摘要
目的:分析广西等地区9种中药饮片的微生物污染现状,为中药饮片微生物限度检查项和限值的制定提供参考。方法:参考中国药典2015年版方法,测定中药饮片的需氧菌总数、霉菌和酵母菌总数、耐热菌数、耐胆盐革兰阴性菌数并进行沙门菌的检查。结果:90批中药饮片的需氧菌总数的l g平均值为3.7,霉菌和酵母菌总数的l g平均值为1.7,耐热菌数的l g平均值为0.9,耐胆盐革兰阴性菌l g值均值为1.1,均未检出沙门菌;不同加工工艺和包装材质的饮片,其微生物污染水平差异有统计学意义(P<0.05)。结论:应根据不同炮制加工方式及给药途径分类建立微生物限度标准,引导中药饮片规范生产,逐步提高中药饮片的质量。
Objective: To investigate the microbial contamination status of Chinese herbal pieces from Guangxi regions and provide reference for the microbial limit standard. Methods: According to Chinese Pharmacopoeia (2015 edition), the herbal pieces were analyzed for the total number of aerobe microbial, yeasts, molds, thermophilic bacteria and bile-resistant gram-negative bacteria, and salmonella was also detected. Results: In 90 batches of Chinese herbal pieces, the lg average value of the total number of aerobe microbial was 3.7, and that of the total yeasts and molds was 1.7, that of thermophilic bacteria was 0.9 and that of bile-resistant gram-negative bacteria was 1.1, and Salmonella was not detected out. There were statistically significant differences (P 〈 0.05) in the microbial contamination levels of herbal pieces with different processing techniques and packaging materials. Conclusion: According to different processing methods and administration, microbial limit standard should be established for classification in order to guide the standardized production of Chinese herbal pieces and improve their quality gradually.
作者
甘永琦
农浚
零文超
陈祺
朱斌
Gan Yongqi;Nong Jun;Ling Wenchao;Chen Qi;Zhu Bin(Guangxi Institute for Food and Drug Control, Nanning 530021, China)
出处
《中国药师》
CAS
2018年第5期922-927,共6页
China Pharmacist
基金
国家药典委员会课题(编号:16)
广西食品药品监督管理局2016年食品药品安全科研项目
广西重大科技专项计划(编号:桂科重1598005-10)
关键词
微生物限度检查
中药饮片标准
耐胆盐革兰阴性菌
耐热菌
Microbial limit test
Chinese herbal pieces standard
Bile-resistant gram-negative bacteria
Thermophilicbacteria