Study on the Preservatives-effectiveness of Pirenoxine Ophthalmic Solution

OBJECTIVE To study the evaluation of preservatives-effectiveness of pirenoxine ophthalmic solution respectively by the Ch.P (2010) and the general public draft 1121 of Ch.P (2015). METHODS using Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Aspergillus and Candida albicans as test strains, the colony-count method validation was studied. According to the verified method, the preservation efficacy test was carried out, the number of colony at each point was determined. RESULTS the effect of bacteriostatic agent of pirenoxine ophthalmic solution was confoumable to the standard of Ch.P (2010), but was not confoumable to the standard of the general public draft 1121 of Ch.P (2015). CONCLUSION there are great differences for the estimate standard of preservatives-effectiveness between the Ch.P (2010) and the general public draft 1121 of Ch.P (2015), and the preservatives-effectiveness in part of the listed varieties do not meet requirement of the latter.