盐酸氨溴索注射液细菌内毒素检查法研究

Study on Bacterial Endotoxin Test of Ambroxol Hydrochloride Injection

目的建立盐酸氨溴索注射液的细菌内毒素检查方法。方法按2005年版《中国药典(二部)》附录Ⅺ E细菌内毒素检查法进行试验。结果盐酸氨溴索注射液经5倍及以上稀释,质量浓度在1.5 g/L以下时对鲎试剂与内毒素的反应无干扰。结论盐酸氨溴索注射液可以采用细菌内毒素检查法(凝胶法)进行细菌内毒素的限量检查。

Objective To establish a method of the bacterial endotoxin test for Ambroxol Hydrochloride Injection.Methods The bacterial endotoxin test was carried out according to the bacterial endotoxin test in the appendix Ⅺof Chinese Pharmacopeia（Vol.Ⅱ,edition 2005）.Results After five times and above dilution,the mass concentration of less than 1.5 g/L had no interference on tachypleus amebocyte lysate（TAL） and the reaction of endotoxin.Conclusion Bacterial endotoxin test（gel process） is applicable to the limit test of bacterial endotoxin for Ambroxol Hydrochloride Injection.