V 약침의 마우스를 이용한 소핵시험

In Vivo Micronucleus Test of V-YAKCHIM in ICR Mice

Objectives : This study was designed to determine the potential of V-YAKCHIM to induce micronuclei in bone marrow cells of mice when dosed once to ICR mice by intramuscular. Methods : The dose range finding study was conducted at dose levels of 0.05, 0.1 and 0.2 mL/animal to determine the high dose level of the main study. As a result, there were no clinical signs and mortality at any dose level. Therefore, the high dose level of the main study was selected at 0.2 mL/animal. Two additional low dose levels(0.05 and 0.1 mL/animal) were produced by a geometric ratio of 2. Also, normal saline injection and mitomycin C were employed as the negative and positive control substances, respectively. In sampling time determining study, all mice was dosed with the high dose (0.2 mL/animal), which was selected in the dose range finding portion of the study. Bone marrow was harvested at each interval of 24, 48 and 72 hours post dosing. Bone marrow slides was prepared and evaluated. The number of micronuclei was not increased 24, 48 and 72 hours. Therefore, 24 hours was selected as the time to harvest bone marrow cells for the main study. Results : In the test substance groups, the incidence of micronucleated polychromatic erythrocyte (MNPCE) among polychromatic erythrocyte (PCE) was not significantly increased when compared to that of the negative control group. Also, the ratio of PCE among total erythrocyte of the test substance groups was not significantly different when compared to that of the negative control group. In the positive control group, the incidence of MNPCE among PCE of the positive control group was significantly increased when compared to that of the negative control group. The ratio of PCE among total erythrocyte of the positive control group was significantly decreased when compared to that of the negative control group. Conclusions : Based on these results, V-YAKCHIM did not have any potential to induce micronuclei formation in bone marrow cells of mice under the conditions of this study.