小儿退热口服液抑菌效力的测定研究

Investigation of bacteriostatic efficacy of pediatric antipyretic oral solution

目的:测定和评价小儿退热口服液抑菌体系的有效性。方法:参考《中国药典》2020年版第四部1121抑菌效力检查法,增加不同来源的洋葱伯克霍尔德菌为挑战菌,确定小儿退热口服液的菌落计数方法,以测定不同时间点的存活菌落数并换算成lg值,建立了小儿退热口服液的抑菌效力检查方法。结果:小儿退热口服液抑菌体系对细菌类抑菌效果良好,对真菌类,有6批抑菌效果达不到《中国药典》2020年版要求。结论:抑菌效力不符合要求的小儿退热口服液存在一定的微生物污染风险,生产企业应建立完善的抑菌体系,以保证小儿退热口服液在有效期内微生物数量符合药典要求。

Objective:To determine and evaluate the effectiveness of antipyretic oral liquid antibacterial system in children.Methods:Referring to the Chinese Pharmacopoeia 2020 PartⅣ1121 bacteriostatic efficacy inspection method,Burkholderia cepacia from different sources was added as a challenge bacterium,and the colony counting method of pediatric antipyretic oral liquid was determined to determine the number of surviving colonies at different time points and converted to lg value,and the bacteriostatic efficacy inspection method of pediatric antipyretic oral liquid was established.Results:The antibacterial system of pediatric antipyretic oral liquid has a good antibacterial effect on bacteria,and for fungi,6 batches of antibacterial effect cannot meet the requirements of the Chinese Pharmacopoeia 2020.Conclusion:There is a certain risk of microbial contamination in pediatric antipyretic oral liquid that does not meet the requirements of bacteriostatic efficacy,and manufacturers should establish a sound antibacterial system to ensure that the number of microorganisms in pediatric antipyretic oral liquid meets the requirements of pharmacopoeia during the validity period.