复方大青叶合剂中苯甲酸钠的含量测定  

Determination of Sodium Benzoate in Compound Daqingye Mixture

作　　者：耿燕楠[1] 王蒙蒙 鞠建峰[1] 韩丽丽 GENG Yan-nan;WANG Meng-meng;JU Jian-feng;HAN Li-li(Shandong Provincial Hospital of Chinese Medicine,Jinan 250014,China;Weifang Inspection Test Center,Weifang 261000,China)

机构地区：[1]山东中医药大学附属医院,山东济南250014 [2]潍坊市检验检测中心,山东潍坊261000

出　　处：《食品与药品》2025年第2期169-172,共4页Food and Drug

基　　金：山东省药品不良反应监测中心委托项目(编号:2023SDADRKY47)。

摘　　要：目的 建立复方大青叶合剂中苯甲酸钠的含量测定方法,并对不同生产企业制剂苯甲酸钠的使用情况进行考察,为其质量控制提供依据。方法 用高效液相色谱法(HPLC)对不同生产企业38批次复方大青叶合剂中苯甲酸钠进行测定。色谱柱为岛津Shim-pack GIST C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.02%甲酸(30:70),检测波长为230 nm。结果 苯甲酸钠在0.136~0.682 mg/ml范围内线性关系良好(R2=0.9999),精密度、重复性均符合要求,平均加样回收率为96.2%,RSD为1.4%(n=6)。38批次样品中苯甲酸钠的含量为1.34~2.91 mg/ml。部分批次不符合《中国药典》2020年版一部中复方大青叶合剂工艺投料要求。结论 该法准确,操作简便,能有效测定复方大青叶合剂中苯甲酸钠的含量。部分批次样品中苯甲酸钠含量差异较大,是否对制剂稳定性存在影响,尚待进一步研究。有必要考察其最佳用量,制定合理的用量范围,保证用药安全、有效。Objective To establish a method for determination of sodium benzoate in Compound Daqingye Mixture and investigate its usage in preparations from different manufacturers,thereby provide reference for quality control.Methods HPLC was employed to determine sodium benzoate in 38 batches of Compound Daqingye Mixture from various manufacturers.Shimadzu Shim-pack GIST C18(250 mm×4.6 mm,5μm) was adopted,using acetonitrile-0.02% formic acid(30:70) as mobile phase.The detection wavelength was set at 230 nm.Results Sodium benzoate showed good linearity within the range of 0.136-0.682 mg/ml(R2=0.9999).The precision and repeatability met requirements,with an average recovery rate of 96.2 % and RSD of 1.4 %(n=6).The content of sodium benzoate in 38 batches of samples ranged from 1.34 mg/ml to 2.91 mg/ml.Some batches failed to comply with the manufacturing process requirements specified in Chinese Pharmacopoeia(2020 Edition,Part I).Conclusion This method is accurate and easy to operate for determination of sodium benzoate in Compound Daqingye Mixture.The content of sodium benzoate in some batches of samples is significantly different,and further research is needed to determine whether it affects the stability of the products.It is necessary to explore its optimal dosage and establish reasonable dosage range to ensure medication safety and efficacy.

关 键 词：复方大青叶合剂 苯甲酸钠 含量测定 质量控制 

分 类 号：R927.1[医药卫生—药学]