TA 약침의 안전성 평가

Safety Study of TA Pharmacopuncture: In Vitro Chromosome Aberration Test using Mammalian Cultured Cells

Objectives : This study was designed to evaluated the potential of TA pharmacopuncture on chromosomal aberrations in Chinese Hamster Lung (CHL/IU) cells. Methods : In order to determine the high dose level of the main study, a dose range finding study was conducted. The high dose was selected at 10.0% of undiluted TA pharmacopuncture and it was sequentially diluted to produce lower dose levels of 5.00, 2.50, 1.25, 0.625 and 0.313% by applying a geometric ratio of 2. The treatment volume was 0.3 mL. As a result, the cytotoxicity and precipitation of the test substance were not evident at any dose level in the short time treatments without and with metabolic activation and the continuous treatment without metabolic activation. Therefore, the dose levels of the main study were selected as 10.0, 5.0, and 2.5%. The treatment volume was 1.3 mL. Also, the negative and positive control groups were set. Results : In main study, the frequency of cells with chromosome aberrations was less than 5% in the short time treatments without and with metabolic activation and the continuous treatment without metabolic activation. Also, there was not statistically significantly different when compared to the negative control group. In the positive control group, the frequency of cells with structural chromosomal aberrations was more than 10% and statistically significantly increased compared to the negative control group. Conclusions : In conclusion, TA pharmacopuncture did not show any indication of potential to induce chromosome aberrations under the conditions of this study.