| 刘萌,姜丽君.动态浊度法检测透析用水和透析液细菌内毒素含量[J].中国药事,2018,32(1):67-75 |
| 动态浊度法检测透析用水和透析液细菌内毒素含量 |
| Determination of Bacterial Endotoxin in Dialysis Water and Dialysate with Dynamic Turbidity Method |
| 投稿时间：2017-01-22 |
| DOI：10.16153/j.1002-7777.2018.01.012 |
| 中文关键词: 透析用水 透析液 细菌内毒素 动态浊度法 方差分析 |
| 英文关键词: dialysis water dialysate bacterial endotoxin dynamic turbidity method variance analysis |
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| 中文摘要: |
| 目的：建立韶关地区医院透析用水和透析液细菌内毒素动态浊度检查法，了解分析韶关地区透析用水和透析液质量状况。方法：按照《中国药典》2015年版第四部通则1143细菌内毒素检查法方法2光度测定法，对韶关地区医院透析用水和透析液进行动态浊度法的方法学研究，使用SPSS软件分析不同稀释倍数下细菌内毒素的回收率，确定检测方法，并按照建立方法检测细菌内毒素含量。结果：建立细菌内毒素标准曲线LgT=2.80493-0.27415 LgC（r＝-0.9983），干扰试验中，稀释倍数越大，回收率越接近100%。不同稀释倍数对透析用水的回收率无显著影响（P=0.521），对透析液的回收率有显著影响（P=0.000），透析用水使用原液进行细菌内毒素检查无干扰作用，透析液使用8倍或16倍稀释液进行细菌内毒素检查无干扰作用。结论：医院透析用水和透析液细菌内毒素检测可用本研究建立的细菌内毒素检查法进行检测，韶关地区医院透析用水和透析液总体质量水平较好，均可达到标准要求。 |
| 英文摘要: |
| Objective: To establish a dynamic turbidity method to determine bacterial endotoxin in dialysis water and dialysate in hospitals of Shaoguan area and to analyze the quality of dialysis water and dialysate in Shaoguan area. Methods: According to the general rule 1143 of part IV of Chinese Pharmacopoeia, 2015 edition-No.2 method of bacterial endotoxin detection (spectrophotometric method), the methodological research of dynamic turbidity method to determine bacterial endotoxin in dialysis water and dialysate in hospitals of Shaoguan area was conducted. The bacterial endotoxin recovery rates at different dilutions were analyzed by using SPSS software, so the detection method was established and the bacterial endotoxin content was detected according to the established method. Results: The standard curve of bacterial endotoxin LgT=2.80493-0.27415 LgC (r=-0.9983) was established and the recovery rate was close to 100% with increased dilution in interference test. Different dilutions had no significant effect (P=0.521) on the recovery of dialysis water but had significant effect (P=0.000) on dialysate. No interference was detected in original dialysis water in 8 or 16 times diluted dialysate. Conclusion: The established bacterial endotoxin determination method could be used to determine the bacterial endotoxin of dialysis water and dialysate in hospitals. The overall quality of dialysis water and dialysate in hospitals of Shaoguan area was good and met the standard requirements. |
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