| 唐先明,刘景波,宋丽阳,王姝.甘油果糖氯化钠注射液细菌内毒素检查法研究[J].中国药品标准,2018,19(6):473-476 |
| 甘油果糖氯化钠注射液细菌内毒素检查法研究 |
| Study on the Bacterial Endotoxins Testing Method for Glycerol Fructose and Sodium Chloride Injection |
| 投稿时间：2018-08-10 修订日期：2018-12-03 |
| DOI： |
| 中文关键词: 甘油果糖氯化钠注射液 细菌内毒素 凝胶法 干扰实验 |
| 英文关键词: Glycerol Fructose and Sodium Chloride Injection bacterial endotoxin gel method interference test |
| 基金项目: |
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| 摘要点击次数: 599 |
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| 中文摘要: |
| 目的：建立甘油果糖氯化钠注射液的细菌内毒素检查方法。方法：按《中国药典》2015年版四部通则进行试验和结果判断。结果：甘油果糖氯化钠注射液稀释2倍时对细菌内毒素检查无干扰,细菌内毒素限值为0.5EU.mL-1。对5批甘油果糖氯化钠注射液进行常规检查,结果均符合规定。结论：所建立的细菌内毒素检查法可用于甘油果糖氯化钠注射液的细菌内毒素检查。 |
| 英文摘要: |
| Objective：To establish a bacterial endotoxins testing method for Glycerol Fructose and Sodium Chloride Injection.Methods：The experiment was carried on and the results were judged according to Chinese Pharmacopeia 2015 edition Vol Ⅳ. Results：The interference on bacterial endotoxin test could be excluded when the sample was diluted 2 times.The limit value of the bacterial endotoxin was 0.5EU.mL-1. According to the established standard, the results of bacterial endotoxin test in 5 batches of samples were conformed to the required stipulation.Conclusion：The established bacterial endotoxin test may be applicable for bacterial endotoxin test of Glycerol Fructose and Sodium Chloride Injection. |
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