Preliminary Study On Preparation And Quality Standards Of Letland In In - Situ Gypsum

The purpose of this paper is mainly prepared in situ gel for ribavirin and anexploratory study of its in vitro release and quality criterion. In this dissertation，aseries of researches related to the ion-setting ophthalmic gel of ribavirin were carriedout，including there search of them atrixmaterial of ophthalmic in situgel and its formulation filtration，the preparation techniques，researches of quality control．And itsdrug release in vitro，stability and irritancy also be inspected．Compared to the ordinary eye drops，in situ gel can significantly improve thebioavailability，and it has a characteristic of sustained release.According to the specialphysiological and environmental conditions of the eye，the mainly investigated iscarried out which sodium alginate is suitable for as matrix material of ophthalmic insitu gel. And the concentration of it is determined by0.5%.According to the results of a series of experiments，the different components ofthe prescription eventually is determined. The in situ gel of ribavirin was preparedwith sodium chloride as buffer to regulate the pH value and osmotic pressure and withsodium polymannuronate as thickener.The quality criteria of ribavirin ophthalmic gel has been researched，includingquality characters，cheching items such as pH，identification and so on．And themethod of quantitative determination is established．The character of its appearance，pH and so on，all have met the law of ophthalmic preparation．The preliminary studyof Stability of molding preparations is carried out.According to the in vivo characteristic of ocular administration，the3rd releasedegree determination method of Chese Pharmacopoeia was used to study the releaserate．The results showed that the gel has a good sustained-release effect.The irritancy and stability of ribavirin in situ Ophthalmic gel has beenresearched．The results show that this preparation is stable in low temperature andunstable in high temperature and strong light exposure（the concentration of someingredients of this preparation has been changed and some impurity has beenproduced）．So this preparation must be stored in a dark and low temperatureenvironment．There is no apparent irritancy to rabbit eyes having been observed，andthis preparation is complied with the law of ophthalmic preparations．...