小儿止咳糖浆苯甲酸钠处方添加量及抑菌效力评估

Evaluation of Prescription Addition and Bacteriostatic Efficacy of Sodium Benzoate in Xiaoer Zhike Syrup

目的评估不同厂家小儿止咳糖浆中抑菌剂苯甲酸钠的添加量。方法采用高效液相色谱(HPLC)法测定小儿止咳糖浆中苯甲酸钠含量,色谱柱为Woburn Stamsil C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.05 mol/L乙酸铵(5∶95,V/V),流速为1 m L/min,检测波长为230 nm,柱温为30℃。按2020年版《中国药典(四部)》选择金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、白色念珠菌、鲁氏酵母菌、黑曲霉,加入样品进行抑菌效力试验,检测微生物在不同时间段的存活情况。结果苯甲酸钠质量浓度在0.2126~1.2756μg/m L范围内与峰面积线性关系良好,精密度、稳定性、重复性试验的RSD均小于1%(n=6);不同厂家、批次样品抑菌剂的种类、添加量、抑菌效力均符合2020年版《中国药典》规定;苯甲酸钠添加量为0.2%时,14 d内细菌、真菌数量下降的lg值均符合标准规定,28 d内细菌、真菌数量的lg值均未增加。结论添加0.2%苯甲酸钠作为小儿止咳糖浆的抑菌剂,抑菌效果较好,且能保证产品的安全性和有效性。

Objective To evaluate the addition of antibacterial agent sodium benzoate in Xiaoer Zhike Syrup from different manufacturers.Methods The content of sodium benzoate in Xiaoer Zhike Syrup was determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Woburn Stamsil C18 column(250 mm×4.6 mm,5μm),the mobile phase was methanol-0.05 mol/L ammonium acetate(5∶95,V/V),the flow rate was 1 m L/min,the detection wavelength was 230 nm,and the column temperature was 30℃.According to the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa,Candida albicans,Saccharomyces routeri and Aspergillus niger were selected and added to the samples for bacteriostatic efficacy test to detect the survival of microorganisms in different periods.Results The linear range of sodium benzoate was 0.2126-1.2756μg/m L.The RSDs of precision,stability and repeatability tests were less than 1%(n=6).The type,addition amount and bacteriostatic efficacy of bacteriostatic agents from different manufacturers or batches of samples met the requirements of the Chinese Pharmacopoeia(2020 Edition).When the addition of sodium benzoate was 0.2%,the lg value of the decrease of bacteria and fungi within 14 d could meet the standard,but the lg value of the decrease of bacteria and fungi within 28 d did not increase.Conclusion Adding 0.2%sodium benzoate as the bacteriostatic agent of Xiaoer Zhike Syrup has a good bacteriostatic efficacy,which can ensure the safety and effectiveness of Xiaoer Zhike Syrup.