中成药中不可接受微生物检测方法的建立

Establishment of Detection Method for Objectionable Microorganisms in Chinese Patent Medicines

摘要: 目的：建立实验室内部对中成药中不可接受微生物监测的定性检查方法，探讨中成药污染的条件致病菌的常见种类。方法：使用胰酪大豆胨液体培养基(TSB)为样品的初增菌培养基，置32.5℃培养24 h。取培养物划线接种于胰酪大豆胨琼脂培养基(TSA)平板中，置32.5℃培养24 h。挑取在TSA中生长的微生物使用全自动快速微生物质谱鉴定系统鉴定。结果：本方法的检测限为1 CFU·mL⁻¹ (g⁻¹)，专属性符合要求，重复性和耐用性良好。样品的蜡样芽孢杆菌和屎肠球菌检出率为3.6%和1.5%，其余条件致病菌未检出。结论：本方法使用非选择性培养基提高中成药中条件致病菌的种类检出，有利于促进实验室对中成药不可接受微生物更有效监测与管理。

Abstract: Objective: To establish a qualitative detection method for objectionable microorganisms in Chinese patent medicines within the laboratory and to identify common pathogenic bacteria responsible for contamination. Methods: Using pancreatic casein soy peptone liquid medium (TSB) as the initial culture medium for the sample, and incubated at 32.5˚C for 24 h. The cultures are streaked onto pancreatic casein soy peptone agar (TSA) plates and incubated at 32.5˚C for 24 h. Microorganisms grow on TSA are identified using an automated rapid microbial mass spectrometry identification system. Results: The detection limit of this method is 1 CFU·mL⁻¹ (g⁻¹). The specificity meets the requirements, with good repeatability and durability. The detection rates of Bacilus cereus and Enterococcus faecium in the samples were 3.6% and 1.5%, respectively; no other opportunistic pathogens were detected. Conclusion: This method employs a non-selective culture medium to enhance the identification of opportunistic pathogens in traditional Chinese patent medicines, thereby facilitating enhanced monitoring and management of objectionable microorganisms in pharmaceutical products by the laboratory.