| 唐先明,刘建辉,宋丽阳,郁玖慧,王姝.喘可治注射液细菌内毒素检查法研究[J].中国药品标准,2018,19(1):64-67 |
| 喘可治注射液细菌内毒素检查法研究 |
| Study on the Bacterial Endotoxins Testing Method for Chuankezhi Injection |
| 投稿时间：2017-11-28 修订日期：2018-02-07 |
| DOI： |
| 中文关键词: 喘可治注射液 细菌内毒素 凝胶法 干扰实验 |
| 英文关键词: chuankezhi injection bacterial endotoxin gel method interference test |
| 基金项目: |
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| 中文摘要: |
| 目的 建立喘可治注射液的细菌内毒素检验方法。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 喘可治注射液稀释 50 倍时对细菌内毒素检查无干扰,细菌内毒素限值为 25 EU.mL-1。结论 所建立的细菌内毒素检查法可用于喘可治注射液的细菌内毒素检查。 |
| 英文摘要: |
| Objective：To establish a bacterial endotoxins testing method for Chuankezhi Injection.Methods：The experiment was carried on and the results were judged according to Chinese Pharmacopeia 2015 edition Vol Ⅳ. Results：After more than 50 times of dilution the Injection was found no interference in the reaction of endotoxin with TAL. The limit value of the bacterial endotoxin was 25 EU.mL-1.Conclusion：The established bacterial endotoxin test may be applicable for bacterial endotoxin test of Chuankezhi injection． |
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