ANBUTA PLUS – safety, toxicity, mutagenicity, and mitogenicity tests

UNIVERSIDADE FEDERAL DO PARANALABORATORIO DE PESQUISA EM CELULASINFLAMATORIAS E NEO PLASICAS

                                     S.C.B – Departmento De Biologia Celular
Centro Politecnico – CEP 81531-970
Curitiba – Parana
Tel. : (41) 3361-1770, 3361-1682 Fax : 3361-1568
E-mail : [email protected] & [email protected]

It was analyzed the toxicity of MODUL8 (ANBUTA PLUS) with K562 (immortalized from human myelogenous leukemia) by flow citometry. It was used the kit from BIOPharmigen, Annexin V-FITC Apoptosis Detection, and it was also used Propidium Iodide (PI) to evaluate cell viability and DNA content in cell cycle. PI is an intercalating DNA agent and a fluorescent molecule. All experiments were performed at least three times, and data, representative of three independent experiments, was performed in a double-bind manner with ANOVA and Tukey test.

Table with results about apoptosis and cell viability of k-562 cell line after modul8 treatment (*p<0,05)

Viable Necrosis Early apoptosis Late apoptosis
Control 85,705 11,00667 0,826667 2,456667
Hidro-alcoholic solution 85,22167 11,74167 1,126667 1,91
Modul8 87,46333 9,128333 1,281667 2,126667

The percentage of viable cells is about 85% and there is no significance between groups after treatment.

There is no difference between G1, S and G2 phases of cell cycle between treated and control cells.

Conclusion: The medication does not interfere in cell cycle, does not damage DNA molecule and does not induce apoptosis. Briefly, it is neither toxic, nor mitogenic, or mutagenic.