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Study on the method of bacterial endotoxin test in bortezomib
Author(s): 
Pages: 210-212
Year: Issue:  4
Journal: Qilu Pharmaceutical Affairs

Keyword:  硼替佐米水不溶性药物甘露醇细菌内毒素干扰试验;
Abstract: 目的 对水不溶性药物硼替佐米经加入制剂辅料甘露醇溶液助溶后,采用凝胶法进行细菌内毒素检查的方法学验证,探讨水不溶性药物的细菌内毒素检查方法.方法 取硼替佐米按制剂的处方加入10%甘露醇助溶后,进行样品溶液的凝胶法检查干扰试验和细菌内毒素检查.结果 硼替佐米原料可溶于10%的甘露醇溶液,经稀释后可排除干扰且干扰试验符合药典规定.结论 将硼替佐米用10%的甘露醇溶液配制成5 mg·mL-1溶液并用BET水稀释至0.0025 mg·mL-浓度时无干扰,可采用细菌内毒素检查法进行其质量控制.
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