摘要
目的:构建针对以甘草流浸膏为主要成分的医疗机构制剂的微生物限度检测方法,并进行有效验证,确保方法的准确性与可靠性。方法:依据《中国药典》2020年版四部通则1105(微生物限度检查法),采用平皿法(1∶101供试液)测定复方甘草口服溶液、小儿复方甘草口服溶液中需氧菌、霉菌和酵母菌回收率;参照通则1106(控制菌检查法),通过涂布法检测大肠埃希菌的检出能力。结果:五种目标菌株的回收率为0.8~1.3,大肠埃希菌可稳定检出,阴性对照无干扰。结论:研究建立的微生物限度与控制菌检查方法符合《中国药典》2020年版技术要求,可客观评估两种制剂的微生物污染水平,为质量控制提供可靠依据。
Objective To establish and effectively validate a microbial limit test method for medical institution preparations with Glycyrrhizae Radix and Rhizoma Extractum as the main ingredient,ensuring the accuracy and reliability of the method.Methods Ac-cording to General Chapter 1105(Microbial Limit Test)of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),the plate method(1∶101 test solution)was used to determine the recovery rates of aerobic bacteria,molds,and yeasts in Compound Glycyrrhizae Oral Solution and Pediatric Compound Glycyrrhizae Oral Solution.With reference to General Chapter 1106(Test for Specified Microorgan-isms),the spread plate method was employed to detect the detection capability for Escherichia coli.Results The recovery rates of the five target strains ranged from 0.8 to 1.3,Escherichia coli could be stably detected,and there was no interference from the negative control.Conclusion The microbial limit test and specified microorganisms test methods established in this study comply with the tech-nical requirements of the Chinese Pharmacopoeia(2020 Edition).They can objectively assess the microbial contamination levels of the two preparations and provide a reliable basis for quality control.
作者
罗伟
何颖
LUO Wei;HE Ying(Department of Pharmacy,Dali Bai Autonomous Prefecture People's Hospital,Dali 671000,China;Department of Clinical Laboratory,Dali Town Health Center,Dali 671000,China)
出处
《中国民族民间医药》
2026年第1期72-75,共4页
Chinese Journal of Ethnomedicine and Ethnopharmacy
基金
5种医院制剂效期延长及稳定性考察(编号:ZB2025WJ002)。
关键词
复方甘草口服溶液
小儿复方甘草口服溶液
微生物限度
方法适用性试验
Compound Glycyrrhizae Oral Solution
Pediatric Compound Glycyrrhizae Oral Solution
Microbial Limit Test
Method Suitability Test
