| 引用本文: | 王贵英，唐继坤，潘正兴.注射用盐酸托泊替康的细菌内毒素检查法研究[J].中国现代应用药学,2011,28(11):1044-1047. |
| WANG Guiying, TANG Jikun, PAN Zhengxing.Study on Bacterial Endotoxins Test of Topotecan Hydrochloride for Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(11):1044-1047. |
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| 摘要: |
| 目的 建立注射用盐酸托泊替康的细菌内毒素检查法。方法 按中国药典2010年版二部附录ⅪE细菌内毒素检查法。结果 本品稀释为0.04 mg·mL-1的溶液对细菌内毒素检查无干扰作用。按拟定标准检验，该品种3批样品细菌内毒素检查结果均符合规定。结论 本品可用细菌内毒素检查法代替家兔热原检查法，其细菌内毒素的限值(L)为50 EU·mg-1。 |
| 关键词: 注射用盐酸托泊替康 细菌内毒素检查 干扰试验 |
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| Study on Bacterial Endotoxins Test of Topotecan Hydrochloride for Injection |
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WANG Guiying, TANG Jikun, PAN Zhengxing
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Guizhou Institute for Drug Control, Guiyang 550004, China
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| Abstract: |
| OBJECTIVE To establish a method for determination of the bacterial endotoxin in topotecan hydrochloride for injection. METHODS According to Chinese Pharmacopoeia 2010 edition Appendix Ⅺ E bacterial endotoxin test. RESULTS Dilution sample to 0.04 mg·mL-1 had no interference to bacterial endotoxin test. The results of bacteria endotoxin test in three batchs all accorded with the standard of the quality control. CONCLUSION It can be used instead of rabbit pyrogen test method for. The limits of bacterial endotoxin was 50 EU·mg-1. |
| Key words: topotecan hydrochloride for injection bacterial endotoxin test interference test |
