2种以甘草流浸膏为主要成分的医疗机构制剂微生物限度检查方法

打开文本图片集

【中图分类号】R285.5 【文献标志码】A 【文章编号】1007－8517（2026）01－0072-04

DOI：10.3969/j.issn.1007-8517.2026. 01. zgmzmjyyzz202601014

Microbial Limit TestMethods for Two Types of Medical Institution Preparationswith Glycyrrhizae Radixand Rhizoma Extractum astheMain Ingredient

LUO Wei' HE Ying2

Department of Pharmacy，Dali Bai Autonomous Prefecture People's Hospital，Dali 671OOo，China;

2.Department of Clinical Laboratory，Dali Town Health Center，Dali 671OOO，China

Abstract：ObjectiveToestablishandefectivelyvalidateamicrobiallimittestmethodformedical institutionpreparationswith Glycyrhizae Radix and Rhizoma Extractum as the main ingredient，nsuringtheaccuracyandreliabilityofthe method.Methods AccordingtoGeneralChapter105（MicrobialLimitTest）oftheChinesePharmacopoeia（2O2OEdition，VolumeIV），theplatemethod （1：101testsolution）wasusedtodeterminetherecoveryratesofaerobicbacteria，molds，ndyeasts inCompoundGlycyrhizaeOral SolutionandPediatricCompoundGlycyhizaeOralSolution.WithreferencetoGeneralChapter1106（TestforSpecifiedMicroorganisms），thespreadplatemethodwasemploedtodetectthedetectioncapabilityforEscherichiacoli.ResultsTherecoveryratesofthe five target strains ranged from 0.8 to1.3，Escherichia coli could be stably detected，and there was no interference from the negative control.ConclusionTemicrobiallimitestandspecifiedmicroorganismstestmethodsstablishdintisstudycomplywithhetec nicalrequirementsofteChinesePharmacopeia（2O2OEdition）.Teyanbjectivelyasesstemicrobialcontaminationlevelsfte two preparations and provide a reliable basis for quality control.

KeyWords：CompoundGlycyrhizaeOralSolution；PediatricCompoundGlycyrhizaeOralSolution；MicrobialLimitTest; Method Suitability Test

复方甘草口服溶液与小儿复方甘草口服溶液作为白族自治州人民医院自主研发的经典院内制剂，凭借其显著的止咳化痰疗效、明确的作用机制及突出的成本效益优势，已成为滇西地区基层医疗不可或缺的呼吸系统疾病治疗药物。（剩余5202字）