论文部分内容阅读
部颁《细菌内毒素检查法》试行两年多以来,我们基层药检所在大量的检查实践中发现:鲎试剂的质量能达到标准要求,核对灵敏度能在标示量的允许范围之内,且在效期内相当稳定.而细菌内毒素工作标准品则存在一些问题.表现为实际装量与标示量不符,且在冰箱2°～5℃保存下内毒素单位仍有逐年下降之趋势.我们对厦门鲎试剂厂配发的六批细菌内毒素工作标准品集中进行了标定,现将标定结果报告如下:
The ministerial “Bacterial Endotoxin Test” more than two years since the pilot, the grass-roots drug testing where a large number of inspection found: 鲎 reagent quality to meet the standard requirements, check the sensitivity can be marked within the allowable range, and in effect The period is quite stable, while the bacterial endotoxin standard work there are some problems. The performance of the actual amount of loading does not match with the labeled amount, and stored in the refrigerator at 2 ° ~ 5 ℃, there is still a downward trend in endotoxin units .We Xiamen鲎 reagent factory distribution of six batches of bacterial endotoxin working standards focused on the calibration, the calibration results are reported as follows: