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目的建立天麻素氯化钠注射液的细菌内毒素检查法。方法按2005年版《中国药典》中细菌内毒素检查法的相关规定进行试验。结果样品对细菌内毒素检查无干扰作用。结论建立的天麻素氯化钠注射液细菌内毒素检查法具有可行性,细菌内毒素限值可定为0.6EU/mL。
Objective To establish a bacterial endotoxin test for gastrodin sodium chloride injection. Methods according to the 2005 edition of “Chinese Pharmacopoeia” bacterial endotoxin test method for the relevant provisions of the test. Results The sample did not interfere with the bacterial endotoxin test. Conclusion The bacterial endotoxin test of gastrodin sodium chloride injection is feasible. The limit of bacterial endotoxin can be set as 0.6EU / mL.