VERFAHREN ZUR HERSTELLUNG EINER STABILEN THYMOSINFRAKTION 5 UND SO ERHALTENE THYMOSINFRAKTION 5.

摘要

RAN 4090/93 A solid stable endotoxin and pyrogen free form of thymosin fraction 5 preparation containing (a) a major amount of thymosin fraction and minor, effective amounts each of (b) a phenolic type antimicrobial agent, and (c) a buffering agent in an amount sufficient to provide a pH of 7-8 on reconstitution and method for preparing same which method comprises (a) ultrafiltering an aqueous solution of thymosin fraction 5 buffered with a volatile weakly basic buffer to a pH of 7 to 8 through a membrane having a molecular weight cut off of about 10,000, (b) adding a phenolic type antimicrobial agent to the permeate and a buffering agent in anmount sufficient to provide of pH of 7-8 on reconstitution and (c) lyophilizing the permeate.