穿琥宁注射液细菌内毒素检查方法研究

Study on Determination of Bacterial Endotoxin in Potassium Dehydroandrograpolide Succinate Injection Using Tachypleus Amebocyte Lysate

目的对穿琥宁注射液进行细菌内毒素检查干扰试验,并建立其细菌内毒素检查方法。方法参照2005年版《中国药典(二部)》附录细菌内毒素检查法进行试验。结果干扰试验证明,按拟定标准检验,本品1个规格共3批供试品的细菌内毒素检查结果均符合规定。结论穿琥宁注射液稀释至0．5 mg/mL时,对细菌内毒素检查无干扰,用鲎试剂法代替家兔法控制穿琥宁注射液的热原是可行的。

Objective To establish a procedure for determination the bacterial endotoxin in Potassium Dehydroandrograpolide Succinate Injection by tachypleus anebocyte lysate. Methods Refering to the demands of testing methods recorded in Chinese Pharmacopoeia （volume 2005）. Results The results of bacterial endotoxin test in three lots all accorded with the standard of the quality control for Potassium Dehydroandrograpolide Succinate Injection. Conclusion It is available for the bacterial endotoxin test by diluting the Potassium Dehydroandrograpolide Succinate Injection to 0. 5 mg/mL in tachypleus amebocyte lysate method and it can substitute for the Rabbit Method in quality control.