| 引用本文: | 刘冰滢,吴伟平,张丽君,薛巧如,穆矛.玻璃酸钠滴眼液中6种抑菌剂及抑菌效力的测定[J].中国现代应用药学,2025,42(8):15-20. |
| Liubingying,Wu Weiping,Zhang Lijun,Xue Qiaoru,Mu Mao.Determination of 6 preservatives and antibacterial efficacy in sodium hyaluronate eye drops[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(8):15-20. |
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| 摘要: |
| 目的 建立超高效液相色谱法同时测定玻璃酸钠滴眼液中6种常用抑菌剂的含量,并对其抑菌效力进行研究。对不含抑菌剂的多剂量样品阻菌效力进行了考察。方法 色谱柱为C18柱,流动相为0.1%磷酸溶液和5%四氢呋喃甲醇溶液,梯度洗脱；检测波长为214nm。按《中国药典》测定抑菌效力；不含抑菌剂的玻璃酸钠滴眼液开封后模拟日常使用,并分时段取样进行微生物检查。结果 三个厂家九批样品抑菌剂种类和含量与与标示一致,抑菌效力符合规定；不含抑菌剂的样品开封后四周内均无微生物生长。结论 该方法操作简便、快速,结果准确,重复性好。不同企业抑菌剂含量相差较大,建议企业在处方筛选时应对抑菌剂的最低有效浓度进行考察；阻菌瓶能有效防止微生物污染。 |
| 关键词: 超高液相色谱法 抑菌剂 玻璃酸钠滴眼液 抑菌效力,阻菌瓶 |
| DOI： |
| 分类号:R284.1；R917.101?????? |
| 基金项目:广东省医学科学技术研究基金(B2021404；B2020198),广东省药品监督管理局科技创新项目(2022TDZ203；2022TDB02),广东省药品检验所所内项目(SN2022022；SN2022003) |
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| Determination of 6 preservatives and antibacterial efficacy in sodium hyaluronate eye drops |
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Liubingying, Wu Weiping, Zhang Lijun, Xue Qiaoru, Mu Mao
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广东省药品检验所
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| Abstract: |
| ABSTRACT: OBJECTIVE To establish an ultra-high performance liquid chromatography method for the determination of six preservatives in sodium hyaluronate eye drops and assess their antimicrobial effectiveness. The microbial contamination of multi-dose sodium hyaluronate eye drops without bacteriostatic agent was investigated. METHODS The determination was performed on a C18 column with mobile phases consisting of 0.1% phosphoric acid solution and 5% tetrahydrofuran methanol solution. The antibacterial efficacy of sodium hyaluronate eye drops were examined according to the antibacterial efficacy inspection method of Chinese Pharmacopoeia. The sodium hyaluronate eye drops without preservatives was simulated for daily use, and aseptic samples were taken within the validity period after opening for microbial inspection. RESULTS The types and contents of preservatives in nine batches of samples from three manufacturers were consistent with the label, and the antibacterial efficacy met the regulations; the samples without preservatives showed no microbial growth within four weeks after opening. CONCLUSION The method is simple, accurate and stable, and can be used for simultaneous determination of 6 preservatives in sodium hyaluronate eye drops. The content of preservatives in different enterprises varies greatly, and it is recommended that enterprises should investigate the minimum effective concentration of preservatives when screening prescriptions. Bacteria-resistant bottles can effectively prevent microbial contamination. |
| Key words: UPLC preservatives sodium hyaluronate eye drops antibacterial efficacy bacteria-resistant bottles |
