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Article(id=1193548061445161071, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193548058421064688, articleNumber=1001-2494(2025)05-0481-07, orderNo=null, doi=10.11669/cpj.2025.05.005, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1722528000000, receivedDateStr=2024-08-02, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1762493632899, onlineDateStr=2025-11-07, pubDate=1741363200000, pubDateStr=2025-03-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1762493632899, onlineIssueDateStr=2025-11-07, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1762493632899, creator=13701087609, updateTime=1762493632899, updator=13701087609, issue=Issue{id=1193548058421064688, tenantId=1146029695717560320, journalId=1190317699101192196, year='2025', volume='60', issue='5', pageStart='441', pageEnd='552', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1762493632178, creator=13701087609, updateTime=1762493856082, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1193548997664146365, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193548058421064688, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1193548997664146366, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193548058421064688, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=481, endPage=487, ext={EN=ArticleExt(id=1193548061600350320, articleId=1193548061445161071, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Developmental Toxicity of Rehmannia glutinosa Leaf Total Glycosides Capsules in Juvenile Rats, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To evaluate the safety characteristics of Rehmannia glutinosa leaf total glycosides capsules in juvenile Wistar rats, and provide reference for the use of Rehmannia glutinosa leaf total glycosides capsules in child and adolescent patients. METHODS Twenty-seven-day-old Wistar rats were randomly divided into control and low-, medium-, and high-dosage groups. Each dosage group was given the Rehmannia glutinosa leaf total glycosides by gavage repeatedly for 8 weeks, followed by a 4 week recovery. The clinical symptoms, body weight, food consumption, hematological and serum biochemical indexes, central nervous system function, learning and memory ability, skeletal development, reproductive function, organ weight and histopathological changes of the rats was observed. RESULTS Rehmannia glutinosa leaf total glycosides capsules did not show significant effects on the clinical symptoms, body weight, food consumption, hematological and serum biochemical indexes, main organ weights, central nervous system function, bones, sexual cycle, sperm counts, vitality and form of the rats. No histopathological changes were observed associated with Rehmannia glutinosa leaf total glycosides capsules. CONCLUSION The no-observed-adverse-effect-level (NOAEL) for Rehmannia glutinosa leaf total glycosides capsules in juvenile rats is determined to be 750 mg·kg-1 in the 8 week feeding study. The data provides reference for the use of Rehmannia glutinosa leaf total glycosides capsules in child and adolescent patients.

, correspAuthors=Xiaobing ZHOU, Yanhua LIU, 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, authorCompany=null, fund=null, authors=null, authorsList=Manman ZHAO, hua XIAO, Ying YANG, Zihe LIANG, Zhi LIN, Xiaobing ZHOU, Yanhua LIU), CN=ArticleExt(id=1193548198997360874, articleId=1193548061445161071, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=地黄叶总苷胶囊对幼龄大鼠发育毒性的研究, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 评价地黄叶总苷胶囊在幼龄Wistar大鼠体内的安全性特征,为地黄叶总苷胶囊应用于儿童及青少年患者提供参考。方法 使用27 d Wistar大鼠,分为辅料对照组和地黄叶总苷胶囊低(30 mg·kg-1)、中(150 mg·kg-1)、高(750 mg·kg-1)剂量组,各给药组重复灌胃给予地黄叶总苷胶囊内容物8周,停药后恢复4周,考察大鼠临床症状、体质量和摄食量变化、血液学和血清生化指标、神经系统功能及学习记忆能力、骨骼发育、生殖系统功能、脏器质量和组织病理学变化特点。结果 地黄叶总苷胶囊对动物临床症状、体质量、摄食量、血液学指标、血清生化指标、主要脏器质量均未见明显影响,对动物中枢神经系统功能及学习记忆能力、骨骼发育未见明显影响,雌性动物性周期、雄性动物精子数量、活力及形态未见明显变化,未见与给予地黄叶总苷胶囊相关的组织病理学改变。结论 地黄叶总苷胶囊重复给药8周对幼龄Wistar大鼠的无明显毒性作用剂量(NOAEL)为750 mg·kg-1。本研究数据可为地黄叶总苷胶囊应用于儿童及青少年患者提供参考。

, correspAuthors=周晓冰, 刘艳华, authorNote=null, correspAuthorsNote=
* 周晓冰,女,博士,研究员 研究方向:药物毒理学 Tel:(010)67872233-8203;
刘艳华,男,硕士,助理研究员 研究方向:药物经济学 Tel:(0838)8104630
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赵曼曼,女,博士,主管药师 研究方向:药物毒理学

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赵曼曼,女,博士,主管药师 研究方向:药物毒理学

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赵曼曼,女,博士,主管药师 研究方向:药物毒理学

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Chin J Reprod Contracept(中华生殖与避孕杂志), 2022, 42(9):879-886., articleTitle=Enlightenment from the contents revised of the 6th edition of the WHO laboratory manual forthe examination and processing of human semen, refAbstract=null), Reference(id=1193576260556259731, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, doi=null, pmid=null, pmcid=null, year=2023, volume=105, issue=6, pageStart=468, pageEnd=478, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=CHEN C, MILBRANDT T A, BABADI E, journalName=J Bone Jt Surg Am, refType=null, unstructuredReference=CHEN C, MILBRANDT T A, BABADI E, et al. Normative femoral and tibial lengths in a modern population of twenty-first-century U.S. children[J]. J Bone Jt Surg Am, 2023, 105(6): 468-478., articleTitle=Normative femoral and tibial lengths in a modern population of twenty-first-century U.S. children, refAbstract=null), Reference(id=1193576260682088852, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, doi=null, pmid=null, pmcid=null, year=2024, volume=32, issue=1, pageStart=49, pageEnd=53, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=CHENG K, LAN L, journalName=Chin J Child Health Care(中国儿童保健杂志), refType=null, unstructuredReference=CHENG K, LAN L. Research advance in the changes of bone mineral density during puberty[J]. Chin J Child Health Care(中国儿童保健杂志), 2024, 32(1): 49-53., articleTitle=Research advance in the changes of bone mineral density during puberty, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1193576254944280887, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, xref=1, ext=[AuthorCompanyExt(id=1193576254952669496, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, companyId=1193576254944280887, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs, Institute for Safety Evaluation, National Institutes for Food and Drug Control, Beijing 100176, China), AuthorCompanyExt(id=1193576254961058105, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, companyId=1193576254944280887, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 中国食品药品检定研究院安全评价研究所,药物非临床安全评价研究北京市重点实验室, 北京 100176)]), AuthorCompany(id=1193576255023972666, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, xref=2, ext=[AuthorCompanyExt(id=1193576255036555579, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, companyId=1193576255023972666, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 Sichuan Medco Pharmaceutical Stock Co., Ltd., Shifang 618400, China), AuthorCompanyExt(id=1193576255049138492, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, companyId=1193576255023972666, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 四川美大康药业股份有限公司, 四川 什邡 618400)]), AuthorCompany(id=1193576255107858749, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, xref=3, ext=[AuthorCompanyExt(id=1193576255112053054, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, companyId=1193576255107858749, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3 State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing 210009, China), AuthorCompanyExt(id=1193576255120441663, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, companyId=1193576255107858749, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3 中国药科大学多靶标天然药物全国重点实验室, 南京 210009)])], figs=[ArticleFig(id=1193576257309868398, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Fig.1, caption=Effects of Rehmannia glutinosa leaf total glycosides on body mass in rats.n=15, x -±s

A-male rats; B-female rats; Low-30 mg·kg-1; Medium-150 mg·kg-1; High-750 mg·kg-1.

, figureFileSmall=enSI/H8FwnDIGGQj8aplig==, figureFileBig=5E+ry/q+WybmEkgaGcB5Eg==, tableContent=null), ArticleFig(id=1193576257364394351, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=图1, caption=地黄叶总苷对大鼠体质量的影响。n=15, x -±s

A-雄鼠;B-雌鼠;Low-低剂量组30 mg·kg-1; Medium-中剂量组150 mg·kg-1; High-高剂量组750 mg·kg-1。

, figureFileSmall=enSI/H8FwnDIGGQj8aplig==, figureFileBig=5E+ry/q+WybmEkgaGcB5Eg==, tableContent=null), ArticleFig(id=1193576257452474736, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Fig.2, caption=Changes of hematological indexes in rats after Rehmannia glutinosa leaf total glycosides administration. x -±s

A-blood cell counts of male rats at the end of administration (n=10); B-blood cell counts of female rats at the end of administration (n=10); C-blood cell counts of male rats at the end of recovery (n=5); D-blood cell counts of female rats at the end of recovery (n=5); WBC-white blood cell; RBC-red blood cell; PLT-platelet;1)P<0.05, compared with the vehicle group.

, figureFileSmall=2bJc3obodDFwAmjmlaml/Q==, figureFileBig=vgWx4IwG5HOmZPc/QQuRHg==, tableContent=null), ArticleFig(id=1193576257536360817, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=图2, caption=地黄叶总苷对大鼠血液学指标的影响。 x -±s

A-给药结束雄鼠血细胞计数结果(n=10);B-给药结束雌鼠血细胞计数结果(n=10);C-恢复结束雄鼠血细胞计数结果(n=5);D-恢复结束雌鼠血细胞计数结果(n=5);WBC-白细胞;RBC-红细胞;PLT-血小板;与辅料对照组比较,1)P<0.05。

, figureFileSmall=2bJc3obodDFwAmjmlaml/Q==, figureFileBig=vgWx4IwG5HOmZPc/QQuRHg==, tableContent=null), ArticleFig(id=1193576257645412722, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Fig.3, caption=Effects of Rehmannia glutinosa leaf total glycosides on organ mass in rats. x -±s

A-organ mass of male rats at the end of administration (n=10); B-organ mass of female rats at the end of administration (n=10); C-organ mass of male rats at the end of recovery (n=5); D-organ mass of female rats at the end of recovery (n=5);1)P<0.05,2)P<0.01, compared with the control group.

, figureFileSmall=kL2/GkjaoyAxeR6CzjMXbA==, figureFileBig=/OShFJi3o2OfVFpc+g4Qcw==, tableContent=null), ArticleFig(id=1193576257733493107, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=图3, caption=地黄叶总苷对大鼠脏器质量的影响。 x -±s

A-给药结束雄鼠脏器质量(n=10);B-给药结束雌鼠脏器质量(n=10);C-恢复结束雄鼠脏器质量(n=5);D-恢复结束雌鼠脏器质量(n=5);与辅料对照组比较,1)P<0.05,2)P<0.01。

, figureFileSmall=kL2/GkjaoyAxeR6CzjMXbA==, figureFileBig=/OShFJi3o2OfVFpc+g4Qcw==, tableContent=null), ArticleFig(id=1193576257825767796, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Fig.4, caption=Results of histopathological examination in rats after Rehmannia glutinosa leaf total glycosides administration(HE staining,×40)

A-I-organs of control group; a-i-organs of high-dosed group. A,a-lung; B,b-liver; C,c-kidney; D,d-heart; E,e-ovary; F,f-testis; G,g-thyroid gland; H,h-spleen; I,i-brain.

, figureFileSmall=aMlgddil6v45+TxCijqI5w==, figureFileBig=eC43fM2U0zYSGm1lzr4rQg==, tableContent=null), ArticleFig(id=1193576257884488053, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=图4, caption=大鼠给予地黄叶总苷后组织病理检查结果[苏木精-伊红(HE)染色,放大40倍]

A~I-对照组动物脏器,a~i-高剂量给药组动物脏器。A,a-肺脏;B,b-肝脏;C,c-肾脏;D,d-心脏;E,e-卵巢;F,f-睾丸;G,g-甲状腺;H,h-脾脏;I,i-脑。

, figureFileSmall=aMlgddil6v45+TxCijqI5w==, figureFileBig=eC43fM2U0zYSGm1lzr4rQg==, tableContent=null), ArticleFig(id=1193576257955791222, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Tab.1, caption=

Changes of serum biochemistry indexes in rats after Rehmannia glutinosa leaf total glycosides administration. x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
t/week Groups n ALT/U·L-1 ALP/U·L-1 CK/U·L-1 CRE/μmol·L-1 UREA/μmol·L-1
8(Male) Control 10 34.0 ±3.5 121.0 ±35.4 585.5 ±240.1 30.3 ±3.2 7.01 ±1.05
Low 10 37.7 ±11.2 117.8 ±17.1 624.0 ±301.0 28.9 ±3.5 7.03 ±1.06
Medium 10 35.9 ±3.0 142.9 ±43.6 581.4 ±130.0 32.5 ±4.1 6.94 ±1.04
High 10 32.8 ±5.6 127.9 ±35.2 562.8 ±160.8 28.5 ±2.2 6.91 ±0.55
8(Female) Control 10 32.8 ±7.1 94.2 ±34.2 778.5 ±237.1 38.5 ±7.9 8.93 ±1.77
Low 10 31.6 ±4.1 82.3 ±20.9 679.9 ±269.1 34.9 ±3.6 8.35 ±1.33
Medium 10 35.7 ±5.9 79.5 ±16.9 564.2 ±136.4 34.7 ±2.4 7.97 ±0.87
High 10 35.2 ±9.2 85.1 ±25.7 595.1 ±171.6 35.9 ±4.1 8.00 ±0.80
12(Male) Control 5 38.8 ±6.3 95.0 ±14.1 528.0 ±110.3 34.2 ±5.8 7.50 ±0.87
Low 5 34.8 ±4.3 88.4 ±20.2 546.2 ±102.8 35.2 ±5.0 7.96 ±0.99
Medium 5 44.2 ±11.7 97.4 ±16.5 602.4 ±164.2 34.4 ±4.5 7.66 ±0.72
High 5 40.0 ±7.9 89.2 ±11.0 527.2 ±167.5 35.6 ±1.1 7.60 ±0.48
12(Female) Control 5 33.4 ±6.7 52.4 ±6.3 387.2 ±67.1 43.6 ±6.3 8.12 ±0.45
Low 5 34.6 ±6.3 59.6 ±17.0 528.4 ±103.2 38.6 ±4.1 8.70 ±1.12
Medium 5 39.4 ±8.4 77.2 ±20.8 619.4 ±129.01) 38.4 ±2.9 8.76 ±0.58
High 5 35.8 ±7.9 52.8 ±9.0 502.6 ±112.2 40.4 ±4.5 8.32 ±0.90
), ArticleFig(id=1193576258035482999, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=表1, caption=

地黄叶总苷对大鼠血清生化指标的影响。 x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
t/week Groups n ALT/U·L-1 ALP/U·L-1 CK/U·L-1 CRE/μmol·L-1 UREA/μmol·L-1
8(Male) Control 10 34.0 ±3.5 121.0 ±35.4 585.5 ±240.1 30.3 ±3.2 7.01 ±1.05
Low 10 37.7 ±11.2 117.8 ±17.1 624.0 ±301.0 28.9 ±3.5 7.03 ±1.06
Medium 10 35.9 ±3.0 142.9 ±43.6 581.4 ±130.0 32.5 ±4.1 6.94 ±1.04
High 10 32.8 ±5.6 127.9 ±35.2 562.8 ±160.8 28.5 ±2.2 6.91 ±0.55
8(Female) Control 10 32.8 ±7.1 94.2 ±34.2 778.5 ±237.1 38.5 ±7.9 8.93 ±1.77
Low 10 31.6 ±4.1 82.3 ±20.9 679.9 ±269.1 34.9 ±3.6 8.35 ±1.33
Medium 10 35.7 ±5.9 79.5 ±16.9 564.2 ±136.4 34.7 ±2.4 7.97 ±0.87
High 10 35.2 ±9.2 85.1 ±25.7 595.1 ±171.6 35.9 ±4.1 8.00 ±0.80
12(Male) Control 5 38.8 ±6.3 95.0 ±14.1 528.0 ±110.3 34.2 ±5.8 7.50 ±0.87
Low 5 34.8 ±4.3 88.4 ±20.2 546.2 ±102.8 35.2 ±5.0 7.96 ±0.99
Medium 5 44.2 ±11.7 97.4 ±16.5 602.4 ±164.2 34.4 ±4.5 7.66 ±0.72
High 5 40.0 ±7.9 89.2 ±11.0 527.2 ±167.5 35.6 ±1.1 7.60 ±0.48
12(Female) Control 5 33.4 ±6.7 52.4 ±6.3 387.2 ±67.1 43.6 ±6.3 8.12 ±0.45
Low 5 34.6 ±6.3 59.6 ±17.0 528.4 ±103.2 38.6 ±4.1 8.70 ±1.12
Medium 5 39.4 ±8.4 77.2 ±20.8 619.4 ±129.01) 38.4 ±2.9 8.76 ±0.58
High 5 35.8 ±7.9 52.8 ±9.0 502.6 ±112.2 40.4 ±4.5 8.32 ±0.90
), ArticleFig(id=1193576258110980472, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Tab.2, caption=

Effect of Rehmannia glutinosa leaf total glycosides on tibia length in rats.mm, x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
Sex (time point) n Control Low Medium High
Male (8 week) 10 39.34±0.63 37.91±1.91 39.00±0.64 39.53±1.46
Female (8 week) 10 34.61±1.30 34.65±0.94 34.59±0.69 34.82±1.11
Male (12 week) 5 41.32±1.48 40.39±0.47 41.02±1.88 41.26±0.68
Female (12 week) 5 38.40±1.47 36.84±2.12 37.49±0.81 37.94±1.56
), ArticleFig(id=1193576258203255161, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=表2, caption=

地黄叶总苷对大鼠胫骨长度的影响。mm, x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
Sex (time point) n Control Low Medium High
Male (8 week) 10 39.34±0.63 37.91±1.91 39.00±0.64 39.53±1.46
Female (8 week) 10 34.61±1.30 34.65±0.94 34.59±0.69 34.82±1.11
Male (12 week) 5 41.32±1.48 40.39±0.47 41.02±1.88 41.26±0.68
Female (12 week) 5 38.40±1.47 36.84±2.12 37.49±0.81 37.94±1.56
), ArticleFig(id=1193576258308112762, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Tab.3, caption=

Effect of Rehmannia glutinosa leaf total glycosides on bone mineral density of femur in rats.g·cm-2, x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
Sex (time point) n Control Low Medium High
Male (8 week) 10 0.352 2±0.020 6 0.366 4±0.021 3 0.352 0±0.017 6 0.339 4±0.016 3
Female (8 week) 10 0.308 4±0.024 3 0.331 5±0.020 0 0.308 1±0.026 2 0.320 7±0.020 2
Male (12 week) 5 0.364 8±0.014 3 0.350 8±0.029 2 0.372 8±0.016 2 0.357 3±0.013 5
Female (12 week) 5 0.312 6±0.007 1 0.338 8±0.049 2 0.335 3±0.016 5 0.358 9±0.024 8
), ArticleFig(id=1193576258412970363, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=表3, caption=

地黄叶总苷对大鼠股骨骨密度的影响。g·cm-2, x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
Sex (time point) n Control Low Medium High
Male (8 week) 10 0.352 2±0.020 6 0.366 4±0.021 3 0.352 0±0.017 6 0.339 4±0.016 3
Female (8 week) 10 0.308 4±0.024 3 0.331 5±0.020 0 0.308 1±0.026 2 0.320 7±0.020 2
Male (12 week) 5 0.364 8±0.014 3 0.350 8±0.029 2 0.372 8±0.016 2 0.357 3±0.013 5
Female (12 week) 5 0.312 6±0.007 1 0.338 8±0.049 2 0.335 3±0.016 5 0.358 9±0.024 8
), ArticleFig(id=1193576258505245052, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Tab.4, caption=

Effect of Rehmannia glutinosa leaf total glycosides on sexual cycle in female rats.d, x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
Time point/week n Control Low Medium High
6~8 10 4.9±2.4 4.3±0.6 4.9±2.4 4.4±0.7
10~12 5 5.7±3.5 4.1±0.1 4.1±0.1 4.2±0.4
), ArticleFig(id=1193576258635268477, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=表4, caption=

地黄叶总苷对雌鼠性周期的影响。d, x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
Time point/week n Control Low Medium High
6~8 10 4.9±2.4 4.3±0.6 4.9±2.4 4.4±0.7
10~12 5 5.7±3.5 4.1±0.1 4.1±0.1 4.2±0.4
), ArticleFig(id=1193576258698183038, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=EN, label=Tab.5, caption=

Effects of Rehmannia glutinosa leaf total glycosides on sperm parameters in male rats.n=5, x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
Time point Index Control Low Medium High
End of administration (8 week) Motility/% 38.3 ±7.0 30.3 ±13.3 39.5 ±5.9 33.8 ±4.5
Total sperms/×106·g-1 448.4 ±61.0 367.3 ±54.6 427.7 ±106.0 338.3 ±118.5
VAP/μm·s-1 189.1 ±9.7 175.1 ±18.3 183.5 ±14.8 183.8 ±26.1
Malformation/% 3.6 ±1.7 4.4 ±1.1 4.6 ±2.0 3.3 ±1.7
End of recovery (12 week) Motility/% 36.8 ±4.7 31.8 ±13.5 36.4 ±4.5 38.4 ±4.9
Total sperms/×106·g-1 562.0 ±84.2 528.4 ±217.1 498.1 ±43.3 529.9 ±110.5
VAP/μm·s-1 207.6 ±10.5 179.7 ±29.2 200.3 ±19.5 206.3 ±18.8
Malformation/% 5.5 ±1.3 5.8 ±1.7 5.4 ±2.3 4.7 ±0.6
), ArticleFig(id=1193576258807234943, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548061445161071, language=CN, label=表5, caption=

地黄叶总苷对雄鼠精子参数的影响。n=5, x -±s

, figureFileSmall=null, figureFileBig=null, tableContent=
Time point Index Control Low Medium High
End of administration (8 week) Motility/% 38.3 ±7.0 30.3 ±13.3 39.5 ±5.9 33.8 ±4.5
Total sperms/×106·g-1 448.4 ±61.0 367.3 ±54.6 427.7 ±106.0 338.3 ±118.5
VAP/μm·s-1 189.1 ±9.7 175.1 ±18.3 183.5 ±14.8 183.8 ±26.1
Malformation/% 3.6 ±1.7 4.4 ±1.1 4.6 ±2.0 3.3 ±1.7
End of recovery (12 week) Motility/% 36.8 ±4.7 31.8 ±13.5 36.4 ±4.5 38.4 ±4.9
Total sperms/×106·g-1 562.0 ±84.2 528.4 ±217.1 498.1 ±43.3 529.9 ±110.5
VAP/μm·s-1 207.6 ±10.5 179.7 ±29.2 200.3 ±19.5 206.3 ±18.8
Malformation/% 5.5 ±1.3 5.8 ±1.7 5.4 ±2.3 4.7 ±0.6
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地黄叶总苷胶囊对幼龄大鼠发育毒性的研究
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赵曼曼 1 , 肖华 2 , 杨莹 1 , 梁子禾 1, 3 , 林志 1 , 周晓冰 1, * , 刘艳华 2, *
中国药学杂志 | 论著 2025,60(5): 481-487
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中国药学杂志 | 论著 2025, 60(5): 481-487
地黄叶总苷胶囊对幼龄大鼠发育毒性的研究
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赵曼曼1, 肖华2, 杨莹1, 梁子禾1, 3, 林志1, 周晓冰1, *, 刘艳华2, *
作者信息
  • 1 中国食品药品检定研究院安全评价研究所,药物非临床安全评价研究北京市重点实验室, 北京 100176
  • 2 四川美大康药业股份有限公司, 四川 什邡 618400
  • 3 中国药科大学多靶标天然药物全国重点实验室, 南京 210009

    • 赵曼曼,女,博士,主管药师 研究方向:药物毒理学

通讯作者:

* 周晓冰,女,博士,研究员 研究方向:药物毒理学 Tel:(010)67872233-8203;
刘艳华,男,硕士,助理研究员 研究方向:药物经济学 Tel:(0838)8104630
Developmental Toxicity of Rehmannia glutinosa Leaf Total Glycosides Capsules in Juvenile Rats
Manman ZHAO1, hua XIAO2, Ying YANG1, Zihe LIANG1, 3, Zhi LIN1, Xiaobing ZHOU1, *, Yanhua LIU2, *
Affiliations
  • 1 Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs, Institute for Safety Evaluation, National Institutes for Food and Drug Control, Beijing 100176, China
  • 2 Sichuan Medco Pharmaceutical Stock Co., Ltd., Shifang 618400, China
  • 3 State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing 210009, China
出版时间: 2025-03-08 doi: 10.11669/cpj.2025.05.005
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摘要
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目的 评价地黄叶总苷胶囊在幼龄Wistar大鼠体内的安全性特征,为地黄叶总苷胶囊应用于儿童及青少年患者提供参考。方法 使用27 d Wistar大鼠,分为辅料对照组和地黄叶总苷胶囊低(30 mg·kg-1)、中(150 mg·kg-1)、高(750 mg·kg-1)剂量组,各给药组重复灌胃给予地黄叶总苷胶囊内容物8周,停药后恢复4周,考察大鼠临床症状、体质量和摄食量变化、血液学和血清生化指标、神经系统功能及学习记忆能力、骨骼发育、生殖系统功能、脏器质量和组织病理学变化特点。结果 地黄叶总苷胶囊对动物临床症状、体质量、摄食量、血液学指标、血清生化指标、主要脏器质量均未见明显影响,对动物中枢神经系统功能及学习记忆能力、骨骼发育未见明显影响,雌性动物性周期、雄性动物精子数量、活力及形态未见明显变化,未见与给予地黄叶总苷胶囊相关的组织病理学改变。结论 地黄叶总苷胶囊重复给药8周对幼龄Wistar大鼠的无明显毒性作用剂量(NOAEL)为750 mg·kg-1。本研究数据可为地黄叶总苷胶囊应用于儿童及青少年患者提供参考。

地黄叶总苷胶囊  /  幼龄大鼠  /  发育  /  毒性评价

OBJECTIVE To evaluate the safety characteristics of Rehmannia glutinosa leaf total glycosides capsules in juvenile Wistar rats, and provide reference for the use of Rehmannia glutinosa leaf total glycosides capsules in child and adolescent patients. METHODS Twenty-seven-day-old Wistar rats were randomly divided into control and low-, medium-, and high-dosage groups. Each dosage group was given the Rehmannia glutinosa leaf total glycosides by gavage repeatedly for 8 weeks, followed by a 4 week recovery. The clinical symptoms, body weight, food consumption, hematological and serum biochemical indexes, central nervous system function, learning and memory ability, skeletal development, reproductive function, organ weight and histopathological changes of the rats was observed. RESULTS Rehmannia glutinosa leaf total glycosides capsules did not show significant effects on the clinical symptoms, body weight, food consumption, hematological and serum biochemical indexes, main organ weights, central nervous system function, bones, sexual cycle, sperm counts, vitality and form of the rats. No histopathological changes were observed associated with Rehmannia glutinosa leaf total glycosides capsules. CONCLUSION The no-observed-adverse-effect-level (NOAEL) for Rehmannia glutinosa leaf total glycosides capsules in juvenile rats is determined to be 750 mg·kg-1 in the 8 week feeding study. The data provides reference for the use of Rehmannia glutinosa leaf total glycosides capsules in child and adolescent patients.

Rehmannia glutinosa leaf total glycosides capsule  /  juvenile rat  /  development  /  toxicity evaluation
赵曼曼, 肖华, 杨莹, 梁子禾, 林志, 周晓冰, 刘艳华. 地黄叶总苷胶囊对幼龄大鼠发育毒性的研究. 中国药学杂志, 2025 , 60 (5) : 481 -487 . DOI: 10.11669/cpj.2025.05.005
Manman ZHAO, hua XIAO, Ying YANG, Zihe LIANG, Zhi LIN, Xiaobing ZHOU, Yanhua LIU. Developmental Toxicity of Rehmannia glutinosa Leaf Total Glycosides Capsules in Juvenile Rats[J]. Chinese Pharmaceutical Journal, 2025 , 60 (5) : 481 -487 . DOI: 10.11669/cpj.2025.05.005
正文
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慢性肾脏病(chronic kidney disease,CKD)在全球发病率较高,并增加心血管疾病和全因死亡率,已成为威胁全球公共健康的重大疾病之一[1]。儿童CKD起病隐匿,病因多样,病情迁延,甚至进展为肾衰竭,严重影响患儿的生活质量[2-3]。而在我国用于肾脏疾病的药物中,约半数以上药物缺乏儿童用药的安全性和有效性方面的信息,儿童用法用量不明确,严重限制了儿童肾病的治疗[4]。地黄叶为玄参科植物地黄(Rehmannia glutinosa Libosch.)的干燥叶,性甘、淡、寒,归心、肝、肾经,功能主治为益气养阴,补肾,活血。地黄叶总苷胶囊是把从地黄叶中提取精制得到的地黄叶总苷制成的胶囊剂,用于成人慢性肾炎治疗的疗效确切[5-7],但在儿童人群用药的安全性风险未知。
儿童的身体组成、器官功能、受体表达和代谢酶活性与成人有很大差异,儿童的生长发育阶段涉及器官系统的成熟过程,这些因素均可能影响药物的吸收、分布、代谢、排泄过程,并引发潜在的非预期毒性反应[8-10]。本研究基于儿童生长发育特点及地黄叶总苷功效特点,采用幼龄大鼠重复灌胃给予地黄叶总苷胶囊内容物,全面考察地黄叶总苷胶囊对幼龄大鼠的一般毒性作用和发育毒性,为其临床应用于儿童人群提供安全性参考。
1 仪器与材料
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1.1 动物
21 d无特定病原体(specific pathogen-free,SPF)级Wistar大鼠120只,雌、雄各60只,雌、雄鼠的体质量范围分别为31.6~55.4 g和33.6~61.0 g,(北京维通利华实验动物技术有限公司),动物生产许可证编号:SCXK(京)2021-0006,合格证号:No.110011231105376552(雌)、No. 110011231105376435(雄)。在温度为20~26 ℃、日温差≤3 ℃、相对湿度为40%~70%、照明时间为每天12 h的条件下饲养于国家药物安全评价监测中心屏障动物房。适应性饲养6 d,自由饮食、饮水。本研究方案通过国家药物安全评价监测中心实验动物福利伦理委员会审查批准(批准号:IACUC-2023-032)。
1.2 药物
地黄叶总苷胶囊(地黄叶总苷占比37.5%,批号:220601)、空白辅料(批号:220901)(四川美大康药业股份有限公司)。地黄叶总苷胶囊内容物用纯水配成质量浓度为2、10、50 mg·mL-1的地黄叶总苷胶囊内容物混悬液制剂(以地黄叶总苷浓度计),空白辅料用纯水配制成空白辅料混悬液制剂(空白辅料含量与50 mg·mL-1地黄叶总苷胶囊内容物混悬液中辅料的含量一致),动物给药前新鲜配制。
1.3 仪器
XN-550型综合血液学检查装置、CA-1500型血凝分析仪(日本Sysmex公司);7180型全自动生化分析仪(日本日立公司);台式H500FR型高速冷冻离心机(日本Kokusan公司);CX41型号显微镜(日本Olympus公司);PB 203-N型天平(瑞士梅特勒公司);TEC5EMJ-2型自动包埋机和DRS-2000 自动染色机及封片机(日本Sakura 公司)。
2 方法
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2.1 实验动物分组及给药
120只Wistar大鼠根据体质量随机分为辅料对照组(空白辅料)及地黄叶总苷低剂量组(30 mg·kg-1)、中剂量组(150 mg·kg-1)、高剂量组(750 mg·kg-1),每组30只,雌雄各半。本品临床拟用人群为6岁及以上儿童和青少年(6~18岁),每日拟用量最大为300 mg,6岁儿童体质量按20 kg计,则临床拟用最大日剂量为15 mg·kg-1。按体质量折算,本实验高剂量约为临床拟用剂量的50倍,按体表面积折算,本实验高剂量约为临床拟用剂量的12.4倍(20 kg人的体表面积约7 556 cm2,200 g大鼠的体表面积约304 cm2)。人6岁约相当于大鼠4周龄,因此本研究自大鼠4周龄开始给药,连续给药8周至大鼠12周龄(已至成年),约相当于人成年,给药期限覆盖临床拟用人群年龄范围。大鼠经口灌胃给药,每天1次,给药体积15 mL·kg-1。给药8周,停药后恢复4周。
2.2 观察和检测指标
实验期间,每天观察动物的临床症状(包括眼睛、口腔、皮肤、被毛、鼻、耳、四肢、活动状况、神经反应、呼吸状态、姿势、食欲、粪便、尿等有无异常),测定动物体质量及摄食量。采用功能观察组合试验(functional observation battery,FOB)评价药物对动物中枢神经系统的影响,包括笼内观察(摄食、饮水、睡眠、绕笼运动、竖毛、攻击同笼动物、垫料潮湿、发声、理毛、姿势、眼睑开合)、手持观察(移出的难易度、操作难易度、血泪症、流泪、流涎、背毛)、开放场观察(唤醒唤起、手指接近、触摸头部、惊恐、抽搐扭动、癫痫痉挛、共济失调步态、肌张力减退步态、刻板行为、扭体症状、异常行为、呼吸、心率、自主活动、觉醒、眼球突出、竖毛、排便、机械运动、震颤、惊恐反应、位置被动反应、僵住症)、反射评价(对视觉刺激的反应、对突然声响的反应、瞳孔反应、耳廓反射、痛觉、地板上的翻正反射、空间翻正反射)及肌肉力(握力、腹部张力、肢体张力、躯体张力)、体温等52个指标进行观察,于动物7~9周龄时进行Y-迷宫测试,评估药物对大鼠学习记忆功能的影响。在末次给药结束解剖每组每种性别10只大鼠,恢复期结束解剖剩余每组同性别5只大鼠,进行血液学、血清生化、骨长、骨密度和组织病理学检查。给药结束及恢复期结束前两周内,测定雌性动物性周期,解剖时测定雄性动物(每组5只)附睾尾部精子数量、活力及形态。
2.3 统计学处理
临床症状观察结果直接列出。体质量、摄食量、血液学指标、血清生化指标、骨长、骨密度、精子检查指标、体温等数据用 x -±s表示,采用单因素方差分析。FOB定性资料数据采用非参数秩和检验,P<0.05为差异有统计学意义。
3 结果
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3.1 临床症状
低剂量组个别动物(1只)于恢复期出现一侧后肢红肿,组织病理学检查未见受试物相关病变。其他实验动物临床症状均未见异常。
3.2 体质量及摄食量
不同时间点各组动物体质量变化见图1。实验期间,动物体质量呈增长趋势,各给药组动物体质量与辅料对照组相比未见统计学差异。
实验期间,与辅料对照组比,给药组雄性及雌性动物个别时间点摄食量略升高或降低,变化幅度较低且未见持续性变化,剂量-反应关系不明显,认为与给予受试物无关。
3.3 对中枢神经系统影响
FOB观察结果显示,在末次给药后20 min,中剂量组4/10只动物“正常坐立”、6/10只动物“站或立朝向观察者”,辅料对照组10/10只动物“正常坐立”,二者相比出现统计差异(P<0.01),中剂量组动物其他检查指标如自主活动、笼中移出难易度等指标均未见明显差异,姿势单一指标的变化且未见明显剂量-反应关系,提示该指标变化与受试物不相关。其他各观察时间点的各观察指标均未见统计学差异。提示受试物对动物中枢神经系统功能未见明显影响。
Y迷宫测定结果显示,辅料对照组比,各给药组动物进入正确臂的次数及逗留时间、进入错误臂的次数及逗留时间指标均未见统计学差异。提示受试物对动物学习记忆功能未见明显影响。
3.4 血液学指标
不同时间点各组动物血液学指标变化见图2。给药结束,低、中、高剂量组动物血液学检查各项指标与辅料对照组相比均未见统计学差异。恢复期结束,低剂量组雌性动物血小板数(platelet,PLT)略降低,无明显剂量-反应关系,认为可能为动物个体差异,与给予受试物无关。
3.5 血清生化指标
不同时间点各组动物血清生化指标变化见表1。给药结束(8周),给药组动物血清生化检查各项指标与辅料对照组相比均未见统计学差异。恢复期结束(12周),与辅料对照组比,中剂量组雌性动物肌酸磷酸激酶(creatine phosphokinase,CK)升高,无明显剂量-反应关系,且心脏、骨骼肌组织病理学检查均未见与给予受试物相关的病变,因此认为上述变化与给予受试物无关。
3.6 骨骼发育
动物胫骨长度结果和股骨骨密度结果分别见表2~3。给药结束及恢复期结束,与辅料对照组比,给药组动物胫骨长度及股骨骨密度均未见统计学差异,提示受试物对动物骨骼发育未见明显影响。
3.7 生殖能力
雌性动物性周期检查结果见表4。在给药期及恢复期,检测了雌性动物14 d内平均性周期天数,结果显示给药组雌鼠平均性周期天数与辅料对照组相比未见统计学差异。
雄性动物精子检查结果见表5。给药结束及恢复期结束,给药组动物运动精子率、总精子数、精子运动速率及畸形率与辅料对照组相比均未见统计学差异。
3.8 脏器质量及病理学检查
动物主要脏器质量结果见图3。给药结束, 给药组动物主要脏器质量与辅料对照组相比未见统计学差异。恢复期结束,与辅料对照组比,各给药组雌性动物的脾脏质量出现不同程度降低(约-15.3%~-23.7%,P<0.05或P<0.01),剂量-反应关系不明显,脾脏组织病理学检查未见与受试物相关的改变,因此认为该变化与给予受试物无关。
对辅料对照组及高剂量组主要脏器进行组织病理学检查,结果见图4。可见各脏器的组织病理学改变不同程度地散发于辅料对照组与给药组中,无明显剂量依赖性,均为动物常见的自发和偶发病变,与给予受试物不相关。
4 讨论
收起
地黄叶总苷胶囊拟用于6岁以上人群,临床使用期限为8周,为充分评估药物对各器官系统的发育毒性风险,本研究选择与人器官发育程度相当的4周龄Wistar大鼠作为实验动物,重复灌胃给予药物8周直至大鼠成年,除一般毒性指标外,还考察了药物对大鼠神经系统、生殖系统及骨骼发育的影响。
儿童青少年时期处于快速生长发育阶段[11],体重是评价体格发育水平的关键指标之一,本研究通过连续测定大鼠体质量变化,发现实验期间大鼠体质量保持持续增长,地黄叶总苷胶囊对大鼠体质量增长无明显影响。中枢神经系统的发育贯穿儿童青少年时期整个过程,应运用成熟的方法检测药物对中枢神经系统关键功能区域的影响,包括评估动物的自发活动、感觉运动功能、反射功能以及学习和记忆功能等多个方面[12-13]。FOB是从Irwin's法优化发展而来的一种实验方法,通过观察机体行为、感觉/反射等功能的改变,对相应的指标进行量化评分,从而定性或定量评价药物对机体中枢和外周神经系统的影响[14-15]。Y-迷宫主要用于研究啮齿类动物空间工作记忆能力[16],宜在动物神经发育最敏感的时期进行习记忆能力测试。研究结果提示地黄叶总苷胶囊对动物中枢神经系统功能未见明显毒性作用。
动物性周期是指上一次发情开始至下一次发情开始的时间间隔,性周期的评估可反映药物对雌性生殖功能及内分泌功能的影响。本研究分别在给药期结束(动物达到性成熟)及恢复期结束分别检测雌性动物性周期,以评估药物对性成熟或生殖功能可能的延迟毒性作用,研究结果表明,地黄叶总苷胶囊对雌性动物生殖功能未见明显影响[17]。精子质量是衡量男性生殖能力重要指标,精子质量高低还影响胚胎质量[18]。精子数量、活力和形态是反映精子质量的关键指标[19],精液量减少、活力降低或畸形率升高均可导致自然受孕率的降低。本研究未发现地黄叶总苷胶囊对雄性动物精子质量的影响。
青春期是骨骼发育的重要时期,在儿童青少年时期给药,应着重评估药物对骨骼系统的影响。胫骨长度反映了骨骼的生长速度和成熟程度[20],如果药物对骨骼生长产生负面影响,可导致机体生长迟缓或发育异常。骨密度即骨骼矿物质密度,反映了骨骼中矿物质的含量和骨骼的强度,骨密度水平可以判断骨骼生长发育状态[21]。在本研究中,给药组动物的胫骨长度与骨密度均无显著性变化,提示地黄叶总苷胶囊不影响动物骨骼系统的生长发育。
综上所述,本研究使用幼龄Wistar大鼠全面评估了地黄叶总苷胶囊的发育毒性风险。研究结果表明,地黄叶总苷胶囊对幼龄Wistar大鼠的无明显毒性作用剂量(NOAEL)为750 mg·kg-1,未见明显发育毒性作用,本研究数据为儿科肾病用药开发提供安全性数据支持。
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doi: 10.11669/cpj.2025.05.005
  • 接收时间：2024-08-02
  • 首发时间：2025-11-07
  • 出版时间：2025-03-08
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  • 收稿日期：2024-08-02
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    1 中国食品药品检定研究院安全评价研究所,药物非临床安全评价研究北京市重点实验室, 北京 100176
    2 四川美大康药业股份有限公司, 四川 什邡 618400
    3 中国药科大学多靶标天然药物全国重点实验室, 南京 210009

通讯作者:

* 周晓冰,女,博士,研究员 研究方向:药物毒理学 Tel:(010)67872233-8203;
刘艳华,男,硕士,助理研究员 研究方向:药物经济学 Tel:(0838)8104630
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2种不同金属材料的力学参数
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Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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