摘要
目的建立吲哚类非甾体抗炎药微生物限度检查法。方法按欧洲药典EP8th版,对吲哚美辛胶囊微生物限度检查方法学进行建立和验证实验。结果吲哚美辛胶囊对金黄色葡萄球菌、枯草芽孢杆菌有很强的抑制作用,本实验方法消除了其抑菌性对微生物限度检查的影响。结论该方法适用于非甾体抗炎药吲哚美辛胶囊的微生物限度检查,且可靠、便于操作。
Objective To establish the microbial limit test for indoles non-steroidal anti-inflammatory drugs. Methods According to European Pharmacopoeia 8th Edition, establishment and validation experiment were made for microbial limit test of indometacin capsules. Results Indometacin capsules contained strong inhibiting effect on staphylococcus aureus and bacillus subtilis. This experimental method eliminated the influence of its antibacterial activity on microbial limit test. Conclusion This method is appropriate for microbial limit test of non-steroidal anti-inflammatory drugs as indometacin capsules, and it is reliable and easily operational.
出处
《中国现代药物应用》
2015年第10期263-265,共3页
Chinese Journal of Modern Drug Application
关键词
非甾体抗炎药
吲哚美辛
微生物限度检查
验证
Non-steroidal anti-inflammatory drugs
Indometacin
Microbial limit test
Validation
