earticle

영어

Purpose: In this study, a microneedle patch (MNP) containing cannabidiol (CBD, YC-2106) was produced, and its efficacy was evaluated for human safety and the treatment of inflammatory diseases. Methods: First, MNPs containing 0%, 1%, and 3% cannabidiol were prepared. To evaluate the anti-inflammatory efficacy, a human skin tissue model (KeraSkin™) was purchased, the culture medium was collected 24 h and 48 h after MNP attachment, and the expression of interleukin-8 (IL-8) was compared and analyzed. A primary dermal irritation test was performed by requesting SGS certification in the United States, where an MNP was attached to 32 participants, and the attachment site was checked after 48 h and 96 h to confirm the occurrence of side effects. Results: No significant decrease in IL-8 expression was observed 24 h after lipopolysaccharide (LPS)-induced inflammation. However, after 48 h, IL-8 expression was significantly inhibited in the group treated with MNPs containing 1% and 3% CBD. In the primary dermal irritation test, no side effects were observed in any of the participants; therefore, safety was confirmed in the percutaneous phase. Conclusion: The CBD-MNP is effective in treating inflammatory diseases through the inhibition of IL-8 expression and exhibits high potential as a percutaneous drug for inflammatory treatment, which is safe for use in the human body.

한국어

목적: 본 연구에서는 대마유래 칸나비디올(CBD, YC-2106)을 포함하는 마이크로니들 패치(MNP)를 제작하고 염증성 질환 치료 효능과 인체 안전성을 평가하고자 하였다. 방법: 먼저 칸나비디올을 각각 0%, 1%, 3% 함유하는 마이크로니들 패치를 제작하였다. 항 염증 효능을 평가하기 위해 인체피부조직모델(KeraSkinTM)을 구입하였고, MNP 부착 24 h과 48 h 뒤에 배양액을 각각 수거하여 인 터루킨-8 (IL-8)의 발현을 비교분석하였다. 피부자극테스트는 미국 SGS사에 의뢰하여 수행하였고, 32명의 피험자에게 MNP를 부 착하고, 48 h과 96 h 뒤에 부착부위를 확인하여 부작용 발생여부를 확인하였다. 결과: LPS로 염증을 유발한 후 24 h 후에는 유의한 IL-8 발현 감소가 나타나지 않았지만, 48 h 후에는 CBD 1%와 3% 함유 MNP를 처리한 군에서 유의한 수준의 IL-8 발현 억제가 확 인되었다. 1차 피부자극테스트에서는 모든 피험자에서 부작용이 나타나지 않아 경피상에서 안전성을 확인하였다. 결론: 칸나비디 올 함유 마이크로니들 패치(CBD-MNP)는 IL-8 발현 억제를 통해 염증성 질환 치료 효능을 나타내며, 인체에 무해하기 때문에 경 피약물 염증치료제로서의 높은 잠재력을 나타내었다.

중국어

目的: 本研究制作了含有大麻二酚(cannabidiol, CBD，YC-2106)微针贴片(microneedle patch, MNP)，评估 了其对人体安全性和对炎症疾病的治疗效果。方法: 首先制备含0%、1%、3%大麻二酚的MNPs，为评价抗炎 效果，购买人体皮肤组织模型(KeraSkinTM)，MNP贴附后24 h、48 h，收集培养基，对比分析白细胞介素-8(IL- 8)表达情况。委托美国SGS认证机构进行单次皮肤刺激试验，32名受试者贴附MNP，48 h、96 h后检查贴附 部位，确认有无副作用发生。结果: 脂多糖(LPS)诱发炎症后24小时IL-8表达无明显下降，但48 h后，含1%和 3%CBD的MNPs组IL-8表达明显受到抑制。在单次皮肤刺激试验中，所有受试者均未观察到副作用，因此证实了 经皮阶段的安全性。结论: CBD-MNP通过抑制IL-8表达有效治疗炎症性疾病，作为经皮炎症治疗药物具有很高的 潜力，且在人体内使用是安全的。