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.
出处
《天津药学》
2003年第2期17-19,共3页
Tianjin Pharmacy
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
the kinetic-turbidimetric technique, Radix Salviae Miltiorrhizae Injection, bacterial endotoxin
