甘肃中医药大学学报2026，Vol.43Issue(4)：25-29,5.DOI:10.16841/j.issn1003-8450.2026.04.05
乳病消片微生物限度检查方法适用性试验研究
Study on suitability test of microbial limit test method for Rubingxiao Tablets(乳病消片)
摘要
Abstract
Objective To validate the suitability of the microbial limit test method for Rubingxiao Tablets(乳病消片).Methods According to the general requirements of the Chinese Pharmacopoeia(2025 Edition,VolumeⅣ),the total aerobic microbial count was determined using the medium dilution method(1∶10,0.2 mL per plate),the total combined yeasts and molds count was determined using the plate method(1∶10,1 mL per plate),and the examination of specified microorganisms(Escherichia coli,bile-tolerant Gram-negative bacteria,and Salmo-nella paratyphi B)was performed using the conventional method.Results The recovery rate ratio of the five test strains(Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans,and Aspergillus niger)were all within the range of 0.5 to 2.0,meeting the specified requirements.The specified microorganisms were detected in both the test group and the positive control group,while no target microorganisms were detected in the negative control group.Conclusion The established microbial limit test method is suitable for the quality control of Rubingxiao Tablets.关键词
乳病消片/微生物限度检查/培养基稀释法/平皿法/适用性试验Key words
Rubingxiao Tablets(乳病消片)/microbial limit test/medium dilution method/plate method/suita-bility test分类
医药卫生引用本文复制引用
戴余雯,武延庆,何洲峰,卢瑞杰,侯俊杰,彭倩,果茵茵,黄燕..乳病消片微生物限度检查方法适用性试验研究[J].甘肃中医药大学学报,2026,43(4):25-29,5.基金项目
甘肃省自然科学基金项目(23JRRA1623,23JRRA1622). （23JRRA1623,23JRRA1622）
