Studies On Povidone-iodine Eye-Drop

Keratitis is one of the most common ophthalmology diseases, which is dangerous and would result in corneal perforation, atrophia bulbi, even losine one's eyesight, with a high incidence. Cornea injury and infection would relsut in keratitis and some microorganisms like bacterium, fungus, virus and mycoplasma also would cause keratitis. There are kinds of drugs to treat ophthalmology diseases, which are poor in healing and have a low membrane permeability into cornea, extremely with high toxicity. Some of them are very expensive for people to afford. So researchers are eager to find some ideal drugs to treat keratitis. Povidone-iodine(PVP-I) consists of PVP and I2, which is a broad-spectrum drug and can kill microorganisms like virus, bacterium, fungus and germ. PVP-I can release free I2, which can combond with amino acids in the tropina to make them denaturation to kill microorganisms. With good stability, low toxicity and being elutined easily, PVP-I is frequently applied in gynecology and dermatology, especially in ophthalmology. According to the rule of drug register, we took a serial studies on formula, preparation stability, pharmacodyamics and security to make a quality standard.Formula and preparation ResearchWe selected general phosphate buffer to adjust pH, add potassuim iodate to stabilize solution and adopt brown plastics vase to pack eye-drop. To investigate the stimulation of eye-drop on eyes, we screened the best tackifier with suitable concentration through HPMC,PVP and SH. Through experiments, 0.2%SH was the one we wanted and we added sufficient peppermint oil,glycerol to decrease eye stimulation. Quality standard ResearchAcccording to the requirements of preparation in ChP, we study from severial sides such as appearance, pH, identification and assaying.Stability ResearchApplying influent factors test and accelerated test to see about the stability of the preparation. The results showed that the preparation was stable to moisture and unstable under high temperature,strong light.Pharmacodynamics StudySelecting Staphylococcus aureus and Blastomyces albicans, we set up animal models to investigate the effects of PVP-I eye-drop on bacterial keratitis and mycotic keratitis. The results showed that 5.0%PVP-I was effective to both of bacterial keratitis and mycotic keratitis. There was no significant difference between 5.0%PVP-I and 2.5%PVP-I(P>0.05) for bacterial keratitis, but was signifiant difference between both of them and norfloxacin(P<0.01). Both of 5.0%PVP-I and 2.5%PVP-I are more effective than norfloxacin on bacterial keratitis. For mycotic keratitis, there was no significant differenc between 5.0%PVP-I and fluconazol(P>0.05), the same as 2.5%PVP-I and 1.0%PVP-I, but with significant difference between 5.0%PVP-I and 2.5%PVP-I,1.0%PVP-I.Eye irritation experimentIt was proved that PVP-I eye-drop has no eye irritation after washing.