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几种常用注射液的细菌内毒素检查法探讨
引用本文:杨彩虹. 几种常用注射液的细菌内毒素检查法探讨[J]. 海南医学院学报, 2000, 6(2): 83-85
作者姓名:杨彩虹
作者单位:武警海南总队医院药局海口 570203
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。

关 键 词:内毒素类  细菌毒素类  干扰实验  质量控制
修稿时间:1999-09-08

A STUDY OF ENDOTOXIN DETECTION IN FREQUENTLY USED INJECTION SOLUTIONS
Yang Caihong. A STUDY OF ENDOTOXIN DETECTION IN FREQUENTLY USED INJECTION SOLUTIONS[J]. Journal of Hainan Medical College, 2000, 6(2): 83-85
Authors:Yang Caihong
Affiliation:Hospital of the Brigade of the people's Armed Police forces
Abstract: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.
Keywords:Endotoxin  bacterial toxin  interference test  quality control
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