注射用果糖二磷酸钠无菌检查方法适用性研究  

Applicability of the Sterility Test Method on Fructose Diphosphate Sodium for Injection

作　　者：张威存 黄丽华 潘弟仪 ZHANG Wei-cun;HUANG Li-hua;PAN Di-yi(The Third Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou 510360,China;Guangdong institute for Drug Control,Guangzhou 510663,China)

机构地区：[1]广州中医药大学第三附属医院,广东广州510360 [2]广东省药品检验所,广东广州510663

出　　处：《海峡药学》2020年第4期69-71,共3页Strait Pharmaceutical Journal

基　　金：广东省医学科学技术研究基金项目(B2018130,B2018220)。

摘　　要：目的建立注射用果糖二磷酸钠无菌检查方法。方法按《中国药典》(2015版)四部通则1101无菌检查法的规定,采用薄膜过滤法,对10家企业生产的注射用果糖二磷酸钠进行无菌检查适用性研究。结果 10家企业(共74批)无菌检查方法均为:取样品量30支,采用薄膜过滤法全量过滤,无需冲洗。结论通过对10家企业生产的注射用果糖二磷酸钠的无菌检查试验,确立了注射用果糖二磷酸钠的无菌检查方法。OBJECTIVE To set up the sterility test method of Fructose Diphosphate Sodium for injection.METHODS According to the four general principles of the Chinese pharmacopoeia 2015 edition,microbial limit test of 1101 sterility test method,the sterility tests on Fructose Diphosphate Sodium for injection from 10 producers were performed by membrane-filtration procedure.RESULTS The sterility tests of all 10 producers(74 batches) were carried out as follows:30 samples were fully filtered by membrane-filtration without wash.CONCLUSION A sterility test method for Fructose Diphosphate Sodium for injection was established by a sterility test for Fructose Diphosphate Sodium for injection produced by 10 companies.

关 键 词：注射用果糖二磷酸钠 无菌检查法 薄膜过滤法 

分 类 号：R927[医药卫生—药学]