The Research And Preparation Of Gel For Periodontal Diasease

The thesis explains the pathogenic mechanism of the periodontal disease, analyses the rationality and necessity of the application of MINO and explores the applying future of the MINO in clinic.In the experiment,the author chooses reasonable and practicable prescription of the ingredients of the gel by using modern pharmaceutical technologies.The thesis is divided into the following parts:The part of literature review shows that the periodontal disease,as one of the most common diseases in the mouth,is the main reason for the missing teeth in people aged 35 and elder.Scientifically calculated,the incidence of the periodontal disease is about 90%among modern developing countries and 50%the developed countries.The World Health Organization has listed the periodontal disease as the third non-infectious disease after the knub and heart disease.The disease of the periodontal organization is closely related to other diseases,and therefore,the treatment of the periodontal disease is quite urgent.In the preformulation study of the gel,the author found out and analyzed the basic physic-chemical quality and preparation quality of the drug and confirmed the necessary drug and gel used in the experiment.This research project chooses MINO as the model drug and it is expected to function well in the treatment of the periodontal disease and be found favorable in clinic in the future.The gel takes CP, SAL-CaCl₂,Poloxamer and chitosan as the main sustained-release materials.The author has chosen the composition of the ground substance and explored the preparation process and shaping operation as well as the basic technological method of each ground substance of the gel.Next part is the study of the prescription.The author further confirmed the composition of the gel and the ratio of the components:CP,SAL-CaCl₂,Poloxamer and chitosan,together with the drug and the related ground substance,the prescription was under the experimental study.The in-vitro Release Experiment was conducted, the gel were optimized with the standard of 1h,12h,1d,within 30%,40-50%and 50-60%.Taking the 99%recovery rate as the guide line,the Recovery Rate Test showed mat the best prescription is that the SAL,CaCl₂ covers 5%and MINO 2%, which is also confirmed by the in-vitro Release Experiment.Thirdly,the Experiment of Affecting Factors was done.It investigated the hardness,viscosity,water absorption,etc,of the gel.The factors influencing release rate were studied and the releasing mechanism was explored.At last the prescription was confirmed.Under the optimum conditions,the in-vitro accumulated release of MINO was 35%,50%,55%at 1h,12h,24h,conforming to the requirement planned before.The viscosity of the gel is suitable enough be given through injection.Finally,the stability experiment of the gel was conducted.The author did the Experiment of Determination,the in-vitro Release Experiment and the Recovery Rate Test upon the gel and used the Ultraviolet Spectrophotometry,an analytical method of strong specificity,accurate,precise and sensitive,to test other factors that may influence the stability of the gel,like sunshine and temperature,etc.The conclusion is that MINO is not stable under the influence of sunshine and temperature,therefore, the gel should be kept cool.It has few reports about development of sustained-release gel home and aboard. With relatively few references,the research work is done in an exploratory way.The research results show that it helps lay a good foundation for the further study of the new delivery system used in oral location.