Preparation Of Periodontitis In Situ Gel

ObjectiveTo investigate determination of release in vitro and Optimize Formulation, we prepare iodine in situ gel for treatment of periodontitis. To establish quality standards for iodine in situ gel, It can be used for quality control of iodine in situ gel. To investigate the stability of the test, irritation test and preliminary pharmacokinetic studies, They provide a reliable basis for clinical drug trials.Methods1.We used quantitative detection kit of urinary iodine to determinate the release of fluid from the iodine in situ gel in vitro. We studied the influence of the dissolve medium, the oscillation frequency and the dosage of release liquid on the release rate.2.By comparing sustained-release time, we screened out the longest in situ gel. By single factor experiment, we regarded releasing rate as the main reference index to select the sustained-release material in situ gel. We adopted orthogonal experiment to optimize the prescription and prepared the in situ gel. We put the release rate of the in situ gel fit with four mathematical models to determine release mechanism of iodine in situ gel.3.The appearance traits of iodine in situ gel were observed and identified by sodium thiosulfate solution. The pH was checked by precision pH meter and the content was detected by potentiometric titration.4. The iodine in situ gel was placed in high-temperature, high light conditions to conduct factors test. Accelerate test was carried out in 30±2℃ with 65±10% relative humidity. Long-term test was conducted in 25±2℃ with 60±10% relative humidity.5.The rabbits were divided into three groups:iodine in situ gel group, blank situ gel group and normal control group. Irritation test was conducted combined with clinical dosage. Each group’s clinical indicators were observed 5 days later.6.Rabbits were randomly divided into two groups, iodine in situ gel group and the general preparation group, to study the preliminary pharmacokinetics. The GCF at different time points were collected by filter strips, pre-processed and measured after treated. The results fitted by WinNonlin software. The pharmacokinetic parameters between two groups were compared to determine the sustained-release effect of iodine in situ gel.Result1.We formulated a reasonable release condition and established the determination method of iodine in situ gel in vitro.2.We optimized the pharmaceutical formulation and preparation process by signal factor experiment and orthogonal test. The release in vitro results indicated that the iodine in situ gel followed first-order kinetic model, complied with Fick’s diffusion mechanism and had good sustained-release capability.3. We preliminary established the quality standard of iodine in situ gel.4. Because of the temperature-sensitive, the iodine in situ gel need be put in cool place. It’s property was stable within 12 months.5.The results indicated that the iodine in situ gel had no irritating response to oral cavity of rabbits, complied with drug safety.6.By compared with iodine glycerin group, iodine in situ gel had sustained-release effect. The drug concentration was greater than the minimum inhibitory concentration within 5 days.ConclusionThis study was prepared iodine in situ gel, the drug quality control, security, stability, achieve sustained-release results. It provides a reliable basis for clinical drug trials.