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目的研究帕米膦酸二钠葡萄糖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》2000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帕米膦酸二钠葡萄糖注射液进行干扰试验研究。结果帕米膦酸二钠葡萄糖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)代替家兔热原检查法控制其产品质量。
Objective To study the interference of pamidronate disodium glucose injection in bacterial endotoxin test and establish the quality standard of bacterial endotoxin test. Methods According to the “Chinese Pharmacopoeia” 2000 edition two Appendix ⅪE bacterial endotoxin test method for the test, with two different manufacturers of 鲎 reagent pamidronate disodium glucose injection interference study. Results Pamidronate disodium glucose injection has an interfering effect on bacterial endotoxin tests, but its interference can be eliminated by dilution. Conclusion Bacterial endotoxin test (gel method) instead of rabbit pyrogen test to control the quality of their products.