摘要
目的:通过对55批红花的微生物限度检查,分析国内中药饮片的微生物污染现状,为制定其微生物限度检查项和限值提供参考。方法:参考中国药典2010年版和日本药典16版方法,测定红花中的需氧菌总数、霉菌和酵母菌总数、耐热菌数、革兰阴性菌数以及进行大肠埃希菌、沙门菌的检查,对耐胆盐革兰阴性菌采用不同检查方法的结果进行比较,并采用全自动细菌鉴定试验系统对红花中检出的耐热菌进行菌株鉴定。结果:55批红花中的需氧菌总数、霉菌和酵母菌总数的lg平均值分别为4.498 6和1.549 5;从44批红花中检出的耐热菌株,均为枯草芽孢杆菌;从5批红花中检出沙门菌。结论:应根据红花的用途制定微生物限度标准;从安全性角度,建议对通过煎煮、冲泡服用的红花至少应控制其中的沙门菌和耐热菌。
Objective:To investigate the microbial contamination of the domestic Chinese herbal pieces through the microbial limit test of 55 batches of Carthamus tinctorius, and provide a reference for the microbial limit standard. Methods: According to Chinese Pharmacopoeia (2010 edition) and the Japanese Pharmacopoeia ( 16 edition), the species and amounts of the total number of aerobe microbial, the total yeasts and molds, the gram-negative bacteria, and the thermoduric bacteria were identified by the automatic bacteria identification test system. And then, the E. co- li ,Salmonella species, and bile-tolerant gram-negative bacteria were compared by using difference methods. Re- suits : The lg average value of the total number of aerobe microbial was 4. 498 6, and the value of the total yeasts and molds was 1. 549 5. The thermoduric bacteria were B. subtilis from 44 batches, and the control bacterial were salmo- nella from 5 batches. Conclusion:The Chinese herbal pieces microbial limit standard should be based on the dosage regimen of Carthamus tinctorius. For safety pledge, it is recommended to control the salmonella and thermodurie bacteria in the preparation of Carthamus tinctorius by decoction.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2015年第7期1257-1262,共6页
Chinese Journal of Pharmaceutical Analysis
关键词
红花
微生物限度检查
中药饮片标准
菌株鉴定
全自动细菌鉴定试验
Carthamus tinctorius
microbial limit test
Chinese herbal pieces standard
strain identification
automaticbacteria identification test