Screening And Development Of Sustained Release Gel Matrix Of Periodontitis

Objective:At present,there are some shortcomings in the treatment of periodontitis,such as long treatment cycle,frequent administration,dose largely,leading to the patient inconvenience and so on.The objective of this study is to choose Iodine with a variety of antimicrobial spectrum and not easy to produce resistance as the main drug,and hydrogel materials and water-insoluble materials were screened to develope in situ gel,characterized by good passability,slow release,material easy to get,for the treatment of periodontitis.The optimal prescription was optimized by single factor experiment and orthogonal experiment with the standard of gel properties and release degree,and investigated the quality and stability of the optimal prescription.The results provided the reference for further study.Methods:First,a method were established to determine the release of fluid from the iodine in situ gel in vitro.We maked sustained-released gel with Poloxamer,resins,PLGA to screen the skeleton materials.The various factors which influence the sustained-released of gel were studied,and used orthogonal experiment to optimize the formulation.Finally the quality and the stability of iodine in situ gel was investigated.The quality include the appearance,identification,centrifugation and content determination.The stability included high temperature experiment,light experiment and accelerated test.Results:We established the determination of in vitro release of iodine in situ gel-UV-Vis spectrophotometry.The gel prepared by water-soluble slow-release material is fine and that the needle is good,but the release time is short and the sustained-release effect is poor.The gel prepared by the RSPO has fast seepage rate and rapid release rate.After adding EC to form a mixed skeleton,it can significantly slow down the release rate,and lead to release time to more than 2 days.EC in the release of the medium is hard,reduction can make it soft,but the release effect will be worse.For the gel prepared by PLGA,we obtained the optimal formulation by single factor and orthogonal design experiments: PLGA 25%,Acacia seyal 2%,PEG400 15%,NMP 28%,PVP 25%,I2 5%.We established quality standard iodine in situ gel.The results showed that the appearance and the centrifugal stability was fine.The UV method was established and the developed method was studied by a series of validation tests.The linearity and specificity of the method were good(R=0.9998),the RSD of the precision experiment and the recovery experiment were less than 2%.The stability experiment showed that the gel was not resistant to high temperature and should be stored in the low temperature and cool place,it is within the12-month nature and stability.Conclusions:It had less reported at home and abroad and no exact standard in current pharmacopoeia as a new type of preparation.The results provided a reference for the preparation and clinical application of a new oral sustained release gel.