蒙医纳米银针的生物学安全性评价研究OA

In order to evaluate the biological safety of Mongolian medical nanometre silver needle,the cytotoxicity test,skin irritation test and skin sensitization test of Mongolian medical nanometre silver needle were conducted according to the biological evaluation requirements of the national standard GB 2024-2016 Acupuncture and Moxibustion Needle.The samples prepared by the same process of Mongolian medicine nanometre silver needles were co-cultured with human skin fibroblasts(HSF cells)for 24 h,and the cell toxicity test was performed by the CCK-8 method.The results showed that there was no significant difference in cell activity indicators compared with the control group(culture medium only).The results of skin irritation test showed that no erythema or edema occurred on the skin of animals in the two kinds of polar and non-polar extraction groups,the reaction score was 0,and the reaction types were very mild.The results of skin sensitization test showed that there was no sensitization reaction in the animal skin of the two kinds of polar and non-polar extraction solution groups,and the grading result was grade 0.The results indicated that Mongolian medical nanometre silver needle had no cytotoxicity,no skin sensitization and very slight skin irritation,and the biological safety evaluation results were in line with the national standard requirements.