贝美前列素滴眼液的抑菌效力研究

摘要

Objective:To determine the antimicrobial effectiveness of benzalkonium chlorideand explore the appropriate dosage of it in Bimatoprost Ophthalmic Solution.Methods:According to the guidance for antibacterial effectiveness test stated in appendix of Chinese Pharmacopoeia (the 2nd volume of 2010 edition), investigated the antimicrobial effect of samples with different dosage of benzalkonium chloride in the prescription and selected the appropriate dosage of antibacterial agent added.Results:The antimicrobial effects to all 5 challenge standard bacterial strains met the requirements of Chinese Pharmacopoeia when the concentration of benzalkonium chloride in Bimatoprost Ophthalmic Solutions reached 0.006%.Conclusion:Recommended concentration of benzalkonium chloride in Bimatoprost Ophthalmic Solution is 0.006%.%目的：测定贝美前列素滴眼液中苯扎氯铵的抑菌效力，探索贝美前列素滴眼液中苯扎氯铵的合理添加剂量。方法：参照《中国药典》2010年版二部附录抑菌剂效力检查法指导原则的方法，对不同配比浓度苯扎氯铵的抑菌效果进行考察，筛选出适宜的抑菌剂加入量。结果：贝美前列素滴眼液中苯扎氯铵的处方量为0.006％时，对5种挑战微生物的抑菌效力均符合药典规定。结论：贝美前列素滴眼液中苯扎氯铵的处方量建议为0.006％。