Article(id=1322245659986612950, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245649572156020, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1599235200000, acceptedDateStr=2020-09-05, onlineDate=1793177531477, onlineDateStr=2026-10-28, pubDate=1619712000000, pubDateStr=2021-04-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177531477, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177531477, creator=13701087609, updateTime=1793177531477, updator=13701087609, issue=Issue{id=1322245649572156020, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='8', pageStart='673', pageEnd='768', issueExtLink='null', onlineDate='null', pubDate='1619712000000', pubDateStr='2021-04-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177528994, creator='13701087609', updateTime=1793177643007, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322246127831863562, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245649572156020, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322246127831863563, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322245649572156020, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=760, endPage=764, ext={EN=ArticleExt(id=1322245660192133847, articleId=1322245659986612950, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The comparison of pyrogen tests for heat-clearing Xingnaojing Injection, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To compare the rabbit method and dynamic turbidity method for pyrogen detection in heat-clearing Xingnaojing injection.
Methods: Three batches of heat-clearing type Chinese medicine injection, Xingnaojing injection, were selected as the research object. Animals were divided into seven groups, including endotoxin, 3 groups of endotoxin+endotoxin test samples, 3 groups of endotoxin test samples. Pyrogen was tested using rabbit pyrogen examination. At the same time, the endotoxin in Xingnaojing Injection was quantitatively detected by dynamic turbidimetry.
Results: No pyrogen reaction was found in 3 batches of test sample groups by rabbit method. The body temperature of rabbits in endotoxin group increased by 0.6 ℃, and the pyrogen reaction occurred. Compared with the endotoxin group, the pyrogen test in endotoxin+test group was false negative. The contents of bacterial endotoxin in 3 batches of Xingnaojing Injection groups were determined by dynamic turbidimetric method, the content of endotoxin was <0.01 EU·mL-1.
Conclusion: Rabbit pyrogen test is easy to produce false negative results for pyrogen test of heat-clearing Xingnaojing Injection, and dynamic turbidimetry can quantitatively detect the contents of bacterial endotoxin.
, authors=Qun LIU
1, Xin RUAN
2, Jian RUAN
1, authorsList=Qun LIU, Xin RUAN, Jian RUAN, authorCompany=null, correspAuthors=Jian RUAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322245660431209176, articleId=1322245659986612950, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=清热类中药醒脑静注射液热原检测方法的比较, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 清热类中药醒脑静注射液热原检测中，对家兔法和动态浊度法进行比较。
方法： 选取3批清热类中药注射剂醒脑静注射液为研究对象，实验分为7个组，内毒素组、外加内毒素制成内毒素+供试品组3个、供试品组3个，采用家兔热原检查法进行热原检查，同时采用动态浊度法对醒脑静注射液中内毒素进行定量检测。
结果： 家兔法测定供试品组3批样品均无热原反应；内毒素组家兔体温升高均达到0.6 ℃，发生热原反应；内毒素+供试品组与内毒素组比较，2批样品的内毒素+供试品组热原检查呈假阴性。动态浊度法测定3批醒脑静注射液的细菌内毒素含量，内毒素含量<0.01 EU·mL-1。
结论： 家兔热原检查法对清热类中药醒脑静注射液热原检测出现假阴性，动态浊度法能定量检测其细菌内毒素的含量。
, authors=刘群
1, 阮新
2, 阮健
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刘群，女，副主任药师，主要从事药品检验和质量标准制研究。联系电话：（0535）6243276-8021，E-mail：liu138535@163.com。
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