RU2308279C1 - Method for preparation of raw materials for production of medicines from blood - Google Patents

Abstract

FIELD: medicine, veterinary, in particular drug production.

SUBSTANCE: disclosed is method for production of hemoglobin-containing agent from erythrocytes wherein slurry of donor erythrocytes is frozen at temperature from -30°C to -60°C and stored at temperature not high than -18°C.

EFFECT: hemoglobin and other protein molecules stability, blockage of oxidative processes.

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Description

The technical field to which the invention relates is the production of medicines, medicine, veterinary medicine.

The level of technology.

Various drugs are obtained from the blood: albumin, immunoglobulins, coagulation factors, aminokrovin, infusamine, hemoglobin-based preparations.

Whole blood (aminokrovin, infusamine) or its components: red blood cells (aminokrovin, infusamine) or blood plasma (albumin and other blood plasma proteins) are used as raw materials for these drugs.

The blood prepared on preservative solutions undergoes significant changes during storage. It increases the content of sodium, potassium, ammonia, phosphates and glucose, the acid-base balance is disturbed, the affinity of hemoglobin for oxygen increases, the morphofunctional properties of red blood cells change and their hemolysis partially occurs, microaggregates from cellular elements appear, etc. Blood components are obtained by sharing the whole blood by centrifugation on cells and plasma [Instructions for the use of blood components (approved by order of the Ministry of Health of Russia of November 25, 2002 No. 363)].

Blood components (erythrocyte mass, plasma) can be used for further fractionation in liquid form, however, the state of labile protein molecules may be impaired [Guide to Transfusion Medicine / Ed. E.P.Svedentsova. - Kirov, 1999. - 716 p.].

A prototype is a method for producing freshly frozen plasma, a raw material for the production of concentrates of blood coagulation factors. Plasma is released from whole blood collected using a plastic container with additional containers by hard centrifugation, preferably during the first 6 hours and no later than 18 hours after donation; freezing should be carried out in a system that allows complete freezing to temperatures below -30 ° C for 1 hour. Thus obtained freshly frozen plasma contains stable coagulation factors, albumin and immunoglobulins in the amount in which they are contained in blood plasma. It contains at least 70% of the initial level of factor VIIIc and at least the same number of other labile coagulation factors and natural inhibitors [Technical Manual of the American Association of Blood Banks / Per. from English - Milan: European School of Transfusion Medicine, 2000. - 1035 p.].

Signs of an analogue coincide with the essential features of the claimed invention — freezing is used to ensure the preservation of protein molecules.

However, dissolved labile proteins remain in the plasma, while the task of maintaining the structural and functional integrity of hemoglobin is not solved.

Modified hemoglobin-based preparations are obtained from a suspension of washed red blood cells. However, in the preparation of washed red blood cells, sterility is impaired and in liquid form they can be stored for no more than a day.

Disclosure of the invention.

Information disclosing the essence of the invention.

SUMMARY OF THE INVENTION

To obtain a sufficient amount of stable hemoglobin, the suspension of red blood cells after receiving is frozen and stored at a negative temperature. The technical result is expressed in the achievement of: stability of protein molecules; lack of microbial growth; blocking oxidative processes; transportation options; opportunities for long-term storage; the possibility of accumulating stocks of raw materials for processing.

The claimed invention is directed to solving the problem of the production of blood products based on hemoglobin. The invention provides for the production of large quantities of stable raw materials for subsequent processing, without microbial contamination, with the possibility of long-term storage and transportation of raw materials.

To prepare raw materials for the production of medicines from the blood, the following actions are performed.

From a donor examined in the prescribed manner, whole blood or a suspension of red blood cells is obtained using a hemoconserving solution. The storage of blood in a liquid state is carried out at a temperature of from +2 to + 6 ° C. Shelf life depends on the type of anticoagulant / preservative solution. For CPDA-1, the shelf life is 35 days.

After centrifugation and maximum removal of the plasma and the leukotrombolayer, the red blood cells are treated by the sequential addition of a cold (+ 4 ° C) isotonic solution and (preferably by refrigerator) centrifugation.

Quality criteria for washed red blood cells: hematocrit - from 0.65 to 0.75; hemoglobin - at least 40 g / dose; hemolysis at the end of storage - not more than 0.8% of red blood cells; the amount of protein in the final supernatant is not more than 0.5 g / dose.

The washed red blood cells are stored at a temperature of +2 to + 6 ° C until freezing. Storage time after washing before freezing: no more than 24 hours if washing and storage was carried out at + 4 ° С and no more than 6 hours if washing and storage was carried out at room temperature.

Freezing is carried out at a temperature of from -40 to -60 ° C. Storage of the frozen product is carried out at a temperature not exceeding -18 ° C.

The implementation of the invention.

An example embodiment of the invention: A blood donor is examined in the manner determined by order of the Ministry of Health of Russia dated September 14, 2001 N 364 "On approval of the medical examination of a blood donor and its components." Carry out a blood preparation in a volume of 450 ml in a plastic container with a preservative solution CPDA-1. The blood container is centrifuged in a refrigerator centrifuge with a separation factor of 5000 g for 7 minutes. Plasma and the platelet layer are transferred to satellite containers. To the remaining erythrocyte mass add 250 ml of chilled (+ 4 ° C) isotonic solution and centrifuged in a refrigerator centrifuge with a separation factor of 4000 g for 7 minutes. The procedure for adding saline and centrifugation is repeated twice. Remove from the container 100 ml of the supernatant. The container is frozen in a quick-freezer to a temperature of -30 ° C. Storage of the container is carried out at a temperature not exceeding -18 ° C. If necessary, transportation in a transport container maintain the storage temperature. At all stages of the invention, medical devices registered for medical use in the Russian Federation are used.

Claims (1)

A method of preparing a hemoglobin-containing agent from red blood cells, characterized in that a suspension of donor red blood cells is frozen at a temperature of minus 30 ° C to minus 60 ° C and stored at a temperature not exceeding minus 18 ° C.