| 郑培培,赵信义,阮建平.FQ氟化物防龋涂膜材料生物相容性的初步评价[J].口腔材料器械杂志,2026,35(1):43-48. |
| FQ氟化物防龋涂膜材料生物相容性的初步评价 |
| Preliminary evaluation of the biocompatibility of FQ fluoride varnish |
| 投稿时间：2024-03-02 修订日期：2025-12-02 |
| DOI：10.11752/j.kqcl.2026.01.08 |
| 中文关键词: 氟 氟涂膜 牙齿 防龋 生物相容性 |
| 英文关键词:Fluoride Fluoride varnish Tooth Anti-caries Biocompatibility |
| 基金项目:陕西省社发攻关项目(2022SF-099); 陕西省科学技术厅重点项目(2024PT-ZCK-2) |
|
| 摘要点击次数: 387 |
| 全文下载次数: 47 |
| 中文摘要: |
| 目的 通过体外细胞毒性试验、皮肤致敏试验、急性经口全身毒性试验、口腔黏膜刺激试验对新型FQ氟化物防龋涂膜材料的生物相容性进行初步评价。方法 参照GB/T 16886和YY/T 0127相关标准开展体外细胞毒性试验，将FQ防龋涂膜材料/多乐氟（Duraphat）浸提液（作为对照材料）分别与L929细胞共培养。按涂膜表面积与浸提培养液3.0 cm2/mL比例制备浸提原液,并将其稀释至1/4、1/16、1/64原浓度作为细胞毒性试验的稀释浸提液，细胞形态和存活率评价。以1.0 cm2/24 mL浓度作为模拟人体口腔浸提比例浓度；在豚鼠皮肤致敏试验中，皮内诱导材料为FQ防龋涂膜材料生理盐水浸提液（3.0 cm2/mL），局部斑贴使用防龋涂膜材料原品。急性经口全身毒性试验：用FQ防龋涂膜材料生理盐水浸提液（同上），按照50 ml/kg剂量对小鼠灌胃，每日观察记录小鼠体征，14 d后处死,对其重要脏器进行组织学观察；口腔黏膜刺激试验：使用金黄地鼠，将涂布有FQ防龋涂膜材料的直径7.5 mm聚乙烯圆片以项圈法固定至地鼠颊囊，24 h后取出试样，肉眼观察颊黏膜反应，并对颊囊黏膜进行组织学观察。结果 FQ涂膜材料1/4原液及Duraphat高浓度浸提液（1/4和1/16原液）细胞存活率低于70%，而1/64原液和模拟人体浸提比例细胞存活率均大于70%；致敏试验显示，激发阶段接触防龋涂膜材料的皮肤无水肿及红斑出现。急性经口全身毒性试验实验组动物无中毒及死亡，动物重要脏器无异常；口腔黏膜刺激试验未见黏膜组织异常；结论 新型FQ氟化物防龋涂膜材料有一定的体外细胞毒性，其细胞毒性与市售Duraphat相当，毒性与浸提比例相关，且无致敏性，无刺激性，可进行更进一步的生物安全性试验。 |
| 英文摘要: |
| Objective TTo conduct a preliminary evaluation of the biocompatibility of a newly developed FQ fluoride varnish through a comprehensive series of biological safety assessments, including cytotoxicity, skin sensitization, acute systemic toxicity, and oral mucosal irritation tests. Methods All experiments were conducted in accordance with the relevant standards of GB/T 16886 and YY/T 0127. Extracts of the FQ fluoride varnish and a commercial product（Duraphat） were prepared at a ratio of 3.0 cm2/mL and diluted to 1/4, 1/16, and 1/64 of the original concentration. L929 fibroblasts were exposed to the extracts, and cell morphology and viability were observed to assess cytotoxicity. The FQ varnish suspension in saline was used for intradermal injection in guinea pigs to evaluate skin sensitization reactions, and no erythema or edema was observed. For the acute systemic toxicity test, mice were administered FQ varnish extracts by gavage at a dose of 50 mL/kg, and their general condition and organ morphology were monitored for 14 days without any signs of poisoning or pathological changes. For the oral mucosal irritation test, polyethylene discs coated with FQ varnish（diameter 7.5 mm） were fixed to the buccal mucosa of hamster cheek pouches for 24 hours, followed by gross and histological examinations of the mucosa. Results The cell survival rate of L929 cells exposed to FQ varnish extracts at 1/4 and 1/16 dilutions was below 70%, whereas that of Duraphat extracts exceeded 70%. No erythema, edema, or sensitization reaction was observed in the skin test. In the systemic toxicity test, no abnormal clinical manifestations, organ damage, or mortality occurred in mice, and the oral mucosa showed no visible or histological lesions after exposure to the FQ varnish. Conclusions The FQ fluoride varnish exhibited mild in vitro cytotoxicity comparable to Duraphat, with no evidence of skin sensitization, systemic toxicity, or oral mucosal irritation. These findings suggest that the FQ fluoride varnish possesses good biocompatibility and biological safety, providing a theoretical foundation for its further optimization and potential clinical application in caries prevention. |
| 查看全文 查看/发表评论 下载PDF阅读器 |
| 关闭 |
|
|
|