氯雷他定糖浆抑菌剂考察及微生物负载评价  

Investigation of Bacteriostatic Agents in Loratadine Syrup and Evaluation of Microbial Load during Use

作　　者：孙荣嵘 张敏 曹克任 宋菁景 SUN Rong-Rong;ZHANG Min;CAO Ke-Ren;SONG Jing-Jing(Jinan Food and Drug Inspection Center,Jinan 250102,China)

机构地区：[1]济南市食品药品检验检测中心,济南250102

出　　处：《中国药物经济学》2025年第3期95-100,共6页China Journal of Pharmaceutical Economics

基　　金：山东省药品监督管理局质量风险专项([2023]187号)。

摘　　要：目的通过测定5个不同厂家氯雷他定糖浆中抑菌剂的浓度和抑菌效力,对氯雷他定糖浆中抑菌剂的使用情况进行分析评价,同时模拟日常用药对其微生物负载情况进行考察。方法采用高效液相色谱(HPLC)法测定氯雷他定糖浆中苯甲酸钠的含量,选择金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、洋葱伯克霍尔德氏菌、白色念珠菌、鲁氏酵母、黑曲霉作为试验菌株,对5个不同厂家的样品进行抑菌效力检查;在普通环境下,模拟药品使用过程中的0~42 d,在不同时间段对样品进行微生物限度检查。结果5个厂家的氯雷他定糖浆剂中苯甲酸钠的添加量为0.1%~0.3%,抑菌剂的添加量和抑菌效力均符合2020年版《中华人民共和国药典》规定,在模拟用药42 d内,样品的微生物限度检查结果均符合规定。结论氯雷他定糖浆添加0.1%苯甲酸钠时,抑菌效力可满足要求,模拟用药42 d内抑菌体系较为稳定,药品安全性良好,建议有关生产厂家可逐步完善处方配比,适当降低抑菌剂浓度,以保证药品的有效性和安全性。Objective To analyze and evaluate the use of bacteriostatic agents in loratadine syrup,the concentration and bacteriostatic efficacy of bacteriostatic agents in loratadine syrup from five different manufacturers was measured,and daily medication simulating was conducted to detect the microbial load during use.the bottles.Methods High performance liquid chromatography(HPLC)was used to determine the content of sodium benzoate in loratadine syrup.Staphylococcus aureus,Pseudomonas aeruginosa,Escherichia coli,Burkholderia cepacia,Candida albicans,Saccharomyces cerevisiae,and Aspergillus niger were selected as test strains to determine the bacteriostatic efficacy of samples from five manufacturers.Within 0~42 days of simulating the medication process in a normal environment,the microbial limit of the samples were tested at different time intervals.Results The content of sodium benzoate in loratadine syrup from different manufacturers ranged from 0.1%to 0.3%,and the addition amount and bacteriostatic efficacy of the bacteriostatic agent were in compliance with the 2020 edition of the Chinese Pharmacopoeia.Within 42 days of simulating the medication process,the microbial limit test of all samples met the requirements.Conclusion When adding 0.1%sodium benzoate to loratadine syrup,the bacteriostatic effect can meet the requirements.The bacteriostatic system is relatively stable and the drug safety is good within 42 days of simulated medication.It is recommended that manufacturers gradually improve the prescription ratio and appropriately reduce concentrations of antibacterial agents to ensure the effect and safety of the drug.

关 键 词：氯雷他定糖浆 抑菌剂 苯甲酸钠 添加量 抑菌效力 微生物负载考察 

分 类 号：R976[医药卫生—药品]