阿莫西林胶囊微生物检查方法学研究

目的为了建立有效、操作简单、成本低廉的阿莫西林胶囊微生物限度和控制菌检查方法。方法采用平皿法、稀释法、薄膜过滤法、中和法共14种方法对阿莫西林胶囊进行微生物限度方法适用性研究,比较了稀释法、薄膜过滤法和中和法去除阿莫西林胶囊抑菌性的能力;考察了聚山梨酯80、卵磷脂和β-内酰胺酶作为中和剂去除其抑菌性的能力;并考察了将中和剂添加于稀释剂、冲洗液、培养基中去除抑菌性的能力。采用直接接种法、中和法共7种方法进行了控制菌方法适用性研究。结果建立阿莫西林胶囊微生物限度和控制菌检查方法。结论可采用在稀释剂TSB中添加1115万单位β-内酰胺酶的方法对阿莫西林胶囊进行需氧菌总数检查。

The research on microbial control methods for amoxillin capsule

Objective To establish effective, simple, and cheap microbial limit and microbe-controlling test methods. Methods A total of 14 kinds of methods, including plate, dilution, membrane filtration, and neutralization, were adopted for the development of microbial limit methodology of amoxillin capsule. The ability of removing amoxillin capsule antibacterial activity by dilution methods, membrane filtration methods, and neutralization methods were compared. The ability of removing antibacterial activity by adding neutralizer to diluter, flushing fluid, and culture medium were investigated. A total of 7 kinds of methods including direct inoculation and neutralization were adopted for microbe-controlling methodology. Results The microbial limit and microbe-controlling methods of amoxillin capsule were established. Conclusion Adding 11150000 units β-lactamase to diluter can be adopted to examine total aerobic