Preparation of  Oral Film and Investigation of Its Antioral Ulcer Action

Li Jie; CHEN Zhe-jie; SHI Jin-feng; XIAO Qian; WANG Mei; JIANG Hua-juan; FU Chao-mei; GENG Fu-neng; ZHANG Jin-ming

doi:10.13422/j.cnki.syfjx.20182007

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Preparation of Oral Film and Investigation of Its Antioral Ulcer Action

更新时间：2024-09-23

- Preparation of Oral Film and Investigation of Its Antioral Ulcer Action
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 24, Issue 23, Pages: 29-36(2018)
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20182007
  CLC： R283.6;R285.5
- Published：2018
- 稿件说明：
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Li Jie, CHEN Zhe-jie, SHI Jin-feng, et al. Preparation of Oral Film and Investigation of Its Antioral Ulcer Action[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(23): 29-36.
DOI：

Li Jie, CHEN Zhe-jie, SHI Jin-feng, et al. Preparation of Oral Film and Investigation of Its Antioral Ulcer Action[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(23): 29-36. DOI： 10.13422/j.cnki.syfjx.20182007.

摘要

目的：基于美洲大蠊抗溃疡作用制备美洲大蠊口腔贴膜剂（PAOF）并考察其药效学作用。方法：以黏附时间、黏附力和溶解时间作为综合评分指标，筛选以美洲大蠊提取物冻干粉为原料的口腔贴膜剂最佳处方，并对制得的PAOF进行性能评价及载药量测定。通过20%冰乙酸灼烧建立家兔口腔溃疡模型，苏木素-伊红（HE）染色和增殖细胞核抗原（PCNA）染色后光镜下观察各组家兔口腔溃疡组织病理学改变，通过生化检测及酶联免疫吸附试验（ELISA）测定超氧化物歧化酶（SOD），丙二醛（MDA），白细胞介素（IL）-2，IL-6，碱性成纤维细胞生长因子（bFGF）和肿瘤坏死因子-α（TNF-α）的含量，对PAOF抗口腔溃疡作用进行评价。结果：以聚乙烯醇17-88 4.0 g，羟丙基纤维素0.3 g，卡波姆934P 0.15 g为成膜材料，分别于25，20，10 mL水中溶胀，充分溶胀后混合3种基质，加入美洲大蠊提取物冻干粉1.0 g和甘油0.6 mL，制得的PAOF黏附时间（152±2）min，溶解时间（173±3）min，黏附力（184±3）N，膨胀度20%，每片载药量2.09 mg（以甘氨酸计）。药效学结果显示，与模型组相比，PAOF高剂量组和醋酸地塞米松粘贴片组口腔黏膜溃疡组织中SOD活性显著升高（P<0.01），MDA含量水平显著降低（P<0.01）；PAOF高、中剂量组和醋酸地塞米松粘贴片组IL-2水平显著升高（P<0.05），IL-6水平显著降低（P<0.05，P<0.01）；PAOF高、中剂量组和醋酸地塞米松粘贴片组TNF-α水平显著降低（P<0.05），bFGF水平显著升高（P<0.05，P<0.01）；模型组家兔口腔黏膜破坏，出现水肿现象；给药组家兔口腔溃疡面有不同程度的组织修复，无水肿现象，提示PAOF可促进家兔口腔溃疡的愈合。结论：优选的美洲大蠊口腔贴膜剂制备工艺简单、可操作性强，且对家兔口腔溃疡具有较为显著的疗效。

Abstract

Objective:Based on the anti-ulcer effect of Periplaneta americana

to prepare P. americana oral film(PAOF) and investigate its pharmacodynamics. Method:Adhesion time

adhesion and dissolution time were used as the comprehensive score index to screen the best prescription of oral film with freeze-dried powder of P. americana extract as raw material.The performance evaluation and the determination of drug loading of PAOF were carried out.Subsequently

model of oral ulcer in rabbits burned with 20% glacial acetic acid was established.The histopathological changes of rabbit oral ulcer tissues were observed under light microscope with hematoxylin-eosin(HE) staining and proliferating cell nuclear antigen(PCNA) staining

the concentrations of superoxide dismutase(SOD)

malondialdehyde(MDA)

interleukin(IL)-2

IL-6

tumor necrosis factor-α(TNF-α) and basic fibroblast growth factor(bFGF) were measured by biochemical test and enzyme linked immunosorbent assay(ELISA)

the effect of PAOF on oral ulcer was evaluated. Result:Taking 4.0 g of ployvinyl alcohol 17-88(PVA 17-88)

0.3 g of hydroxypropyl cellulose(HPC)

0.15 g of carbomer 934P as film forming materials

they were dissolved in 25

10 mL of ultrapure water

respectively.These three matrices after fully swelling were mixed

and 1 g of freeze-dried powder of P. americana extract and 0.6 mL of glycerine were added in the mixture.The PAOF had good performance for its long adhesion time[(152±2) min]

long dissolution time[(173±3) min]

strong adhesion force[(184±3) N] and low expansion degree(20%).Drug loading of each oral film was 2.09 mg(with glycine as index).Compared with the model group

SOD activity in oral mucosal ulcer tissues increased significantly in the PAOF high-dose group and dexamethasone acetate adhesive tablets group(P<0.01)

and MDA content decreased significantly(P<0.01).IL-2 level was significantly increased(P<0.05) and IL-6 level was significantly decreased(P<0.05

P<0.01) in the PAOF high and medium dose group and dexamethasone acetate adhesive tablets group.TNF-α level was significantly decreased(P<0.05) and bFGF level was significantly increased(P<0.05

P<0.01) in the PAOF high and medium dose group and dexamethasone acetate adhesive tablets group;oral mucosa of rabbits in model group was damaged and then edema phenomenon appeared.There were different levels of tissue repair and no edema in the oral cavity ulcer in rabbits

which was significantly different from the model group.It suggested that the PAOF could promote the healing of oral ulcer in rabbits. Conclusion:This optimized preparation technology of PAOF is simple and feasible

and it has a significant effect on oral ulcer in rabbits.

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