status)

  Included in the FDA Inactive Ingredients Database (oral, tablets, film-coatings; IV injections, IV infusions and subcutaneous injectables). Included in parenteral products licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

一般的な血清アルブミン（高分子） 生産企業

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