目的:建立瑞格列奈的微生物限度检查方法。方法:用离心法制备供试品溶液,采用平皿法,选取大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌、黑曲霉作为验证菌进行方法学验证。结果:本方法可满足中国药典2010年版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对瑞格列奈最敏感,可作为瑞格列奈微生物限度检查方法的质控菌株。结论:该方法可作为瑞格列奈常规微生物限度检查方法。 OBJECTIVE: To establish a microbial limit test for repaglinide. Methods: The test solution was prepared by centrifugation. The method of plate method was used to verify the method of selecting Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Candida albicans and Aspergillus niger as verification bacteria. Results: The method can meet the basic requirements of the 2010 Chinese Pharmacopoeia validation test. Among the five strains, Bacillus subtilis was the most sensitive to repaglinide and could be used as a quality control strain for the reptile limit of repaglinide. Conclusion: This method can be used as the limit of detection of repaglinide in traditional microorganisms.