蓝仕康口腔凝胶的安全性及其对大鼠口腔溃疡作用的研究  

Safety of LANSHIKANG Oral Gel and its effect on oral ulcer in rats

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

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：《中医临床研究》2020年第24期136-139,共4页Clinical Journal Of Chinese Medicine

基　　金：福建中医药大学药学学科开放性课题(FJTCM-2019017)。

摘　　要：目的:对蓝仕康口腔凝胶进行急性毒性、口腔黏膜刺激性及对大鼠口腔溃疡作用的研究。方法:以高于临床给药浓度100倍的口腔凝胶浓缩液,采用灌胃方式对小鼠给药,测定该口腔凝胶的急性毒性;将该口腔凝胶喷入大鼠口腔下颊黏膜数日,以大鼠下颊部黏膜做病理组织学切片观察结果评定口腔凝胶的黏膜刺激性;以醋酸造模形成的下颊黏膜溃疡大鼠为模型,给药数日通过受药颊部及周围组织的组织切片,苏木精-伊红染色法(Hematoxylin-eosin staining,简称HE染色法)染色观察,并对各组口腔下颊组织中肿瘤坏死因子-α(Tumor Necrosis Factor-α,TNF-α)、白细胞介素-1β(Interleukin-1β,IL-1β)、白细胞介素-6(Interleukin-6,IL-6)含量比较来探讨口腔凝胶对大鼠口腔溃疡的作用。结果:该口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半数致死量(Median Lethal Dose,LD50);黏膜刺激性实验中,口腔凝胶组未发现大鼠黏膜及全身状况异常,HE染色组织切片显示大鼠下颊部组织上皮细胞及黏膜未见异常;对口腔溃疡作用实验中,口腔凝胶组上皮细胞组织层次清晰,黏膜上皮完整,并且口腔凝胶能在一定程度上降低下颊黏膜溃疡大鼠炎症部位TNF-α、IL-1β、IL-6水平。结论:蓝仕康口腔凝胶安全性较高,对口腔黏膜无刺激,对溃疡面有一定的促进愈合的作用。Objective:To study the acute toxicity,oral mucosal irritation and the effect of LANSHIKANG(蓝仕康)Oral Gel on oral ulceration in rats.Method:The acute toxicity of the oral gel was studied using the oral gel concentrate(100 times higher than the clinical drug concentration)by gavage in mice.After the oral gel was sprayed into the buccal mucosa of the rat for several days,the mucosal irritation of the oral gel was evaluated by observing the mucosa and the histological slice of the buccal mucosa of the rat.The buccal mucosa ulcer model was established by acetic acid in rats.After spraying the oral gel on buccal mucosa ulcer surface for several days,the effect on the buccal mucosa ulcer model was evaluated by observing buccal mucosa tissue sections after HE staining and detecting the contents of TNF-α,IL-1βand IL-6 in the oral buccal tissues of each group.Result:The LD50 was not detected when the oral gel was administered to the maximum allowable concentration and the maximum allowable volume.In the mucosal irritation test,no abnormal change of the mucosal system and whole body were found in the oral gel group.No abnormal change of epithelial cells and mucosa was observed in HE stained tissue sections of the oral gel group.In the experiment of oral ulcer assay,the epithelial cells and tissue was clear and mucosal epithelium was intact in the oral gel group.The content of TNF-α,IL-1βand IL-6 in buccal mucosa ulcer in rats of the oral gel group were decreased to some extent.Conclusion:LANSHIKANG Oral Gel has high safety,it has no irritation to oral mucosa,and has effect as a therapy for buccal mucosa ulcer to some extent.

关 键 词：口腔凝胶 口腔溃疡 安全性试验 黏膜刺激性 急性毒性 

分 类 号：R785[医药卫生—口腔医学]