中国药业Issue(11):40-40,41,2.
玻璃酸钠注射液细菌内毒素检查法研究
Study on Method of Bacterial Endotoxin Test for Sodium Hyaluronate Injection
张婷婷 1姜素云 1鲁军1
作者信息
- 1. 辽宁省大连市食品药品检验所,辽宁 大连 116021
- 折叠
摘要
Abstract
Objective To establish the method of bacterial endotoxin test for Sodium Hyaluronate Injection. Methods To carry out the bacterial endotoxin test according to the APPendix Ⅺ E in the Chinese PharmacoPoeia ( edition 2010, Vol.Ⅱ) . Results The test solution of Sodium Hyaluronate Injection in the mass concentration of 1. 25 g/L had no interference effect on the bacterial endotoxin test. Conclusion The established method of the bacterial endotoxin test is aPPlicable for Sodium Hyaluronate Injection and the endotoxin limit value may be set at 0. 05 EU/mg.关键词
玻璃酸钠注射液/细菌内毒素检查/干扰试验Key words
Sodium hyaluronate injection/bacterial endotoxin test/interfering test分类
医药卫生引用本文复制引用
张婷婷,姜素云,鲁军..玻璃酸钠注射液细菌内毒素检查法研究[J].中国药业,2014,(11):40-40,41,2.