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引用本文:江志杰,高春.玻璃酸钠滴眼液抑菌效力的评价[J].中国现代应用药学,2013,30(7):788-792.
JIANG Zhijie,GAO Chun.Study on the Bacteriostatic Effect of Sodium Hyaluronate Eye Drops[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(7):788-792.
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玻璃酸钠滴眼液抑菌效力的评价
江志杰, 高春
北京市药品检验所,北京 100035
摘要:
目的 测定3个厂家生产的玻璃酸钠滴眼液的抑菌效力。方法 以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、黑曲霉和白色念珠菌为试验菌株,进行菌落计数方法学验证,然后进行微生物的挑战试验,按验证方法测定各时间点的菌落数。结果 3个厂家的玻璃酸钠抑菌系统稳定,各测定时间点符合药典要求。结论 采用该方法可有效地判定眼用制剂的抑菌效力。
关键词:  玻璃酸钠滴眼液  抑菌效力
DOI:
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基金项目:
Study on the Bacteriostatic Effect of Sodium Hyaluronate Eye Drops
JIANG Zhijie, GAO Chun
Beijing Institute for Drug Control, Beijing 100035, China
Abstract:
OBJECTIVE To evaluate the bacteriostatic effect of sodium hyaluronate eye drops from three manufacturers. METHODS Using Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Candida albicans and Aspergillus niger as test strains, the colony-count method validation was studied. According to the verified method, the microbial challenge test was carried out, the number of colony at each point was determined. RESULTS The antibacterial system was stable, each measured time point in line met pharmacopoeia specified requirements. CONCLUSION Using of the method can effectively determine the bacteriostatic effect of ophthalmic preparations.
Key words:  sodium hyaluronate eye drops  bacteriostatic potency
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