Abstract
This research is to study on preparation and characterization of diclofenac sodium β-cyclodextrin (DS-β-CD) inclusion complex eye drops in order to improve the solubility of diclofenac sodium (DS) and reduce the irritation of DS eye drops in the market. First, DS-β-CD inclusion complex was prepared by co-precipitation method and then mixed with excipients to prepare inclusion complex eye drops. Finally, instruments were used to determine the basic properties of eye drops and animal experiments were used to investigate the irritation of the DS-β-CD inclusion complex eye drops. The drug content, the encapsulation efficiency and the yield of DS-β-CD inclusion complex were respectively 17.11, 84.20 and 60.00%. And the DS-β-CD inclusion complex was identified by FTIR, DSC, XRD and 1HNMR. The solubility of the inclusion complex was 20 times more than DS. The pH value, the osmotic pressure, the viscosity and the drug content of the eye drops were respectively 7.20, 298 mosmol/kg, 4.88 mPa s and 97.98%. In brief, DS-β-CD inclusion complex eye drops had stable properties, high solubility and the test items met the requirements. The eye drops were almost non-irritating, significantly reducing the irritation of the original prescription (P < 0.01).
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