启脾丸微生物限度检查法的研究及微生物污染情况分析

Microbial Limit Test of Qipi Pills and Analysis of Microbial Contamination

启脾丸是含药材原粉的中药制剂,易受到微生物污染。按现行标准检验了10家生产企业的149批启脾丸样品,并分析结果。随后,通过探索性研究建立启脾丸的微生物限度检查方法,并采用基质辅助激光解析电离-飞行时间质谱(MALDI-TOF-MS)或16S rRNA基因测序技术鉴定检出的微生物,分析其微生物污染状况。结果显示,149批样品微生物限度检查结果均符合规定。建立的启脾丸微生物限度检查法为需氧菌总数1∶20平皿法、霉菌和酵母菌总数计数1∶10平皿法,控制菌大肠埃希菌、耐胆盐革兰阴性菌、沙门菌均采用常规法;污染菌鉴定结果中,90%为芽孢杆菌属,提示各生产企业仍需加强微生物的过程控制。

Qipi pills,a traditional Chinese medicine formulation composed of raw medicinal herb powder,are highly susceptible to microbial contamination.In this study,149 batches of samples from 10 different manufacturers were tested in accordance with current standards and the results were analyzed.Subsequently,exploratory research was conducted to establish a microbial limit detection method for Qipi pills.The detected microorganisms were identified using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry(MALDI-TOF-MS)or 16S rRNA gene sequencing technology,and their microbial contamination status was assessed.The results revealed that all 149 batches of samples complied with the regulations upon microbial limit inspection.The established microbial limit inspection method for Qipi pills was 1∶20 for total aerobic bacteria count,1∶10 for total mold and yeast count,while standard methods were employed for specified microorganisms including Escherichia coli,bile salt-tolerant Gram-negative bacteria,and Salmonella.Among the identified contaminating bacteria,90%were Bacillus spp.,suggesting an enhancement in process control over microorganisms by manufacturers was necessary.