| 唐先明,刘建辉,宋丽阳,王姝.注射用核糖核酸Ⅱ细菌内毒素检查法研究[J].中国药品标准,2018,19(6):469-472 |
| 注射用核糖核酸Ⅱ细菌内毒素检查法研究 |
| Study on the Bacterial Endotoxins Testing Method for Ribonucleic Acid for Injection Ⅱ |
| 投稿时间：2018-07-03 修订日期：2018-12-03 |
| DOI： |
| 中文关键词: 注射用核糖核酸Ⅱ 细菌内毒素 凝胶法 干扰实验 |
| 英文关键词: Ribonucleic Acid for Injection Ⅱ bacterial endotoxin gel method interference test |
| 基金项目: |
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| 中文摘要: |
| 目的 建立注射用核糖核酸Ⅱ的细菌内毒素检查方法。方法 按《中国药典》2015年版四部通则进行实验和结果判断。结果 注射用核糖核酸Ⅱ稀释至1.0mg.mL-1时对细菌内毒素检查无干扰,细菌内毒素限值为0.5EU.mg-1。对3批注射用核糖核酸Ⅱ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注射用核糖核酸Ⅱ的细菌内毒素检查。 |
| 英文摘要: |
| Objective：To establish a bacterial endotoxins testing method for Ribonucleic Acid for Injection Ⅱ.Methods：The experiment was carried on and the results were judged according to Chinese Pharmacopeia 2015 edition Vol Ⅳ. Results：There was no interference in the agglutination reaction between tachypleus amebocyte lysatein and endotoxin when 1.0 mg.ml-1 solution of Ribonucleic Acid sodium was utilized.The limit value of the bacterial endotoxin was 0.5 EU.mg-1. According to the established standard, the results of bacterial endotoxin test in 3 batches of samples were conformed to the required stipulation.Conclusion：The established bacterial endotoxin test may be applicable for bacterial endotoxin test of Ribonucleic Acid for Injection Ⅱ． |
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