새로운 괴립구 콜로니 자극인자 ( rhG-CSF ) DA-3030 의 국소자극성에 관한 연구 = Studies on Local Irritation of DA-3030 , a new granulocyte colony stimulating factor

다국어 초록 (Multilingual Abstract)

As a series of safety studies of DA-3030, a new rhG-CSF, its local irritancy was examined in the rabbits after the following treatment; application into the conjunctival sac of the eye(singie), subcutaneous injection(single), intramuscular injection(single), and intravenous injection(8-day repeated). In addition, paravenous irritation of DA-3030 was investigated in mice. The results obtained were as follows. 1. In the result of ocular irritation test, 0.03% solution of DA-3030 could be considered as a non-irritating material. 2. The local irritation of DA-3030 by an injection of 0.5 ml of its solution subcutaneously or intramuscularly was negligible and not so much different from that of saline. 3. In the vascular irritancy test, macro- and microscopic observations revealed that the irritating activity of DA-3030 in blood vessels was not different from that of saline when they were injected once a day into vein retroauricularis of rabbits for 8 days. 4. The paravenous administration of DA-3030 did not induce any abnormal changes at injection sites except mild swelling in 1 mouse at 3 hours after injection which was thought to be due to slow absorption. The above-mentioned results suggest that DA-3030 has no irritating activity when injected through intravenous or subcutaneous route for clinical practice as 0.03% solution.