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Article(id=1322627824498885082, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, 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=1603382400000, acceptedDateStr=2020-10-23, onlineDate=1793268646597, onlineDateStr=2026-10-29, pubDate=1615737600000, pubDateStr=2021-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268646597, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268646597, creator=13701087609, updateTime=1793268646597, updator=13701087609, issue=Issue{id=1322627786464936095, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='5', pageStart='385', pageEnd='480', issueExtLink='null', onlineDate='null', pubDate='1615737600000', pubDateStr='2021-03-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268637529, creator='13701087609', updateTime=1793269201588, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322630152530539005, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322630152530539006, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=434, endPage=440, ext={EN=ArticleExt(id=1322627824641491419, articleId=1322627824498885082, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Toxicity evaluation of repeated dose of Children Fengye Kechuanping Mixture in juvenile rats, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To explore the non-clinical safety evaluation method of Traditional Chinese medicine in juvenile rats, and observe the 4-week toxicity of Children Fengye Kechuanping Mixture, so as to provide reference for clinical medication in children.

Methods:

A total of 120 juvenile SD rats were randomly divided into 4 groups according to bodyweight, with 30 rats in each group, half male and half female. Four groups were solvent control group, Children Fengye Kechuanping Mixture low (extract 7.0 g·kg-1), medium (extract 14.0 g·kg-1) and high (extract 22.5 g·kg-1) dose groups. Each group was given the medication once a day by gavage. PND21 were given for 4 weeks in total, and the solvent control group was given the same amount of deionized water. General status, bodyweight, food intake, growth and development, hematology, blood biochemistry, coagulation, urine, immunity, hormones, organs and histopathological changes were detected.

Results:

In high-dose group, the weight, food intake, hematological indexes (RET, RET% increase), organ weight or coefficient (thymus decrease, liver increase) changed. Growth retardation was observed in male juvenile rats (manifested as decreased top hip length, shortened tibia length, increased tibia total density and cortex density). No obvious toxic target organs were observed. The effect of the above expression in juvenile male rats was more obvious.

Conclusion:

The safe dose of Children Fengye Kechuanping Mixture was 7.0 g·kg-1 (low dose, equivalent to raw dose 79.8 g·kg-1), 2.5 times of the equivalent dose and 14.9 times of the clinical dose in juvenile SD rats given by gavage for 4 weeks.

, authors=Li ZHOU1, 2, 3, Zhen-yu XUAN4, Li-ming CHONG1, 2, 3, Yi-wen HOU1, 2, 3, Yang YANG1, 2, 3, Sai-wei LU4, Lei LI1, 2, 3, Fen WANG1, 2, 3, Zhong-hui WANG1, 2, 3, Li-fen CHEN1, 2, 3, Xin ZHANG1, 2, 3, Zu-yue SUN1, 2, 3, authorsList=Li ZHOU, Zhen-yu XUAN, Li-ming CHONG, Yi-wen HOU, Yang YANG, Sai-wei LU, Lei LI, Fen WANG, Zhong-hui WANG, Li-fen CHEN, Xin ZHANG, Zu-yue SUN, authorCompany=null, correspAuthors=Zu-yue SUN, 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=1322627824838623708, articleId=1322627824498885082, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=离乳大鼠给予小儿风叶咳喘平合剂的重复给药毒性评价, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的：

探索刚离乳幼龄大鼠的中药非临床安全性评价方法，观察小儿风叶咳喘平合剂4周灌胃给药对幼龄SD大鼠的毒性反应，为儿童临床用药提供参考。

方法：

刚离乳SD大鼠120只，按体重随机分为4组，每组30只，雌雄各半，分为溶媒对照组，风叶咳喘平合剂低（浸膏7.0 g·kg-1）、中（浸膏14.0 g·kg-1）和高（浸膏22.5 g·kg-1）剂量组；各剂量组动物每天灌胃给药1次，PND21开始给药，共4周，溶媒对照组给予等量的去离子水；检测一般状况、体重、摄食量、生长发育、血液学、血液生化学、凝血、尿液、免疫、激素、脏器和病理组织学变化。

结果：

高剂量组雌雄幼龄大鼠体重降低、摄食量减少、血液学指标（网织红细胞计数RET和RET%增加）、脏器重量或系数（胸腺减轻、肝脏增加）有所改变；雄性幼龄大鼠生长发育迟缓，表现为雄鼠顶臀长减少，胫骨长缩短、胫骨总密度和皮质密度增加；未见明显毒性靶器官；上述表现对雄性幼龄大鼠的影响更加明显。

结论：

幼龄SD大鼠4周灌胃给予风叶咳喘平合剂的安全剂量为浸膏7.0 g·kg-1（低剂量，相当于生药量79.8 g·kg-1），为大鼠等效剂量的2.5倍，临床剂量的14.9倍。

, authors=周莉1, 2, 3, 玄振玉4, 崇立明1, 2, 3, 侯祎雯1, 2, 3, 杨阳1, 2, 3, 陆赛卫4, 李雷1, 2, 3, 王芬1, 2, 3, 王忠辉1, 2, 3, 陈丽芬1, 2, 3, 张鑫1, 2, 3, 孙祖越1, 2, 3, authorsList=周莉, 玄振玉, 崇立明, 侯祎雯, 杨阳, 陆赛卫, 李雷, 王芬, 王忠辉, 陈丽芬, 张鑫, 孙祖越, authorCompany=null, correspAuthors=孙祖越, authorNote=

玄振玉，男，教授级工程师，主要从事新药研发。E-mail：。

周莉，女，研究员，主要从事药物生殖药理毒理学研究、新药非临床安全性评价工作。E-mail：。

, correspAuthorsNote=
孙祖越，男，研究员，主要从事药物生殖药理毒理学及新药非临床安全性评价研究。E-mail：。
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周莉，女，研究员，主要从事药物生殖药理毒理学研究、新药非临床安全性评价工作。E-mail：。

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周莉，女，研究员，主要从事药物生殖药理毒理学研究、新药非临床安全性评价工作。E-mail：。

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tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627824498885082, language=CN, orderNo=4, keyword=安全性评价)], refs=[Reference(id=1322627832262541892, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627824498885082, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=鹿振辉, 张惠勇, 张琼, 等. 风叶咳喘平合剂治疗急性支气管炎咳嗽(风热犯肺)的随机双盲多中心临床研究[J]. 中成药, 2014, 36(6): 1151-1155., articleTitle=null, refAbstract=null), Reference(id=1322627832375788101, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627824498885082, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=黄芳华, 王庆利, RIDINGS J, 等. 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(2020) [2020-09-16]. http://www.cde.org.cn/ichWeb/news/getNewsDetail/2/3ac68cf61f65114d8fce5e9ede086bba/1., articleTitle=null, refAbstract=null), Reference(id=1322627832694555210, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627824498885082, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=国家食品药品监督管理总局. 药物重复给药毒性试验技术指导原则[EB/OL]. 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离乳大鼠给予小儿风叶咳喘平合剂的重复给药毒性评价
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周莉 1, 2, 3 , 玄振玉 4 , 崇立明 1, 2, 3 , 侯祎雯 1, 2, 3 , 杨阳 1, 2, 3 , 陆赛卫 4 , 李雷 1, 2, 3 , 王芬 1, 2, 3 , 王忠辉 1, 2, 3 , 陈丽芬 1, 2, 3 , 张鑫 1, 2, 3 , 孙祖越 1, 2, 3
中国新药杂志 | 实验研究 2021,30(5): 434-440
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中国新药杂志 |实验研究 2021 , 30 (5) : 434 -440
离乳大鼠给予小儿风叶咳喘平合剂的重复给药毒性评价
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周莉，女，研究员，主要从事药物生殖药理毒理学研究、新药非临床安全性评价工作。E-mail：。

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周莉，女，研究员，主要从事药物生殖药理毒理学研究、新药非临床安全性评价工作。E-mail：。

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周莉1, 2, 3 , 玄振玉4 , 崇立明1, 2, 3, 侯祎雯1, 2, 3, 杨阳1, 2, 3, 陆赛卫4, 李雷1, 2, 3, 王芬1, 2, 3, 王忠辉1, 2, 3, 陈丽芬1, 2, 3, 张鑫1, 2, 3, 孙祖越1, 2, 3
作者信息
  • 1上海市计划生育科学研究所药理毒理学研究室，中国生育调节药物毒理检测中心，上海　200032
  • 2国家人口和计划生育委员会计划生育药具重点实验室，上海　200032
  • 3复旦大学生殖与发育研究院，上海　200032
  • 4苏州玉森新药开发有限公司，苏州　215000
通讯作者:
孙祖越，男，研究员，主要从事药物生殖药理毒理学及新药非临床安全性评价研究。E-mail：。
作者简介:

玄振玉，男，教授级工程师，主要从事新药研发。E-mail：。

周莉，女，研究员，主要从事药物生殖药理毒理学研究、新药非临床安全性评价工作。E-mail：。

Toxicity evaluation of repeated dose of Children Fengye Kechuanping Mixture in juvenile rats
Li ZHOU1, 2, 3 , Zhen-yu XUAN4 , Li-ming CHONG1, 2, 3, Yi-wen HOU1, 2, 3, Yang YANG1, 2, 3, Sai-wei LU4, Lei LI1, 2, 3, Fen WANG1, 2, 3, Zhong-hui WANG1, 2, 3, Li-fen CHEN1, 2, 3, Xin ZHANG1, 2, 3, Zu-yue SUN1, 2, 3
Affiliations
  • 1Shanghai Institute of Planned Parenthood Research, National Evaluation Centre for Toxicology of Fertility Regulating Drugs, Shanghai 200032, China
  • 2Key Laboratory of Reproduction Regulation of NPFPC, Shanghai 200032, China
  • 3Reproductive and Developmental Research Institute of Fudan University, Shanghai 200032, China
  • 4Suzhou Youseen New Drug R&D Co., Ltd., Suzhou 215000, China
出版时间: 2021-03-15
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摘要
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目的：

探索刚离乳幼龄大鼠的中药非临床安全性评价方法，观察小儿风叶咳喘平合剂4周灌胃给药对幼龄SD大鼠的毒性反应，为儿童临床用药提供参考。

方法：

刚离乳SD大鼠120只，按体重随机分为4组，每组30只，雌雄各半，分为溶媒对照组，风叶咳喘平合剂低（浸膏7.0 g·kg-1）、中（浸膏14.0 g·kg-1）和高（浸膏22.5 g·kg-1）剂量组；各剂量组动物每天灌胃给药1次，PND21开始给药，共4周，溶媒对照组给予等量的去离子水；检测一般状况、体重、摄食量、生长发育、血液学、血液生化学、凝血、尿液、免疫、激素、脏器和病理组织学变化。

结果：

高剂量组雌雄幼龄大鼠体重降低、摄食量减少、血液学指标（网织红细胞计数RET和RET%增加）、脏器重量或系数（胸腺减轻、肝脏增加）有所改变；雄性幼龄大鼠生长发育迟缓，表现为雄鼠顶臀长减少，胫骨长缩短、胫骨总密度和皮质密度增加；未见明显毒性靶器官；上述表现对雄性幼龄大鼠的影响更加明显。

结论：

幼龄SD大鼠4周灌胃给予风叶咳喘平合剂的安全剂量为浸膏7.0 g·kg-1（低剂量，相当于生药量79.8 g·kg-1），为大鼠等效剂量的2.5倍，临床剂量的14.9倍。

小儿风叶咳喘平合剂  /  幼龄SD大鼠  /  重复给药毒性  /  安全性评价
Objective:

To explore the non-clinical safety evaluation method of Traditional Chinese medicine in juvenile rats, and observe the 4-week toxicity of Children Fengye Kechuanping Mixture, so as to provide reference for clinical medication in children.

Methods:

A total of 120 juvenile SD rats were randomly divided into 4 groups according to bodyweight, with 30 rats in each group, half male and half female. Four groups were solvent control group, Children Fengye Kechuanping Mixture low (extract 7.0 g·kg-1), medium (extract 14.0 g·kg-1) and high (extract 22.5 g·kg-1) dose groups. Each group was given the medication once a day by gavage. PND21 were given for 4 weeks in total, and the solvent control group was given the same amount of deionized water. General status, bodyweight, food intake, growth and development, hematology, blood biochemistry, coagulation, urine, immunity, hormones, organs and histopathological changes were detected.

Results:

In high-dose group, the weight, food intake, hematological indexes (RET, RET% increase), organ weight or coefficient (thymus decrease, liver increase) changed. Growth retardation was observed in male juvenile rats (manifested as decreased top hip length, shortened tibia length, increased tibia total density and cortex density). No obvious toxic target organs were observed. The effect of the above expression in juvenile male rats was more obvious.

Conclusion:

The safe dose of Children Fengye Kechuanping Mixture was 7.0 g·kg-1 (low dose, equivalent to raw dose 79.8 g·kg-1), 2.5 times of the equivalent dose and 14.9 times of the clinical dose in juvenile SD rats given by gavage for 4 weeks.

Children Fengye Kechuanping Mixture  /  juvenile SD rats  /  repeated dose toxicity  /  safety evaluation
周莉, 玄振玉, 崇立明, 侯祎雯, 杨阳, 陆赛卫, 李雷, 王芬, 王忠辉, 陈丽芬, 张鑫, 孙祖越. 离乳大鼠给予小儿风叶咳喘平合剂的重复给药毒性评价. 中国新药杂志, 2021 , 30 (5) : 434 -440 .
Li ZHOU, Zhen-yu XUAN, Li-ming CHONG, Yi-wen HOU, Yang YANG, Sai-wei LU, Lei LI, Fen WANG, Zhong-hui WANG, Li-fen CHEN, Xin ZHANG, Zu-yue SUN. Toxicity evaluation of repeated dose of Children Fengye Kechuanping Mixture in juvenile rats[J]. Chinese Journal of New Drugs, 2021 , 30 (5) : 434 -440 .
基金
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  • 国家“重大新药创制”科技重大专项资助项目(2018ZX09201017-002; 2019ZX09201004-002-051)
  • 上海市科委研发平台专项(18DZ2292100)
文献
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参考文献 引证文献
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鹿振辉, 张惠勇, 张琼, 等. 风叶咳喘平合剂治疗急性支气管炎咳嗽(风热犯肺)的随机双盲多中心临床研究[J]. 中成药, 2014, 36(6): 1151-1155.
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周莉, 孙祖越. 非临床安全性评价中离乳前给药的幼龄动物分组设计[J]. 中国新药杂志, 2016, 25(20): 2483-2488.
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崇立明, 杨阳, 陈丽芬, 等. 幼龄SD大鼠重复给药毒性试验背景数据的建立[J]. 中国新药杂志, 2021, 30(1): 17-24.
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孙祖越, 周莉. 儿科用药非临床安全性研究[M]. 上海: 上海科学技术出版社, 2020.
2021年第30卷第5期
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  • 首发时间：2026-10-29
  • 出版时间：2021-03-15
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  • 录用日期：2020-10-23
基金
国家“重大新药创制”科技重大专项资助项目(2018ZX09201017-002; 2019ZX09201004-002-051)
上海市科委研发平台专项(18DZ2292100)
作者信息
    1上海市计划生育科学研究所药理毒理学研究室，中国生育调节药物毒理检测中心，上海　200032
    2国家人口和计划生育委员会计划生育药具重点实验室，上海　200032
    3复旦大学生殖与发育研究院，上海　200032
    4苏州玉森新药开发有限公司，苏州　215000

通讯作者:

孙祖越，男，研究员，主要从事药物生殖药理毒理学及新药非临床安全性评价研究。E-mail：。
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
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