The Stability and the Stabilization of Testicular Hyaluronidase

Abstract

The stability of hyaluronidase in bulk, in aqueous soln. and in sterile vials was studied at 10[degree]C, at room temp., and under conditions of accelerated aging at 60[degree]C. The influence of human serum, gelatin and polypeptide on the stability of hyaluronidase was investigated. The activity of the enzyme was measured tur-bidimetrically and the results expressed in turbidity reducing units (TRU) per mg. It was found that bulk hyaluronidase assaying 25 and 150 TRU/mg. was stable at both 10[degree]C and at room temp. for more than 1 year. Enzyme assaying 500 TRU/mg. was stable for 2 months at 10[degree]C but at room temp. it was much less stable. All bulk prepns. lost activity rapidly at 60[degree]C. Sterile hyaluronidase in concentrated aqueous solns. was stable for several months at 10[degree]C while dilute solns. were stabilized by the addition of 2 mg./ml. of polypeptide. The addition of polypeptide not only prevented losses during freeze-drying of small amts. of hyaluronidase in vials, but also greatly extended the half-life of the enzyme at 60[degree]C. Bacteriostatic agents such as zephiran and phenylmercuric nitrate were used in the production of hyaluronidase, without decreasing the activity of the enzyme.