基于国家药品抽检的布洛芬混悬液中抑菌剂含量测定及评价  

Evaluation and determination of preservatives contents in ibuprofen suspension based on national drug sampling

作　　者：章娟[1] 丁怡[1] 石颖 ZHANG Juan;DING Yi;SHI Ying(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《沈阳药科大学学报》2023年第12期1608-1613,共6页Journal of Shenyang Pharmaceutical University

基　　金：广东省药品监督管理局科技创新资助项目(2020ZDB06);广州市科技计划资助项目(202201011739)。

摘　　要：目的 对国家药品抽检品种布洛芬混悬液中苯甲酸钠、山梨酸、羟苯甲酯、羟苯乙酯、羟苯丙酯和羟苯丁酯6种抑菌剂进行监测、分析和评估,以期为国家药品监管提供参考,确保公众用药安全。方法 采用ZORBAX SB C_(18)(250 mm×4.6 mm, 5μm)色谱柱,以浓度为0.01 mol·L^(-1)乙酸铵溶液(用氨试液调pH值至8.0)为流动相A,甲醇为流动相B,梯度洗脱,检测波长分别为230 nm和254 nm,流速为1.0 mL·min^(-1)。结果 苯甲酸钠、山梨酸、羟苯甲酯、羟苯乙酯、羟苯丙酯和羟苯丁酯等6种抑菌剂分别在0.644 8~161.2、0.237 1~47.43、0.314 9~52.48、0.203 4~50.85、0.218 0~54.49μg·mL^(-1)和0.208 3~52.07μg·mL^(-1)浓度范围内与峰面积呈良好的线性关系;平均回收率在99.4%~100.8%之间,RSD在0.2%~1.7%之间(n=9);对市售8个企业共61批样品进行抑菌剂的含量测定。结论 本实验建立的分析方法专属性强、灵敏度高、适用性好,首次应用于国家药品抽检品种61批布洛芬混悬液抑菌剂的质量控制和评价分析。Objective To establish an HPLC method for screening analysis of six preservatives in ibuprofen suspension based on national drug sampling, to provide a reference for administrative supervision and improve public medication safety.Methods The chromatography was performed on ZORBAX SB C_(18) column(250 mm×4.6 mm, 5 μm),0.01 mL·min^(-1) ammonium acetate solution(adjust the pH to 8.0 with ammonia TS)was used as mobile phase A and methanol as mobile phase B in gradient elution mode at a flow rate of 1.0 mL·min^(-1).The detection wavelengths were 230 nm and 254 nm.Results Sodium benzoate, sorbic acid, methylparaben, ethylparaben, propylparaben and butyl-p-hydroxybenzoate showed good linear relationships with the peak area in the concentration range of 0.644 8-161.2,0.237 1-47.43,0.314 9-52.48,0.203 4-50.85,0.218 0-54.49 μg·mL^(-1) and 0.208 3-52.07 μg·mL^(-1).The average recoveries were 99.4%-100.8% with an RSD of 0.2%-1.7%(n=9).The contents of preservatives in 61 samples from 8 manufacturers were determined.Conclusion The proposed HPLC method shows good specificity, accuracy and serviceability.It can be successfully applied in quality control and evaluation of preservatives in 61 batches of ibuprofen suspensions based on national drug sampling.

关 键 词：布洛芬混悬液 高效液相色谱法 抑菌剂 含量 质量控制 

分 类 号：R917[医药卫生—药物分析学]