苦参注射液细菌内毒素检查法的探讨

On bacterial endotoxin inspection for matrine injection

目的探讨苦参注射液细菌内毒素检查法的可行性。方法根据中国药典2000年版二部细菌内毒素检查方法及指导原则进行实验。将苦参注射液经40倍稀释,用标示灵敏度为0.5Eu·ml-1的鲎试剂检测其细菌内毒素。结果苦参注射液40倍稀释液对鲎试剂的细菌内毒素检查无干扰作用。

Aim To establish bacterial endotoxin inspection for matrine injection.Method The experiment is implemented according to bacterial endotoxin test procedure and guiding principle in Chinese Phamacopoeia. To dilute Matrine injection 40 times, and bacterial endotoxin can be tested by amebocyte lysate with accuracy of 0.5 Eu·ml -1 .Results The interference elements can be excluded by diluting matrine injection 40 times.Conclusion Bacterial endotoxin inspection method can be used in determining the pyrogen of matrine injection.