Study On The Stability Of Andrographolide Solid Dispersion

The purpose of this paper is to study the difference in the properties of andrographolide solid dispersion prepared by different carriers,and to explore the effects of the carrier on the physical and chemical properties and pharmaceutics properties of the solid dispersion,and provide a basis for the carrier selection of andrographolide solid dispersion.The properties of temperature and humidity on the stability of the andrographolide solid dispersion,and the main influencing factors in the aging process of solid dispersion,in order to provide a basis for determining the reasonable storage environment of solid dispersion.In this paper,the method of spray drying was used to prepare andrographolide solid dispersion,and using semi-crystalline polymer(polyethylene glycol 8000,poloxamer 188)and amorphous polymer(polyvinylpyrrolidone,acrylic resin,Soluplus~?)as carrier materials.The physicochemical properties and pharmaceutics properties were characterized by infrared spectroscopy,thermogravimetric analysis,differential scanning calorimetry,X-ray diffraction,scanning electron microscopy,hygroscopicity,particle size,specific surface area,pore volume and dissolution curve.The analysis results show that the intermolecular force,surface morphology,particle size,specific surface area and pore volume of crystal AG-SD and amorphous AG-SD are significantly different;The thermal stability of the crystal AG-SD is better than that of the amorphous AG-SD;the crystallinity of AG in the amorphous AG-SD is lower than that of the crystal AG-SD.The results of dissolution experiments showed that AG-PEG8000-SD,AG-Eudragit II-SD and AG-Soluplus~?-SD,were the most effective in improving the dissolution of andrographolide.rate.The effect of temperature and humidity on the stability of andrographolide solid dispersion was investigated.The prepared andrographolide solid dispersion was placed at a temperature of 40°C and 60°C and a relative humidity(RH)of(55±5)%,(75±5)%,and(95±5)%,respectively.Samples were taken in 5,15,30d.Characterized by infrared spectroscopy,thermogravimetry,differential scanning calorimetry,X-ray diffraction,water content and dissolution curve,and the effects of different humidity and temperature on the stability of andrographolide solid dispersion were compared,and how the influencing factors changed during the aging process of andrographolide solid dispersion was discussed,so as to provide a basis for determining the suitable storage environment of solid dispersion.Partial least square method and other statistical methods were used to analyze the response values of various factors affecting SD stability under different temperature and humidity conditions.Determine the order of factors affecting SD stability at different humidity and temperature,and find out the biggest inducement of affecting stability of andrographolide solid dispersion,and its aging mechanism was analyzed to provide some guiding Suggestions for storage environment of solid dispersion.