细菌内毒素检测法与家兔法同步检测4种中药注射液热原的研究  

Study on the Simultaneous Detection of Four Kinds of Pyrogens in Traditional Chinese Medicine Injection by Bacterial Endotoxin Detection Method and Rabbit Method

作　　者：何露 阳姣 吴梅 熊涛 张翅 He Lu;Yang Jiao;Wu Mei;Xiong Tao;Zhang Chi(China Resources San Jiu(Ya′an)Pharmaceutical Co.,Ltd.,Sichuan,Ya'an 625000,China)

机构地区：[1]华润三九(雅安)药业有限公司,四川雅安625000

出　　处：《中国中医急症》2022年第4期591-594,599,共5页Journal of Emergency in Traditional Chinese Medicine

基　　金：四川省科技计划项目(重点研发项目)(2020YFS0567)。

摘　　要：目的研究中药注射液生产过程中热原安全性问题,为中药注射液的热原安全性检查方式提供一定的研究思路。方法采用《热原检查法》和《细菌内毒素定量检查法》,分别对参附注射液、参麦注射液、生脉注射液、红花注射液4种中药注射剂的提取过程和制剂过程进行热原、细菌内毒素检验。结果提取和制剂阶段的热原检查均合格;细菌内毒素和热原结果均较稳定,发现有一定的相关性。结论试验中4种中药注射液生产过程中样品进行家兔热原法和细菌内毒素检查法(动态浊度法)比较,为中药注射液过程质量控制的提高提供了一定的研究思路和理论依据,基于上述的比较研究,提示细菌内毒素检查法可为4种注射液过程控制中热原检查的补充方法,更好地控制质量。Objective:To study the safety of pyrogen in the production of traditional Chinese medicine injection,so as to provide some research ideas for the pyrogen safety inspection square of traditional Chinese medicine injection.Methods:"Pyrogen Inspection Method"and"Bacterial Endotoxin Quantitative Inspection Method"were used to carry out pyrogen and bacterial endotoxin tests during the extraction process and preparation process of Shenfu Injection,Shenmai Injection,Shengmai Injection,and Honghua Injection,respectively.Results:The pyrogen tests during the extraction and preparation process were all qualified;the results of bacterial endotoxin and pyrogen were relatively stable,and a certain correlation was found.Conclusion:In the experiment,the rabbit pyrogen method and the bacterial endotoxin test method(dynamic turbidity method)were compared with the samples during the production process of the above 4 kinds of Chinese medicine injections,which has provided certain research ideas and theoretical basis for the improvement of the quality control in the Chinese medicine injection process.Based on the above comparative study,it is suggested that the bacterial endotoxin test method can be used as a supplementary method for the pyrogen test in the production process of 4 kinds of injections,which can improve the quality control of the injections.

关 键 词：中药注射剂 细菌内毒素 动态浊度法 热原检查 

分 类 号：R285.5[医药卫生—中药学]