The Compound Neomycin Sulfate Thermosensitive Gel: Preparation And The Effect On Oral Ulcer

Objectives:In this study,a compound neomycin sulfate thermosensitive gel was developed through prescription screening.Besides,the rat oral ulcer model was established by glacial acetic acid burning method to study the pharmacodynamics of the prepared neomycin sulfate thermosensitive gel.In addition,the compound neomycin sulfate thermosensitive gel was applied to the patients with mild recurrent oral ulcer the clinic for investigating the clinical effects.Methods:In this study,on the basis of the active ingredients of the original prescription of"complex neomycin sulfate oral ulcer coating",a temperature-sensitive gel was used as a carrier to prepare the temperature-sensitive gel:liquid at room temperature and quickly transformed into a semi-solid non-chemical under oral temperature after administration.The rheological analysis technology was used to investigate the rheological properties of the gel matrix,and screen the optimal thermosensitive gel prescription.The rat model of traumatic oral ulcer was established by burning the mucosa of the lower lip of the rat with 50%glacial acetic acid.The rats were randomly divided into model group,blank gel group,control group and high-frequency administration group,medium-frequency administration group,low-frequency administration group,respectively.After administering with different administrations,the healing of oral ulcer in rats,the change of ulcer surface area,and the pathological sections of oral mucosa was analyzed to investigate the pesticide effect.Fifty patients with mild recurrent oral ulcers meeting the inclusion criteria were selected and randomly divided into two groups:treating with a compound neomycin sulfate thermosensitive gel and a blank gel.The effects of the two groups were statistically analyzed by measuring the changes in the area of the ulcer surface and the changes in the pain score.Results:The compound neomycin sulfate oral thermosensitive gel was successfully constructed,overcoming the deficiency of the original compound neomycin sulfate coating for oral ulcer.It was in a liquid state at room temperature and could be administered locally by spraying.After administration,the semi-solid cross-linked coagulation was rapidly formed under the action of oral temperature,with the advantages of convenient administration,long acting time and sustained release effect.With different treating,the ulcer areas in the model,blank gel,control,high,medium and low frequency administration group on the second day of administration were(21.52±0.98)mm~2,(20.49±1.12)mm~2,(12.27±0.78)mm~2,(9.99±0.62)mm~2,(11.86±0.54)mm~2,(15.57±0.65)mm~2.The ulcer area on the third day of administration were(17.72±0.94)mm~2,(16.72±0.93)mm~2,(9.45±0.49)mm~2,(6.12±0.82)mm~2,(7.57±0.92)mm~2,(10.96±0.4)mm~2.On the fourth day of administration,the ulcer area of the groups was(14.07±0.69)mm~2,(13.73±0.68)mm~2,(7.67±0.47)mm~2,(2.01±0.6)mm~2,(3.81±0.77)mm~2,(9.2±0.35)mm~2.The results indicated that the ulcer diameter of the compound neodymium sulfate thermosensitive gel preparation was reduced in each dose group with dose dependent,and the difference was statistically significant(P<0.05).After 4 days of administration,the ulcer surface of each administration group healed well,the ulcer surface was smooth,and the inflammatory reaction was light.Pathological observation showed that the control group,the high-frequency administration group and the medium-frequency administration group had complete epithelial tissue,good healing,and a small number of inflammatory cells infiltrated.The clinical efficacy of 46 cases showed that compared with the control group,the pain of the patients in the drug-administered group subsided faster,the course of ulcer recovery was significantly shortened,and the total effective rate was significantly improved.Conclusions:The results of the study indicated that the formulated compound neomycin sulfate thermosensitive gel has a reasonable composition and a feasible preparation method.It can promote the healing of traumatic oral ulcer induced by glacial acetic acid,and performed perfect clinical effect.The study provides an important theoretical and practical significance for the design and development of new formulations for oral ulcer.