Preparation method of human serum albumin

Abstract

The invention relates to a method for separating and extracting protein in a biological product technology, in particular to a preparation method of human serum albumin. The preparation method comprises the following steps of: separating components I, II and III, separating a component IV, separating a component V, and refining and purifying; and performing ultrafiltration, pasteurization and sterilized filling, examining a finished product, and packaging the qualified product by pasting a label, boxing and the like. According to the preparation method disclosed by the invention, a relatively-moderate pressure-filtration separation method is adopted, so that the molecular structure of the protein is not influenced, and the human serum albumin with high quality is ensured to be prepared; moreover, the product yield is greatly increased, the human serum albumin which is low in aluminum ion content or even does not contain aluminum ions can be provided for clinical application, and the quality of the human serum albumin is improved.

Description

technical field [0001] The invention relates to a protein separation and extraction method in biological product technology, in particular to a preparation method of human serum albumin. Background technique [0002] Human plasma albumin (HPA) is a single-chain non-glycoprotein composed of 585 amino acids, with a molecular weight of 66KD. It is the most abundant protein in plasma. The main physiological function of HPA in the human body is to maintain blood osmotic pressure and carry blood A variety of ligands (including fatty acids, amino acids, steroids, metal ions and drugs) have physiological functions such as exchange with tissues, and are mainly used clinically for surgical blood transfusion and rehydration of critically ill patients, and for the treatment of traumatic shock, fever, edema, and hypoalbuminemia It is an important clinical drug, and it is also the protein drug with the largest output and largest dosage so far. At present, the clinical use of HPA is huge....

AI Technical Summary

Problems solved by technology

[0003] In the prior art, low-temperature ethanol technology is often used to separate plasma proteins, and centrifugation is often used to separate components. It has the following disadvantages: one is the influence of centrifugal shear force on protein, and the centrifugal separation speed is generally above 14,000 revolutions per minute. , the damage caused by ultra-high-speed shear force to protein precipitated particles may cause changes in the three-dimensional structure of the protein; the second is to use ultra-high-speed centrifugation for centrifugation, generally reaching above 14,000 rpm, and the heat produced by the machine needs to be close to -30 °C. Provide a cold environment around the drum of the centrifuge to reduce the heat generated by the ultra-high-speed rotation of the drum and prevent protein denaturation due to heat

On the other hand, the main components of the depth filter plate used for pressure filtration are cellulose fiber, diatomaceous earth, perlite, etc., and aluminum ions are also released into the product; and there is also a large volume of ultrafiltration dialysis water for injection. Defect: In order to remove the aluminum ions introduced in the production process, in the ultrafiltration process of the production process, at least 10 times the water for injection of the first concentrated solution needs to be repeatedly dialyzed, so that it is possible to make the aluminum ions in the product less than 200 micrograms per liter, And even if the dialysis multiple is increased, the aluminum ion will always be greater than 100 μg / L

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