Objective: To assess the quality of human erythrocyte superoxide dismutase (SOD) injection reaching the official standard for its clinical uses.

Methods: Human erythrocyte SOD injection prepared by McCord-Fridovich's method without column chromatography but with some modifications was used in preclinical trials, to observe the general pharmacology and pharmacodynamics of the product.

Results: The quality of human erythrocyte SOD injection conformed to the official standard of a biological product, which was found to be non-toxic and did not have any effects on the central and autonomic nervous systems as well as cardiovascular and respiratory systems. The efficacy of anti-inflammation and promotion of immuno-regulation especially on carrageenan and adjuvant-induced polyarthritis were shown in animals.

Conclusion: Human erythrocyte SOD injection is appropriate for prophylactic and therapeutic uses in clinical trials.