代煎中药汤剂微生物限度研究  

Study on the Microbial Limit of Commissioned Decoction

作　　者：安雅婷[1] 杨新建[1] 张善革[1] 付彬[1] 李学林[2] 王雷[1] AN Yating;YANG Xinjian;ZHANG Shange;FU Bin;LI Xuelin;WANG Lei(Department of Pharmacy,Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine,Tianjin 300120,China;Department of Pharmacy,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China)

机构地区：[1]天津市中医药研究院附属医院药学部,天津300120 [2]河南中医药大学第一附属医院药学部,郑州450000

出　　处：《医药导报》2021年第11期1538-1543,共6页Herald of Medicine

基　　金：2017年国家重点研发计划中医药现代化重点专项“中药饮片智能调剂与煎煮设备关键技术研究”(2017YFC1703400)及“中药饮片智能化煎煮设备及煎药信息化系统研发”课题(2017YFC1703402)。

摘　　要：目的比较不同贮藏条件对代煎中药汤剂微生物限度的影响。方法选择已经过微生物限度方法验证的32个制剂处方,在经过环境检测的中药煎药室内,使用中药煎药机煎煮、包装机密封包装,每个处方为一组,将每组中一半数量汤剂置冰箱冷藏室(2~8℃)、另一半置室温避光(20±5℃)储存,分别于第0,1,3,7,14,21天观察汤剂性状,随机抽取不同储存条件下的各组汤剂,依据《中华人民共和国药典》2020年版规定进行微生物限度检验。结果各组代煎中药汤剂未见明显性状改变。清热类代煎汤剂与补益类代煎汤剂各时间点微生物限度检测差异无统计学意义;各时间点冰箱冷藏室(2~8℃)储存代煎汤剂微生物限度检验合格;室温避光(20±5℃)储存代煎汤剂14 d内微生物限度检验合格,第21天有5组霉菌和酵母菌含量>20 cfu·mL^(-1),微生物限度不合格。结论在煎药操作和环境可控条件下,将密封包装代煎中药汤剂置低温、避光贮藏条件下,更有利于抑制代煎中药汤剂微生物滋生,保证用药安全。Objective To compare the different effects of storage methods on microbial limit of decoction.Methods A total of 32 formulations that had been verified by microbial limit method,in the environmental qualified Chinese medicine decocting room,the decocting machine was used to decoct and the packaging machine was used to seal the package.A half of the decoctions were stored in refrigerator(2-8℃)and the other half was placed in dark at room temperature(20±5℃).Characteristics and microbial limit test of the decoction were observed,according to Chinese Pharmacopoeia on day 0,1,3,7,14 and 21,respectively.Results No significant change of characteristics in the decoction in each group was detected,and no significant difference in microbial limit between Qingre decoction and Buyi decoction at each time point.The microbial limit of the decoction stored in the refrigerator(2-8℃)was qualified at all time points.In the decoctions stored in dark under room temperature(20±5℃)at the 21st day,there were 5 groups of decoctions was unqualified in microbial limit(molds and yeasts content>20 cfu·mL^(-1)).Conclusion Under controlled operating and environmental conditions,sealed packaged,and stored in dark at low temperature,it was more conducive to reduce the microbial breeding of the decoction and to ensure the medication safety of patients.

关 键 词：中药汤剂 代煎 煎煮 贮藏 微生物限度 

分 类 号：R286[医药卫生—中药学] R927.1[医药卫生—中医学]