注射用氨力农细菌内毒素检查方法学研究

Study on Methodology of Bacterial Endotoxin Test in Amrinone for Injection

目的建立注射用氨力农细菌内毒素检查方法.方法对凝胶法注射用氨力农细菌内毒素检查进行干扰试验研究,用氢氧化钠溶液调节注射用氨力农溶液pH值,以排除干扰.结果注射用氨力农以其专用溶媒溶解后,用1mol·L-1氢氧化钠溶液调节pH值至6.0,可以排除细菌内毒素检查干扰因素,进行检测.结论建立的细菌内毒素检查方法简便经济、科学合理,可用于注射用氨力农的质量控制.

OBJECTIVE To establish a method for bacterial endotoxin test of Amrinone for Injection. RESULTS To operate the interferential test for bacterial endotoxin test of Amrinone for Injection by gel-clot method. Adding 1mol · L^-1 sodium hydroxide to adjust pH of the sample solution in order to prevention interference in the test. RESULTS After dissolution of Amrinone for Injection in its special solvent, the pH of sample solution can be adjusted and interferential factor can be removed. CONCLUSION The established method of bacterial endotoxin test is simple,economic and reliable. This method can be used for bacterial endotoxin test in Amrinone for Injection.