Process for preparing rabies human immune globulin

Abstract

The invention discloses a process for preparing rabies human immune globulin. According to the process, immune globulin is extracted and separated by using a low-temperature ethanol filter press technique, a chromatography method, an ultrafiltration method, a nano filtering method, a secondary ultrafiltration method and a washing, baking and filling linked sub-packaging process technique. The process is characterized in that a one-step ion exchange chromatography method is adopted as the chromatography method, the component III supernate is firstly refined before chromatography, then the premasters of the refined component III supernate are adjusted so that the protein concentration of the refined component III supernate is 3-6%, the pH value of the refined component III supernate is 6.4-6.6, and the conductivity is 0.18-0.22s / m when the temperature is 19 DEG C, after the adjustment, column chromatography purification is performed by using an ion exchange column, DEAESepharoseFF packing is adopted in chromatography, and the pH value is adjusted to be 3.8-4.0 after chromatography is completed. Compared with a conventional process, the process has the advantages that the yield is increased by 19.2-25%, small dosage is needed, and the use of human immune globulin is reduced, so that the scarce plasma resource is saved.

Description

technical field [0001] The invention relates to a preparation process of rabies patient immunoglobulin, which belongs to the field of biopharmaceuticals. Background technique [0002] Rabies is an elastic virus whose pathogen is ribonucleic acid. According to the statistics of the World Health Organization, more than two-thirds of the countries and regions in the country have rabies epidemics. my country and Southeast Asia are in the world's high incidence of rabies, and its cases account for more than 70% of the world. However, once the onset of rabies, there is currently no cure, and the mortality rate is almost 100%. If a sufficient amount of rabies patient's immunoglobulin can be provided in time, so that the antibody in the patient's serum can reach above 0.5IU / ml, the patient can be effectively protected. Therefore, it is very necessary for the preparation of rabies patient immunoglobulin, the special drug for treating rabies, and as far as the production technology of...

AI Technical Summary

Problems solved by technology

Therefore, it is very necessary for the preparation of rabies patient immunoglobulin, the special drug for treating rabies, and as far as the production technology of anti-rabies patient immunoglobulin is concerned, the products on the domestic market mostly adopt a single low-temperature ethanol separation process, and the separation steps Many, the yield of immunoglobulin is low, leading to the shortage of domestic rabies immunoglobulin

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