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This leads to diverse mass transfer patterns during manufacturing and poses challenges in controlling the uniformity and stability of the final preparations. This review summarizes existing analytical techniques for characterizing component states. By establishing the correlation between component states and the solution environment, a confined mass transfer mathematical model is developed to quantitatively describe component states and association coefficients in complex TCM solutions. Combined with strategies for modulating the solution environment and ultrasonic-assisted delamination techniques, this approach provides a methodological framework for resolving supramolecular assemblies in TCM systems. Furthermore, based on the intrinsic relationship among production parameters, component states, and mass transfer behavior, a new concept for regulating TCM preparation processes is proposed, aiming to enhance the orderliness and controllability of TCM production., authors=XING Dantong, QIU Ranyun, SHEN Xin, ZHI Xinglei, DONG Zhengqi, LI Cunyu, authorsList=XING Dantong, QIU Ranyun, SHEN Xin, ZHI Xinglei, DONG Zhengqi, LI Cunyu, authorCompany=null, correspAuthors=null, 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=1304140196849672919, articleId=1304140196635763414, tenantId=1146029695717560320, journalId=1302319053441957962, language=CN, title=中药复杂溶液环境中成分存在状态解析及制药控制研究, columnId=1304140194685415572, journalTitle=中草药, columnName=综述, runingTitle=null, highlight=null, articleAbstract=中药制药过程涉及的溶液环境复杂，成分多以分子态、离子态、缔合态、复合态等多状态共存体系形式存在，造成制药环节中多样性的物质传递规律，出现制剂均一性和稳定性难以控制的生产现状。通过对现有的成分状态分析技术手段进行综述，并基于成分存在状态与溶液环境的相关性，构建限域传质数学模型，定量拟合复杂溶液体系中成分状态和缔合系数，进而结合溶液环境调控与超声剥离技术，为中药复杂溶液体系中超分子化合物的解析提供研究思路。根据“生产参数-成分状态-物质转移”的内在关系，构建中药制剂生产调控的新理念，从而提升中药制剂生产的有序性和可控性。, authors=邢丹彤1,2 , 丘燃云1,2 , 沈欣1,2 , 支兴蕾1,2 , 董政起3 , 李存玉1,2 , authorsList=邢丹彤, 丘燃云, 沈欣, 支兴蕾, 董政起, 李存玉, authorCompany=1 南京中医药大学药学院, 江苏 南京 210023; et al . Functional properties of saponins from sisal (Agave sisalana ) and Juá (Ziziphus joazeiro ): Critical micellar concentration, antioxidant and antimicrobial activities [J]. Colloids Surf A Physicochem Eng Aspects , 2013, 436: 736-743.et al . Simple modeling of donnan separation processes [J]. J Membr Sci , 2015, 476: 348-355.et al . Solution-diffusion-film model for the description of pressure-driven trans-membrane transfer of electrolyte mixtures: One dominant salt and trace ions [J]. J Membr Sci , 2011, 368(1/2): 192-201.J Membr Sci , 1997, 126(1): 91-105.2+ 及在不同干燥工艺条件下对牛乳胶束酪蛋白的结构及功能性质的影响 [J]. 食品与发酵工业, 2024, 50(1): 105-111.et al . Mixed micelles formulation for carvedilol delivery: in-vitro characterization and in-vivo evaluation [J]. Int J Pharm , 2022, 611: 121294.et al . Nanostructured gadolinium (III) micelles: Synthesis, characterization, cytotoxic activities, and MRI applications in vivo [J]. Nanomedicine , 2024, 62: 102770.Trac Trends Anal Chem , 2016, 77: 44-53.et al . Preparation and characterization of micelles of oligomeric chitosan linked to all-trans retinoic acid [J]. Carbohydr Polym , 2012, 87(2): 1176-1184.et al . Effects of polymer molecular weight on curcumin amorphous solid dispersion at-line monitoring system based on attenuated total reflectance mid-infrared and near-infrared spectroscopy [J]. J Drug Deliv Sci Technol , 2021, 61: 102278.et al . Effect of degree of substitution of octenyl succinate on starch micelles for synthesis and stability of selenium nanoparticles: Towards selenium supplements [J]. Int J Biol Macromol , 2024, 280(Pt2): 135586.Anal Chem , 2019, 91(3): 1962-1967.et al . Research progress of NMR in natural product quantification [J]. Molecules , 2021, 26(20): 6308.et al . Novel thymoquinone loaded chitosan-lecithin micelles for effective wound healing: Development, characterization, and preclinical evaluation [J]. Carbohydr Polym , 2020, 230: 115659.et al . Structural and compositional characterization of Ca- and β-casein enriched casein micelles [J]. Food Hydrocoll , 2024, 151: 109811.et al . A SAXS and USAXS study of the influence of pH on the casein micelle structure [J]. Food Chem , 2024, 443: 138606.Molecular Light Scattering and Optical Activity [M]. 2nd ed. Cambridge: Cambridge University Press, 2004.et al . Applications of circular dichroism (CD) for structural analysis of proteins: Qualification of near- and far-UV CD for protein higher order structural analysis [J]. J Pharm Sci , 2011, 100(11): 4642-4654.et al . Study on internal structure of casein micelles in reconstituted skim milk powder [J]. Int J Biol Macromol , 2023, 224: 437-452.et al . Formulation and characterization of choline oleate-based micelles for co-delivery of luteolin, naringenin, and quercetin [J]. Food Chem , 2023, 429: 136911.et al . Hyaluronic acid-quercetin conjugate micelles: Synthesis, characterization, in vitro and in vivo evaluation [J]. Colloids Surf B Biointerfaces , 2014, 123: 778-786.et al . Block copolymer micelles with acid-labile ortho ester side-chains: Synthesis, characterization, and enhanced drug delivery to human glioma cells [J]. J Control Release , 2011, 151(1): 18-27.et al . Preparation and characterization of thermosensitive pluronic F127-b-poly(ɛ-caprolactone) mixed micelles [J]. Colloids Surf B Biointerfaces , 2011, 86(1): 45-57.et al . Enhancing the pharmaceutical behavior of nateglinide by cocrystallization: Physicochemical assessment of cocrystal formation and informed use of differential scanning calorimetry for its quantitative characterization [J]. J Pharm Sci , 2019, 108(4): 1529-1539.et al . Quantitative determination of acetaminophen in pharmaceutical formulations using differential scanning calorimetry. Comparison with spectrophotometric method [J]. Drug Dev Ind Pharm , 2007, 33(8): 830-840.et al . Amphiphilic chitosan derivative-based core-shell micelles: Synthesis, characterisation and properties for sustained release of Vitamin D3 [J]. Food Chem , 2014, 152: 307-315.Adv Biol Med Phys , 1968, 12: 85-137.Food Chem , 2010, 119(1): 202-208.et al . Synthesis and characterization of stimuli responsive micelles from chitosan, starch, and alginate based on graft copolymers with polylactide-poly(methacrylic acid) and polylactide- poly [2(dimethyl amino)ethyl methacrylate] side chains [J]. Int J Biol Macromol , 2023, 253(Pt7): 127170.A -甘草酸自组装纳米胶束的制备及体外抗脑胶质瘤评价 [J]. 南京中医药大学学报, 2022, 38(6): 534-540.et al . Comparison on properties between normal and A2 bovine milk fermented using commercial bacteria mixed with/without two probiotics from human milk [J]. Int J Biol Macromol , 2022, 216: 105-113.
中草药
|综述
2026
, 57
(3) :
1123
-1137
中药复杂溶液环境中成分存在状态解析及制药控制研究
全屏
邢丹彤1,2 , 丘燃云1,2 , 沈欣1,2 , 支兴蕾1,2 , 董政起3 , 李存玉1,2
作者信息
1 南京中医药大学药学院, 江苏 南京 210023;
通讯作者:
李存玉
作者简介:
邢丹彤: 邢丹彤，硕士研究生，研究方向为纳滤分离在中药制药产业的应用。E-mail:202410966@njucm.edu.cn
Analysis of existence states of components in complex solution environment of traditional Chinese medicine and research on pharmaceutical control
XING Dantong, QIU Ranyun, SHEN Xin, ZHI Xinglei, DONG Zhengqi, LI Cunyu
Affiliations
doi: 10.7501/j.issn.0253-2670.2026.03.028
文章导航
中药制药过程涉及的溶液环境复杂，成分多以分子态、离子态、缔合态、复合态等多状态共存体系形式存在，造成制药环节中多样性的物质传递规律，出现制剂均一性和稳定性难以控制的生产现状。通过对现有的成分状态分析技术手段进行综述，并基于成分存在状态与溶液环境的相关性，构建限域传质数学模型，定量拟合复杂溶液体系中成分状态和缔合系数，进而结合溶液环境调控与超声剥离技术，为中药复杂溶液体系中超分子化合物的解析提供研究思路。根据“生产参数-成分状态-物质转移”的内在关系，构建中药制剂生产调控的新理念，从而提升中药制剂生产的有序性和可控性。
中药制剂
/
缔合物
/
存在状态
/
纳滤
/
质量控制
The solution environment involved in the pharmaceutical process of traditional Chinese medicine (TCM) is complex, with components coexisting in multiple states—including molecular, ionic, aggregated, and composite forms. This leads to diverse mass transfer patterns during manufacturing and poses challenges in controlling the uniformity and stability of the final preparations. This review summarizes existing analytical techniques for characterizing component states. By establishing the correlation between component states and the solution environment, a confined mass transfer mathematical model is developed to quantitatively describe component states and association coefficients in complex TCM solutions. Combined with strategies for modulating the solution environment and ultrasonic-assisted delamination techniques, this approach provides a methodological framework for resolving supramolecular assemblies in TCM systems. Furthermore, based on the intrinsic relationship among production parameters, component states, and mass transfer behavior, a new concept for regulating TCM preparation processes is proposed, aiming to enhance the orderliness and controllability of TCM production.
Chinese medicine preparation
/
association
/
existence state
/
nanofiltration
/
quality control
邢丹彤, 丘燃云, 沈欣, 支兴蕾, 董政起, 李存玉.
中药复杂溶液环境中成分存在状态解析及制药控制研究.
中草药,
2026
, 57
(3)
: 1123
-1137
.
DOI: 10.7501/j.issn.0253-2670.2026.03.028
XING Dantong, QIU Ranyun, SHEN Xin, ZHI Xinglei, DONG Zhengqi, LI Cunyu.
Analysis of existence states of components in complex solution environment of traditional Chinese medicine and research on pharmaceutical control[J].
Chinese Traditional and Herbal Drugs ,
2026
, 57
(3)
: 1123
-1137
.
DOI: 10.7501/j.issn.0253-2670.2026.03.028
国家自然科学基金资助项目(82274106);中药制药过程控制与智能制造技术全国重点实验室创新项目(NZYSKL240207);南京中医药大学中药学一流学科科学研究培育项目(ZYXPY2024-006)
参考文献
引证文献
马百平, 康利平, 庞旭, 等. 中药化学成分分析、分离技术及策略 [J]. 国际药学研究杂志, 2015, 42(4): 413-426.et al . Functional properties of saponins from sisal (Agave sisalana ) and Juá (Ziziphus joazeiro ): Critical micellar concentration, antioxidant and antimicrobial activities [J]. Colloids Surf A Physicochem Eng Aspects , 2013, 436: 736-743.et al . Simple modeling of donnan separation processes [J]. J Membr Sci , 2015, 476: 348-355.et al . Solution-diffusion-film model for the description of pressure-driven trans-membrane transfer of electrolyte mixtures: One dominant salt and trace ions [J]. J Membr Sci , 2011, 368(1/2): 192-201.J Membr Sci , 1997, 126(1): 91-105.2+ 及在不同干燥工艺条件下对牛乳胶束酪蛋白的结构及功能性质的影响 [J]. 食品与发酵工业, 2024, 50(1): 105-111.et al . Mixed micelles formulation for carvedilol delivery: in-vitro characterization and in-vivo evaluation [J]. Int J Pharm , 2022, 611: 121294.et al . Nanostructured gadolinium (III) micelles: Synthesis, characterization, cytotoxic activities, and MRI applications in vivo [J]. Nanomedicine , 2024, 62: 102770.Trac Trends Anal Chem , 2016, 77: 44-53.et al . Preparation and characterization of micelles of oligomeric chitosan linked to all-trans retinoic acid [J]. Carbohydr Polym , 2012, 87(2): 1176-1184.et al . Effects of polymer molecular weight on curcumin amorphous solid dispersion at-line monitoring system based on attenuated total reflectance mid-infrared and near-infrared spectroscopy [J]. J Drug Deliv Sci Technol , 2021, 61: 102278.et al . Effect of degree of substitution of octenyl succinate on starch micelles for synthesis and stability of selenium nanoparticles: Towards selenium supplements [J]. Int J Biol Macromol , 2024, 280(Pt2): 135586.Anal Chem , 2019, 91(3): 1962-1967.et al . Research progress of NMR in natural product quantification [J]. Molecules , 2021, 26(20): 6308.et al . Novel thymoquinone loaded chitosan-lecithin micelles for effective wound healing: Development, characterization, and preclinical evaluation [J]. Carbohydr Polym , 2020, 230: 115659.et al . Structural and compositional characterization of Ca- and β-casein enriched casein micelles [J]. Food Hydrocoll , 2024, 151: 109811.et al . A SAXS and USAXS study of the influence of pH on the casein micelle structure [J]. Food Chem , 2024, 443: 138606.Molecular Light Scattering and Optical Activity [M]. 2nd ed. Cambridge: Cambridge University Press, 2004.et al . Applications of circular dichroism (CD) for structural analysis of proteins: Qualification of near- and far-UV CD for protein higher order structural analysis [J]. J Pharm Sci , 2011, 100(11): 4642-4654.et al . Study on internal structure of casein micelles in reconstituted skim milk powder [J]. Int J Biol Macromol , 2023, 224: 437-452.et al . Formulation and characterization of choline oleate-based micelles for co-delivery of luteolin, naringenin, and quercetin [J]. Food Chem , 2023, 429: 136911.et al . Hyaluronic acid-quercetin conjugate micelles: Synthesis, characterization, in vitro and in vivo evaluation [J]. Colloids Surf B Biointerfaces , 2014, 123: 778-786.et al . Block copolymer micelles with acid-labile ortho ester side-chains: Synthesis, characterization, and enhanced drug delivery to human glioma cells [J]. J Control Release , 2011, 151(1): 18-27.et al . Preparation and characterization of thermosensitive pluronic F127-b-poly(ɛ-caprolactone) mixed micelles [J]. Colloids Surf B Biointerfaces , 2011, 86(1): 45-57.et al . Enhancing the pharmaceutical behavior of nateglinide by cocrystallization: Physicochemical assessment of cocrystal formation and informed use of differential scanning calorimetry for its quantitative characterization [J]. J Pharm Sci , 2019, 108(4): 1529-1539.et al . Quantitative determination of acetaminophen in pharmaceutical formulations using differential scanning calorimetry. Comparison with spectrophotometric method [J]. Drug Dev Ind Pharm , 2007, 33(8): 830-840.et al . Amphiphilic chitosan derivative-based core-shell micelles: Synthesis, characterisation and properties for sustained release of Vitamin D3 [J]. Food Chem , 2014, 152: 307-315.Adv Biol Med Phys , 1968, 12: 85-137.Food Chem , 2010, 119(1): 202-208.et al . Synthesis and characterization of stimuli responsive micelles from chitosan, starch, and alginate based on graft copolymers with polylactide-poly(methacrylic acid) and polylactide- poly [2(dimethyl amino)ethyl methacrylate] side chains [J]. Int J Biol Macromol , 2023, 253(Pt7): 127170.A -甘草酸自组装纳米胶束的制备及体外抗脑胶质瘤评价 [J]. 南京中医药大学学报, 2022, 38(6): 534-540.et al . Comparison on properties between normal and A2 bovine milk fermented using commercial bacteria mixed with/without two probiotics from human milk [J]. Int J Biol Macromol , 2022, 216: 105-113.
2026年第57卷第3期
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doi: 10.7501/j.issn.0253-2670.2026.03.028
接收时间：2025-07-14
首发时间：2026-09-08
https://castjournals.cast.org.cn/joweb/zcy/CN/10.7501/j.issn.0253-2670.2026.03.028
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2种不同金属材料的力学参数
科 属数 种数 占总种数比例 属 种数 占总种数比例 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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