摘要
目的:建立乙酰谷酰氨氯化钠注射液的无菌检查方法。方法:本试验参照《中国药典》2010年版二部无菌检查法进行试验。结果:采用方法验证试验进行乙酰谷酰氨氯化钠注射液的无菌检查,供试品无菌生长,而阳性对照菌生长良好。结论:采用验证过的试验方法进行乙酰谷酰氨氯化钠注射液的无菌检查可行。
Objective： A test method for sterility of Aeeglutamide and Sodium Chloride Injection was established. Methods：The test method was carried out according to the method of volume two,Chinese Pharmacopoeia Edition 2010. Results：The validation tests were engaged,and the thild one show that all of seven strains positive control tubes reveal growth of mierooganism and the test control gives no evidence of growth. Conclusion： The method can be used to test for sterility of lifts preparation.
出处
《黑龙江医药》
CAS
2011年第2期200-201,共2页
Heilongjiang Medicine journal
关键词
乙酰谷酰氨氯化钠注射液
无菌检查法
方法学验证
Aceglutamide and Sodium Chloride Injection
test for sterility
method validation tests
