凝胶法和光度法测定灯盏花素注射液中细菌内毒素的含量

Study on Bacterial Endotoxins Test for Breviscapine Injection by Gel Clot Techniques and Photometric Techniques

目的建立凝胶法和光度测定灯盏花素注射液中细菌内毒的含量的方法.方法按《中国药典》2005年版二部附录ⅪE进行实验和结果判断.结果对于细菌内毒素检查凝胶法及光度法,灯盏花素注射液的最大不干扰浓度为0.125g/L.结论该药采用细菌内毒素检查法代替热原检查法控制质量,方法可行.

Objective To set up bacterial endotoxins determination method for Breviscapine injection by Gel Clot techniques and Photometric techniques.Method The experiment was carried on and the result as judged according to the appendix XI E of Chinese Pharmacopoeia 2005 Vo1.Ⅱ.Result Maximum nondisturb concentration of Breviscapine injection for bacterial endotoxins test was 0.125 g/L.Conclusion It is feasible for bacterial endotoxin test instead of pyrogen test for quality control