摘要
目的建立鞣酸苦参碱胶囊微生物限度检查的方法。方法本试验取鞣酸苦参碱胶囊,按《中国药典2010年版》规定,进行了微生物限度检查方法验证试验。结果鞣酸苦参碱胶囊对金黄色葡萄球菌、枯草芽孢杆菌有明显的抑制作用。结论根据方法验证结果建议霉菌、酵母菌采用培养基稀释法检查,细菌和控制菌采用离心沉淀+薄膜过滤法检查。
OBJECTIVE To establish a method for microbial limit of Sophora Alkaloids Tannale Cap sules. METHODS As regulated by Chinese pharmacopoeia 2010, the microbiological tests method of Sophora Al kaloids Tannale Capsules was used. RESULTS Sophora Alkaloids Tannale Capsules had the inhibited effect on Staphylococcus aureus and Bacillus subtilis. CONCLUSION By the validation conclusion advise mould and mi crozyme adopt culture nedium diluted method, Centrugal and membraneliter procedure were used for bacteria and controlled bacleria.
出处
《海峡药学》
2012年第7期67-70,共4页
Strait Pharmaceutical Journal
关键词
鞣酸苦参碱胶囊
微生物限度检查
方法验证
Sophora Alkaloids Tannale Capsules
Microbial limit test
Validation
