Article(id=1321425925091209283, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425881147495164, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.18.008, 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=1769443200000, acceptedDateStr=2026-01-27, onlineDate=1792982091448, onlineDateStr=2026-10-26, pubDate=1790697600000, pubDateStr=2026-09-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982091448, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982091448, creator=13701087609, updateTime=1792982091448, updator=13701087609, issue=Issue{id=1321425881147495164, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='18', pageStart='1905', pageEnd='2016', issueExtLink='null', onlineDate='null', pubDate='1790697600000', pubDateStr='2026-09-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982080970, creator='13701087609', updateTime=1792982834300, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429040930599029, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425881147495164, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429040930599030, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425881147495164, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1956, endPage=1967, ext={EN=ArticleExt(id=1321425925242204228, articleId=1321425925091209283, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Optimization of extraction process for the modified new formulation of Compound Nanxing Zhitong Plaster based on pharmacodynamic evaluation combined with orthogonal design, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To optimize the extraction process for the modified new formulation of Compound Nanxing Zhitong Plaster.

Methods:

Pharmacological effects were evaluated using adjuvant-induced arthritis rat models and acetic acid-induced writhing mouse models, while skin irritation was tested in rabbits. The differences in efficacy and skin safety between two extraction methods (FFNX-1: ethanol-water-ethanol extraction; FFNX-2: percolation+ethanol extraction) were compared. Active ingredient contents (including aconitine, eugenol, etc.) and dry extract yield were used as indicators to optimize extraction parameters through orthogonal experimental design.

Results:

FFNX-2 (percolation+ethanol extraction) exhibited optimal anti-swelling, anti-inflammatory and analgesic effects, along with lower skin irritation in rabbits, establishing it as the optimal extraction process for the improved new drug formulation of Compound Nanxing Zhitong Plaster.

Conclusion:

The optimized extraction parameters were as follows: Six herbs including Caryophylli Flos extracted three times (1 h each) with 4 volumes of 50% ethanol; Arisaematis Rhizoma and Aconiti Radix extracted by percolation with 70% ethanol (particle size 2~5 mm, soaked for 24 h, flow rate 1 mL·min-1·kg-1, collecting 8 volumes of effluent). The optimized extraction process effectively retains active components while reducing toxicity risks, providing a scientific basis for the modern development of Compound Nanxing Zhitong Plaster.

, authors=Feng-shou LUO1, Zhi-qiang LI1, Xin-yan LIN2, Ye YANG1, Qun SUN1, Ying ZHOU1, Jin-feng YU1, Xin-peng QIN1, Shu-mei YIN2, Li LIN2, Ji-feng LI2, Wen-jun LIU1, *, Liang CAO1, Zhen-zhong WANG1, Wei XIAO1, *, authorsList=Feng-shou LUO, Zhi-qiang LI, Xin-yan LIN, Ye YANG, Qun SUN, Ying ZHOU, Jin-feng YU, Xin-peng QIN, Shu-mei YIN, Li LIN, Ji-feng LI, Wen-jun LIU, Liang CAO, Zhen-zhong WANG, Wei XIAO, authorCompany=null, correspAuthors=Wen-jun LIU, Wei XIAO, 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=1321425925527416901, articleId=1321425925091209283, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=基于药效学评价结合正交设计的复方南星止痛膏改良型新药提取工艺优化研究, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的:

确定并优化复方南星止痛膏改良型新药提取工艺。

方法:

采用佐剂性关节炎(adjuvant-induced arthritis, AIA)大鼠模型、冰醋酸致小鼠疼痛模型进行药效学评价,同时对家兔皮肤刺激性进行考察,比较2种提取工艺(FFNX-1:醇提+水提+醇提;FFNX-2:渗漉+醇提)在药效和皮肤安全性方面的差异;再以活性成分(乌头碱、丁香酚等)含量及干膏得率为指标,结合正交实验优化提取参数。

结果:

FFNX-2(渗漉+醇提)在抑制大鼠足趾肿胀、降低炎症因子及镇痛作用上效果最优,同时能降低家兔的皮肤刺激性,确定为复方南星止痛膏改良型新药的最佳提取工艺路线。

结论:

优化后的最佳提取工艺参数为:丁香等六味以4倍量50%乙醇提取3次(每次1 h),生天南星、生川乌以70%乙醇渗漉提取(粒径2~5 mm,浸渍24 h,流速1 mL·min-1·kg-1,收集8倍量)。优化后的提取工艺在有效保留关键药效物质的同时,显著降低了潜在毒性风险,为复方南星止痛膏的现代化开发及临床应用提供了科学依据。

, authors=罗丰收1, 李志强1, 林新艳2, 杨野1, 孙群1, 周颖1, 余金凤1, 秦鑫鹏1, 殷书梅2, 林丽2, 李吉峰2, 刘文君1, *, 曹亮1, 王振中1, 肖伟1, *, authorsList=罗丰收, 李志强, 林新艳, 杨野, 孙群, 周颖, 余金凤, 秦鑫鹏, 殷书梅, 林丽, 李吉峰, 刘文君, 曹亮, 王振中, 肖伟, authorCompany=null, correspAuthors=刘文君, 肖伟, authorNote=

罗丰收,男,中级工程师,主要从事中药新药研究。E-mail: 。

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* 肖伟,男,研究员,博士生导师,主要从事中药新药研发及过程质量控制研究。E-mail: 。
* 刘文君,男,高级工程师,主要从事创新中药的研究与开发。E-mail: 。
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基于药效学评价结合正交设计的复方南星止痛膏改良型新药提取工艺优化研究
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罗丰收 1 , 李志强 1 , 林新艳 2 , 杨野 1 , 孙群 1 , 周颖 1 , 余金凤 1 , 秦鑫鹏 1 , 殷书梅 2 , 林丽 2 , 李吉峰 2 , 刘文君 1, * , 曹亮 1 , 王振中 1 , 肖伟 1, *
中国新药杂志 | 实验研究 2026,35(18): 1956-1967
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中国新药杂志 |实验研究 2026 , 35 (18) : 1956 -1967
基于药效学评价结合正交设计的复方南星止痛膏改良型新药提取工艺优化研究
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罗丰收,男,中级工程师,主要从事中药新药研究。E-mail: 。

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罗丰收,男,中级工程师,主要从事中药新药研究。E-mail: 。

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罗丰收1 , 李志强1, 林新艳2, 杨野1, 孙群1, 周颖1, 余金凤1, 秦鑫鹏1, 殷书梅2, 林丽2, 李吉峰2, 刘文君1, * , 曹亮1, 王振中1, 肖伟1, *
作者信息
  • 1中药制药过程控制与智能制造技术全国重点实验室(江苏康缘药业股份有限公司),南京 211112
  • 2江苏康缘阳光药业有限公司,南京 210046
通讯作者:
* 肖伟,男,研究员,博士生导师,主要从事中药新药研发及过程质量控制研究。E-mail: 。
* 刘文君,男,高级工程师,主要从事创新中药的研究与开发。E-mail: 。
作者简介:

罗丰收,男,中级工程师,主要从事中药新药研究。E-mail: 。

Optimization of extraction process for the modified new formulation of Compound Nanxing Zhitong Plaster based on pharmacodynamic evaluation combined with orthogonal design
Feng-shou LUO1 , Zhi-qiang LI1, Xin-yan LIN2, Ye YANG1, Qun SUN1, Ying ZHOU1, Jin-feng YU1, Xin-peng QIN1, Shu-mei YIN2, Li LIN2, Ji-feng LI2, Wen-jun LIU1, * , Liang CAO1, Zhen-zhong WANG1, Wei XIAO1, *
Affiliations
  • 1State Key Laboratory of Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture (Jiangsu Kanion Pharmaceutical Co., Ltd.), Nanjing 211112, China
  • 2Jiangsu Kangyuan Sunshine Pharmaceutical Co., Ltd., Nanjing 210046, China
出版时间: 2026-09-30 doi: 10.20251/j.cnki.1003-3734.2026.18.008
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目的:

确定并优化复方南星止痛膏改良型新药提取工艺。

方法:

采用佐剂性关节炎(adjuvant-induced arthritis, AIA)大鼠模型、冰醋酸致小鼠疼痛模型进行药效学评价,同时对家兔皮肤刺激性进行考察,比较2种提取工艺(FFNX-1:醇提+水提+醇提;FFNX-2:渗漉+醇提)在药效和皮肤安全性方面的差异;再以活性成分(乌头碱、丁香酚等)含量及干膏得率为指标,结合正交实验优化提取参数。

结果:

FFNX-2(渗漉+醇提)在抑制大鼠足趾肿胀、降低炎症因子及镇痛作用上效果最优,同时能降低家兔的皮肤刺激性,确定为复方南星止痛膏改良型新药的最佳提取工艺路线。

结论:

优化后的最佳提取工艺参数为:丁香等六味以4倍量50%乙醇提取3次(每次1 h),生天南星、生川乌以70%乙醇渗漉提取(粒径2~5 mm,浸渍24 h,流速1 mL·min-1·kg-1,收集8倍量)。优化后的提取工艺在有效保留关键药效物质的同时,显著降低了潜在毒性风险,为复方南星止痛膏的现代化开发及临床应用提供了科学依据。

复方南星止痛膏  /  改良型新药  /  药效学  /  正交设计  /  提取工艺  /  乌头碱  /  丁香酚
Objective:

To optimize the extraction process for the modified new formulation of Compound Nanxing Zhitong Plaster.

Methods:

Pharmacological effects were evaluated using adjuvant-induced arthritis rat models and acetic acid-induced writhing mouse models, while skin irritation was tested in rabbits. The differences in efficacy and skin safety between two extraction methods (FFNX-1: ethanol-water-ethanol extraction; FFNX-2: percolation+ethanol extraction) were compared. Active ingredient contents (including aconitine, eugenol, etc.) and dry extract yield were used as indicators to optimize extraction parameters through orthogonal experimental design.

Results:

FFNX-2 (percolation+ethanol extraction) exhibited optimal anti-swelling, anti-inflammatory and analgesic effects, along with lower skin irritation in rabbits, establishing it as the optimal extraction process for the improved new drug formulation of Compound Nanxing Zhitong Plaster.

Conclusion:

The optimized extraction parameters were as follows: Six herbs including Caryophylli Flos extracted three times (1 h each) with 4 volumes of 50% ethanol; Arisaematis Rhizoma and Aconiti Radix extracted by percolation with 70% ethanol (particle size 2~5 mm, soaked for 24 h, flow rate 1 mL·min-1·kg-1, collecting 8 volumes of effluent). The optimized extraction process effectively retains active components while reducing toxicity risks, providing a scientific basis for the modern development of Compound Nanxing Zhitong Plaster.

Compound Nanxing Zhitong Plaster  /  improved new formulation  /  pharmacodynamics  /  orthogonal design  /  extraction technology  /  aconitine  /  eugenol
罗丰收, 李志强, 林新艳, 杨野, 孙群, 周颖, 余金凤, 秦鑫鹏, 殷书梅, 林丽, 李吉峰, 刘文君, 曹亮, 王振中, 肖伟. 基于药效学评价结合正交设计的复方南星止痛膏改良型新药提取工艺优化研究. 中国新药杂志, 2026 , 35 (18) : 1956 -1967 . DOI: 10.20251/j.cnki.1003-3734.2026.18.008
Feng-shou LUO, Zhi-qiang LI, Xin-yan LIN, Ye YANG, Qun SUN, Ying ZHOU, Jin-feng YU, Xin-peng QIN, Shu-mei YIN, Li LIN, Ji-feng LI, Wen-jun LIU, Liang CAO, Zhen-zhong WANG, Wei XIAO. Optimization of extraction process for the modified new formulation of Compound Nanxing Zhitong Plaster based on pharmacodynamic evaluation combined with orthogonal design[J]. Chinese Journal of New Drugs, 2026 , 35 (18) : 1956 -1967 . DOI: 10.20251/j.cnki.1003-3734.2026.18.008
  • 江苏省基础研究计划自然科学基金资助项目:前沿引领技术基础研究专项(BK20232014)
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2026年第35卷第18期
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doi: 10.20251/j.cnki.1003-3734.2026.18.008
  • 首发时间:2026-10-26
  • 出版时间:2026-09-30
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  • 录用日期:2026-01-27
基金
江苏省基础研究计划自然科学基金资助项目:前沿引领技术基础研究专项(BK20232014)
作者信息
    1中药制药过程控制与智能制造技术全国重点实验室(江苏康缘药业股份有限公司),南京 211112
    2江苏康缘阳光药业有限公司,南京 210046

通讯作者:

* 肖伟,男,研究员,博士生导师,主要从事中药新药研发及过程质量控制研究。E-mail: 。
* 刘文君,男,高级工程师,主要从事创新中药的研究与开发。E-mail: 。
参考文献
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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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