【 文献重点摘要 】

This study was conducted according to the method presented in the Republic of Korea Pharmacopoeia 11th Revision, aseptic test method to evaluate the suitability of sterilization for a sterile needle (4 Pin Multi-needle). In this study, four tests were conducted: sterility test, cytotoxicity test, acute toxicity test, skin sensitization test. First, in the aseptic test, the microorganism was not proliferated in the aseptic test of the medium. As a result of the performance test of the medium, it was confirmed that the microorganism developed within 3 days and the fungus was evident within 5 days. Based on this, it was confirmed that the medium was suitable, and as a result of the aseptic test, the development of microorganisms was not observed during the total culture period. Based on these results, tests were conducted which were confirmed to be suitable for aseptic testing because the development of bacteria on the provided samples was not recognized. For cytotoxicity tests ISO10993-5; 2009 (Biological Evaluation of Medical Devices, Part 5: Test for in vitro Cytotoxicity). As a result, the MEM eluate of the test substance caused very slight cytotoxicity to the fibroblasts of the mouse and was judged to be Grade 1 (Slightly cytotoxic) according to the judgment standard of ISO 10993-5. On the other hand, solvent control, negative control and positive control showed the expected results on the test. Acute Toxicity Test Results: It was judged that there was no systemic toxicity change when ICR mice were treated with 50 mL/kg B.W. of the eluate of sterile injectable needle for 72 hours. Skin sensitization test result: The Hartley guinea pig was evaluated as a substance which is evaluated as a substance which does not induce any skin reaction when skin sensitization is applied to the dissected material of the sterile injectable needle and is weak in skin sensitivity. Based on the above tests, we will study the stability and efficacy of more reliable medical devices based on the verification and performance of medical devices.

Keywords

Meso-therapy, multi-Needle, medical device, safety evaluation

本研究参照韩国药典第11版无菌试验法评价无菌针头(4针多针)灭菌的适宜性。本研究进行了四项试验：无菌试验、细胞毒性试验、急性毒性试验、皮肤致敏试验。首先，在无菌试验中，微生物在培养基的无菌试验中没有增殖。通过对培养基的性能测试，确认微生物在3d内生长，真菌在5d内明显生长。在此基础上，确定了该培养基是合适的，并通过无菌试验，在整个培养过程中没有观察到微生物的生长发育。根据这些结果，进行的测试被证实适合进行无菌测试，因为所提供的样品上没有发现细菌的生长。细胞毒性试验ISO10993-5；2009(医疗器械的生物学评价，第5部分：体外细胞毒性试验)。结果表明，受试物的MEM洗脱液对小鼠成纤维细胞的细胞毒性很小，按国际标准化组织10993-5标准判定为1级(轻度细胞毒性)。溶剂对照、阴性对照和阳性对照均取得了预期的试验结果。急性毒性试验结果：无菌注射针洗脱液50mL/kg体重处理ICR小鼠72h，判断无全身毒性变化。皮肤致敏试验结果：对Hartley豚鼠进行皮肤致敏试验，评价为对无菌注射针的解剖材料进行皮肤致敏时不会引起任何皮肤反应的物质，皮肤敏感度较弱。在上述测试的基础上，我们将在医疗器械验证和性能的基础上，研究更可靠的医疗器械的稳定性和有效性。

关键词

中胚层疗法、多针、医疗器械、安全性评价