摘要
目的:建立并优化美罗培南及其注射剂的无菌检查方法。方法:采用薄膜过滤法,摸索去除美罗培南抑菌性的方法,通过接种6株阳性试验菌的生长情况进行对比分析。结果:采用薄膜过滤法,添加β-内酰胺酶Ⅳ作为中和剂,以0.1%无菌蛋白胨水溶液500 mL进行冲洗,6株阳性试验菌生长良好。结论:β-内酰胺酶Ⅳ作为美罗培南无菌检查方法的中和剂,能有效去除其抑菌性,并能应用于美罗培南及其注射剂的无菌检查,该方法准确,能有效控制该产品的质量。
Objective:To establish and optimize the sterility test method for Meropenem and its preparations.Methods:Membrane filtration method was used to explore the method for eliminating the bacteriostatic effect of meropenem,and a comparative analysis was conducted by inoculating the growth of 6 positive test bacteria.Results:The membrane filtration method was accepted with addingβ-lactamaseⅣas a neutralizing agent,and flushing with 500 mL 0.1%sterile peptone solution.6 positive test bacteria grew well.Conclusions:As a neutralizing agent for meropenem sterility test method,β-lactamaseⅣcan effectively eliminate its bacteriostasis and can be applied to sterility test of meropenem and its injection.This method is accurate and efficient,and can effectively control the quality of the drug.
作者
张平
彭春丹
王健美
石春红
ZHANG Ping;Peng Chundan;WANG Jianmei;SHI Chunhong(Shanghai Songjiang Institute for Food and Drug Control,Shanghai 201600,China;Haikou Pharmaceutical Factory Co.,Ltd.,Haikou 570311,China;Shanghai Medicilon Inc,Shanghai 200120,China)
出处
《中国药品标准》
CAS
2021年第5期458-464,共7页
Drug Standards of China
基金
松江区科学技术攻关项目(18SJKJGG51)。
