一种氢溴酸瑞马唑仑细菌内毒素的检测方法

本发明公开了一种氢溴酸瑞马唑仑细菌内毒素的检测方法,包括如下步骤:鲎试剂灵敏度复核;确定氢溴酸瑞马唑仑细菌内毒素限值以及最小稀释浓度;方法进行干扰实验,确认不存在干扰的供试品浓度;实验中用10-30mg/mL的聚山梨酯80的水溶液溶解供试品,并用细菌内毒素检测用水稀释得到供试品溶液;氢溴酸瑞马唑仑细菌内毒素检查:用10-30mg/mL聚山梨酯80的水溶液溶解氢溴酸瑞马唑仑供试品,并用细菌内毒素检查用水稀释至不存在干扰的有效浓度进行细菌内毒素检查。该方法用一定浓度的聚山梨酯-80水溶液溶解样品,可以消除供试品对细菌内毒素的干扰作用,方法简便易操作,实用性高。 The invention disc...

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Format Patent
LanguageChinese
Published 12.07.2022
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Summary:本发明公开了一种氢溴酸瑞马唑仑细菌内毒素的检测方法,包括如下步骤:鲎试剂灵敏度复核;确定氢溴酸瑞马唑仑细菌内毒素限值以及最小稀释浓度;方法进行干扰实验,确认不存在干扰的供试品浓度;实验中用10-30mg/mL的聚山梨酯80的水溶液溶解供试品,并用细菌内毒素检测用水稀释得到供试品溶液;氢溴酸瑞马唑仑细菌内毒素检查:用10-30mg/mL聚山梨酯80的水溶液溶解氢溴酸瑞马唑仑供试品,并用细菌内毒素检查用水稀释至不存在干扰的有效浓度进行细菌内毒素检查。该方法用一定浓度的聚山梨酯-80水溶液溶解样品,可以消除供试品对细菌内毒素的干扰作用,方法简便易操作,实用性高。 The invention discloses a detection method of remimazolam hydrobromide bacterial endotoxin. The detection method comprises the following steps: rechecking the sensitivity of a tachypleus amebocyte lysate; determining the limit value and the minimum dilution concentration of the remimazolam hydrobromide bacterial endotoxin; performing an interference experiment to confirm the concentration of a test sample without interference, wherein in the experiment, the test sample is dissolved by using an aqueous polysorbate-80 solution with a concentration of 10-30 mg/mL, and diluted by using water for bacterial endotoxin detection to obtain a test sample solution; and detecting the remimazolam hydrobromide bacterial endotoxin by dissolving a
Bibliography:Application Number: CN202011294497