Survey on the preservatives used in domestic ofloxacin eye drops
Pages: 516-520
Year: 2017 Issue: 6
Journal: Chinese Journal of Antibiotics
Abstract: Objective To have a full view of the domestic eye drops from the studies of the domestic ofloxacin eye drops and discuss the formula screening procedure and quality control of preservatives during the research and development of a certain eye drop formula.Methods The types and amounts of preservatives in 122 bacthes of ofloxacin eye drops from 28 manufactures have been determined according to the methods of ofloxacin eye drop and acyclovir eye drop adopted in Pharmacopeia of Republic of China 2010 (ChP2010).Antimicrobial efficacy of twentyeight formulas meet the standards required in ChP2010 Appendix XIXN.Results Four formulas out of twentyeight had no preservatives.Sixteen of twenty-eight employ the quaternary ammonium salt,and had a wide range of concentrations.Six of twenty-eight use the parabens,one formula use thiomersal,and one formula use chloretone.Preservatives in most of the 122 bacthes have a content of 80％～120％ of the claimed amount.All formulas had a good antimicrobial efficacy.Conclusion Varieties of preservatives with excessive quantity are used in domestic ofloxacin eye drops.The current formulas have much room for improvement.There should be efficacy evaluation for the microbe and physicochemical control during the eye drops formula screening procedure.
Year: 2017 Issue: 6
Journal: Chinese Journal of Antibiotics
Abstract: Objective To have a full view of the domestic eye drops from the studies of the domestic ofloxacin eye drops and discuss the formula screening procedure and quality control of preservatives during the research and development of a certain eye drop formula.Methods The types and amounts of preservatives in 122 bacthes of ofloxacin eye drops from 28 manufactures have been determined according to the methods of ofloxacin eye drop and acyclovir eye drop adopted in Pharmacopeia of Republic of China 2010 (ChP2010).Antimicrobial efficacy of twentyeight formulas meet the standards required in ChP2010 Appendix XIXN.Results Four formulas out of twentyeight had no preservatives.Sixteen of twenty-eight employ the quaternary ammonium salt,and had a wide range of concentrations.Six of twenty-eight use the parabens,one formula use thiomersal,and one formula use chloretone.Preservatives in most of the 122 bacthes have a content of 80％～120％ of the claimed amount.All formulas had a good antimicrobial efficacy.Conclusion Varieties of preservatives with excessive quantity are used in domestic ofloxacin eye drops.The current formulas have much room for improvement.There should be efficacy evaluation for the microbe and physicochemical control during the eye drops formula screening procedure.
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