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Article(id=1322923154166919697, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923011518628427, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.03.030, 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=null, acceptedDateStr=null, onlineDate=1793339058677, onlineDateStr=2026-10-30, pubDate=1741536000000, pubDateStr=2025-03-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793339058677, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793339058677, creator=13701087609, updateTime=1793339058677, updator=13701087609, issue=Issue{id=1322923011518628427, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='3', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1741536000000', pubDateStr='2025-03-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793339024666, creator='13701087609', updateTime=1793340602374, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322929628976906432, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923011518628427, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322929628981100737, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923011518628427, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=166, endPage=170, ext={EN=ArticleExt(id=1322923154380829202, articleId=1322923154166919697, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Exploration of Distinctive Processing Varieties in Drug Juice Processing：Processing Technology and Quality Standard of Huanglian（Coptidis Rhizoma）-Processed Wuzhuyu（Euodiae Fructus）, columnId=1256183361521967297, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Target on National Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To optimize the processing technology of Huanglian（Coptidis Rhizoma）-processed Wuzhuyu（Euodiae Fructus）and establish quality standards for the decoction pieces of Wuzhuyu（Euodiae Fructus）.

Methods

Limonin，evodiamine，rutecarpine and ethanol soluble extractives were used as the evaluation indicators，and soaking time，frying temperature and frying time were the influencing factors. Orthogonal experiments were used to optimize the optimal process parameters for preparing Huanglian（Coptidis Rhizoma）-processed Wuzhuyu（Euodiae Fructus）. And through thin layer identification，determination of moisture，ash content，alcohol extract，active ingredient content and characteristic maps of 10 batches of samples，a quality standard for Huanglian（Coptidis Rhizoma）-processed Wuzhuyu（Euodiae Fructus）was established.

Result

The best processing technology was decocting for 40 min and roasting at 140℃for 11 min. The experimental results show that the processing technology is stable and feasible. It is recommended to stipulate that the water content of the decoction pieces should not exceed 10%，the total ash content should not exceed 10%，and the alcohol soluble extract should not be less than 30%. The mass fractions of limonin，evodiamine and rutecarpine should not be less than 1.0%，0.1% and 0.1%，respectively.

Conclusion

The optimized processing technology for Huanglian（Coptidis Rhizoma）-processed Wuzhuyu（Euodiae Fructus）is stable and feasible，with strong controllability of quality standard.

, authors=Yongkang LI, Lukai ZUO, Zhi CHEN, authorsList=Yongkang LI, Lukai ZUO, Zhi CHEN, authorCompany=null, correspAuthors=Zhi CHEN, 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=1322923155949498913, articleId=1322923154166919697, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=药汁制特色炮制品种挖掘-黄连制吴茱萸的炮制工艺及质量标准研究, columnId=1256183362172142382, journalTitle=中华中医药学刊, columnName=国家项目点击, runingTitle=null, highlight=null, articleAbstract=
目的

优选黄连制吴茱萸的炮制工艺并建立黄连制吴茱萸饮片的质量标准。

方法

以柠檬苦素、吴茱萸碱、吴茱萸次碱、醇浸出物为评价指标，润制时间、炒制温度、炒制时间为影响因素，采用正交实验优选黄连制吴茱萸的最佳工艺参数。并通过对10批样品的薄层鉴别，水分、灰分、醇浸出物、有效成分含量测定及特征图谱，建立黄连制吴茱萸的质量标准。

结果

黄连制吴茱萸最佳炮制工艺是黄连汁润制吴茱萸40 min，140℃炒制11 min。验证实验结果良好，说明该炮制工艺稳定、可行。建议规定黄连制吴茱萸饮片的水分不得过10%，总灰分不得过10%，醇溶性浸出物不低于30%。柠檬苦素、吴茱萸碱、吴茱萸次碱质量分数分别不得少于1.0%、0.1%、0.1%。

结论

优选的黄连制吴茱萸炮制工艺稳定、可行，质量标准可控性强。

, authors=李永康, 左录凯, 陈智, authorsList=李永康, 左录凯, 陈智, authorCompany=null, correspAuthors=陈智, authorNote=

李永康（2001-），男，山东青岛人，硕士在读，研究方向：中药新药与中药炮制原理。

, correspAuthorsNote=
陈智（1984-），男，山东济南人，副教授，硕士研究生导师，博士，研究方向：中药新药与中药炮制原理。E-mail：。
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李永康（2001-），男，山东青岛人，硕士在读，研究方向：中药新药与中药炮制原理。

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李永康（2001-），男，山东青岛人，硕士在读，研究方向：中药新药与中药炮制原理。

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注：1-柠檬苦素，2-吴茱萸碱，3-吴茱萸次碱。

, figureFileSmall=CONUVVQ2zxS4NVsFvizd/w==, figureFileBig=pURS3JUKFuG7zncHm0hvWg==, tableContent=null), ArticleFig(id=1322923158021485122, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923154166919697, language=EN, label=null, caption=null, figureFileSmall=wzo1+rufC5+r2L9HjUm8tA==, figureFileBig=4tycmiBzMOGH3zztGpKvWg==, tableContent=null), ArticleFig(id=1322923158084399683, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923154166919697, language=CN, label=图2, caption=各对照品标准曲线

注：A为柠檬苦素对照品标准曲线，B为吴茱萸碱对照品标准曲线，C为吴茱萸次碱对照品标准曲线。

, figureFileSmall=wzo1+rufC5+r2L9HjUm8tA==, figureFileBig=4tycmiBzMOGH3zztGpKvWg==, tableContent=null), ArticleFig(id=1322923158159897156, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923154166919697, language=EN, label=null, caption=null, figureFileSmall=8ATbdFN/0QUD4pPowez95g==, figureFileBig=RpF3d/lRHnuZ0ilcP1vZfQ==, tableContent=null), ArticleFig(id=1322923158227006021, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923154166919697, language=CN, label=图3, caption=单因素考察结果, figureFileSmall=8ATbdFN/0QUD4pPowez95g==, figureFileBig=RpF3d/lRHnuZ0ilcP1vZfQ==, tableContent=null), ArticleFig(id=1322923158298309190, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923154166919697, language=EN, label=null, caption=null, figureFileSmall=ezIUc1EKC2W+6bWDLqdYow==, figureFileBig=GosE+NOfF3Wqo6Gg/l8dlw==, tableContent=null), ArticleFig(id=1322923158365418055, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923154166919697, language=CN, label=图4, caption=1～10批黄连制吴茱萸外观形态, figureFileSmall=ezIUc1EKC2W+6bWDLqdYow==, figureFileBig=GosE+NOfF3Wqo6Gg/l8dlw==, tableContent=null), ArticleFig(id=1322923158428332616, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923154166919697, language=EN, label=null, caption=null, figureFileSmall=4RJERalj66KxrUffjZeIlw==, figureFileBig=NJQhCQG/aohlVL9YW4vzng==, tableContent=null), ArticleFig(id=1322923158499635785, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923154166919697, language=CN, label=图5, caption=黄连制吴茱萸TLC鉴别图谱

注：A中1为吴茱萸碱对照品，2为吴茱萸次碱对照品；B中1为盐酸小檗碱对照品，2为黄连对照药材；3～7为1号至5号样品，8～12为6号至10号样品。

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注：1-柠檬苦素，3-吴茱萸，5-吴茱萸次碱。

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化合物回归方程相关系数线性范围/（μg）
柠檬苦素y=203.79x+32.340.99781.01~20.2
吴茱萸碱y=10854x+101.0310.17~3.4
吴茱萸次碱y=6596.9x-77.910.11~2.2
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线性范围

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化合物回归方程相关系数线性范围/（μg）
柠檬苦素y=203.79x+32.340.99781.01~20.2
吴茱萸碱y=10854x+101.0310.17~3.4
吴茱萸次碱y=6596.9x-77.910.11~2.2
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水平A/（℃）B/（min）C/（min）
1120407
2140609
31608011
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正交实验因素水平

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水平A/（℃）B/（min）C/（min）
1120407
2140609
31608011
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编号（℃）A/B/（min）C/（min）柠檬苦素/（%）吴茱萸碱/（%）吴茱萸次碱/（%）醇浸出物/（%）评分加权
11112.780.490.2346.1368
21222.930.350.2548.3765
31334.240.330.3152.1878
42123.950.640.3446.9292
52234.260.420.3846.7487
62314.230.390.2951.3278
73134.510.620.3452.3497
83213.470.370.1743.5862
93323.40.370.3147.2174
k170.33385.66769.33376.333
k285.66771.33377.00080.000
k377.66776.66787.33377.333
R15.33414.33418.003.667
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正交实验结果

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编号（℃）A/B/（min）C/（min）柠檬苦素/（%）吴茱萸碱/（%）吴茱萸次碱/（%）醇浸出物/（%）评分加权
11112.780.490.2346.1368
21222.930.350.2548.3765
31334.240.330.3152.1878
42123.950.640.3446.9292
52234.260.420.3846.7487
62314.230.390.2951.3278
73134.510.620.3452.3497
83213.470.370.1743.5862
93323.40.370.3147.2174
k170.33385.66769.33376.333
k285.66771.33377.00080.000
k377.66776.66787.33377.333
R15.33414.33418.003.667
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因素偏差平方和自由度F比F临界值P值
A352.889216.37119.000
B314.889214.60819.000
C489.556222.71119.000*
误差0.062
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方差分析

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因素偏差平方和自由度F比F临界值P值
A352.889216.37119.000
B314.889214.60819.000
C489.556222.71119.000*
误差0.062
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样品编号产地水分总灰分醇溶性浸出物
WZY-01江西省赣州市4.9818.17552.154
WZY-02浙江省绍兴市5.2647.50247.159
WZY-03贵州省遵义市3.9198.31750.937
WZY-04浙江省金华市4.7228.25247.282
WZY-05云南省昆明市4.3839.33747.750
WZY-06安徽省亳州市3.8648.57147.626
WZY-07安徽省宣城市2.8216.53933.450
WZY-08江西省宜春市4.4638.46949.527
WZY-09广西省蒙山县5.2238.65149.333
WZY-10浙江省杭州市7.3188.07349.973
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水分、总灰分及醇溶性浸出物测定结果

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样品编号产地水分总灰分醇溶性浸出物
WZY-01江西省赣州市4.9818.17552.154
WZY-02浙江省绍兴市5.2647.50247.159
WZY-03贵州省遵义市3.9198.31750.937
WZY-04浙江省金华市4.7228.25247.282
WZY-05云南省昆明市4.3839.33747.750
WZY-06安徽省亳州市3.8648.57147.626
WZY-07安徽省宣城市2.8216.53933.450
WZY-08江西省宜春市4.4638.46949.527
WZY-09广西省蒙山县5.2238.65149.333
WZY-10浙江省杭州市7.3188.07349.973
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编号含水量柠檬苦素含量吴茱萸碱含量吴茱萸次碱含量
WZY-014.982.260.190.12
WZY-025.261.30.140.12
WZY-033.924.520.550.24
WZY-044.721.240.110.18
WZY-054.3811.992.650.97
WZY-063.863.740.540.23
WZY-076.189.762.971.16
WZY-084.462.330.330.19
WZY-095.2213.852.310.77
WZY-107.3214.642.870.98
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黄连制吴茱萸中柠檬苦素、吴茱萸碱、吴茱萸次碱含量

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WZY-014.982.260.190.12
WZY-025.261.30.140.12
WZY-033.924.520.550.24
WZY-044.721.240.110.18
WZY-054.3811.992.650.97
WZY-063.863.740.540.23
WZY-076.189.762.971.16
WZY-084.462.330.330.19
WZY-095.2213.852.310.77
WZY-107.3214.642.870.98
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药汁制特色炮制品种挖掘-黄连制吴茱萸的炮制工艺及质量标准研究
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李永康 , 左录凯 , 陈智
中华中医药学刊 | 国家项目点击 2025,43(3): 166-170
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中华中医药学刊 |国家项目点击 2025 , 43 (3) : 166 -170
药汁制特色炮制品种挖掘-黄连制吴茱萸的炮制工艺及质量标准研究
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李永康, 左录凯, 陈智
作者信息
  • 山东中医药大学药学院，山东 济南 250355
通讯作者:
陈智（1984-），男，山东济南人，副教授，硕士研究生导师，博士，研究方向：中药新药与中药炮制原理。E-mail：。
作者简介:

李永康（2001-），男，山东青岛人，硕士在读，研究方向：中药新药与中药炮制原理。

Exploration of Distinctive Processing Varieties in Drug Juice Processing：Processing Technology and Quality Standard of Huanglian（Coptidis Rhizoma）-Processed Wuzhuyu（Euodiae Fructus）
Yongkang LI, Lukai ZUO, Zhi CHEN
Affiliations
  • College of Pharmacy，Shandong University of Traditional Chinese Medicine，Jinan 250355，Shandong，China
出版时间: 2025-03-10 doi: 10.13193/j.issn.1673-7717.2025.03.030
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摘要
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目的

优选黄连制吴茱萸的炮制工艺并建立黄连制吴茱萸饮片的质量标准。

方法

以柠檬苦素、吴茱萸碱、吴茱萸次碱、醇浸出物为评价指标，润制时间、炒制温度、炒制时间为影响因素，采用正交实验优选黄连制吴茱萸的最佳工艺参数。并通过对10批样品的薄层鉴别，水分、灰分、醇浸出物、有效成分含量测定及特征图谱，建立黄连制吴茱萸的质量标准。

结果

黄连制吴茱萸最佳炮制工艺是黄连汁润制吴茱萸40 min，140℃炒制11 min。验证实验结果良好，说明该炮制工艺稳定、可行。建议规定黄连制吴茱萸饮片的水分不得过10%，总灰分不得过10%，醇溶性浸出物不低于30%。柠檬苦素、吴茱萸碱、吴茱萸次碱质量分数分别不得少于1.0%、0.1%、0.1%。

结论

优选的黄连制吴茱萸炮制工艺稳定、可行，质量标准可控性强。

黄连  /  吴茱萸  /  柠檬苦素  /  吴茱萸碱  /  吴茱萸次碱  /  质量标准
Objective

To optimize the processing technology of Huanglian（Coptidis Rhizoma）-processed Wuzhuyu（Euodiae Fructus）and establish quality standards for the decoction pieces of Wuzhuyu（Euodiae Fructus）.

Methods

Limonin，evodiamine，rutecarpine and ethanol soluble extractives were used as the evaluation indicators，and soaking time，frying temperature and frying time were the influencing factors. Orthogonal experiments were used to optimize the optimal process parameters for preparing Huanglian（Coptidis Rhizoma）-processed Wuzhuyu（Euodiae Fructus）. And through thin layer identification，determination of moisture，ash content，alcohol extract，active ingredient content and characteristic maps of 10 batches of samples，a quality standard for Huanglian（Coptidis Rhizoma）-processed Wuzhuyu（Euodiae Fructus）was established.

Result

The best processing technology was decocting for 40 min and roasting at 140℃for 11 min. The experimental results show that the processing technology is stable and feasible. It is recommended to stipulate that the water content of the decoction pieces should not exceed 10%，the total ash content should not exceed 10%，and the alcohol soluble extract should not be less than 30%. The mass fractions of limonin，evodiamine and rutecarpine should not be less than 1.0%，0.1% and 0.1%，respectively.

Conclusion

The optimized processing technology for Huanglian（Coptidis Rhizoma）-processed Wuzhuyu（Euodiae Fructus）is stable and feasible，with strong controllability of quality standard.

Huanglian（Coptidis Rhizoma）  /  Wuzhuyu（Euodiae Fructus）  /  limonin  /  evodiamine  /  rutecarpine  /  quality standard
李永康, 左录凯, 陈智. 药汁制特色炮制品种挖掘-黄连制吴茱萸的炮制工艺及质量标准研究. 中华中医药学刊, 2025 , 43 (3) : 166 -170 . DOI: 10.13193/j.issn.1673-7717.2025.03.030
Yongkang LI, Lukai ZUO, Zhi CHEN. Exploration of Distinctive Processing Varieties in Drug Juice Processing：Processing Technology and Quality Standard of Huanglian（Coptidis Rhizoma）-Processed Wuzhuyu（Euodiae Fructus）[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (3) : 166 -170 . DOI: 10.13193/j.issn.1673-7717.2025.03.030
正文
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吴茱萸，始载于汉代《神农本草经》，被列为中品[1]。《中华人民共和国药典》2020年版规定吴茱萸为芸香科吴茱萸Euodia rutaecarpa（Juss.）Benth.、石虎Euodia rutaecrpa（Juss.）Benth.var. Officinalis（Dode）Huang或疏毛吴茱萸Euodia rutaecarpa（Juss.）Benth.var.hodinieri（Dode）Huang的干燥近成熟果实[2]。吴茱萸辛温性热，辛行走窜，具有祛寒、缓解因寒凝导致的疼痛的功效，其归肝经、胃经等，又可治疗因肝寒犯胃导致的呕吐吞酸[3-5]。现代研究发现其含有柠檬苦素类、生物碱类、黄酮苷类、苯丙素类等化学成分[6-7]，具有镇痛、降血压、抗肿瘤、抗炎、保护胃肠道等多种药理作用[8-12]。临床研究发现吴茱萸有小毒，故在临床使用中常用其炮制品，或者与其他药物作为药对配伍使用[13-15]。吴茱萸炮制的历史可以追溯到汉代，黄连制吴茱萸最早记载于明代《奇效良方》中“同黄连一处炒，各半两”[16]。吴茱萸辛热，少佐黄连，以苦助其燥，以寒制其热，可辛开苦降，相得益彰，并可增强吴茱萸降逆止呕的作用。由于黄连汁炮制方法繁琐，黄连制吴茱萸现代研究少有报道，使得临床应用受限，炮制科学内涵不明，炮制工艺仍不规范，为有效挖掘、传承特色中药炮制品种，有必要对黄连制吴茱萸进行相应的炮制工艺及质量标准研究。本研究对黄连制吴茱萸炮制工艺进行深入探讨，以综合评分值为评价指标，采用单因素结合正交设计实验优化黄连制吴茱萸的炮制工艺，建立质量标准，为其饮片的质量控制提供更加精确、高效、可量化的方法，保证临床用药有效。
1　仪器与材料
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1.1　仪器
安捷伦1260高效液相色谱仪，美国安捷伦公司；MT4型红外测温仪，泰安雷沃仪器设备有限公司；KQ5200E型超声波清洗器，昆山市超声仪器有限公司；数显恒温水浴锅，天津赛得利实验分析仪器制造厂；ME104E/02电子分析天平，梅特勒-托利多仪器有限公司。
1.2　药材与试剂
实验共收集10批不同产地的吴茱萸饮片及1批黄连饮片，经山东中医药大学徐凌川教授鉴定，该10批吴茱萸均为芸香科吴茱萸的干燥成熟果实，黄连为毛茛科植物黄连的干燥根茎。柠檬苦素对照品（批号H23J9K65962，上海源叶生物科技有限公司）；吴茱萸碱对照品（批号X26A8P34704，上海源叶生物科技有限公司）；吴茱萸次碱对照品（批号C10J6Y1，上海源叶生物科技有限公司）；小檗碱对照品（批号S01A10K94340，上海源叶生物科技有限公司）；硅胶板（批号20230206，青岛海洋化工有限公司）；实验用冰醋酸、乙腈、甲醇为色谱纯，水为娃哈哈纯净水，其他实验过程中的试剂为分析纯。
2　方法与结果
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2.1　黄连制吴茱萸饮片的炮制工艺
2.1.1　黄连汁的制备
称取黄连饮片250 g，加入2000 mL纯化水浸润1 h，武火加热煮沸后，文火加热保持微沸2 h，四层纱布趁热滤过，滤液另置容器中储存，滤渣加入1500 mL纯化水继续煎煮1.5 h，滤过，弃去药渣，将两次滤液合并，加热浓缩至500 mL。
2.1.2　黄连制吴茱萸制备
分别量取25 mL黄连汁（热）倒入100 g吴茱萸药材中，闷润，药透汁尽后，文火炒干，晾凉[17-18]。
2.2　黄连制吴茱萸主要指标成分的检测
2.2.1　色谱条件
Kromasil 100-5-C18色谱柱（4.6 mm×250 mm，5μm）；流动相选用乙腈-水-四氢呋喃-冰醋酸（41∶59∶1∶0.2）；柱温25℃；流速为1.0 mL/min；检测波长为225 nm；进样体积10μL。
2.2.2　混合对照品制备
分别精密称取柠檬苦素、吴茱萸碱、吴茱萸次碱对照品10.1、1.7、1.1 mg，转移至同一10 mL容量瓶中，甲醇定容。
2.2.3　供试品溶液制备
精密称取黄连制吴茱萸样品粉末约0.5 g（粉碎后过二号筛）至锥形瓶中，加入80%乙醇25 mL，称重，浸泡1 h，超声40 min，冷却至室温，称重，80%乙醇补足失重，摇匀，滤过，取续滤液，0.22μm薄膜滤过，即得[19-20]。
2.2.4　系统适应性考察
分别精密进样混合对照品溶液、黄连制吴茱萸供试品溶液10μL，结果见图1。在上述色谱条件下，3种成分分离度良好（R>1.5），表明本方法系统适应性良好。
2.2.5　线性关系考察
取混合对照品溶液，梯度稀释，依照2.2.1项下色谱条件，分别进样测定，记录色谱图中的数据，以进样量（X）为横坐标，峰面积（Y）为纵坐标，进行线性回归分析，结果见插页ⅩⅩⅫ图2、表1。由实验结果可知，各成分在相应质量浓度区间范围内线性关系良好。
2.2.6　方法学考察
精密度实验考察计算柠檬苦素、吴茱萸碱、吴茱萸次碱峰面积的RSD分别为1.21%、0.79%、1.52%，表明仪器精密度良好。三种成分在12 h内峰面积的RSD分别为0.93%、1.79%、1.54%，表面供试品溶液在12 h内稳定性良好。重复性考察三种成分的RSD分别为1.02%、1.54%、1.87%，表明该方法重复性良好。
2.2.7　加样回收率实验
称取6份样品，每份0.1 g，置50 mL容量瓶中，每份样品中加入柠檬苦素、吴茱萸碱、吴茱萸次碱对照品溶液适量，50%甲醇溶解，超声，50%甲醇定容，摇匀，滤过，取滤液，按照2.2.1项下方法记录各成分的峰面积，计算柠檬苦素、吴茱萸碱、吴茱萸次碱峰面积的RSD分别为1.78%、1.91%、1.45%，平均加样回收率分别为98.14%、96.91%、101.72%，结果表明该方法回收率良好。
2.2.8　样品测定
取黄连制吴茱萸样品粉末（过二号筛），按2.2.3项下规定方法制备供试品溶液，依照2.2.1项下方法进样分析，测定，计算样品中三种有效成分含量。
2.3　醇浸出物的测定
分别精密称取黄连制吴茱萸样品3 g，精密加100 mL50%乙醇溶解，按照醇溶性浸出物测定方法（《中华人民共和国药典》2020年版通则2201）项下的热浸法测定。
2.4　综合评分方法
以柠檬苦素、吴茱萸碱、吴茱萸次碱和醇溶性浸出物成分质量分数为工艺优选指标，综合分析各成分在质量控制、药理、药效方面的价值，分别赋以0.3、0.3、0.3和0.1的权重，计算综合得分。加权评分＝（柠檬苦素含量/柠檬苦素含量最大值）×30+（吴茱萸碱含量/吴茱萸碱含量最大值）×30+（吴茱萸次碱含量/吴茱萸次碱含量最大值）×30+（浸出物/浸出物平均值）×10。
2.5　单因素考察炮制工艺
分别取100 g吴茱萸、25 mL黄连提取液，润制20、40、60、80、100、120 min，在150℃相同翻炒频次下炒10 min，考察润制时间对柠檬苦素、吴茱萸碱、吴茱萸次碱及醇溶性浸出物的影响。分别取100 g吴茱萸、25 mL黄连提取液，润制60 min，在100、120、140、160、180、200℃相同翻炒频次下炒10 min，考察炒制温度对柠檬苦素、吴茱萸碱、吴茱萸次碱及醇溶性浸出物的影响。分别取100 g吴茱萸、25 mL黄连提取液，润制60 min，在140℃相同翻炒频次下炒5、7、9、11、13、15 min，考察炒制时间对柠檬苦素、吴茱萸碱、吴茱萸次碱及醇溶性浸出物的影响。结果见插页ⅩⅩⅫ图3，由实验结果选择润制时间60 min，140℃，炒制11 min进行正交实验设计。
2.6　正交实验优化炮制工艺
根据单因素考察及预实验结果，选择以炒制温度（A）、润制时间（B）、炒制时间（C）为考察因素，每个因素设3个水平，因素水平设计见表2，选用L9（34）正交表设计实验方案，正交实验设计、结果与方法分析见表3、表4。根据正交实验结果，综合极差分析和方差分析，黄连制吴茱萸工艺中影响因素为C（炒制时间）>A（炒制温度）>B（润制时间），且C对结果有显著性影响（P<0.05），根据实验结果结合实际生产实际，确定黄连制吴茱萸最佳炮制工艺为A2 B1 C3，即采用黄连汁润制吴茱萸40 min，炒制温度140℃，炒制11 min。
2.7　最佳工艺验证实验
分别称取同一批次吴茱萸饮片100 g，共3份，按照2.4项下确定的最佳炮制工艺进行验证实验，结果表明3份黄连制吴茱萸综合评分值的平均分值为95.84，RSD为2.55%，说明该炮制工艺合理、切实可行。
2.8　黄连制吴茱萸质量标准研究
将收集到的10批吴茱萸，按照2.4项下确定的最佳炮制工艺进行加工处理，备用，编号分别为WZY-01～WZY-10。
2.8.1　性状
本品呈球形，有残留果梗，质地坚硬且脆，表面棕褐色至黑色，粗糙具点状突起，有放射状裂纹，有焦香气味，味苦。1～10号样品外观形状见插页ⅩⅩⅫ图4。
2.8.2　薄层鉴别
（1）吴茱萸碱、吴茱萸次碱检识：取各供试品粉末适量，乙醇超声提取，过滤，滤液作为供试品溶液。分别精密称取吴茱萸碱、吴茱萸次碱对照品适量，乙醇溶解。分别吸取上述3种溶液，点于同一硅胶G薄层板上，石油醚（60～90℃）-乙酸乙酯-三乙胺（7∶3∶0.1）展开，置于365 nm紫外光灯下检视。
（2）盐酸小檗碱检识：取各供试品粉末适量，甲醇超声处理，过滤，滤液作为供试品溶液。另取黄连对照药材，同法制成对照药材溶液。盐酸小檗碱对照品适量，甲醇溶解，为对照品溶液。上述三种溶液分别点于同一硅胶G薄层板上，环己烷-乙酸乙酯-异丙醇-甲醇-水-三乙胺（3∶3.5∶1∶1.5∶0.5∶1）展开，置于365 nm紫外灯下检视。见插页ⅩⅩⅩⅢ图5。
由实验结果可知，1～10批样品在与吴茱萸碱、吴茱萸次碱、盐酸小檗碱相应位置上显相同颜色的荧光斑点。
2.8.3　检查
分别参照《中华人民共和国药典》2020年版通则0832第二法，《中华人民共和国药典》2020年版通则2302，对10批黄连制吴茱萸样品进行水分及总灰分测定，结果见表5。由实验结果可知10批黄连制吴茱萸样品水分含量为2.821%～7.318%，总灰分含量范围为6.539%～9.337%，结合生产实际，确定黄连制吴茱萸水分不得过10.0%，总灰分含量不得过10.0%。
2.8.4　醇溶性浸出物
照醇溶性浸出物测定方法（《中华人民共和国药典》2020年版通则2201），采用热浸法测定10批黄连制吴茱萸样品的醇溶性浸出物，结果见表5。由实验结果可知，10批黄连制吴茱萸样品醇溶性浸出物范围为33.450%～52.154%，结合生产实际，确定黄连制吴茱萸醇溶性浸出物应不低于30.0%。
2.8.5　指标成分含量测定
按照2.2项下方法，测定10批黄连制吴茱萸样品中柠檬苦素、吴茱萸碱、吴茱萸次碱的含量，结果见表6。由结果可知，10批黄连制吴茱萸样品中柠檬苦素含量范围为1.3%～14.64%，吴茱萸碱含量范围为0.11%～2.97%，吴茱萸次碱含量范围为0.12%～1.16%，因此规定黄连制吴茱萸柠檬苦素含量≥1%，吴茱萸碱和吴茱萸次碱均不得低于0.1%。
2.8.6　特征图谱建立
将10批次黄连制吴茱萸样品检测的HPLC图谱数据导入“中药色谱指纹图谱相似度评价系统（2012版）”，S1为参照图谱，时间窗宽度0.1，中位数法，多点校正，匹配，生成对照图谱，见插页ⅩⅩⅩⅢ图6，共标定5个共有峰，通过与对照品比对，最终指认了3个色谱峰，见插页ⅩⅩⅩⅢ图7。
3　讨论
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现代研究发现，生物碱为吴茱萸中的主要药效成分，具有抗阿尔茨海默病、抗癌、抗炎等多种药理作用[21-24]。影响吴茱萸中生物碱含量的主要因素为产地、成熟度、新鲜程度、品种、炮制方法等[25]。本研究采用单因素与正交实验方法，将柠檬苦素、吴茱萸碱、吴茱萸次碱的含量作为黄连制吴茱萸质量评价的重要指标，分别赋以不同权重，综合评分，确定黄连制吴茱萸最佳炮制工艺，为药汁制特色炮制品种挖掘提供实验依据。为保证吴茱萸质量的普遍性，本研究收集了10批不同产地吴茱萸进行相关炮制，实验结果表明，新鲜吴茱萸的吴茱萸内酯（柠檬苦素）及生物碱的含量远远大于陈久者，长久储存与炮制均可使吴茱萸中吴茱萸内酯及生物碱含量降低，不同产地、不同批次黄连制吴茱萸中成分差异加大，实验过程中收集的广西蒙山、云南昆明、浙江杭州所产吴茱萸炮制后上述三种成分含量远超其他批次样品，质量较优。
黄连-吴茱萸是临床应用中最为经典和最常用的药对之一，两味药配伍比例不同，可表现出不同甚至截然相反的药理作用和临床功效，且不同批次饮片中成分含量差异加大，因此有必要对黄连制吴茱萸进行合理的质量控制[26]。本实验补充了黄连制吴茱萸特征图谱，完善了各地方炮制规范中缺少黄连制吴茱萸特征图谱研究的情况，为黄连制吴茱萸质量评价提供新的方法，制定了黄连制吴茱萸质量标准，有利于更好地控制黄连制吴茱萸药材质量，保证其临床使用的安全有效。
基金
收起
  • 国家中医药管理局中药炮制技术传承基地项目(国中医药科技中药〔2022〕59号)
  • 山东省自然科学基金面上项目(ZR2021MH009)
  • 山东省中医药科技项目(2021M143)
文献
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2025年第43卷第3期
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doi: 10.13193/j.issn.1673-7717.2025.03.030
  • 首发时间：2026-10-30
  • 出版时间：2025-03-10
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基金
国家中医药管理局中药炮制技术传承基地项目(国中医药科技中药〔2022〕59号)
山东省自然科学基金面上项目(ZR2021MH009)
山东省中医药科技项目(2021M143)
作者信息
    山东中医药大学药学院，山东 济南 250355

通讯作者:

陈智（1984-），男，山东济南人，副教授，硕士研究生导师，博士，研究方向：中药新药与中药炮制原理。E-mail：。
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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
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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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