鼻腔用冷敷凝胶的急性毒性及纤毛毒性实验研究  

Acute toxicity study and ciliary toxicity of nasal cold gel

作　　者：严国鸿[1] 林亚娟 胡博志 徐伟[2] 王晓颖[2] YAN Guohong;LIN Yajuan;HU Bozhi;XU Wei;WANG Xiaoying(People′s Hospital Affiliated to Fujian University of Traditional Chinese Medicine,Fuzhou 350122,China;Fujian University of Traditional Chinese Medicine,Fuzhou 350122,China;Lanjiatang Bio-MedicineCo.,Ltd.,Fuzhou 350007,China)

机构地区：[1]福建中医药大学附属人民医院,福建福州350122 [2]福建中医药大学,福建福州350122 [3]蓝佳堂生物医药<福建>有限公司,福建福州350007

出　　处：《药学研究》2020年第2期74-76,共3页Journal of Pharmaceutical Research

基　　金：福建中医药大学药学学科开放性课题(No.FJTCM-2019017)。

摘　　要：目的对鼻腔用冷敷凝胶(鼻腔凝胶)进行急性毒性试验及纤毛毒性实验研究。方法以高于临床给药浓度100倍的鼻腔凝胶浓缩液,采用灌胃方式对小鼠给药,测定该鼻腔凝胶的急性毒性;牛蛙上颚黏膜作为动物模型,以生理盐水作空白对照,1%去氧胆酸钠作阳性对照,于显微镜下观察纤毛运动,记录纤毛停止摆动时间,计算纤毛持续运动时间的百分率(PPV),考察鼻腔凝胶对鼻纤毛运动的影响。结果用鼻腔凝胶最大允许浓度和最大允许容量给予动物时仍未能测出LD 50,表明鼻腔凝胶的安全性较高。纤毛毒性实验中,生理盐水组和鼻腔凝胶组纤毛清晰完整,排列整齐,有规律地向同一方向摆动,纤毛运动活跃,呈“风吹麦浪”式摆动,且摆动频率极快。采用间隔30 min多次给予鼻腔凝胶后,纤毛持续运动时间的百分率为69%,用生理盐水冲洗黏膜上鼻腔凝胶,纤毛可恢复摆动。结论该鼻腔凝胶安全性良好,对纤毛的毒性很小,可以用于鼻腔局部。Objective To study acute toxicity and cilia toxicity on nasal cold gel.Methods The acute toxicity of the nasal gel were determined by oral administration in mice at a concentration higher than 100 times of the clinical concentration.Ciliary toxicity was evaluated using bullfrog palate mucosa model.Normal saline(0.9%)used as blank control and 1%sodium deoxycholate were used as positive control,respectively.The ciliary movement was observed under the microscope,and the cilia stop swing time was recorded.The percentage of persistent vibration(PPV)value was calculated for evaluated the effect of the nasal gel on ciliary movement.Results The LD 50 was not detected when the mice were given the maximum allowable concentration and maximum allowable volume of the nasal gel,indicating that the nasal gel was safe.The cilia of the saline group and the nasal gel group were clear and complete,arranged neatly,and oscillated in the same direction regularly.The cilia movement was active in a extremely fast swing frequency.After multiple dosing administrated with the nasal gel at a 30 min interval,the percentage of cilia sustained movement time was 69%.The cilia movement was be back to normal after the nasal gel was washed away by normal saline solution.Conclusion The nasal gel was safe.The ciliary toxicity of nasal cilia was feeble.It can be used in nasal systems.

关 键 词：鼻腔凝胶 安全性 急性毒性 鼻纤毛毒性 

分 类 号：R994.39[医药卫生—毒理学]