Identification Of New Artificial Saliva Prescription And Its Biological Study

Objective:Xerostomia seriously affects the quality of life of patients,which has a variety of treatment options.Artificial saliva,topical application,is the simplest,safest and most effective method.However,the existing artificial saliva is still unable to fully possess the complex biological functions of natural saliva,such as adhesion,lubrication,moisturizing and antibacterial.Therefore,it remains the future research direction to developing saliva substitutes.Methods:The artificial saliva hydrogel containing Cetylpyridinium Chloride（CPC）was prepared by reverse spherification（RVS）,using sodium alginate（SA）and hydroxypropyl methyl cellulose（HPMC）as agents of film forming,glycerin（GLY）as plasticizer and CPC as active drug ingredient.Firstly,three main factors（HPMC,glycerin concentration and glycerin immersion time）affecting the preparation of gel beads were selected based on the single factor experiment results.Orthogonal tests were carried out on the different proportions of the three factors,and the optimal proportions of the three factors were determined.Then,considering the effect of stevioside on the flavor of gel beads,the encapsulation efficiency of gel beads was calculated to determine the best formula.In order to confirm that CPC was encapsulated in calcium alginate microspheres,the content of CPC in gel beads was studied by HPLC.Finally,pharmacological and toxicological experiments were conducted to verify the safety of the preparation.Results:The basic artificial saliva group is made up of inorganic ions,thickeners,lubricants,taste correction agents,preservatives and so on.The loading efficiency（LC）was calculated by the orthogonal experiment.The main factors and levels based on the single factor test results are1.5%HPMC concentration,1%glycerol concentration and 15 s glycerol immersion time.According to the above results,the 0.01%content of CPC and the validity of the sample for 2 years are selected to configure the gel beads.In Microbial contamination test,no escherichia coli and pathogenic bacteria were detected.After treated for 2 minutes,the average bacteriostasis rate of the sample against escherichia coli,staphylococcus aureus,candida albicans and pseudomonas aeruginosa were 95.65%,90.31%,84.39%and 92.43%,respectively.Toxicological tests showed that the sample had no irritation to the acute eye stimulation test of rabbits.Acute oral toxicity test showed that THE LD₅₀of KM mice was more than 5000 mg/kg,which was actually non-toxic.Moreover,the micronucleus test showed that the sample had no damage to chromosomes in vivo.Conclusion:Artificial salivary gel beads were prepared by reverse spherification,which had good physical and biological characteristics.