| 引用本文: | 肖贵南,程朝辉,孙清萍.快速鉴别注射用盐酸大观霉素中的细菌内毒素[J].中国现代应用药学,2014,31(12):1507-1510. |
| XIAO Guinan,CHENG Zhaohui,SUN Qingping.Rapid Identification of Bacterial Endotoxins in Spectinomycin Hydrochloride for Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(12):1507-1510. |
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| 摘要: |
| 目的 探讨快速鉴别注射用盐酸大观霉素中细菌内毒素的可行性。方法 应用Molisch法对药品中的细菌内毒素进行快速鉴别，与鲎试验方法进行验证比较。结果 1批注射用盐酸大观霉素呈现明显的阳性紫环反应，同时鲎试验检查判断为不符合规定，4批注射用盐酸大观霉素呈阴性反应，两种方法的检查结果一致。结论 Molisch法可用于快速鉴别注射用盐酸大观霉素中的细菌内毒素，该方法为热原反应药害应急事件的处理提供了一种新思路。 |
| 关键词: 注射用盐酸大观霉素 细菌内毒素 鉴别 Molisch法 |
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| 基金项目:广东省食品药品监管局药检系统科研项目(YJ200909) |
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| Rapid Identification of Bacterial Endotoxins in Spectinomycin Hydrochloride for Injection |
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XIAO Guinan, CHENG Zhaohui, SUN Qingping
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Guangdong Institute for Food and Drug Control, Guangzhou 510180, China
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| Abstract: |
| OBJECTIVE To explore the feasibility for rapid identification of bacterial endotoxins in spectinomycin hydrochloride for injection. METHODS Molisch method was applied to detect bacterial endotoxins in drugs quickly, the result was compared with that of gel-clot lysate test. RESULTS One batch of spectinomycin hydrochloride for injection showed positive reaction of purple ring by application of Molisch method, four batches showed negative reaction, it showed good correlation between this new method and routine lysate test. CONCLUSION Molisch method can be applied to detect bacterial endotoxins in spectinomycin hydrochloride for injection quickly, it provides a new way to deal with the drug emergency induced by pyrogen reaction. |
| Key words: spectinomycin hydrochloride for injection bacterial endotoxins identification Molisch method |
