Yanhong Sun1, Yinhuan Wang2, Jianming Zhou1, Qingxue Zhou3, Shilei Dong4. 1. Department of Clinical Laboratory, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou 310052, China. 2. NMPA Key Laboratory for Testing and Warning of Pharmaceutical Microbiology, Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China. 3. Department of Clinical Laboratory, Hangzhou Maternity Hospital, Hangzhou 310008, China. 4. Department of Clinical Laboratory, Zhejiang Hospital, Hangzhou 310013, China.
Abstract
OBJECTIVE: To explore the optimal concentration and antimicrobial effectiveness of antimicrobial preservative in betastatin besylate nasal spray. METHODS: By using Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus niger as test strains, the antimicrobial effectiveness of betastatin besylate nasal spray containing different concentrations of antimicrobial preservative (0.02%, 0.0125%, and 0.005% benzalkonium chloride, respectively) was determined by using bacteriostatic effect test (Chinese Pharmacopoeia, 2015 edition). RESULTS: The antimicrobial effectiveness of betastatin besylate nasal spray containing 0.02% and 0.0125% benzalkonium chloride, respectively, complied with the regulations of Chinese Pharmacopoeia (2015 Edition) against five test strains. However, the antimicrobial effectiveness of betastatin besylate nasal spray containing 0.005% benzalkonium chloride against P. aeruginosa did not meet the requirements of Chinese Pharmacopoeia. CONCLUSION: Benzalkonium chloride at a concentration of 0.125% can be used as an added antimicrobial preservative in betastatin besylate nasal spray.
OBJECTIVE: To explore the optimal concentration and antimicrobial effectiveness of antimicrobial preservative in betastatin besylate nasal spray. METHODS: By using Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus niger as test strains, the antimicrobial effectiveness of betastatin besylate nasal spray containing different concentrations of antimicrobial preservative (0.02%, 0.0125%, and 0.005% benzalkonium chloride, respectively) was determined by using bacteriostatic effect test (Chinese Pharmacopoeia, 2015 edition). RESULTS: The antimicrobial effectiveness of betastatin besylate nasal spray containing 0.02% and 0.0125% benzalkonium chloride, respectively, complied with the regulations of Chinese Pharmacopoeia (2015 Edition) against five test strains. However, the antimicrobial effectiveness of betastatin besylate nasal spray containing 0.005% benzalkonium chloride against P. aeruginosa did not meet the requirements of Chinese Pharmacopoeia. CONCLUSION: Benzalkonium chloride at a concentration of 0.125% can be used as an added antimicrobial preservative in betastatin besylate nasal spray.
Authors: M De Saint Jean; F Brignole; A F Bringuier; A Bauchet; G Feldmann; C Baudouin Journal: Invest Ophthalmol Vis Sci Date: 1999-03 Impact factor: 4.799