羟乙基淀粉200/0.5氯化钠注射液细菌内毒素检查的可行性研究  

Study on the test method of bacterial endotoxin in Hydroxyethyl Starch 200/0. 5 and Sodium Chloride Injection

作　　者：金曼 程春萍 周树美 

机构地区：[1]山东齐都药业有限公司,山东淄博255400

出　　处：《药学研究》2013年第9期521-522,529,共3页Journal of Pharmaceutical Research

摘　　要：目的对羟乙基淀粉200/0.5氯化钠注射液进行凝胶法干扰试验,建立羟乙基淀粉200/0.5氯化钠注射液细菌内毒素的检查方法。方法按2010年版《中国药典》(二部)"细菌内毒素检查法",用不同厂家的鲎试剂对不同批号的羟乙基淀粉200/0.5氯化钠注射液分别进行干扰试验。结果羟乙基淀粉200/0.5氯化钠注射液进行2倍以上稀释的溶液对细菌内毒素检查无干扰作用。结论羟乙基淀粉200/0.5氯化钠注射液进行细菌内毒素检查是可行的。Objective To establish a bacterial endotoxin test for Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection. Methods According to the bacterial endotoxin test in Chinese Pharmacopoeia 2010. Different batches of Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection from different TAL manufacturers were underwent the interfer- ence tests. Results There was no interference in the bacterial endotoxin test when the concentration of Hydroxyethyl Starch 200/0.5 was for more than 2 times diluted solution. Conclusion Carrying out the bacterial endotoxin test for Hydroxyethyl Starch 200/0.5 and Sodium Chloride Injection was feasible.

关 键 词：羟乙基淀粉200 0 5氯化钠注射液 细菌内毒素检查法 干扰试验 

分 类 号：R927.12[医药卫生—药学]