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Article(id=1308455371480257069, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1308455335962894804, articleNumber=null, orderNo=null, doi=10.16438/j.0513-4870.2024-1278, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1735056000000, receivedDateStr=2024-12-25, revisedDate=1744560000000, revisedDateStr=2025-04-14, acceptedDate=null, acceptedDateStr=null, onlineDate=1789889670485, onlineDateStr=2026-09-20, pubDate=1749657600000, pubDateStr=2025-06-12, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1789889670485, onlineIssueDateStr=2026-09-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1789889670485, creator=13701087609, updateTime=1789889670485, updator=13701087609, issue=Issue{id=1308455335962894804, tenantId=1146029695717560320, journalId=1189982191388893191, year='2025', volume='60', issue='6', pageStart='1573', pageEnd='1964', issueExtLink='null', onlineDate='null', pubDate='1749657600000', pubDateStr='2025-06-12', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1789889662017, creator='13701087609', updateTime=1789893590327, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1308471812564734358, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1308455335962894804, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1308471812564734359, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1308455335962894804, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1654, endPage=1660, ext={EN=ArticleExt(id=1308455371685777967, articleId=1308455371480257069, tenantId=1146029695717560320, journalId=1189982191388893191, language=EN, title=Progress in the application of gels in ulcerative colitis, columnId=1190335348648547107, journalTitle=Acta Pharmaceutica Sinica, columnName=Reviews, runingTitle=null, highlight=null, articleAbstract=

Ulcerative colitis (UC) is a chronic, non-specific inflammatory disease of the colon that is characterized by complex etiologies, challenging treatment, and high recurrence rate. At present, the main clinical therapeutic agents include suppositories, foams, and liquid enema formulations. But they have problems such as low adhesion and short drug residence time. As a new dosage form, gel has the characteristics of high bioavailability, long drug retention time, high safety and appropriate biological adhesion. This article reviews the relevant literature at home and abroad in the past five years, and analyzes and summarizes the classification of gels, prescription design of various gels, matrix selection, preparation process and pharmacological effects. The results show that the gel can effectively prolong the action time of the drug and alleviate the inflammatory response, which can offer a promising therapeutic strategy for UC management.

, authors=Qiu-ling CHEN, Rui LUO, Li-hong WANG, Si-han CHENG, Jun WAN, Xia ZHOU*, authorsList=Qiu-ling CHEN, Rui LUO, Li-hong WANG, Si-han CHENG, Jun WAN, Xia ZHOU, authorCompany=null, correspAuthors=Xia ZHOU, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2025 Acta Pharmaceutica Sinica. All rights reserved., 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=1308455374386909749, articleId=1308455371480257069, tenantId=1146029695717560320, journalId=1189982191388893191, language=CN, title=凝胶剂在溃疡性结肠炎中的应用进展, columnId=1190335349655180086, journalTitle=药学学报, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

溃疡性结肠炎(ulcerative colitis, UC) 是一种慢性非特异性炎性疾病, 病因复杂、治疗困难、易复发。目前临床治疗剂型主要有栓剂、泡沫剂和液态灌肠剂等, 但存在黏附性低、药物停留时间短等问题。凝胶剂作为一种新剂型, 具有生物利用度高、药物滞留时间长、安全性高、有适当生物黏附力等特点。本文梳理了近5年国内外相关文献, 从凝胶剂的分类、处方设计、基质选择、制备工艺及药理作用等方面进行分析总结, 结果显示凝胶剂能有效延长药物靶区停留时间、缓解炎症反应, 可为UC的治疗带来全新体验。

, authors=陈秋伶, 罗锐, 王利宏, 程思寒, 万军, 周霞*, authorsList=陈秋伶, 罗锐, 王利宏, 程思寒, 万军, 周霞, authorCompany=null, correspAuthors=周霞, authorNote=

作者贡献:

陈秋伶负责论文的撰写和图片绘制; 罗锐、王利宏、程思寒负责文献调研和论文撰写; 万军负责论文的校稿; 周霞负责论文选题、整体设计与指导。

, correspAuthorsNote=
周霞, Tel: 13982177386, E-mail:
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凝胶剂在溃疡性结肠炎中的应用进展
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陈秋伶 , 罗锐 , 王利宏 , 程思寒 , 万军 , 周霞 *
药学学报 | 综述 2025,60(6): 1654-1660
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药学学报 |综述 2025 , 60 (6) : 1654 -1660
凝胶剂在溃疡性结肠炎中的应用进展
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陈秋伶, 罗锐, 王利宏, 程思寒, 万军, 周霞*
作者信息
  • 西南交通大学生命科学与工程学院, 四川 成都 610031
通讯作者:
周霞, Tel: 13982177386, E-mail:
作者简介:

作者贡献:

陈秋伶负责论文的撰写和图片绘制; 罗锐、王利宏、程思寒负责文献调研和论文撰写; 万军负责论文的校稿; 周霞负责论文选题、整体设计与指导。

Progress in the application of gels in ulcerative colitis
Qiu-ling CHEN, Rui LUO, Li-hong WANG, Si-han CHENG, Jun WAN, Xia ZHOU*
Affiliations
  • School of Life Science and Engineering, Southwest Jiaotong University, Chengdu 610031, China
出版时间: 2025-06-12 doi: 10.16438/j.0513-4870.2024-1278
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摘要
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溃疡性结肠炎(ulcerative colitis, UC) 是一种慢性非特异性炎性疾病, 病因复杂、治疗困难、易复发。目前临床治疗剂型主要有栓剂、泡沫剂和液态灌肠剂等, 但存在黏附性低、药物停留时间短等问题。凝胶剂作为一种新剂型, 具有生物利用度高、药物滞留时间长、安全性高、有适当生物黏附力等特点。本文梳理了近5年国内外相关文献, 从凝胶剂的分类、处方设计、基质选择、制备工艺及药理作用等方面进行分析总结, 结果显示凝胶剂能有效延长药物靶区停留时间、缓解炎症反应, 可为UC的治疗带来全新体验。

溃疡性结肠炎  /  凝胶剂  /  原位凝胶  /  药理研究  /  直肠给药

Ulcerative colitis (UC) is a chronic, non-specific inflammatory disease of the colon that is characterized by complex etiologies, challenging treatment, and high recurrence rate. At present, the main clinical therapeutic agents include suppositories, foams, and liquid enema formulations. But they have problems such as low adhesion and short drug residence time. As a new dosage form, gel has the characteristics of high bioavailability, long drug retention time, high safety and appropriate biological adhesion. This article reviews the relevant literature at home and abroad in the past five years, and analyzes and summarizes the classification of gels, prescription design of various gels, matrix selection, preparation process and pharmacological effects. The results show that the gel can effectively prolong the action time of the drug and alleviate the inflammatory response, which can offer a promising therapeutic strategy for UC management.

ulcerative colitis  /  gel  /  in situ gel  /  pharmacological study  /  rectal administration
陈秋伶, 罗锐, 王利宏, 程思寒, 万军, 周霞. 凝胶剂在溃疡性结肠炎中的应用进展. 药学学报, 2025 , 60 (6) : 1654 -1660 . DOI: 10.16438/j.0513-4870.2024-1278
Qiu-ling CHEN, Rui LUO, Li-hong WANG, Si-han CHENG, Jun WAN, Xia ZHOU. Progress in the application of gels in ulcerative colitis[J]. Acta Pharmaceutica Sinica, 2025 , 60 (6) : 1654 -1660 . DOI: 10.16438/j.0513-4870.2024-1278
正文
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凝胶剂(gel) 是指药物与能形成凝胶的辅料制成的均一、混悬或乳剂型的乳胶稠厚液体或半固体制剂[1]。凝胶剂可分为普通凝胶剂与原位凝胶剂两大类。普通凝胶按基质类型可分为亲水性凝胶、亲脂性凝胶与乳剂型凝胶等。原位凝胶因所受外界刺激的不同, 可分为温度敏感型凝胶、pH敏感型凝胶和离子敏感型凝胶等。凝胶剂可用于治疗皮肤、眼睛与腔道等疾病[2], 有十分广阔的应用前景。
溃疡性结肠炎(ulcerative colitis, UC) 是一种病因复杂, 治疗困难, 异常免疫介导的直肠和结肠反复发作的慢性非特异性炎性疾病, 主要影响结肠和直肠的黏膜层, 表现为弥漫性炎症和溃疡形成[3], 目前临床给药途径以口服和灌肠为主。UC在世界人口中的发病率较高, 在亚洲有逐年增长的趋势[4]。
传统的口服给药治疗UC存在首过效应、滞留时间短、定位不够准确等缺点; 而凝胶灌肠剂具有避免首过效应、增加药物滞留时间、提高生物的利用度、有适当生物黏附力等优势, 为临床治疗UC提供了更多的选择(图1)。
1　普通凝胶剂在UC中的应用
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根据基质的不同, 普通凝胶剂可分为水凝胶与油凝胶。在UC的治疗中, 水凝胶的应用更为广泛。
1.1　水凝胶
水凝胶是一种应用历史悠久的传统凝胶剂, 其以水为分散介质, 具有极具亲水性的三维网状结构, 该结构使水凝胶具有较强的溶胀性和持水性。此外, 水凝胶良好的生物相容性与靶向性使其广泛用于组织工程和药物输送[5]。鉴于水凝胶的诸多优点, 目前其仍是国内外凝胶剂研究热点之一。
根据水凝胶组成单元的粒径不同, 可分为微观凝胶(纳米级和微米级) 和宏观凝胶(柱状、纤维状、膜状、球状等)。因宏观水凝胶在UC的治疗中应用较少, 故本节主要介绍微观水凝胶。
1.1.1　纳米水凝胶
纳米水凝胶即纳米级的水凝胶颗粒, 是由高分子聚合物通过物理或化学交联形成的三维网状系统[6]。水凝胶与纳米材料相结合, 可重新赋予材料新的功能, 如靶向性、稳定性和改进的力学性能等。
UC使肠道上皮通透性增加, 带正电的蛋白质在炎症区域积聚, 与含有带负电荷的纳米颗粒结合的水凝胶很容易积聚在受损区域。基于此, Zhou等[7]研制了乙二醇壳聚糖-琥珀酰强的松龙纳米凝胶, 并将其命名为NG (S), 用于负载糖皮质激素强的松龙。带负电的NG (S) 灌胃后可靶向结肠病变区, 高效转移且减少不良反应[8]。Zhang等[9]开发了纳米乳凝胶负载厚朴挥发油, 将挥发油制成纳米乳, 增加其稳定性和溶解度, 外层用海藻酸钠和透明质酸制备了一层水凝胶, 保护药物, 减少胃及小肠突释, 在结肠持续释放。药效学验证其能调节炎症因子的分泌, 显著提高claudin-1、ZO-1紧密连接蛋白的表达, 对于改善结肠黏膜屏障损伤展现出了优越疗效。为克服淫羊藿口服后的首过效应及生物利用度低等局限性, Zhang[10]构建了一种以生物聚合物壳聚糖、氧化硫酸软骨素、邻苯二酚壳聚糖为基质、具有肠道黏附性的纳米复合水凝胶, 结果显示可有效提高生物利用度, 且生物安全性良好。并且纳米粒-水凝胶的复合系统具有良好的力学性能, 可以实现直肠注射给药。
1.1.2　微米水凝胶
微米水凝胶即微米级水凝胶颗粒, 通过体外化学交联与物理包载工艺预先成型, 具有水凝胶共有的靶向性和生物相容性。与纳米水凝胶相比, 其较大的粒径使其呈现出良好的机械性能和稳定性。
选用pH敏感载体材料, 可使该类凝胶在给药前已成型, 但其溶胀性能在不同pH环境中有极为显著的变化, 从而实现药物控释。利用该特点, 将牛至油微球包载在海藻酸钠/壳聚糖双交联水凝胶中, 并且通过单因素和响应面实验优化了水凝胶的制备工艺[11]。体外溶胀及释放度实验结果显示, 此水凝胶仅在人工结肠液条件下能够充分溶胀, 在人工胃液或人工肠液条件下几乎不溶胀, 且此水凝胶具有良好的靶向性, 能高效提升局部药物浓度, 提高生物利用度。由于微米水凝胶是一类与活体组织相似的支架聚合生物材料, 生物相容性与机械性能良好。目前已有多功能仿生水凝胶[12], 在体外制备成型, 可在灌肠后稳定黏附在溃疡部位, 并迅速建立人工屏障, 保护底层健康细胞免受有毒物质和有害菌群的刺激, 同时该凝胶表现出良好的组织黏附性和机械阻力, 不易断裂和脱落。
1.2　油凝胶
油凝胶为结构化的液体油基质凝胶, 是指在无交联剂的情况下将液体油转化为凝胶状物体, 可实现液态药物的固体化[13]。Wang[14]通过新型固化技术解决了挥发油液态、易挥发、不稳定等成药型缺陷, 制备的广藿香油凝胶不仅载药量高、释放快速, 还体现出较好的抗炎效果。
由上可见, 普通凝胶剂组分合理、制备工艺简洁, 可负载不同性质的药物治疗UC, 均可较好发挥调节炎症因子, 改善黏膜损伤的作用。其中, 水凝胶因其生物安全性高、靶向性良好等特点, 广泛应用于UC的治疗。
2　原位凝胶剂在UC中的应用
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原位凝胶的形成取决于高分子基质对外界环境的响应, 利用聚合物在生理条件下发生分散或聚合的可逆变化, 完成溶液-凝胶的转变过程, 具体机制如图2所示。目前研究较多的有非复合型和复合型原位凝胶[15]。pH敏感型和离子敏感型多用于眼部和鼻腔, 温度敏感型原位凝胶多用于直肠给药。温敏原位凝胶在直肠给药时受体温影响从液态变为凝胶态, 具有良好的黏附和缓释效果。
2.1　非复合型原位凝胶
非复合型原位凝胶由单一类型的基质材料构成, 对环境因素敏感。在直肠给药中, 由于直肠环境限制, 常用温度敏感型原位凝胶, 能够在生理条件下从液态转变为凝胶态, 无痛给药并持续释放, 提高患者依从性。
泊洛沙姆具有热可逆凝胶化特性, 能够负载多种药物、改善循环时间、增强渗透性和保留效果[16]。Wu等[17]使用泊洛沙姆407 (Poloxamer 407, P407)、泊洛沙姆188 (Poloxamer 188, P188) 和硫酸软骨素改性羧甲基壳聚糖, 制成载有美洲大蠊提取物的热敏原位凝胶, 该制剂易于给药, 能增强药物区域输送, 减少给药频率, 延长药物在结肠的滞留时间, 有效缓解右旋糖酐硫酸钠诱导的UC小鼠结肠损伤。Chen等[18]研究布地奈德(budesonide, Bud) 温敏型原位凝胶制剂实现了预期的直肠定位递送特性, 避免了灌肠剂溶液渗漏问题, 实现药物制剂在局部病灶的长期滞留、持续释药, 生物利用度高, 直肠吸收显著增加, 患者依从性高。Lei[19]选用P407、P188和羟丙甲基纤维素作为原位凝胶基质, 制剂生物黏附性良好, 体外释放速率较快, 在直肠的滞留时间达到6 h以上, 累积渗透率达80%, 使药物在直肠的滞留时间显著延长, 并改善了药物吸收。
2.2　复合型原位凝胶
复合型原位凝胶是将多种制药技术有机地结合起来, 共同制成的一类原位凝胶。传统的微粒给药系统, 由于微粒分散系自身特性, 其稳定性较差且部分微粒表现出局部毒性, 加载原位凝胶可较好解决上述问题, 药物的释放亦受到多层阻隔, 可有效解决药物突释问题。复合型原位凝胶根据药物载体结构特性的不同, 可分为脂质体及其衍生物、包合物、固体分散体、胶束等类型。
2.2.1　脂质体-原位凝胶
脂质体是由一个或多个双分子层包裹水相内核的磷脂囊泡。脂质体双分子层可以以“凝胶状态”存在。制备成脂质体温敏原位凝胶能够利用脂质体的特性增加药物溶解度、升高靶部位浓度; 同时结合原位凝胶的特点, 促进药物均匀分布、提高局部黏附性能[16]。Bud作为第二代类固醇皮质激素, 局部给药, 能缓解轻中度UC症状。但亲脂性药物较难分散于水溶性凝胶中。脂质的磷脂双分子层可提高药物分散度, 增加溶解度, 从而增加Bud在直肠的局部吸收和局部药物浓度[20]。Zhao等[21]建立了能够实现结肠局部靶向的布地奈德脂质体温敏凝胶, 脂质体可增加药物的结肠局部吸收, 温敏凝胶则延长药物的滞留时间, 改善UC症状, 显现出修复结肠黏膜, 改善炎症因子的异常表达的卓越疗效。
甘油体作为新一代脂质体, 能够改变脂质体的理化及载药功能, 从而使药物更有效地通过生物膜传递, 是近年来新兴的透皮药物递送系统[22, 23]。大量甘油的加入能够改变磷脂双层的流动性, 提高甘油体的渗透性。Salem等[23]采用Box-Behnken设计法制备盐酸度洛西汀-甘油黏膜脂质体(duloxetine HCl-glycerosomal, DXH-GLYS) 原位凝胶, 囊泡通过直肠时其渗透效率受其粒径的影响显著, 而制备成小尺寸的GLYS则增大了其透过直肠黏膜的透过效率, 极大促进了药物的吸收, 并展现出更好的持续释药模式。甘油体磷脂双层的可变形性和流动性也使药物能够更容易通过直肠生物膜, 与DXH口服液相比, 其生物利用度提高了2.24倍。
2.2.2　包合物-原位凝胶
环糊精包合技术能够提高药物生物利用度, 提供更好的溶解性和稳定性[24]。Lei等[25]选用羟丙基-β-环糊精对美洛昔康进行包合, 再制成温敏凝胶用于直肠递送, 成功提高了生物利用度, 延长直肠滞留时间且未引起直肠刺激性, 并减少了给药次数, 较好解决了美洛昔康水溶性差、口服生物利用度低等问题。
2.2.3　固体分散体-原位凝胶
固体分散技术也是一种常用的改善难溶性药物溶解度的方法。Liu等[26]研制了一种基于固体分散体的温敏性原位凝胶, 用于负载布洛芬的直肠给药。以P407和黏膜黏附性聚合物为原料制备原位凝胶, 分散体形成无定形状态后能促进药物释放。实验组2 h内的释放度可达80%左右, 而传统固体栓剂不到30%, 其溶解度、累积释放量显著增加, 体外释放效果更优, 凝胶状态可以通过黏附在直肠上延长吸收提高生物利用度。
2.2.4　胶束-温敏原位凝胶
纳米颗粒药物输送系统(nanoparticle drug delivery system, NDDS) 具有较长的循环时间, NDDS中胶束的纳米尺寸效应和原位凝胶系统的生物黏附相结合, 能够克服药物在体内的非特异性分布等问题。免疫抑制环孢素A (cyclosporine A, CsA) 是一种具有高疏水性的环状代谢肽, 采用薄膜分散法将CsA装载到两亲性聚乙二醇-聚己内酯(polyethylene glycol-polycaprolactone, PEG-PCL) 胶束中, 包埋在水凝胶中, 构建的热敏性和黏膜黏附性水凝胶药物递送系统(thermosensitive and mucoadhesive hydrogel drug delivery system, PLCP) 在发炎的结肠中表现出很强的滞留性, 减少了药物的迁移[27], 该系统表现出载药量大、胶凝化快速稳定等特点。
综上所述, 原位凝胶不仅提升了普通凝胶的生物相容性和药物控释能力, 也增加了直肠给药的便捷性和有效性。在原位凝胶基础上发展起来的复合型原位凝胶, 结合了多种药物制剂新技术及载体的优势, 如脂质体、包合物或固体分散体, 可显著改善药物的溶解性、稳定性及释药特性, 为UC的治疗带来了全新的策略。
3　凝胶剂治疗UC的药理研究
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目前, UC的发病机制尚不明确, 现代医学认为可能与饮食习惯[28]、自身免疫疾病[29]、信号通路异常[30]、遗传因素[31]等原因有关。其临床常用药物主要包括氨基水杨酸类药物、单克隆抗体、免疫抑制剂、皮质类固醇药物等[32], 且多采用药物的二联或三联来对症治疗, 给药方式多为口服给药、局部给药。常用剂型为汤剂、胶囊、栓剂、凝胶剂等, 而凝胶剂因其黏附性更佳、生物利用度高, 在UC治疗上成为一种备受关注的新剂型。
3.1　凝胶剂治疗UC的动物实验
Xiao等[28]通过负载CsA的PEG-PCL胶束, 并与壳聚糖-聚氧乙烯-聚丙二醇水凝胶形成互穿聚合物网络, 制备了CsA-PLCP热敏型水凝胶。结果显示, 该凝胶载药效率可达17.2%, 在三硝基苯磺酸溶液(picrylsulfonic acid solution, TNBS) 诱导的小鼠模型中, 与游离DiR给药组相比, 凝胶组给药的结肠荧光信号提高10.1倍, 显著延长了药物保留时间。此外, 与5倍剂量的环孢素乳剂相比, CsA-PLCP水凝胶显示出更卓越的抗结肠炎疗效。另一项研究[33]采用大豆磷脂酰胆碱、甘油二酯和乙醇为基质、以拉喹莫德(laquinimod, LAQ) 为主药制成拉喹莫德-黏稠透明油(LAQ-BBLG) 凝胶, 在TNBS诱导的UC小鼠模型中对LAQ/BBLG的治疗效果进行评价。以P407为基质的凝胶为对照, BBLG在结肠中凝胶化保留的时间更长; 游离LAQ混悬液与LAQ-BBLG给药方式的比较表明, 后者在结肠形态恢复方面表现更佳; 其中最显著的是, LAQ在水中溶解度仅为10.5 μg·mL-1, 而LAQ以无定形形式包埋在BBLG后, 溶解度显著提高至7 mg·mL-1, 这一试验表明, 凝胶剂可显著提高药物溶解度, 使得给药量更大, 且在作用时间、药物停留时间上都更有优势。Xiong等[34]开发的壳聚糖-藻酸盐水凝胶在90 min内显示出超过90%的黏液渗透性, 并在体内外实验中均表现出良好的生物相容性, 且根据荧光标记显示, 凝胶组药物滞留时间远高于游离药物(P < 0.05); 一款由白及多糖、壳聚糖和β-甘油磷酸制备的热敏性凝胶[35]具有良好的稳定性, 且在结肠中的保留时间延长; 而基于ROS/热双敏感白及多糖的水凝胶[36]可黏附性强, 能在作用部位长时间附着, 显现出卓越的安全性与生物相容性。
3.2　凝胶剂治疗UC的细胞实验
Wu等[17]制备的载有美洲大蠊提取物的热敏原位凝胶在体外炎症模型中显示出显著的抗炎效果。该模型中采用脂多糖(lipopolysaccharide, LPS) 刺激的Raw264.7巨噬细胞, 实验结果显示, 该凝胶能够显著降低细胞内促炎性细胞因子TNFα、IL-6、IL-18和白细胞介素IL-1β水平, 对减轻炎症反应显现卓越疗效。值得注意的是, 此款凝胶在降低IL-1β水平方面表现出比美洲大蠊提取物更优的效果(P < 0.01), 这意味着其在抗炎治疗中具有更高的应用价值。
另一项研究[37]开发的口服体外间充质干细胞条件培养基(ectodermal mesenchymal stem cells-conditional medium, EMSCs-CM) 水凝胶在LPS诱导的大鼠肠上皮细胞-6 (intestinal epithelial cell 6, IEC-6) 模型中也展现出显著的治疗效果。该水凝胶能够显著提高IL-10的表达, 与空白处理组比较, EMSCs-CM显著降低Villin蛋白水平所示的损伤(P < 0.01), 显示出对细胞损伤的保护作用。此外, EMSCs-CM水凝胶还能增强IEC-6细胞在LPS刺激下的增殖能力, 有效阻止细胞损伤的发生。
近年来, UC的发病率逐步上升, 但在临床上缺乏特异性药物。最常用的是氨基水杨酸类药物, 但不同剂型临床效果亦有差异。随着新材料的快速发展, 治疗UC的剂型也在不断更新, 包括原位凝胶、液体栓、新型灌肠剂等, 而以凝胶作为载药系统的直肠给药剂型已展现出良好的应用前景。
4　总结与问题
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4.1　市售治疗UC剂型
目前, 市售治疗UC剂型依然以汤剂、栓剂、胶囊剂等为主, 凝胶剂较为少见。普通凝胶剂与原位凝胶剂均可增强药物的黏附性, 延长药物的作用时间, 提高药物的浓度, 并具有良好的修复结肠黏膜、缓解炎症的作用。其中, 原位凝胶剂与普通凝胶剂相比, 有更好的药物释放控制能力, 在生物相容性、患者顺应性等方面都有显著提升。
4.2　凝胶剂的临床转化障碍
尽管凝胶剂具有一定优势, 但也存在临床转化障碍。首先, 凝胶剂的生产过程通常较为复杂, 尤其是对于那些具有特殊结构和功能的凝胶剂, 大规模生产的难度较大。由于生产工艺复杂和原材料成本高, 凝胶剂的制备成本相对较高, 这在一定程度上限制了其临床转化和广泛应用; 其次, 凝胶剂的给药途径相对有限, 目前主要为外用, 也有皮下注射、局部植入等, 而对于一些需要全身给药的药物, 凝胶剂可能不是最佳选择, 包括药物释放特性和生物相容性, 尚需在临床应用中进一步验证; 再者, 在凝胶剂的制备过程中, 某些化学交联剂的使用可能带来潜在的安全性问题。
4.3　凝胶剂在UC治疗中的局限
4.3.1　药物释放
目前, 凝胶剂的药物释放速度可能难以精确控制, 导致药物在肠道内的浓度不稳定, 影响治疗效果。而肠道环境的酸碱性、结肠组织溃疡面离子分布及肠道菌群, 也许可为一些高分子材料提供条件, 研发根据肠道环境变化自动调节药物释放的智能凝胶。
4.3.2　个体差异的影响
不同患者的肠道生理环境不同, 对凝胶剂的吸收和反应也存在差异, 可能导致治疗效果的不确定性。针对这一问题, 可通过基因检测、肠道菌群分析等手段, 为患者制定个性化的凝胶剂治疗方案, 以提高治疗的针对性和有效性。但这也将带来研发及生产成本的增高。
另外, 凝胶剂的作用范围、长期使用对肠道菌群的影响等也需考虑。相信随着医疗及制药技术的发展, 具有更好生物相容性、可降解性和药物负载能力的新型凝胶材料将进一步发挥凝胶的优势, 其也将成为临床治疗UC的热门剂型之一, 必将给患者带来更好的治疗体验和疗效。
5　展望与挑战
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尽管凝胶剂在UC的治疗中展现出延长药物滞留时间、提高生物利用度和靶向性等优势, 但其临床转化仍面临生产工艺优化、材料创新及个性化治疗等挑战。未来可进一步优化及验证工艺的简洁与安全性, 以有效地推动其临床转化; 同时开发智能凝胶材料, 以实现更精准的药物释放调控; 从患者顺应性角度考虑, 个性化治疗方案仍是一个实施难度较大的方案。尽管面临以上困难, 但跨学科合作、药用材料发展必将加速凝胶剂在UC治疗中的突破, 为患者提供更安全、高效的全新治疗策略。

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2025年第60卷第6期
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doi: 10.16438/j.0513-4870.2024-1278
  • 接收时间：2024-12-25
  • 首发时间：2026-09-20
  • 出版时间：2025-06-12
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  • 收稿日期：2024-12-25
  • 修回日期：2025-04-14
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    西南交通大学生命科学与工程学院, 四川 成都 610031

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2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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