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.
LD
50 (monkey, IV): >12.5 g/kg
LD
50 (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） 上流と下流の製品情報
原材料
準備製品