药物制剂中抑菌剂的要求及检测方法探讨

Discussion on the Requirements and Testing of Antibacterial Agents in Pharmaceutical Preparations

抑菌剂作为药物制剂重要的辅料,对防止或减少制剂受微生物污染保证药品质量起着重要的作用。抑菌剂都具有一定的毒性,科学规范的控制用法用量凸显重要。笔者梳理了中国药典、食品安全国家标准和化妆品安全技术规范对于抑菌剂(防腐剂)的种类、要求和测定方法,及ICH、EMA对于抑菌剂的要求和规定。对药品标准关注抑菌剂测定方法和限度要求的必要性等问题进行探讨,旨在规范抑菌剂的使用。

Antibacterial agents,as important adjuncts in pharmaceutical preparations,play an important role in preventing or reducing microbial contamination of the preparations and ensuring drug quality.Antibacterial agents have certain toxicity,and scientific and standardized control of usage and dosage is particularly important.This article compares the types,requirements,and determination methods of antibacterial agents(preservatives)in the Chinese Pharmacopoeia,National food safety standards,and Safety and Technical Standards for Cosmetics,and the requirements and regulations of ICH and EMA for antibacterial agents.Exploring the necessity of paying attention to the determination methods and limit requirements of antibacterial agents in drug standards,with the aim of standardizing the use of antibacterial agents.