论文部分内容阅读
目的:考察色甘酸钠滴眼液中抑菌剂对羟基苯甲酸乙酯(尼泊金乙酯)浓度的合理性。方法:采用Agilent HC-C18色谱柱(250 mm×4.6 mm,5μm),以0.005 mol·L-1醋酸铵溶液(每1000 mL中含三乙胺10 mL,用冰醋酸调pH5.0±0.5)-乙腈(50∶50)为流动相,流速1.0 mL·min-1,检测波长256 nm,对色甘酸钠滴眼液中抑菌剂对羟基苯甲酸乙酯浓度的测定;选择有代表性的微生物金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念珠菌、黑曲霉,在色甘酸钠滴眼液样品中加入含不同量对羟基苯甲酸乙酯后进行抑菌效力测定。结果:采用RP-HPLC法对羟基苯甲酸乙酯浓度在0.31~310μg·mL-1范围内线性关系良好(r=0.9999),平均回收率(n=6)为99.3%,RSD=0.75%;样品中对羟基苯甲酸乙酯浓度为0.024%不能符合中国药典中抑菌效力判断标准,而浓度为0.06%对上述的5种菌有良好的抑制作用,为最低有效剂量。结论:RP-HPLC法能准确地测定色甘酸钠滴眼液中对羟基苯甲酸乙酯,浓度0.06%为其滴眼液中最低有效抑菌浓度。
Objective: To investigate the rationality of antibacterial agent ethylparaben (ethylparaben) in sodium cromoglycate eye drops. METHODS: The samples were separated on a Agilent HC-C18 column (250 mm × 4.6 mm, 5 μm) with 0.005 mol·L-1 ammonium acetate solution (10 mL of triethylamine in 1000 mL and pH 5.0 ± 0.5 ) -acetonitrile (50:50) as the mobile phase at a flow rate of 1.0 mL · min-1 at a detection wavelength of 256 nm. The concentration of ethyl p-hydroxybenzoate in cromolyn sodium eye drops was determined. A representative Of the microorganisms Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Aspergillus niger, in cromolyn sodium eye drops samples containing different amounts of ethyl p-hydroxybenzoate antibacterial efficacy was determined . Results: The RP - HPLC method showed good linearity (r = 0.9999) for the concentration of ethylparaben in the range of 0.31 ~ 310μg · mL-1. The average recovery was 99.3% and the RSD was 0.75%. The concentration of p-hydroxybenzoate in the sample was 0.024%, which could not meet the criteria of antibacterial activity in Chinese Pharmacopoeia. However, the concentration of ethyl p-hydroxybenzoate was 0.06%, which showed good inhibitory effect on the above five kinds of bacteria. Conclusion: RP-HPLC method can accurately determine cromolyn sodium eye drops ethyl p-hydroxybenzoate, the concentration of 0.06% for the eye drops the lowest effective inhibitory concentration.