摘要: |
建立18-氨基酸注射液细菌内毒素定量测定方法,控制药品质量.采用动态浊度法,对18-氨基酸注射稀释液进行干扰预实验、干扰实验定量检测.结果18-氨基酸注射液在8倍稀释时无干扰作用.因此用动态浊度法定量检查18-氨基酸注射液细菌内毒素的含量,结果准确,在实际应用中完全可行. |
关键词: 18-氨基酸注射液 动态浊度法鲎试验 细菌内毒素 |
DOI: |
分类号:Q503 |
基金项目: |
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Study on Kinetic Turbidimetric Assay of 18-Amino Acid Injection |
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Abstract: |
The analytical method for quantita tive detection of the bacterial endotoxin in 18-amino acid injection was established. The kinetic turbidimetric assay was used for dilutions of 18-amino acid injection.No interference action was found in the 8-fold dilution.Quantitative detection of bacterial endotoxin in 18-amino acid injection by kinetic turbidimetric assay is entirely feasible in practice. |
Key words: amino acid injection kinetic turbidimetric limulus test bacterial endotoxin |