Study On Solid Dispersions Of Sofalcone

Sofalcone is a type of flavonoid and a synthetic derivate of sophoradine which is isolated from the root of the Chinese medicinal plant sophora subprostrat. It is an anti-ulcer agent with mucosa protective.The topic take developing a new dosage-form for sofalcone as a goal, through to its related physics and chemistry nature research as well as to prescription examination, a new oral solid preparation-the capsule with solid dispersion of sofalcone is made.At first, it is found that sofalcone is insoluble drug in physiologica environment of human but with good permeability of the membrane in the gastrointestinal tract through the study on the related nature of physics and chemistry research. It shows that it can be prepare a new oral administration preparation of gastro-intestinal tract absorption by solubilization technology. Setting up the topic by that, solid dispersion was studied to innovate on its dosage-form.The polyethylene glycol (PEG4000) and the polyethylene pyrrolidone (PVPk30) were firstly used as the carrier of solid dispersions of sofalcone. Then, it was found that the dissolution in vitro of the mass ratio of SD with PEG 4000(1: 8) had increased obviously. After that, it had taken the DSC method to inspecte its thermodynamics characteristic. The result showed sofalcone had been completely dispersed in PEG4000 into the amorphous state. Subsequently, it was added the surfactant to the carrier materials to reduce the total volume of carrier. Finally, we obtained the prescription for the solid dispersion: Sofalcone: PEG4000: mannitol: the polyethyleneoxide-35 castor oil mass ratio is 4: 6: 3: 1, it is the mass ratio of sofalcone and carries is 1: 1.25, the prescription reduce the 68.75% amount of the carries of the original prescription. It is taken the prescription to make capsules and to study the quality work of it.Finally, it is inspected the stability for the formulation on the basis of the quality study. The results show that the current solid dispersion of capsules are stable because the data of theirs contents is not appear ageing. It is feasibilitily for developing it into the clinical preparation.