蒙医纳米银针的生物学安全性评价研究  

Research on the Biological Safety Evaluation of Mongolian Medical Nanometre Silver Needle

作　　者：韩晓梅 陈英松 HAN Xiaomei;CHEN Yingsong(College of Mongolian Medicine and Pharmacy,Inner Mongolia Minzu University,Tongliao 028043,China;National and Local Joint Engineering Research Center for Mongolian Medicine Research and Development,Tongliao 028000,China)

机构地区：[1]内蒙古民族大学蒙医药学院,内蒙古通辽028043 [2]蒙药研发国家地方联合工程研究中心,内蒙古通辽028000

出　　处：《内蒙古民族大学学报(自然科学版)》2025年第2期31-37,共7页Journal of Inner Mongolia Minzu University:Natural Sciences Edition

基　　金：内蒙古自治区科技计划项目(2022YFSH0040)。

摘　　要：为了评价蒙医纳米银针的生物学安全性,按照GB 2024—2016《针灸针》的生物学评价要求,对蒙医纳米银针进行细胞毒性试验、皮肤刺激试验和皮肤致敏试验。将采用蒙医纳米银针同样工艺方法制备成的样品与人皮肤成纤维细胞(HSF细胞)共同培养24 h,采用CCK-8法进行细胞毒性检测结果显示,细胞活性指标与对照组(仅含培养基)细胞相比无显著差异;皮肤刺激试验结果显示,极性及非极性2种浸提液组豚鼠皮肤未发生红斑和水肿,反应记分为0分,反应类型均为极轻微;皮肤致敏试验结果显示,极性及非极性2种浸提液组豚鼠皮肤均未发生致敏反应,分级结果为0级。说明蒙医纳米银针无细胞毒性、无皮肤致敏反应和极轻微的皮肤刺激反应,生物学安全性评价结果均符合国家标准要求。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.

关 键 词：蒙医 针刺 纳米 生物学评价 

分 类 号：R29[医药卫生—民族医学]