氨茶碱注射液细菌内毒素检查法的探讨

目的：建立氨茶碱注射液（ＡＭＰＨ）的细胞内毒素检查法。方法：确定ＡＭＰＨ的细菌内毒素限值，用稀释的方法排除ＡＭＰＨ对细菌内毒素试验的干扰。通过干扰试验测得ＡＭＰＨ的最大非抑制浓度及进行样品的细菌内毒素检查时最大可选用的鲎试剂灵敏度。结果：ＡＭＰＨ的细菌内毒素限值为２０Ｅｕ．ｍｌ＾－１，最大非抑制浓度为２５ｍｇ．ｍｌ＾－１，腚选用小于或等于１．０Ｅｕ．ｍｌ＾－１灵敏度的鲎试剂。结论：ＡＭＰＨ可用细菌

A Study on Bacterial Endotoxin Test of Aminophylline Injection

ObjectiveTo establish the bacterial endotoxin test of Aminophylline Injection(AMPH). Meth-ods To determine the bacterial endotoxin limit of AMPH. The method of dilution was used to prevent the interference of AMPH to the bacterial endotoxin test. To deterrnine the maximum uninhibited concentra-tion of AMPH the labeled TAL Reagent sensitivity should be chosen- Results The bacterial endotoxin limit of AMPH is 20Eu. ml-1, The maximum uninhibited concentration of AMPH is 25 mg. ml-1,and we should use less than or equal to 1.0Eu. ml-1 labeled TAL Regent sensitivity for the bacterial endotoxin test. Conclusion The bacterial endotoxin test can be used for the controlling of pyrogen of AMPH.