A method of obtaining a solution of albumin

 

The invention relates to the medical industry. Spend the plasma fractionation on a fractional tables with selection of raw sludge albumin. Dissolving it in pyrogen-free distilled water with subsequent brightening filtration and ultrafiltration installation Sartakon-2. Filling vials and pasteurization of the drug. The invention improves the quality of the product. 1 C.p. f-crystals, 1 Il.

The invention relates to the medical industry and can be used to obtain a solution of albumin used for intravenous hemodynamic actions and parenteral nutrition.

The main raw material for the production of albumin are different types of donor plasma prepared according to the following documents: 1. Instructions for the fractionation of blood cellular components and plasma, approved by the USSR Ministry of health 06-14/24 from 11.06.87,

2. Instructions for medical examination of donors of blood, plasma, blood cells, approved by the RF Ministry of health from 16.11.98,

3. The Ministry of health of the USSR for 155 from 12.04. 90, "On improvement of activity of the institutions of the blood service".

Albumin refers to polypeptides, the shape of the macromolecule is Sora reached by changing at different stages of fractionation of pH, alcohol concentration, temperature and ionic strength. In the process of fractionation of chemical reactions will not occur.

A method of obtaining solution of albumin, developed by research Institute of Hematology and blood transfusion MOH SSR (standard regulation for production of albumin 5, 10, and 20%), which was approved in 1987,

The method consists in the plasma fractionation on a fractional tables with selection of raw sludge albumin and dissolving it in pyrogen-free distilled water, centrifuged and clarifying filtration with subsequent filling for freezing and drying. After the stage of lyophilization dry albumin is dissolved, is subjected to sterilizing filtration, produce bottling in bottles and pasteurized.

The disadvantages of this method are the complexity of the process and the impossibility of obtaining a higher quality product. Qualitative indicators of albumin obtained by a known method, follow the target.

The invention solved the problem of improving product quality and reducing the complexity of the process.

To achieve the mentioned technical result in the proposed method, which includes stages of fractionation of the plasma on the ode with the subsequent brightening filtering, filling vials and pasteurization of the drug, the stage of freeze drying is replaced by ultrafiltration installation Sartakon-II (laundering molecules of ethanol and other low molecular weight impurities 5-fold volume of water).

This allows us to improve the quality of the obtained solution of albumin and reduce the complexity of the process.

The proposed method is illustrated by a drawing, which shows a diagram of the production of albumin (drawing). The diagram shows the fractional tables (1), refrigerated centrifuge (2), brightening filter (3), Sartakon (4), sterile filter (5), seaming machine (6), thermostat (7).

The method is as follows.

Fractionation of plasma proteins produced by the gradual separation of each fraction.

Stage 1.5 TA, TA 1.7, 1.8 TA, TA 1.9 held on the same hardware.

Plasma (stage 1.5), and then centrifugate stages TS 1.7 TS 1.8 loaded into the boiler fraction table (1). The conditions required for the selection and maturation of sediment to a specific fraction of proteins. Then the whole mixture is fed into the centrifuge and after centrifugation the precipitate is recycled, and centrifuged again supplied to the boiler (1).

Received centrifugal on stage TP 1.9 utilized, and wet the apparatus "Sartakon II (4).

The ready solution of albumin is supplied to the plant for sterile filtration (5) and filling the solution in the vials. Run caps are produced on the seaming machine (6). Thermostats (7) the finished product is pasteurized and temperature control. Example.

I. Allocation of fraction I.

The raw material was taken plasma, pre-tested for the absence of antibodies to human immunodeficiency virus (HIV), hepatitis C virus and the surface antigen of hepatitis C.

In four of the boiler, located in two fractional tables with most of the shirts (two in each), downloaded on 20 l plasma - a total of 80 l of plasma.

The plasma is cooled to +1oAnd added to it chilled in a small bath to -20oWith 96% ethyl alcohol, at the rate of 90 ml of alcohol per 1 l of plasma. By the end of the deposition temperature of the mixture drops to -3oC. after the addition of alcohol the mixture was stirred 2 h and then left for two hours. In these conditions in the sediment falls fraction 1 plasma proteins, containing mainly fibrinogen. The precipitate is separated on stakanchikov refrigerated centrifuge Sorvall RC 3C Plus at t = -3oC and 3000 rpm for 30 minutes the Precipitate is not used II. The allocation fraction II+III.

Centrifugal I the temperature centrifugate reaches -5 -6oWith buffer 1 pH brought to the 5.8 to 5.9. Then, at the rate of 150 ml/l of centrifugate I, is added 96% ethanol cooled to -20oWith a speed of 15 ml/min. the Precipitate Matures 12 o'clock the sludge Separation is carried out on the centrifuge Sorvall RC 3C Plus at a temperature of -6oWith and 3200 rpm for 30 minutes the Precipitate is not used.

III. The allocation fraction IV.

Centrifugal II is placed in the boiler fraction boiler and cooled to a temperature of -7oBack To him with the speed of 15 ml/min is added 96% ethanol, pre-cooled to a temperature of -20oWith a rate of 450 ml/l of centrifugate II. After adding the alcohol mixture is left to ripen the sediment at 12 hours the Precipitate is separated by centrifuge Sorvall RC 3C Plus at a temperature of -7oWith and 3500 rpm for 45 minutes the Precipitate is not used.

IV. The allocation fraction V (albumin).

Before selecting the fraction V, centrifugal III is subjected to clarifying filtration using pressure tank and filter with pores of 0.8 to+0.65m in the boiler fraction buffet at a temperature of -7oC. After filtration of the intake samples for determination of pH. Then, using buffer 2 pH is brought to 4.7 and 4.9. For completeness of precipitation of albumin mixture remains in the Fugue Sorvall RC 3C Plus at a temperature of -7oWith and 3700 rpm for 60 min. the Supernatant liquid is not used. The residue is weighed and stored at -20oWith no more than 30 days. Thus, there is an accumulation of sediment.

V. Processing of raw sludge albumin. For additional purification from the globulin precipitate albumin dissolved in pyrogen-free distilled water, pre-cooled to +5oSince, in the ratio of 1:3. The dissolution is effected in the boiler, placed in fractional table, with constant stirring at a temperature of +5oC for 2 hours While albumin is dissolved and volatile impurities precipitate. The sludge separation of volatile impurities is carried out using a clarifying filtration on filters with pores of 0.8 to+0.65m

VI. Ultrafiltration of a solution of albumin.

The release of albumin from alcohol is carried out on the device "Sartakon II in stainless steel tanks at a temperature of +4 +6oC. one volume of a solution of albumin is added to one volume of pyrogen-free distilled water and starts ultrafiltration at an input pressure of 2 bar, the output of 1.3-1.5 bar. In descending order solution is added to five volumes of pyrogen-free distilled water. By albumin and adjust the pH of the solution (pH should be 6.5 to 7.2).

VII. Getting the finished product.

Prepared 10% solution of albumin is transmitted to sterilizing filtration. Sterilizing filtration and bottling albumin vials is performed under sterile conditions in a laminar box with a filter with pores of 0.45+0,2m and pressure tank. Bottles youprivate rubber plugs and obkatyvalisj aluminum caps. The entire series of the preparation is heated in a thermostat at a temperature of 601oC for 10 h to inactivate the virus of infectious hepatitis (pasteurization). After pasteurization, the product is aged at a temperature of +37oWith in 2 weeks (stabilization of proteins), and then is subjected to all kinds of control, labeling and packaging.

There was obtained a solution of albumin with the following parameters (analytical passport attached).

The inventive method allows to obtain the solution of albumin with higher quality characteristics (increased albumin levels, reduced color content of the polymers, sodium ion and potassium ion). Greatly reduced the complexity of the process, i.e., reduced production space, reduced energy consumption, easier conditions trusia.

Claims

1. A method of obtaining a solution of albumin, which includes stages of fractionation of the plasma on a fractional tables with selection of raw sludge albumin and dissolving it in pyrogen-free distilled water followed by filtration, filling into vials and pasteurization of the drug, wherein the stage after clarifying filtration conduct ultrafiltration.

2. The method according to p. 1, wherein the ultrafiltration is carried out at the installation Sartakon-II.

 

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