| 基于层次分析法和正交设计优选长效缓释口腔溃疡膜的制备工艺研究 |
| 投稿时间：2021-09-13 修订日期：2022-07-24 点此下载全文 |
| 引用本文：许翔,陈旭,柯月娇,刘志宏,陈钰芳,周欣,宋洪涛.基于层次分析法和正交设计优选长效缓释口腔溃疡膜的制备工艺研究[J].药学实践杂志,2023,41(8):501~508 |
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| 作者 | 单位 | E-mail | | 许翔 | 福建医科大学福总临床医学院（联勤保障部队第九〇〇医院）药剂科, 福建 福州 350025
福建医科大学药学院, 福建 福州350122 | | | 陈旭 | 福建省妇幼保健院, 福建医科大学附属医院, 福建 福州 350001 | | | 柯月娇 | 福建医科大学福总临床医学院（联勤保障部队第九〇〇医院）药剂科, 福建 福州 350025 | | | 刘志宏 | 福建医科大学福总临床医学院（联勤保障部队第九〇〇医院）药剂科, 福建 福州 350025 | | | 陈钰芳 | 福建医科大学药学院, 福建 福州350122 | | | 周欣 | 福建医科大学福总临床医学院（联勤保障部队第九〇〇医院）药剂科, 福建 福州 350025 | fzzyyg@163.com | | 宋洪涛 | 福建医科大学福总临床医学院（联勤保障部队第九〇〇医院）药剂科, 福建 福州 350025
福建医科大学药学院, 福建 福州350122 | sohoto@vip.163.com |
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| 中文摘要:目的 研制具有较长的黏附时间与溶蚀时间的缓释膜剂，同市售口腔溃疡膜进行比较。方法 对该膜剂以黏附力、黏附时间、溶胀系数、溶蚀时间等作为考察指标，采用单因素考察与层次分析法相结合，对成膜材料进行筛选；考察处方中克霉唑、奥硝唑和冰片的分散方法，防止药物沉淀析出；采用正交试验与层次分析法相结合的方法对羧甲基纤维素钠（CMC-Na）、聚乙烯醇-1788（PVA-1788）及甘油的用量进行优化；并与市售产品进行比较。结果 通过单因素考察和正交试验，优选出辅料最佳配比为CMC-Na∶PVA-1788∶甘油（3∶1∶0.08）；采用物理凝聚法对水不溶成分克霉唑、奥硝唑和冰片分散效果良好；采用最优方法制备膜剂，黏附力为102 g，黏附时间为55 min，最大溶胀系数为1 939.52%，平均溶蚀时间为110 min，外观呈现白色，表面无气泡且柔软，有一定弹性，在60 ℃成膜时间为300 min，脱模效果较好可完全撕取，厚度适中。结论 本方法制备的口腔溃疡膜外观良好，使用舒适，黏附力强，具有较长的黏附时间和溶蚀时间，可长时间滞留于溃疡面形成物理隔离，并在溶蚀的过程中缓慢释放药物，对口腔溃疡起到长效止痛、抗菌、消炎和促愈合的作用。 |
| 中文关键词:阿弗他溃疡 成膜材料 层次分析法 正交试验 |
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| Study on preparation technology of long-acting sustained-release oral ulcer membrane based on analytic hierarchy process and orthogonal design |
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| Abstract:Objective To prepare a sustained-release membrane with longer adhesion time and dissolution time, and compare it with the commercially available oral ulcer membrane. Method Adhesion strength, adhesion time, swelling coefficient, dissolution time, etc. were used as the inspection indicators, and a combination of single factor inspection and analytic hierarchy process were used to screen the membrane -forming materials. The dispersion method of clotrimazole, ornidazole and borneol were investigated to prevent the drug from seed out. The method of combining orthogonal experiment and analytic hierarchy process were used to optimize the dosage of CMC-Na, PVA-1788 and glycerin; and the commercial products were compared. Results Through single-factor investigation and orthogonal experiment, the optimal ratio of excipients was selected as CMC-Na∶PVA-1788∶glycerol (3∶1∶0.08). The water-insoluble component clotrimazole, ornidazole and borneol were treated by precipitation in liquid with good effect. The best method was used to prepare the membrane. The adhesion strength was 102 g. The adhesion time was 55 min. The swelling coefficient was 1 939.52. The average dissolution time was 110 min. The appearance was white and the surface was free of bubbles, soft and elastic. The membrane forming time at 60 ℃ was 300 min and the demolding effect was better which could be completely peeled off with moderate thickness. Conclusion The oral ulcer membrane developed in this method has good appearance, comfortable use, strong adhesion, long adhesion time and dissolution time, and could stay on the ulcer surface for a long time to form physical isolation, and slowly release the drug during the dissolution process, which could play the role of long-term pain relief, antibacterial, anti-inflammatory and promote healing effects on oral ulcers. |
| keywords:aphthous ulcer membrane-forming material analytic hierarchy process orthogonal experiment |
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