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目的研究盐酸罂粟碱注射液对细菌内毒素检查实验的干扰情况,并建立其细菌内毒素检查的质量标准。方法参照《中国药典》2005年版二部附录ⅪE细菌内毒素检查法进行试验,用两个不同厂家的鲎试剂对盐酸罂粟碱注射液进行干扰试验研究。结果盐酸罂粟碱注射液对细菌内毒素检查有干扰作用,但通过稀释可消除其干扰。结论可以用细菌内毒素检查法(凝胶法)控制其产品质量。
Objective To study the interference of papaverine hydrochloride injection on bacterial endotoxin test and establish the quality standard of bacterial endotoxin test. Methods The experiment was conducted with reference to the bacterial endotoxin test method of Annex XIE of the 2005 edition of the Chinese Pharmacopoeia. The interference test of papaverine hydrochloride injection was conducted with two different manufacturer’s limulus reagents. Results The papaverine injection interfered with bacterial endotoxin test, but the interference could be eliminated by dilution. Conclusion The bacterial endotoxin test (gel method) can be used to control the product quality.