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作 者:王领 汤湛[1] 王俏[1] WANG Ling;TANG Zhan;WANG Qiao(Institute of Materia Medica, Zhejiang Academy of Medical Sciences, Hangzhou ZHEJIA NG 310013, China)
机构地区:[1]浙江省医学科学院药物研究所,浙江杭州310013
出 处:《中国新药与临床杂志》2017年第12期693-700,共8页Chinese Journal of New Drugs and Clinical Remedies
基 金:浙江省科技计划项目(2017F30005);浙江省公益基金项目(2016C37074)
摘 要:多剂量滴眼剂往往需要添加抑菌剂以达到无菌的要求,但越来越多的研究表明抑菌剂会对眼组织造成损伤。因此如何做到既可避免滴眼液受到微生物的污染,又能减轻抑菌剂对眼组织的伤害是滴眼剂研究者必须考虑的问题。2015版中国药典明确要求滴眼剂必须通过抑菌效力评价,确定合理的抑菌剂浓度。开发使用新型低毒抑菌剂、通过添加具有黏膜黏附性大分子或增溶剂从而降低给药频率、添加高分子聚合物保护眼组织及改进无抑菌剂滴眼剂瓶设计等几个方面是滴眼液抑菌增效的研究方向。Multiple dose eye drops are often required to add antibacterial agents to meet the requirements of sterility, but more and more studies have showed that antibacterial agents can damage the ocular tissues. So how to balance the microbial contamination of eye drops and the lesion of ocular tissues caused by bacteriostatic agent is a question that eye drops researchers must consider. The 2015 edition of the Chinese Pharmacopoeia requires that the reasonable concentration of antibacterial agent must be determined by the method of evaluation of bacteriostatic efficacy. Development of new low toxicity of antibacterial agents, application of mucosal adhesion molecules or the solubilizing agent to reduce dosing frequency, addition of polymer to protect ocular tissues and improvement of bottle design of eye drops without antibacterial agents are the directions of antibacterial and synergistic research of eye drops.
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