摘要
目的 :对细菌内毒素检查法在临床的应用进行探讨。方法 :参照中国药典九五版 (二部 )中的有关细菌内毒素检查法规定 ,采用最大有效稀释倍数法进行干扰实验。结果 :通过对 3 0批大输液进行细菌内毒素检查 ,甘露醇注射液 6批 ,阴性 6批 ;葡萄糖氯化纳注射液 1 8批 ,阴性 1 8批 ;低分子右旋糖酐注射液 6批 ,阳性 1批 ,阴性 5批。结论 :细菌内毒素检查法灵敏、方便、快捷 ,有利于大输液成品的质量控制。
Objective: To study the clinical application of bacterial endotoxin detection. Method: Several frequently used injection solutions were tested by means of maximum effective dilution coefficient with the limulus reagent on the basis of the endotoxin detecting methods ruled by the Chinese Pharmacopoeia (2 nd Volume, 1995 Edition). Results: 30 batches of solutions were tested, including 6 batches of mannitol solution, 18 batches of glucose sodium chloride solution, and 6 batches of dextran 40 glucose solution, Only one batch of dextran 40 glucose injection solution was positive. Conclusion: Bacterial endotoxin test can serve as a sensitive,convenient and easy approach for quality control of injection solutions.
出处
《海南医学院学报》
CAS
2000年第2期83-85,共3页
Journal of Hainan Medical University
关键词
干扰实验
质量控制
注射液
细菌内毒素
Endotoxin
bacterial toxin
interference test
quality control
