Studies On The Application Of Konjac Glucomannan As The Carrier Materials In Sustained Release Matrix Tablet

Matrix tablet is the main kind of sustained-release preparation;it is a lamellar solid preparttion made by the technology of spring clip from the mixture of drug,one or more kind of matrix material and other adjuvants.With the characteristic of simply technology of spring clip, safe,and easy to be grouped, matrix tablet play an important role in the development of sustained-release preparation.At present,the simplest sustained-release and controlled release materials can be divided into natural and synthetic materials according to the origin and the nature. to the origin the materials.Compared with the synthetic materials,the natural material is economic,and its security has been confirmed by the long-term use and so on merits characteristic.Konjac glucomannan(KGM) is a high-molecular weight water-soluble non-ionic polysaccharide derived from tubers of Amorphophallus rivieri. It has been used in food and pharmaceutical industry and so on. The resource and yield of Amorphophallus rivieri in our country are the richest and the biggest of the world, but it is deficient for its futher processing and application. So the key to make full use of its resource is that how to develop its new application.The physical constants of KGM which have different viscosity specification were studied by measuring the angle and critical relative humidity in this thesis,and the result is that,all the three kind of viscosity specification's KGM have met the requirements of the powder direct sheeting requirement. The solubility increases along with the viscosity reduces, the solubility of KGM increases along with the viscosity reduces while the swelling capacity increases . The pH value of the medium and the ionic strength has little effect on the solubility and the swelling capacity of KGM. With an environment humidity over 75%, the KGM hygroscopic moisture content increases obviously;It is found that the drug and the supplementary material has no interaction, through the different scanning calorimetry analysis between the medicine and the supplementary material.The ultraviolet spectrophotometric method has been established to test the solubility of model medicine,the amount of the drug release in vitro ,and to determinate the content of the main medicine in different media, the skeleton piece release and the main medicine content.Water-soluble drug aminophylline and the infusibile drug aspirin were selected as the model drug, hydrophilic matrix tablets meet the requirement of in vitro release were made by direct powder compression and the wet legal system grain of sheeting with different prescription,the effect of prescription composition,the preparation craft and in vitro release condition to the drug release from hydrophilic matrix tablet.Different test methods,pH values of dissolution media,rotation speeds,the type and the amount of assist gels,the ratio of gels and assist gels,the amount of matrix materials, the kind of bulking agent,ionic strength of dissolution media,the amount of Eudragit L100 all has the significance influence on the drug release of both Water-soluble drug and the infusibility drug have a great impact.Lactose and MCC can accelerate the rate of drug release,but have no significant influence.The particle size of KGM and the model drug, technology of spring clip,pressure of spring clip have the same influence on the drug release.The amount of drug release was confirmed in different mathematical model, calculate the AIC value ,base on the AIC value smallest method, the release of drug exhibited Peppas equation.Uses of the weight method to calculate the swelling index,water uptake,polymer eroded,to study the release mechanism of drug from hydrophilic matrix tablets though the fitting parameter of Peppas equation.It is found that the release mechanism of drug from hydrophilic matrix tablets is non-Fickian release that coupled diffusion and erosion model.The results of stability test indicated that the hydrophilic matrix tablets were stable under acceleration conditions for 6 months.In vitro release tests have indicated that KGM has good sustained release character, it is better to use KGM couple together with natural polymer than synthetical polymer ,KGM can be used in sustained delivery systems as a good candidate for hydrophilic polymer.