骨肽注射液细菌内毒素检查方法的建立
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篇名: | 骨肽注射液细菌内毒素检查方法的建立 |
TITLE: | |
摘要: | 目的:建立骨肽注射液细菌内毒素的检查方法。方法:依据2015年版《中国药典》“细菌内毒素检查法”项下凝胶法的要求,通过干扰试验确定样品主成分最大无干扰质量浓度,并进行方法学验证。结果:样品主成分质量浓度稀释至0.333 mg/ml或以下时对鲎试剂与细菌内毒素的凝集反应无干扰作用。结论:所建立的方法可用于骨肽注射液的细菌内毒素检查。 |
ABSTRACT: | OBJECTIVE: To establish the bacterial endotoxin test method of Ossotide injection. METHODS: According to the appendix of the gel method under “bacterial endotoxin test method” in Chinese Pharmacopiea (2015 edition), the maximal non-interference concentrations of samples were determined by interference test, and then methodology validation was conducted. RESULTS: The agglutination of LAL with bacterial endotoxin had no interference when the sample was diluted to 0.333 mg/ml or below. CONCLUSIONS: The established method can be used to detect the bacterial endotoxin of Ossotide injection. |
期刊: | 2016年第27卷第36期 |
作者: | 王婷婷,周瑞 |
AUTHORS: | WANG Tingting,ZHOU Rui |
关键字: | 骨肽注射液;细菌内毒素检查;凝胶法;干扰试验 |
KEYWORDS: | Ossotide injection; Bacterial endotoxin test; Gel method; Interference test |
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