摘要
本研究旨在验证抗球虫中药常山口服液的微生物限度检查法,为其质量控制、研发新兽药奠定基础。试验通过直接接种法考察常山口服液的抑菌活性,并采用验证过的试验条件和方法(常规法)进行细菌计数、回收率测定及控制菌的检查,建立常山口服液微生物限度检查方法,并进行验证试验。结果证实常山口服液无抑菌作用或抑菌作用极其微弱,可采用常规法建立检查方法。常山口服液对大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌及黑曲霉的加菌回收率均大于70%,且供试品和所用稀释剂对此结果无干扰。按常规方法对大肠埃希菌、乙型副伤寒沙门氏菌、金黄色葡萄球菌、铜绿假单胞菌进行控制菌验证检查发现,试验组、阳性对照组均检出相应的试验菌,阴性对照组和供试液组均未检出相应的试验菌。综上所述,常规法可用于常山口服液细菌、霉菌和酵母菌的计数检验,控制菌检查及微生物限度检查,试验过程符合微生物限度检查法规定,且方法简便,可操作性强,结果准确可靠。
The purpose of this study was to validate the microbial limit test method for anticoccidial drug Dichroa febrifuga oral liquid(DFOL),and provide data base for its quality control and researching the new veterinary drug.The direct inoculation method was used to validate the antibacterial activity for DFOL,and the bacterial counting,determination of recovery rate and inspection of control bacteria were measured using a validated test condition and method(conventional method).The results showed that DFOL had no or faint bacteriostasis verified by validated test method,the determination and inspection of bacteria could be determined by conventional method.The normal plate counting were used to detect the amount of Escherichia coli,Staphylococcus aureus,Bacillus subtilis,Candida albicans and Aspergillus niger in DFOL in which the recovery rate were all more than70%,and the results were not disturbed by sample and diluents.The control bacteria including Escherichia coli,Salmonella paratyphi B,Staphylococcus aureus,and Pseudomonas aeruginosa were tested according to conventional method,whose growth were detected in the test group and positive control group,while no growth were detected in the negative control group and sample group.In conclusion,the microbial limit test method for DFOL had been validated in this study,and the conventional method could be applied to DFOL for bacteria,moulds and yeast counting as well as the inspection for control bacteria.The process of test was in accordance with the regulations of microbial limits test method,the method was convenient and simple,and the results was reliable.
作者
王玲
郭志廷
杨峰
李宏胜
魏小娟
周绪正
WANG Ling;GUO Zhi ting;YANG Feng;LI Hong sheng;WEI Xiao juan;ZHOU Xu zheng(Key Laboratory of Veterinary Pharmaceutics Discovery,Ministry of Agriculture,Lanzhou Institute of Animal Science and Veterinary Pharmaceutics,Chinese Academy of Agricultural Sciences (CAAS),Lanzhou 730050,China)
出处
《中国畜牧兽医》
CAS
北大核心
2017年第11期3365-3371,共7页
China Animal Husbandry & Veterinary Medicine
基金
中央级公益性科研院所专项资金项目(1610322017018、1610322017020)
甘肃省科技支撑计划(1604NKCA069-01)
关键词
常山口服液
微生物限度
方法验证
常规法
Dichroa febrifuga oral liquid (DFOL)
microbial limit
method validation
conventional method
