Preparation And Evaluation Of Acteoside Eye Drops

Acteoside belongs to the category of the compounds of the phenyl group,that is extract obtained from traditional Chinese medicine rehmannia root or Cistanche. Acteoside has strong antibacterial and anti-inflammatory activity. It could protect human livers from disease, relieve fatigue and other effects. There is no reports about acteoside preparation on the market so far. In this study, we prepared acteoside eye drops and evaluated them. Then, we did lot of preliminary investigations about quality control, stability test and irritation study of the eye drops.Acteoside and boric acid were used as active pharmaceutical ingredient, adjustment of pH value and osmotic pressure of eye drops, respectively. In addition, sodium alginate(SA) and ethylparaben were employed to enhance the viscosity and preservative. In order to observe the mucosal irritation and stability of acteoside eye drops, the effect of concentration of ingredients such as HPMC, PVP and SA were evaluated. After that, we detected such important parameters as pH, osmotic pressure and content of acteoside eye drops to establish to standard of quality control by HPLC. After that, three batches of eye drops were prepared and characterized in terms of accelerated stability test. Finally, irritation test of Acteoside eye drops were performed on healthy New Zealand rabbits.The formulation of acteoside eye drops is as follows: acteoside-0.5g, boric acid-1.8g, sodium alginate(SA)-1.0g and ethylparaben-0.01 g were added to water till to 100 mL. The acteoside eye drops is colorless or light yellow liquid, the pH is about 5.5, the osmotic pressure is about 320 mOsmol/Kg, which are met with requirements of “Chinese Pharmacopoeia”(2015 version). Results of stress test showed that the content of acteoside in eye drops was influenced by the strong lightness and high temperature. The results of long term stability test of acteoside eye drops showed that there was no significant change of API concentration. So it is important to choose suitable package materials to enhance stability of acteoside eye drops. Mucosal irritation test indicated that acteoside eye drops could cause slight congest in rabbit eyes and occasionally induce eye excreta. The pharmacodynamics studies of acteoside eye drops are undergoing.