热原检测结果浅析  

Analysis of the Pyrogen Test

作　　者：林丽花 LIN Li-hua(Xiamen institute for Food and Drug Quality Control,Xiamen 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门361012

出　　处：《海峡药学》2020年第8期77-79,共3页Strait Pharmaceutical Journal

摘　　要：目的分析国内外非肠道用制品及药品包装容器(材料)热原检测结果,并进行安全性评价。方法对非肠道用制品及药品包装容器(材料)进行家兔热原检查法(Rabbit pyrogen test,RPT)或细菌内毒素检查法(Bacterial endotoxin test,BET),其检验和判定方法按照《中国药典》2015年版进行。结果 2016~2018年间共对223批非肠道用制品及药品包装容器(材料)进行热原检测,总合格率为98.2%,其中97批进行家兔热原检查法试验,其合格率为95.9%;126批进行细菌内毒素检查法试验,其合格率为100%;化学药、抗生素、中药、药包材检品合格率为100%,其他检品合格率为87.9%。结论检测的非肠道用制品及药品包装容器(材料)部分具有潜在危害性,需加强监管。OBJECTIVE To analyze and evaluate the pyrogen test of parenteral products and pharmaceutical packaging containers(materials).METHODS Rabbit pyrogen test(RPT)or bacterial endotoxin test(BET)of parenteral products and pharmaceutical packaging containers(materials)were detected and evaluated by the method in“Chinese pharmacopoeia”(2015).RESULTS 223 parenteral products and pharmaceutical packaging containers(materials)were tested for pyrogen in 2016~2018,which total qualification rate was 98.2%.The qualification rate was 95.9%in RPT for 97 samples and 100%in BET for 126 samples.CONCLUSION The pyrogen test of parenteral products and pharmaceutical packaging containers(materials)inspected have potentially harmfulness,which need to strengthen supervision.

关 键 词：热原 家兔热原检查法 细菌内毒素检查法 

分 类 号：R927[医药卫生—药学]