滴眼液中抑菌剂的快速高通量测定及抑菌效力的研究初探

发布时间：2018-11-08 12:13

【摘要】：目的建立快速高通量测定滴眼液中10个抑菌剂(氯己定、苯甲醇、三氯叔丁醇、山梨酸、苯甲酸、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、硫柳汞和苯扎氯铵)的高效液相色谱方法并探索其抑菌效力。方法色谱柱为Waters XBridge C_(18)(4.6 mm×150 mm,5μm);流动相为0.1%磷酸溶液-甲醇-四氢呋喃;梯度洗脱,流速为1.0 m L·min~(-1);检测波长为214 nm;对两种滴眼液的抑菌效力进行评价。结果 10个抑菌剂的峰面积与浓度线性关系良好(r为0.999 3~1.000 0),加样回收率为96.1%~101.8%。一种滴眼液抑菌效力不符合规定。结论建立的高通量测定方法简便快速,准确,重复性好,样品基质等几乎不干扰测定,可用于滴眼液中抑菌剂的快速高通量测定。研发过程中应对抑菌剂的添加剂量进行处方筛选或进行最低抑菌效力考察代替经验值。
[Abstract]:Objective to establish a rapid and high-throughput determination of 10 antimicrobial agents (chlorhexidine, benzyl alcohol, trichlorotert-butanol, sorbic acid, benzoic acid, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate) in eye drops. High performance liquid chromatography (HPLC) of thiomersal and benzalkonium chloride and its bacteriostasis. Methods Waters XBridge C _ (18) (4.6 mm 脳 150 mm,5 渭 m);) column was used as mobile phase, 0.1% phosphoric acid solution-methanol-tetrahydrofuran, gradient elution, flow rate 1.0 mL min~ (-1), detection wavelength 214 nm;. The bacteriostatic effect of two kinds of eye drops was evaluated. Results the linear relationship between peak area and concentration of 10 antimicrobial agents was good (r = 0.999), and the recovery rate was 96.1% and 101.8% respectively. A kind of eye drops does not conform to the regulation of bacteriostatic effect. Conclusion the established method is simple, rapid, accurate and reproducible, and can be used for the rapid determination of antimicrobial agents in eye drops. In the process of research and development, the dosage of additives should be screened or the minimum bacteriostatic efficacy should be tested instead of empirical value.
【作者单位】：上海市食品药品检验所;复旦大学化学系;
【分类号】：R927

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