冠心宁注射液中细菌内毒素含量的微量动态显色法定量检测研究  

Study on Quantitative Detection of Bacterial Endotoxin in Guanxinning Injection(冠心宁注射液)by Micro-dynamic Chromogenic Method

作　　者：杨海燕[1] 辛琰琰 周继春[1] 张军霞[1] 李振国[1] 王健[1] 毛国梁 YANG Hai-yan;XIN Yan-yan;ZHOU Ji-chun;ZHANG Jun-xia;LI Zhen-guo;WANG Jian;MAO Guo-liang(Henan Provincial Insititute of Food and Drug Control,Zhengzhou Henan 450003,China;Women&Infants Hospital of Zhengzhou,Zhengzhou Henan 450003,China;Quality Department of Shiyao Yinhu Pharmaceutical Co.,Ltd.,Yuncheng Shanxi 044000,China)

机构地区：[1]河南省食品药品检验所,河南郑州450003 [2]郑州市妇幼保健院,河南郑州450003 [3]石药银湖制药有限公司质量部,山西运城044000

出　　处：《中医药导报》2020年第12期40-43,46,共5页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：河南省科技攻关项目(162102310067)。

摘　　要：目的:探讨微量动态显色法用于冠心宁注射液类复方中药制剂中细菌内毒素定量检测的可行性。方法:应用微量动态显色法对冠心宁注射液中细菌内毒素进行定量检测,并与家兔热原法及凝胶法试验结果进行比较。结果:应用微量动态显色法试剂对冠心宁注射液稀释80倍及以下浓度时,微量动态显色法鲎试剂与细菌内毒素凝集反应无干扰作用,回收率50%~200%,该检测结果与凝胶法一致,家兔法检查热原均符合规定。结论:微量动态显色法可用于冠心宁注射液细菌内毒素定量检测,结果准确,灵敏度高,过程可监控。Objective: To explore the feasibility of the micro-dynamic chromogenic method for quantitative detection of bacterial endotoxin in Guanxinning injection-like compound Chinese medicine preparations. Methods:The content of the bacterial endotoxins in Guanxinning injection was quantitatively detected by micro-dynamic chromogenic method, and the results were compared with that of the gel-clot method and the rabbit pyrogen method. Results: When Guanxinning injection was diluted 80 times or below, the micro-dynamic chromogenic reagent did not interfere with the bacterial endotoxin agglutination reaction, and the recovery rate was 50% to 200%. The test results are consistent with the gel-clot method, and the rabbit pyrogens method meets the requirements. Conclusion: The micro-dynamic chromogenic method can be used for the quantitative detection of bacterial endotoxins in Guanxinning injection, with accurate results, high sensitivity, and process monitoring.

关 键 词：冠心宁注射液 微量动态显色法 内毒素定量检测 凝胶法 热原检查法 显色基质 

分 类 号：R284.1[医药卫生—中药学]