强力枇杷露抑菌效力的影响因素考察  

Study on Influence Factors of Bacteriostatic Effect of Qiangli Pipa Syrup

作　　者：张静 熊乐乐 章瑛 张春华 熊蔚 ZHANG Jing;XIONG Lele;ZHANG Ying;ZHANG Chunhua;XIONG Wei(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2023年第2期143-146,共4页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2020JS18)。

摘　　要：目的对不同企业强力枇杷露的抑菌效力进行研究,探索样品pH值、水活度、有效期等不同因素对抑菌剂苯甲酸钠抑菌效力的影响。方法按2020年版《中国药典》四部通则1121抑菌效力检查法对不同有效期、不同pH值、不同水活度的强力枇杷露进行抑菌效力实验。自制阴性样品,使用枸橼酸调节pH、蔗糖调节水活度,以此考察不同条件下强力枇杷露中苯甲酸钠抑菌效力的不同。结果不同有效期、pH值、水活度的强力枇杷露均通过抑菌效力实验。当阴性样品pH低于4.5时,苯甲酸钠添加浓度为0.2%即可通过抑菌效力检查;当阴性样品pH高于4.5、水活度低于0.95时,抑菌剂添加浓度为0.2%也可通过抑菌效力检查。结论不同有效期对抑菌效力影响不大,pH和水活度对添加的抑菌剂抑菌效力影响较大;强力枇杷露中抑菌剂苯甲酸钠受样品p H和水活度影响较大,pH越高抑菌效力越低,水活度越低抑菌效力越高。Objective To study the bacteriostatic efficacy of qiangli pipa syrup from different enterprises,and explore the influence of different factors such as pH value,water activity and term of validity on the bacteriostatic efficacy of sodium benzoate.Methods The bacteriostatic efficacy of qiangli pipa syrup with different term of validity,different pH value and different water activity was tested according to the bacteriostatic efficacy test method of general rule 1121 of Volume Ⅳ of Chinese Pharmacopoeia(Edition 2020).For homemade negative samples,citrate acid was used to adjust pH and sucrose to regulate water activity,so as to investigate the different antibacterial efficacy of sodium benzoate in qiangli pipa syrup under different conditions.Results Qiangli pipa syrup with different validity period,pH value and water activity were passed the bacteriostatic efficacy test.When the pH of the negative sample was lower than 4.5,the bacteriostatic effect can be checked if the added concentration of bacteriostatic agent was 0.2%.When the pH of the negative sample was higher than 4.5,the water activity is lower than 0.95,the bacteriostatic effect can also be checked if the added concentration of bacteriostatic agent is 0.2%.Conclusion Different term of validity has little influence on the bacteriostatic efficacy,and pH and water activity have great influence on the bacteriostatic efficacy of the added bacteriostatic agent.The bacteriostatic agent sodium benzoate in qiangli pipa syrup is greatly affected by the pH and water activity of the sample.The higher the pH,the lower the bacteriostatic efficacy,and the lower the water activity,the higher the bacteriostatic efficacy.

关 键 词：防腐剂 药物 枇杷属 抑菌效力 苯甲酸钠 水活度 PH 有效期 

分 类 号：R285[医药卫生—中药学]