摘要
目的:研究评价在药品微生物检验中使用均质器制备供试液的效果。方法:采用两种不同均质器进行药品污染微生物的回收率试验。结果:细菌回收率对比试验结果证明旋刀式均质器回收率略高于拍击式均质器,不同剂型药物细菌回收率有明显差异。结论:药品微生物检验供试液制备使用的均质器,必须根据不同的剂型进行方法适用性试验,依据试验结果选择合适的均质器,才能提高检出率保证检验结果的可靠性。
Objective:To study and evaluate the effects of homogenizer in microbial testing sample preparation.Methods:Two kinds of different homogenizer were used to test the recovery rates of microbial contamination of drugs .Results:The recovery rates of bacteria by knife-homogenier were slightly higher than that of slap-homogenier , and different dosage form had significant difference.Conclusion:The application of homogenizer in microbial testing sample preparation must be according to the results of suitability test for different dosage form.
出处
《中国药品标准》
CAS
2014年第3期190-193,共4页
Drug Standards of China
关键词
均质器
微生物检验
供试液制备
homogenizer
microbiological test
sample preparation