SU700132A1 - Method of obtaining dry preporation of immunoglobulin - Google Patents

Description

Isabreta does not belong to the vaccine drainage industry.

It is known to obtain a dry preparation of immunoglobulin by freeze drying in the presence of stabilizer 1.

However, the drug and immunoglobulin obtained by the H3iB © CTiHbiM method is poorly soluble and the deficiency of | 0 is stable.

The purpose of the invention is to increase the solubility and stability of the drug.

This goal is achieved by the fact that iBH: Cym Vavie is produced in the case of a sucrose-gelatin stabilizer with a final concentration of sucrose and gelatin in the target product of 0.75 and 0.5%, respectively.

Before drying normal I Mmunoglobulin, t-Stab | I1 is prepared with the following composition: 50 g of gelatin, 75 g of sucrose, up to 1 l of pyrogen-free DI | CT | ILYLO | BATH water at pH 7.3. The stabilizer is twice processed in autoclave at 120 ° C for 1 h to convert gelatin to gelatin and sterilize. Under storage conditions at 4 ° C, the stabilizer is suitable for use for 7-10 days.

Normal liquid human I1mmunoglobulin, sterile, atrogenic, harmless, containing not less than 10.5% of protein and its basic fraction not less than 97%,

reduced under sterile conditions with a stabilizer, in a 10: 1 ratio. To do this, take 900 ml F | Idkago im monoglobulin and 100 ml of the stabilizer. As a result, prepared for drying immunoglobulia contains 9.5% protein; 0.5% gelatose and 0.75 / o sucrose. It is poured under sterile conditions into vacuum vials of an HOU type (capacity b ml) 1.5 ml each.

Ampoules with dilution and | Mmunoglobulin are installed vertically in apiarato drying tapes: B and frozen at minus 50 ° C for 18 hours. Frozen preparation is transferred from t to a vacuum dryer, from which air is pumped out. With a residual pressure, not prvvyshayui1, I eat 100-150 mm Hg. Art., include heating, the temperature in the chamber should not exceed 30-35 ° C. Drying time 48-72 hours so that the residual moisture does not exceed 2%. After drying, the ampoule is sealed under a vacuum: cuumo, m and subjected to control. The dry preparation is a decorated tablet of white or slightly creamy color.

The proposed method for the preparation of a dry preparation of immunoglobulin makes it possible to obtain an instant preparation with a high specific activity, so that the KHiK titer of antiviral and anti-bacterial antibodies persists for two years or more. The preparation is harmless, since it is not ra: Spliced (fragmented) in the process of storage under the action of ferments; me, 1Ime1CI: Xc in the VIN, K01M IIM | mu1H011-1b-5 line. Immunoglobulin Vysokotelyustabilen dry (withstands the dissolution of pralrev at 57 ° C for 4 hours). Prelarat does not have a residual alcohol, which also excludes protein denaturation, etc., and is stored ii.iO Formula and 3 obrete ni Method for the preparation of a dry preparation of immunoglobulin by freeze drying, in the presence of a stabilizer, which is different In order to increase the stability of the preparation and increase the stability of the preparation, drying is carried out in the morning, and sucrose 0 gelatinizes a stabilizer with {a single concentration of sucrose and gelatin in the target product 0.75 - and 0.5% respectively. Sources of information taken into account in the examination 1. Issues of bacteriology, virology and immunology. Proceedings of the conference of young scientists | Kov MosNIIVS, vol. 14, 1959.