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).
betweenand 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 stabilir against the effects of heat, such as sodium caprylate (sodium octanoate) or N-acetyltryptophan or a combination of the two, at a suitable concentration,
may be added but no antimicrobial prervative is added at any stage during preparation. The solution is pasd through a bacteria-retentive filter and distributed aptically into sterile containers which are then clod 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
fdaf A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. 澄清，微粘稠的液体，。
IDENTIFICATION鉴别
看牙医英文 Examine by a suitable immunoelectrophoresis technique免疫电泳技术. Using antirum抗血清 to normal human rum正常人血清对比, compare normal human rum and the preparation to be examined, both diluted to contain浓度go dutch 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 rum. The preparation may show the prence of small quantities of other plasma proteins血浆蛋白.
lockedTESTS
1 牛奶美容护肤小窍门pH(2.2.3)
6.7 to 7.3. 与中国药典有出入
Dilute the preparation to be examined with a 9 g/l solution of sodium chloride R to obtain a solution containing 10 g/l of protein.
2 Total protein
Dilute the preparation to be examined with a 9 g/l solution of sodium chloride R to obtain a solution containing about 15 mg of protein in 2 ml. To 2.0 ml of this solution in a round-bottomed centrifuge tube add 2 ml of a 75 g/l solution of sodium molybdate R and 2 ml of a mixture of 1 volume of nitrogen-free sulphuric acid R and 30 volumes of water R. Shake, centrifuge for 5 min, decant the supernatant liquid and allow the inverted tube to drain on filter paper. Determine the nitrogen in the residue by the method of sulphuric acid digestion (2.5.9) and calculate the quantity of protein by multiplying by 6.25. The preparation contains not less than 95 per cent and not more than 105 per cent of the quantity of protein stated on the label.
3 Protein composition八年级上册英语书 蛋白成分
Zone electrophoresis(2.2.31).区带电泳 auts
U strips of suitable cellulo acetate gel as the supporting medium and barbital buffer solution pH 8.6 R1gpa是什么单位 as the electrolyte solution.
Test solution Dilute the preparation to be examined with a 9 g/l solution of sodium chloride R to a protein concentration of 20 g/l.
Reference solution Dilute 英雄英文human albumin for electrophoresis BRP with a 9 g/l solution of sodium chloride R to a protein concentration of 20 g/l.
To a strip apply 2.5 µl of the test solution as a 10 mm band or apply 0.25 µl per millimetre if a narrower strip is ud. To another strip, apply in the same manner the same volume of the reference solution. Apply a suitable electric field such that the most rapid band migrates at least 30 mm. Treat the strips with amido black 10B solution R for 5 min. Decolori with a mixture of 10 volumes of glacial acetic acid R and 90 volumes of methanol R until the background is just free of colour. Develop the transparency of the strips with a mixture of 19 volumes of glacial acetic acid R and 81 volumes of methanol R. Measure the absorbance of the bands at 600 nm in an instrument having a linear respon over the range of measurement. Calculate the result as the mean of 3 measurements of each strip. In the electropherogram obtained with the test solution, not more than 5 per cent of the protein has a mobility different from that of the principal band.
The test is not valid unless, in the electropherogram obtained with the reference preparation, the proportion of protein in the principal band is within the limits stated in the leaflet accompanying the reference preparation.
