人血白蛋白---BP2005.doc

DEFINITION Human albumin solution is an aqueous solution of protein obtained from plasma that complies with the requirements of the monograph on Plasma for fractionation, human (0853). PRODUCTION Separation of the albumin is carried out under controlled conditions, particularly of pH, ionic strength and temperature so that in the final product not less than 95 per cent of the total protein is 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 stabiliser 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 bacteria-retentive 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 ± 1.0 °C and maintained at this temperature for not less than 10 h. The containers are then incubated at 30-32 °C for not less than 14 days or at 20-25 °C for not less than 4 weeks and examined visually for evidence of microbial contamination. CHARACTERS外观 A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. 澄清，微粘稠的液体，。 IDENTIFICATION鉴别 Examine by a suitable immunoelectrophoresis technique免疫电泳技术. Using antiserum抗血清 to normal human serum正常人血清对比, compare normal human serum and the preparation to be examined, both diluted to contain浓度 10 g/l of protein. The main component二者主要成分应该一致 of the preparation供试品 to be examined corresponds to the main component of normal human serum. The preparation may show the presence of small quantities of other plasma proteins血浆蛋白. TESTS 1 pH(2.2.3) 6.7 to 7.3. 与中国药典有出入 Dilute the preparation to be examined wi