The local irritation test of LBD-008 = LBD-008의 국소자극성에 관한 연구

Abstract

This study was performed to examine the local irritation of LBD-009. With the volume of 1mℓ at the concentration of 20㎍ /mℓ which is expected clinical dose in human, two groups of rabbit were injected subcutaneously on back amd intremuscularly in Vastys lateralis muscle once or 5 times for 5 days. And the other groups of rabbits were intravenously once with 1mℓ of saline or test material. For positive control material, 6% or 0.75% actic acid was used, and for negative saline. The results were as followed; 1. In all groups expect positive control, no clinical sign was shown in all rabbits. 2. In the groups of rabbits injected 5 times in muscle in muscle and subcutaneous tissue with LBD-008 or saline, There were the limited and slight histopathological changes in both site of test material and saline. From the results of these, we conclude that LBD-008 was not to be irritant on rabbit's muscle and subcutaneous tissue at the cincentration of 20㎍ /mℓ.