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目的:建立鸦胆子油乳注射液细菌内毒素检查法。方法:依据《中华人民共和国药典》(2010年版一部)附录“细菌内毒素检查法”及临床用量,用不同厂家鲎试剂对10个批号的鸦胆子油乳注射液进行细菌内毒素检查和干扰试验。结果:经10批样品干扰试验验证,鸦胆子油乳注射液80倍稀释液对细菌内毒素检查无干扰。结论:鸦胆子油乳注射液采用细菌内毒素检查方法可行。
Objective: To establish bacterial endotoxin test of Brucea javanica oil injection. Methods: Bacterial endotoxin test was performed on 10 batches of Brucea javanica oil emulsion injection with different manufacturers’ reagent according to the appendix of “Pharmacopoeia of the People’s Republic of China” (2010 edition) “bacterial endotoxin test ” and clinical dosage. And interference test. Results: After 10 batches of samples were tested for interference, the 80-fold dilution of Brucea Javanica oil emulsion did not interfere with bacterial endotoxin test. Conclusion: Brucea javanica oil injection using bacterial endotoxin test method is feasible.