The objective of this research is to assess the mean time of resolution of diarrhea in pediatric patients receiving different intervention combinations for the management of acute diarrhea. Specifically, the study aims to compare the effectiveness of four intervention groups: Group 1 receiving zinc and probiotic supplementation, Group 2 receiving zinc, probiotic, and prebiotics. Group 3 receiving zinc, probiotics, and anti-secretory agents, and Group 4 receiving zinc, probiotic, anti-secretory agents, and adsorbents. The primary outcome measure will be the mean time from the initiation of treatment to the resolution of diarrhea symptoms. This objective seeks to provide evidence-based insights into the optimal management strategies for childhood diarrhea and inform clinical practice guidelines.

开始日期2024-09-15

申办/合作机构-

ChiCTR2300078918 / RecruitingIIT

Prospective study of gold bifidum combined with montmorillonite powder in perioperative intestinal mucosal barrier protection in patients with colorectal cancer

开始日期2024-01-01

申办/合作机构-

ChiCTR2400091329 / RecruitingN/AIIT

The Safety, Tolerability, and Efficacy of Smectite in Children with Attention-Deficit/Hyperactivity Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

开始日期2023-10-25

申办/合作机构

西京医院第四军医大学

100 项与蒙脱石相关的临床结果

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100 项与蒙脱石相关的转化医学

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100 项与蒙脱石相关的专利（医药）

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754

项与蒙脱石相关的文献（医药）

2024-12-01·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Montmorillonite restricts free fatty acid liberation and alters self-assembled structures formed during in vitro lipid digestion

Article

作者: Salim, Malinda ; Joyce, Paul ; Prestidge, Clive ; Boyd, Ben J ; Ariaee, Amin

The global rise in obesity necessitates innovative weight loss strategies. Naturally occurring smectite clays, such as montmorillonite (MMT), offer promise due to their unique properties that interfere with free fatty acid (FFA) liberation, reducing systemic uptake. However, the mechanisms of MMT-FFA interactions and their implications for weight management are undefined. This study investigates these interactions by adding MMT (10 % w/w) to in vitro lipolysis media containing medium chain triglycerides (MCTs), and monitoring FFA liberation using pH-stat titration. Nanoparticle tracking analysis (NTA) and synchrotron-based small-angle X-ray scattering (sSAXS) observed time-dependent structural changes, while electron microscopy examined clay morphology during digestion. A 35 % reduction in FFA liberation occurred after 25 min of digestion with MCT + MMT, with digestion kinetics following a biphasic model driven by calcium soap formation. NTA revealed a 17-fold decrease in vesicular structures with MCT + MMT, and sSAXS highlighted a rapid lamellar phase evolution linked to calcium soap formation. This acceleration is attributed to MMT's adsorption to unionized FFAs via hydrogen bonding, supported by TEM images showing a decrease in d-spacing, indicating FFA intercalation is not the main adsorption mechanism. These findings highlight MMT's potential as a novel intervention for reducing dietary lipid absorption in obesity and metabolic diseases.

2024-12-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Spectroscopic study on volasertib: Highly stable complexes with albumin and encapsulation into alginate/montmorillonite bionanocomposites

Article

作者: Darder, Margarita ; Albaladejo, José ; Herrera-Ochoa, Diego ; Fernández-Sainz, Jesús ; Pacheco-Liñán, Pedro J ; Garzón-Ruiz, Andrés ; Bravo, Iván

In the present work, we study different physicochemical properties related to LADME processes of volasertib, a Polo-like kinase 1 inhibitor in advanced clinical trials. Firstly, the protonation equilibria, the extent of ionization at the physiological pH and pK_a values of this drug are studied combining spectroscopic techniques and computational calculations. Secondly, the binding process of volasertib to the human serum albumin (HSA) protein is analyzed by fluorescence spectroscopy. We report a high binding constant to HSA (K_a = 4.10 × 10⁶ M^-1) and their pharmacokinetic implications are discussed accordingly. The negative enthalpy and entropy (ΔH⁰ = -54.49 kJ/mol; ΔS⁰ = -58.90 J K^-1 mol^-1) determined for the binding process suggests the implication of hydrogen bonds and van der Waals interactions in the formation of the HSA-volasertib complex. Additionally, volasertib is encapsulated in an alginate/montmorillonite bionanocomposite as a proof of concept for an oral delivery nanocarrier. The physical properties of that nanocomposite as well as volasertib delivery kinetics are analyzed.

2024-12-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Self-gelling, tunable adhesion, antibacterial and biocompatible quaternized cellulose/tannic acid/polyethylene glycol/montmorillonite composite powder for quick hemostasis

Article

作者: Hu, Junjie ; Kang, Min ; Liu, Xuanyu ; Wei, Yan ; Bai, Miaomiao ; Huang, Di ; Hu, Yinchun

Hemostatic powders are widely used in incompressible or irregularly shaped bleeding wounds, but traditional hemostatic powders exhibit low adhesion, unsatisfactory hemostatic effect, limited infection control, and are not suitable for clinical or emergency situations. This study developed a novel self-gelling hemostatic powder (QTPM) consisting of quaternized cellulose (QC)/ tannic acid (TA)/ polyethylene glycol (PEG)/ montmorillonite (MMT). QTPM could absorb interfacial liquid hydrating to a stable hydrogel which form a switchable adhesion to tissues. Moreover, QTPM exhibits excellent antibacterial property by the synergistic effect of QC and TA. Furthermore, QTPM directly activate intrinsic and extrinsic coagulation hemostatic pathways to enhance hemostasis, and it concentrate coagulation factors. In vivo hemostasis study results show that QTPM significantly accelerated hemostasis and reduced blood loss compared with the blank group (>75 % reduction in hemostatic time, >85 % reduction in blood loss) in liver bleeding model (hemostasis time of 71.67 ± 7.09 s, blood loss of 19.23 ± 2.60 mg) and tail amputation model (hemostasis time of 91.03 ± 12.05 s, blood loss of 15.24 ± 1.77 mg). Therefore, the advantages of QTPM including rapid and effective hemostasis, easy usage, easy storability and adaptability make it a potential biomaterial for rapid hemostasis direction in the clinical setting.

项与蒙脱石相关的新闻（医药）

2024-07-28

·罗欣药业

罗欣药业注射用头孢哌酮钠舒巴坦钠、蒙脱石散通过仿制药质量和疗效一致性评价

近日，罗欣药业集团股份有限公司（股票代码：002793.SZ，以下简称“罗欣药业”）旗下注射用头孢哌酮钠舒巴坦钠（2.0g）、蒙脱石散（3g、2g、1g）两款产品顺利通过仿制药质量和疗效一致性评价。截止目前，罗欣药业已有24款药物通过仿制药质量和疗效一致性评价。头孢哌酮/舒巴坦的抗菌成分头孢哌酮为第三代头孢菌素，其通过在细菌繁殖期抑制敏感细菌细胞壁粘肽的生物合成而达到杀菌作用。头孢哌酮/舒巴坦复方制剂对所有对头孢哌酮敏感的细菌均具有抗菌活性。另外它对多种细菌，特别是下列细菌均表现出协同抗菌作用，例如：流感嗜血杆菌、拟杆菌属、葡萄球菌属、醋酸钙不动杆菌等。在体外试验中，头孢哌酮/舒巴坦对临床许多重要致病菌具有抗菌活性，例如：革兰阳性菌、革兰阴性菌、厌氧菌。蒙脱石散用于成人急、慢性腹泻，儿童急性腹泻，为天然蒙脱石微粒粉剂，具有层纹状结构和非均匀性电荷分布，对消化道内的病毒、病菌及其产生的毒素、气体等有极强的固定、抑制作用，使其失去致病作用；此外对消化道黏膜还具有很强的覆盖保护能力，修复、提高黏膜屏障对攻击因子的防御功能，具有平衡正常菌群和局部止痛作用。此次两款产品顺利通过仿制药一致性评价，一方面有利于产品提高市场竞争力及占有率，同时也进一步表明罗欣药业在一致性评价产品的研究及仿制药开发领域已经积累了丰富的实践经验，为后续更多产品过评奠定基础。未来，罗欣药业将继续秉持“传递健康”理念，深入实施科技创新，关注未被满足的临床需求，持续推进高质量创新药品研发成果落地，为全球患者提供更多创新药物选择。

一致性评价

2024-07-27

·药融云

稳坐“销冠”宝座！超70亿大品种，罗欣迎来过评……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 7月24日，据NMPA官网最新公示，罗欣药业其下属子公司山东罗欣药业集团的注射用头孢哌酮钠舒巴坦钠一致性评价补充申请获批过评。此外，其下属子公司山东罗欣乐康制药的蒙脱石散一致性评价补充申请获批过评。截图来源：NMPA官网注射用头孢哌酮钠舒巴坦钠是一种高效抗感染复方制剂，有效防止头孢哌酮酶解，提升抗菌活性，并拓宽抗菌谱，展现出良好的协同效果。适用于敏感菌引发的多部位感染，包括呼吸道、泌尿道、腹腔及皮肤软组织等感染。据药融云数据库显示，该品种在2023年全国院内市场销售额超70亿元。截图来源：药融云全国医院销售数据库在全国院内销售规模超过千亿元的系统用抗感染药物（包括化学和生物药）市场中，注射用头孢哌酮钠舒巴坦钠持续稳坐“销冠”宝座。在2023年，该产品以9.03%的市场份额稳居榜首，进一步巩固了其销冠地位。截图来源：药融云全国医院销售数据库目前，注射用头孢哌酮钠舒巴坦钠有超过百家企业拥有生产批文。在众多竞争者中，仅山东罗欣药业、国药集团、湖南科伦制药、齐鲁安替制药、苏州二叶制药等18家企业通过一致性评价。值得一提的是，福安药业集团、苏州二叶制药、山东润泽制药、成都倍特药业、深圳立健药业、湖南科伦制药、齐鲁安替制药、海南合瑞制药以及苏州东瑞制药这9家药企的注射用头孢哌酮钠舒巴坦钠纳入8批集采。截图来源：药融云过评药品汇总数据库截止目前，罗欣药业（含子公司）有38个品种获批过评，今年以来仅注射用头孢哌酮钠舒巴坦钠、蒙脱石散2个品种获批过评。据药融云数据库显示，目前，国内共有45家药企拥有蒙脱石散批文，其中35家药企已过评。 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“报告”，获取数十篇药融云出品独家报告后台回复关键词“CSCO”，获取2023CSCO指南后台回复关键词“ASCO”，获取2023ASCO分癌种摘要后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复关键词“医保”，获取2022年医保目录联系我们，体验药融云更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击阅读原文，申请药融云企业版免费试用！

一致性评价ASCO会议

2024-07-26

·米内网

【市场】10亿大品种，罗欣过评了

精彩内容 7月25日，罗欣药业发布公告，其下属子公司山东罗欣乐康制药的蒙脱石散一致性评价补充申请获批过评。米内网数据显示，蒙脱石散在2023年中国三大终端六大市场（统计范围见文末）销售规模超过10亿元。此外，其下属子公司山东罗欣药业集团的注射用头孢哌酮钠舒巴坦钠2.0g规格一致性评价补充申请获批过评。蒙脱石散由IPSEN PHARMA研发，用于成人急、慢性腹泻，儿童急性腹泻。近年中国零售药店终端蒙脱石散销售情况（单位：亿元）来源：米内网格局数据库蒙脱石散在2023年中国三大终端六大市场销售规模超过10亿元，其中，院外市场（零售药店终端：城市实体药店+网上药店）是主力销售渠道，同比增长超过60%，是止泻药、肠道抗炎/抗感染药TOP2产品，法国益普生的市场份额最大。米内网数据显示，蒙脱石散有44家企业拥有生产批文，山东罗欣乐康制药、湖南方盛制药、扬子江药业集团等35家企业过评，暂无一致性评价补充申请在审，福建太平洋制药、四川依科制药等5家企业以仿制4类报产在审，获批后视同过评。罗欣药业消化系统及代谢药过评情况来源：米内网一致性评价数据库截至目前，罗欣药业在消化系统及代谢药领域已有11款产品通过/视同通过一致性评价。注射用奥美拉唑钠、奥美拉唑肠溶胶囊、艾司奥美拉唑镁肠溶片等4款产品在2023年中国三大终端六大市场均是10亿级别的大品种。资料来源：公司公告、米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

一致性评价

100 项与蒙脱石相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	蒙脱石	A07BC05	DB13654

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
腹痛	中国	浙江仟源海力生制药有限公司	1998-01-01
腹泻	法国	Ipsen SA	1975-01-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
水样腹泻	临床3期	马来西亚	Ipsen SA	2006-07-01
慢性腹泻	临床1期	荷兰	Ipsen SA	2016-08-01
慢性腹泻	临床1期	英国	Ipsen SA	2016-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03045926 (CTgov)	临床1期	慢性腹泻	35	Smecta	醖蓋獵積鏇憲夢築願鏇(憲糧齋襯糧窪鏇獵糧膚) = 鏇製醖繭壓鹽製壓鬱衊憲膚鑰構襯壓窪糧餘構 (襯憲餘齋製廠築選鑰鬱, 齋鹽鹽範窪遞齋壓鑰選 ~ 選獵構選簾鬱鏇鏇艱願) 更多	-	2019-03-11