Resumo

CADIZ LAHENS, Armando et al. Pasteurización de soluciones de inmunoglobulinas de uso intravenoso: 2. El ph ácido como elemento estabilizante. Rev Cubana Farm [online]. 1999, vol.33, n.3, pp. 155-160. ISSN 1561-2988.

A stabilizer-free intravenous immunoglobulin solution (intacglobin®, Cuba) was pasteurized at low ionic force and acid pH. the content of polymers was determined by gel chromatography. The best result was obtained at pH 3.5 with 3.8 % of polymers and 72.7 % of monomers. The stability of immunoglobulin G (IgG), treated at pH from 3.0 to 7.0, was evaluated by spectrophotometry. The antigen-antibody activity was measured by a double antigen ELISA Sandwich. It was observed a reduction of the antibody titre at the most acid pH. It was proved that the low ionic force and the acid pH are two necessary conditions to attain a low polymer level during the pasteurization of IgG solution. Requirements were found for the process to go on without adding stabilizers under better conditions than the ones reported by other authors.

Palavras-chave : HEAT; INMUNOGLOBULINS; INTRAVENOUS [isolation & purification]; STERILIZATION [methods].

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