DR.C Medical Medicine Co. Ltd., Shinjuku, Tokyo, Japan.
Medical Lab Partners Corporation, Chiyoda, Tokyo, Japan.
Eur Arch Otorhinolaryngol. 2022 Sep;279(9):4425-4433. doi: 10.1007/s00405-022-07289-8. Epub 2022 Mar 6.
We report the manufacture of particles containing a mixture of hydroxyapatite-argentum-titanium oxide (HAT), followed by attachment to nonwoven polyester fabrics to produce HAT-coated sheets (HATS) for use in masks. The purpose of the present study was to perform cellular, in vivo, and clinical studies to further examine the safety of HATS for use in masks to improve nasal allergy.
Reverse mutation tests for HAT were performed using five bacterial strains. A cellular toxicity test was performed using a Chinese hamster cell line incubated with the HATS extracts. Skin reactions after intradermal administration were examined in rabbits. Skin sensitization tests in guinea pigs were performed using the HATS extracts. HAT was administered to the nasal cavity and conjunctival sac of the rabbits. An oral administration study was performed in rats. Finally, a human skin patch test was performed using the HATS.
Reverse mutation tests showed negative results. The cellular toxicity test showed that the HATS extract had moderate cytotoxicity. The intradermal skin reaction and skin sensitization tests were all negative. The administration of HAT to the nasal cavity and intraocular administration showed negative results. No toxicity was observed after oral administration of HAT powder up to a dose of 2000 mg/kg. Finally, the skin patch test result was negative.
Although HAT showed moderate cytotoxicity, in vivo results indicated that HAT is safe because it does not come in direct contact with cells in normal usage, and HATS is safe when used in masks.
我们报告了一种载有羟基磷灰石-银-氧化钛（HAT）混合物的颗粒的制造方法，随后将其附着到非织造聚酯织物上，以生产用于口罩的 HAT 涂层片（HATS）。本研究的目的是进行细胞、体内和临床研究，以进一步检查 HATS 在改善鼻过敏的口罩中的使用安全性。
使用五种细菌菌株进行 HAT 的回复突变测试。使用中国仓鼠细胞系孵育 HATS 提取物进行细胞毒性测试。在兔子中检查皮内给药后的皮肤反应。使用 HATS 提取物对豚鼠进行皮肤致敏试验。将 HAT 施用于兔子的鼻腔和结膜囊。在大鼠中进行口服给药研究。最后，使用 HATS 进行人体皮肤斑贴试验。
回复突变测试结果为阴性。细胞毒性测试表明 HATS 提取物具有中度细胞毒性。皮内皮肤反应和皮肤致敏试验均为阴性。鼻腔和眼内给药的 HAT 给药结果为阴性。口服 HAT 粉末至 2000mg/kg 剂量时未观察到毒性。最后，皮肤斑贴试验结果为阴性。
尽管 HAT 显示出中度细胞毒性，但体内结果表明 HAT 是安全的，因为在正常使用中它不会与细胞直接接触，并且 HATS 在口罩中使用是安全的。
