Preparation and Clinical Evaluation of Streptokinase Jelly for Intractable Decubitus and Skin Ulcer

For the purpose of treating intractable decubitus and skin ulcer, streptokinase (SK) jellies containing different types of thickening agents were prepared. Adhesion to the affected sites, the spreading ability of the jelly preparation, and the properties of the SK in the jelly, which are all considered to greatly affect the clinical efficacy, were examined pharmaceutically using the viscosity, spreading area, and release and stability of SK as indexes. Regarding the viscosity and spreading area which are thought to affect both adhesion and spreading greatly, when sodium polyacrylate (PANa) was used as a thickener, higher viscosity and smaller spreading area were obtained in comparison with carboxymethylcellulose sodium (CMCNa) and sodium alginate (Alg Na). In addition, the viscosity and the spreading area obtained with PANa were also slightly more affected by temperature than with CMCNa and AlgNa. Regarding the release of SK from the jelly preparations, with PANa no initial burst was observed and SK was continuously released at a constant rate in contrast with CMCNa and AlgNa, thus obviously showing the superiority of PANa in the retention of SK. Although no loss of the potency of SK was found in the jellies containing PANa, CMCNa or AlgNa at 5°C, for 30 days, the remaining potency was greatly decreased to 49-62% at 25°C after 30 days and 33-42% at 37°C after 30 days. These results showed that the adhesion, spreading ability and SK-release were greatly different among the tested thickening agents, and the properties of PANa were found to be clearly superior to those of the other agents. According to these results, SK jelly containing 2% PANa was used for the treatment of intractable decubitus and skin ulcer, and an excellent therapeutic effect was obtained.