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本文应用新型显色基质鲎试剂盒,通过改良条件,对44批白蛋白制剂的内毒素进行定量测定,并与兔法对比。结果表明,内毒素浓度与相应的吸光度呈良好的线性关系,相关系数r=0.998;方法重复性好,CV％为2.92,平均回收率为98.7%。以兔法判断,合格品与不合格品之间的内毒素浓度有极显著差异(P<0.001);与兔法结果相比较,符合率为97.7％。新型显色基质法鲎试验具有操作简便、省时、灵敏度高、重复性好、可准确定量等优点,不失为白蛋白制剂中内毒素检测的有效方法。
In this paper, a new chromogenic matrix 鲎 kit was used to determine the endotoxin of 44 batches of albumin preparations by improving the conditions and compared with the rabbit method. The results showed that the endotoxin concentration showed a good linear relationship with the corresponding absorbance. The correlation coefficient was 0.998. The reproducibility of the method was good, the CV% was 2.92 and the average recovery was 98.7%. Judged by the rabbit method, there was a significant difference in endotoxin concentration between qualified and unqualified products (P <0.001). Compared with the rabbit results, the coincidence rate was 97.7%. The new chromogenic matrix method 鲎 test has the advantages of easy operation, time saving, high sensitivity, good repeatability and accurate quantification, which is an effective method for detecting endotoxin in albumin preparations.