羧甲淀粉钠微生物限度方法适用性试验研究  

Methodological study on microbial limit test of carboxymethyl starch sodium

作　　者：杨亚宗 高瑾 王鹤萌 毛宁 于波 齐永亮 YANG Yazong;GAO Jin;WANG Hemeng;MAO Ning;YU Bo;QI Yongliang(Being Union Pharmaceutical Factory limited company,Beijing 102600,China)

机构地区：[1]北京协和药厂有限公司,北京102600

出　　处：《中国药品标准》2024年第6期596-599,共4页Drug Standards of China

摘　　要：目的:建立羧甲淀粉钠的微生物限度检查方法。方法:依据《中国药典》2020版第四部通则1105及1106的要求对羧甲淀粉钠进行微生物限度方法适用性试验。结果:采用中和剂稀释为1∶20的供试液后进行平皿法计数,各试验菌的回收率均在0.5~2范围内;大肠埃希菌检查采用1∶20的供试液直接接种法,结果符合要求。结论:建立的中和剂方法简单可行,可有效消除羧甲淀粉钠的抑菌作用。Objective:To establish a method for microbial limit test of carboxymethyl starch sodium.Methods:According to the requirements of General chapters 1105 and 1106 of the fourth part of the Chinese Pharmacopoeia 2020,the applicability of microbial limit method for carboxymethyl starch sodium was tested.Results:The test solution diluted with neutralizer to 1∶20 was counted by plate method.The recoveries of each test bacteria were in the range of 0.5-2.Escherichia coli was examined by direct inoculation with 1∶20 test solution,and the results met the requirements.Conclusion:The established neutralizer method is simple and feasible,and can effectively eliminate the bacteriostatic effect of carboxymethyl starch sodium.

关 键 词：羧甲淀粉钠 微生物限度检查 方法适用性 中和法 聚山梨酯80 卵磷脂 

分 类 号：R921.2[医药卫生—药学]