Study on preparation technology of long-acting sustained-release oral ulcer membrane based on analytic hierarchy process and orthogonal design

Xiang XU; Xu Chen; Yuejiao KE; Zhihong Liu; Yufang Chen; Xin Zhou; Hongtao Song

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Study on preparation technology of long-acting sustained-release oral ulcer membrane based on analytic hierarchy process and orthogonal design

VernacularTitle: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
Author: Xiang XU ^{1
,

2} ; Xu CHEN ³ ; Yuejiao KE ⁴ ; Zhihong LIU ⁴ ; Yufang CHEN ² ; Xin ZHOU ⁴ ; Hongtao SONG ^{1
,

2}
Author Information

1. Department of Pharmacy, Fuzong Clinical Medical College of Fujian Medical University (The 900^th Hospital of Joint Logistic Support Force of PLA), Fuzhou 350025, China
2. Department of Pharmacy, Fujian Medical University, Fuzhou 350122, China.
3. Fujian Maternity and Child Health Hospital, Gynecology and Pediatrics Clinical Medical College of Fujian Medical University, Fuzhou 350001, China.
4. Department of Pharmacy, Fuzong Clinical Medical College of Fujian Medical University (The 900^th Hospital of Joint Logistic Support Force of PLA), Fuzhou 350025, China.
Keywords: aphthous ulcer; membrane-forming material; analytic hierarchy process; orthogonal experiment
From: Journal of Pharmaceutical Practice 2023;41(8):501-508
CountryChina
Language:Chinese
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.