Abstract

In order to obtain the pharmaceutical information on the compatibility of mitomycin C ophthalmic solutions, we investigated the stability test for prepared eye drops and the sensory test for eye drop resolvent of mitomycin C by 5 volunteers (pharmacists). Six kinds of mitomycin C ophthalmic solutions, 0.04% mitomycin C in 5% glucose solution, isotonic sodium chloride solution, water for injection, artificial tear solution, Palitzsch buffer (pH8.0) and phosphate buffer (pH8.0) which were used postoperative instillation in the treatment of primary pterygium were used for stability test, and we observed the change in appearance, pH, osmotic pressure, and quantitatively analysed mitomycin C at regular intervals. When stored at room temperature or 5°C, in the Palitzsch buffer (pH8.0) or phosphate buffer (pH8.0), mitomycin C was comparatively stable, while in 5% glucose solution, the change was observed after 2 weeks and the concentrations of mitomycin C were reduced to 69.0%, 85.4% respectively. The stability of mitomycin C was influenced by the pH of the solutions, the degradation constant (k) of mitomycin C at 30°C was pH8.0< pH7.0< pH9.0< pH6.0< pH5.0.From the results of sensory test, all the 5 volunteers felt obvious stimulations in eyes by water for injection.

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