혈청알부민요오드

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.

생산 방법Albumin 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.