复方丹参注射液中细菌内毒素定量检测研究  

Measurement of Endotoxin in Radix Salviae Miltiorrhizae Injection Using the Kinetic-turbidimetric Technique

作　　者：苑庆华[1] 唐元泰[1] 芮菁[1] 华晓东[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《天津药学》2003年第2期17-19,共3页Tianjin Pharmacy

摘　　要：目的 :对复方丹参注射液进行细菌内毒素定量检查试验 ,建立定量检测复方丹参注射液中细菌内毒素试验方法。方法 :采用《中国药典》2 0 0 0年版附录检测细菌内毒素动态比浊法。结果 :复方丹参注射液在稀释至 40倍时检测可排除干扰因素的影响 ,内毒素回收率在 5 0 %～ 2 0 0 %范围内。结论Objective: To investigate the feasibility to use the kinetic-turbidimetric technique as the practical Quality Control on Endotoxin Content in Radix Salviae Miltiorrhizae Injection. Method: The bacterial endotoxin content in Radix Salviae Miltiorrhizae Injection was measured by the kinetic-turbidimetric technique in CP2000. Result: Neither inhibition nor enhancement was found after diluted Radix Salviae Miltiorrhizae Injection to 1:40, the recovery was 50%~200%. Conclusion: These results suggested that the kinetic-turbidimetric technique of LAL-test was suitable for the detection of endotoxin in Radix Salviae Miltiorrhizae Injection.

关 键 词：复方丹参注射液 细菌内毒素 定量检测 试验 中药注射剂 

分 类 号：R284.1[医药卫生—中药学]