Method for the production of therapeutically administrable plasm

Drug – bio-affecting and body treating compositions – Fermentate of unknown chemical structure – Having a known elemental analysis

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A61K 3516

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046082549

ABSTRACT:
There is disclosed a method for the production of therapeutically administrable plasma derivatives filled in final containers, which are free of prekallikrein activator, hypotensively active constituents and other undesired pharmacologically active substances, of plasma or plasma crude fractions by stepwise enrichment of the plasma proteins, sterile filtration and optionally virus inactivation. In order to make available such plasma fractions that do not develop pharmacologically negative side effects when applied and are producible with an improved activity and yield, C.sub.1 -esterase inhibitor is added during the production process of the plasma derivative, yet prior to its filling into final containers.

REFERENCES:
van der Starre et al--New England J. of Med. (May 31, 1979) p. 1276.
U.S. Pharmacopeia--20th revision, Jul. 1, 1980, "Plasma Protein Fraction" monograph.
Chem. Abst. Gen. Subj. Index, 10th Coll. (1977-1981) p. 4992GS.
Alving, B. M. et al, "Hypotension Associated with Prekallikrein Activator (Hageman-Factor Fragments) in Plasma Protein Fraction." The New England Journal of Medicine, vol. 299, No. 2 (1978), pp. 66-70.
Snape, T. J., Griffin, D., Vallet, D. L. and Wesley, E. D., "The Assay of Prekallikrein Activator in Human Blood Products." Develop. Biol. Standard, vol. 44 (1979), pp. 115-120.
Schreiber, A. D., Kaplan, A. P. and Austen, K. F., "Inhibition by ClINH of Hageman Factor Fragment Activation of Coagulation, Fibrinolysis, and Kinin Generation." The Journal of Clinical Investigation, vol. 52 (1973), pp. 1402-1409.
Vogelaar, E. F., Brummelhuis, H. G. J. and Krijnen, H. W., "Contributions to the Optimal Use of Human Blood." Vox Sang., vol. 26 (1974), pp. 118-127.
Trautschold, I., "Assay Methods in the Kinin System." Handbook of Experimental Pharmacology, vol. 25 (1970), pp. 52-59.

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