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Optimization of extraction process for the modified new formulation of Compound Nanxing Zhitong Plaster based on pharmacodynamic evaluation combined with orthogonal design
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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, *
Chinese Journal of New Drugs | 2026, 35(18) : 1956 - 1967
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Chinese Journal of New Drugs | 2026, 35(18): 1956-1967
Optimization of extraction process for the modified new formulation of Compound Nanxing Zhitong Plaster based on pharmacodynamic evaluation combined with orthogonal design
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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
Published: 2026-09-30 doi: 10.20251/j.cnki.1003-3734.2026.18.008
Outline
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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
Year 2026 volume 35 Issue 18
47
8
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.18.008
  • Online Date:2026-10-26
  • Published:2026-09-30
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History
  • Accepted:2026-01-27
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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
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表12种不同金属材料的力学参数
科
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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