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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,2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。
Objective To explore the feasibility of rapid identification of bacterial endotoxin in spectinomycin hydrochloride for injection. Methods Rapid identification of bacterial endotoxin in drugs by Molisch method was used to verify the comparison with the test method. Results One batch of spectinomycin hydrochloride for injection showed a significant positive purple ring reaction, while 鲎 test to determine non-compliance, 4 batches of spectinomycin hydrochloride injection was negative, the results of the two methods are consistent. Conclusion The Molisch method can be used to rapidly identify bacterial endotoxin in spectinomycin hydrochloride for injection. This method provides a new idea for the treatment of emergency events caused by pyrogen reaction.