医用聚乙二醇小檗碱液的细菌内毒素检测___
Bacterium endotoxin test of medical macrogol 400 berberine hydrochloride
分类号：
出版年·卷·期（页码）：2009,29 (10):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的：考察医用聚乙二醇小檗碱液（粘连平）细菌内毒素检查方法的可行性。方法：依据中国药典2005年版附录XIE细菌内毒素检查法，确定粘连平的有效的稀释浓度和细菌内毒素限值。结果：粘连平在稀释50倍后对细菌内毒素实验无干扰作用，其细菌内毒素限值符合规定。结论：该产品可以采用细菌内毒素检查法。
-----英文摘要：---------------------------------------------------------------------------------------
Objective:The research reviewed bacterium endotoxin test of medical macrogol 400 berberine hydrochloride.Method:The bacterium endotoxin test were performed to detect valid dilution concentration and limit value according to the Chinese pharmacopoeia edited 2005.Result:The sample which were diluted 50 times didnt disturb the bacterium endotoxin test and the limit value accord with demand.Conclusion:The product may use bacterium endotoxin test.
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