注射用亚叶酸钙细菌内毒素检测方法的研究  

Study of Test for Bacterial Endotoxins in Calcium Folinate for Injection

作　　者：陈华龙 王莉蓓 吴招娣 

机构地区：[1]广东省韶关市药品检验所,韶关512028 [2]广东省药品检验,广州510180

出　　处：《海峡药学》2004年第6期51-53,共3页Strait Pharmaceutical Journal

摘　　要：目的　考察注射用亚叶酸钙进行细菌内毒素检查的可行性 ,为控制药品质量提供基础。 方法 　应用凝胶法鲎试验对样品进行细菌内毒素的检测。结果 　注射用亚叶酸钙稀释至 0 .2 778mg· m L- 1时对细菌内毒素检查无干扰作用。结论 　注射用亚叶酸钙的细菌内毒素限值可定为 0 .9EU·mg- 1 ,日常细菌内毒素检查时可将样品稀释至 0 .2 778mg· m L-OBJECTIVE To inspect the feasibility of bacterial endotoxins test for Calcium Folinate for injection and provide basis for drug control.METHODS Gel-clot limulus test was applied to detect the bacterial endotoxins in samples.RESULTS After diluted to 0.277mg·mL -1.Three batehes of Calcium Folinate for injection didn't interfere with the test for bacterial endotoxins.CONCLUSION The bacterial endotoxin linit of Calcium Folinate for injection is 0.9EU·mg -1,samples can be diluted to 0.2278mg·mL -1to avoid interfering effects on routine bacterial endotoxins test.

关 键 词：注射用亚叶酸钙 细菌内毒素检查法 干扰试验 

分 类 号：R927.12[医药卫生—药学]