摘要
目的:建立散瘀止痛软膏的微生物限度检查方法,保证方法的科学性和检查结果的准确、可靠。方法:采用大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌和黑曲霉等5种试验菌株,进行细菌、霉菌及酵母菌的回收率试验,并进行控制菌检查的方法学验证。结果:采用常规法、培养基稀释法和离心法,5种试验菌株的回收率均小于70%;采用离心-培养基稀释法,5种试验菌株的回收率均达到70%以上;控制菌金黄色葡萄球菌、铜绿假单胞菌采用培养基稀释法(200 m L)可检出。结论:散瘀止痛软膏的微生物限度检查中,细菌、霉菌及酵母菌计数采用离心-培养基稀释法;控制菌金黄色葡萄球菌和铜绿假单胞菌的检查可采用培养基稀释法。
Objective：To establish the method of microbial limit test for Sanyu Zhitong Ointment,scientific methods and test results to ensure that the correct,reliable. Methods：Using Escherichia coli,Staphylococcus aureus,Bacillus subtilis,Candida albicans and Aspergillus niger strains and other five kinds of tests carried out recovery test bacteria,molds and yeasts,and bacteria control method validation check. Results：Using conventional methods,media dilution and centrifugation,five kinds of recovery test strains were less than 70%;Centrifugal- medium dilution method,five kinds of recovery test strains are up more than 70%;Control bacteria Staphylococcus aureus,Pseudomonas aeruginosa can be detected using the media dilution method（200 m L）. Conclusion：Microbial limits Sanyu Zhitong Ointment,the bacteria,yeast and mold count must centrifugal- medium dilution method,Staphylococcus aureus and Pseudomonas aeruginosa check using medium dilution method.
出处
《辽宁中医药大学学报》
CAS
2016年第5期84-86,共3页
Journal of Liaoning University of Traditional Chinese Medicine
基金
黄冈市科技计划项目(黄科字[2014]71号)
关键词
散瘀止痛软膏
微生物限度检查
离心-培养基稀释法
培养基稀释法
方法验证试验
Sanyu Zhitong Ointment
microbial limit
centrifugal-medium dilution method
medium dilution method
verification of methodology test
