色甘酸钠滴眼液中抑菌剂的考察  

Study on the Bacteriostatic Agents in Sodium Cromoglicate Eye Drops

作　　者：田向斌 崔毓城 牟建平 张玉娟 张晓明 TIAN Xiang-bin;CUI Yu-cheng;MU Jian-ping;ZHANG Yu-juan;ZHANG Xiao-ming(Gansu Institute for Drug Control,Lanzhou 730070,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070

出　　处：《海峡药学》2023年第9期34-38,共5页Strait Pharmaceutical Journal

摘　　要：目的建立同时测定10种抑菌剂的高效液相色谱(HPLC)梯度洗脱方法,对48批样品进行测定,考察国产色甘酸钠滴眼剂中抑菌剂的种类以及使用剂量,结合色甘酸钠滴眼剂中抑菌剂的抑菌效力测定结果,分析抑菌剂使用的合理性。方法抑菌剂测定方法Agela Technologies,Venusil MP C_(18)(4.6 mm×250 mm,5μm)色谱柱;以:0.1 mol·L^(-1)磷酸二氢钠(用磷酸调节pH值至3.7)(A)-乙腈(B)为流动相,梯度洗脱,流速1.0 mL·min^(-1),柱温:35℃,检测波长214 nm。抑菌效力按照《中国药典》2020年版要求测定和判断抑菌效力。结果同时测定滴眼液中10种抑菌剂的HPLC梯度洗脱方法经方法学试验,均符合药典要求;测定的抑菌剂种类与说明书标示种类一致,抑菌剂浓度在0.02%~0.05%之间;色甘酸钠滴眼液的抑菌效力均达不到药典要求。结论该方法可用于色甘酸钠滴眼液中抑菌剂的筛查。色甘酸钠滴眼液的抑菌效力未达到药典要求,抑菌剂的合理性有待进一步研究。OBJECTIVE To establish a HPLC gradient method for simultaneous determination of 10 antibacterial agents.48 batches of samples were determined to investigate the types and dosages of bacteriostatic agents in domestic sodium cromoglicate eye drops.To analyze the rationality of the bacteriostatic agent in sodium cromoglicate eye drops according to the results of the bacteriostatic efficacy of the bacteriostatic agent.METHODS The HPLC gradient method was performed on Agela Technologies Venusil MP C_(18)column(4.6 mm×250 mm,5μm)with mobile phase consisted of 0.1 mol·L^(-1)sodium dihydrogen phosphate solution(the pH value was adiusted to 3.7 by phosphoric acid)acetonitril with the flow rate of 1.0 mL·min^(-1).The column temperature was 35℃,and the detection wavelength was set at 214 nm.The antibacterial effect was determined and judged according to Chinese Pharmacopoeia(2020 Edition).RESULTS The HPLC Gradient elution method for 10 kinds of antimicrobial agents showed good linear relationship,the precision,stability,limit of detection,limit of quantitation and recovery all meet the requirements of Pharmacopoeia,the method is feasible.The type of antibacterial agent determined was consistent with drug instructions,and the concentration of antibacterial agent ranged from 0.02%to 0.05%.The antibacterial effect of sodium cromoglicate eye drops can not meet the requirements of Pharmacopoeia.CONCLUSION This method can be used to screen antimicrobial agents in sodium cromoglicate eye drops.The antibacterial effect of sodium cromoglicate eye drops can not meet the requirements of Pharmacopoeia,and the rationality of the antibacterial agent needs to be further studied.

关 键 词：色甘酸滴眼剂 抑菌剂 高效液相色谱 抑菌效力 合理性 

分 类 号：R927[医药卫生—药学]