2种人工唾液抑菌剂用量筛选与抑菌效力研究  

Dosage Screening and Antibacterial Efficacy of Two Bacteriostatic Agents in Artificial Saliva

作　　者：卢锦华 苏畅 赵万钧 LU Jinhua;SU Chang;ZHAO Wanjun(Shenzhen Nanyue Pharmaceutical Co.,Ltd.,Shenzhen,Guangdong,China 518110)

机构地区：[1]深圳南粤药业有限公司,广东深圳518110

出　　处：《中国药业》2025年第2期73-76,共4页China Pharmaceuticals

摘　　要：目的探讨人工唾液中抑菌剂苯甲酸钠和山梨酸的合理使用量。方法根据2020年版《中国药典(四部)》通则1121抑菌效力检查法,以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念珠菌和黑曲霉为试验菌株,进行菌落计数方法适用性试验,建立人工唾液抑菌效力检查方法。以抑菌剂的组合及添加量为考察因素,抑菌效力为评价指标,采用2因素4水平制备16份处方样品,筛选抑菌剂的合理添加量。结果苯甲酸钠0.1%和山梨酸0.075%联合使用对人工唾液中各种微生物生长繁殖均有良好抑制作用,且为最低有效剂量,故作为该人工唾液产品的抑菌剂配比用量。结论所筛选的抑菌剂用量可为后期工业化生产提供依据。Objective To investigate the rational addition dosage of bacteriostatic agents sodium benzoate and sorbic acid in artificial saliva.Methods Based on the general rule 1121 antibacterial efficacy test of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),a suitability test for colony counting method was conducted with Staphylococcus aureus,Pseudomonas aeruginosa,Escherichia coli,Candida albicans,and Aspergillus niger as test strains to establish a method for testing the antibacterial efficacy of artificial saliva.With the combination and addition dosage of bacteriostatic agents as the investigation factors,and with antibacterial efficacy as the evaluation indicator,16 prescription samples were prepared based on two factors and four levels to screen for the rational addition dosage of bacteriostatic agents.Results The combination of 0.1%sodium benzoate and 0.075%sorbic acid exhibited a good inhibitory effect on the growth and reproduction of various microorganisms in artificial saliva,which was the lowest effective dosage and chosen as the rational addition dosage of bacteriostatic agents for this artificial saliva product.Conclusion The screened bacteriostatic agent dosage can provide a basis for later industrial production.

关 键 词：人工唾液 抑菌效力 剂量筛选 苯甲酸钠 山梨酸 

分 类 号：R965[医药卫生—药理学]