Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes: A Pilot Randomized Clinical Study

This pilot 12-week randomized open-label study compares metformin and berberine in newly diagnosed type 2 diabetes patients stratified by the TCF7L2 (rs7903146) genotype (TT vs. CC). The primary goal is to assess changes in HbA1c between metformin and berberine treated groups within each genotype. Secondary outcomes include fasting and postprandial glucose, insulin levels, HOMA-IR, body weight/BMI, lipid profile and adverse events.
The central hypothesis is that berberine, through its additional effect on TCF7L2-linked pathways, will provide superior glycemic control in high-risk TT carriers compared to metformin, whereas both treatments will yield comparable results in CC carriers. By enrolling only TT and CC genotypes, this study aims to estimate effect sizes and feasibility, guiding a future, larger-scale trial on genotype-tailored diabetes therapies.

开始日期2025-07-01

申办/合作机构-

NCT05720299

/ RecruitingN/AIIT

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.

The Akkermania muciniphila may play an important role in the occurrence and development of Prediabetes. The purpose of this study was to evaluate the safety and efficacy of AKK in the treatment of Prediabetes among obese patients. In this study, a single center, randomized, double-blind, placebo-controlled design is adopted. 90 obese subjects with Prediabetes are included in this study, and are allocated to AKK group, BBR group, and placebo group at a ratio of 1:1:1. The study treatment lasts for 12 weeks. The changes of body fat, glucose metabolism, lipid metabolism indicators compared with the baseline at the end of the treatment will be analyzed. In addition, glucagon like peptide-1 (GLP-1) and inflammatory markers (hsCRP、TNF-α、IL-6、IL-8、IL-1β) in blood will be analyzed before and after treatment. The changes in fecal flora structure and the AKK bacteria also will be analyzed.

开始日期2025-03-12

申办/合作机构-

CTR20244648

/ Recruiting临床1期

小儿盐酸小檗碱无水吞服颗粒与盐酸小檗碱片在健康受试者中的相对生物利用度临床试验

主要目的：以昆明邦宇制药有限公司生产的小儿盐酸小檗碱无水吞服颗粒为受试制剂，以上海信谊天平药业有限公司持证，浙江前进药业有限公司生产的盐酸小檗碱片为对照药品，对比在中国健康成年受试者中空腹及餐后给药条件下人体内的吸收速度及吸收程度药代动力学特征，比较在健康成年人群中肠道排泄的差异。次要目的：观察评估空腹和餐后状态条件下单次口服受试制剂小儿盐酸小檗碱无水吞服颗粒和对照药品盐酸小檗碱片在中国健康受试者成年人群中的安全性。

开始日期2025-02-05

申办/合作机构

昆明邦宇制药有限公司

100 项与盐酸小檗碱相关的临床结果

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100 项与盐酸小檗碱相关的转化医学

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100 项与盐酸小檗碱相关的专利（医药）

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13,102

项与盐酸小檗碱相关的文献（医药）

2025-12-31·Gynecological Endocrinology

Study on the mechanism of action of berberine combined with Jianpi Yishen Huazhuo formulation in treating obese polycystic ovary syndrome by activating PI3K/AKT signaling pathway

Article

作者: Ji, Dejiang ; Ye, Gaxi ; Feng, Yahong ; Du, Cuizhong ; Ahmad, Aqsa ; Zhang, Xiaojing ; Zhang, Yan ; Liang, Lijun

OBJECTIVESThis study aims to investigate the effects and potential mechanisms of berberine in conjunction with Jianpi Yishen Huazhuo formulation (JPYSHZF) on obese rats that serve as a model for polycystic ovary syndrome (PCOS).METHODSLetrozole combined with high-fat diet (HFD) was used to establish an overweight PCOS rat model. After successful modeling, each intervention group was monitored for 28 d. An oral glucose tolerance test (OGTT) is performed to assess glucose metabolism. Enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of sex hormones and serum levels of gastrointestinal hormones in rats. Biochemical analyzers were used to assess blood lipid levels. The protein expression levels of p38, PI3K, GLUT4, and AKT in ovarian tissue were demonstrated using Western Blotting (WB). Real-time fluorescence quantitative PCR (RT-qPCR) was used to measure the mRNA expression levels of p38, PI3K, GLUT4 and AKT in the same tissue. The morphological changes of ovarian tissue were observed using Hematoxylin-eosin (HE).RESULTSTreatment with berberine in conjunction with JPYSHZF has been shown to reduce serum testosterone T and luteinizing hormone (LH) levels while increasing serum follicle-stimulating hormone (FSH) and E2 levels. This combination therapy also decreases the LH/FSH ratio and ameliorates polycystic ovary-like pathological changes in the ovaries of rats with PCOS. Additionally, this treatment decreases serum TC, TG, and LDL-c levels while increasing HDL-c levels. It also reduces levels of GLU and Ghrelin while enhancing levels of CCK, PYY, and GLP-1. Furthermore, the relative 6 of PI3K and AKT proteins, as well as the mRNA levels of PI3K, GLUT4, and AKT, were found to be increased.CONCLUSIONSBerberine combined with JPYSHZF can improve the sex hormone levels, ovarian function, glucose and lipid metabolism levels, and gastrointestinal hormone levels in obese PCOS rats by activating the PI3K/AKT signaling pathway, thereby playing a role in treating obese PCOS.

2025-12-01·Molecular Biology Reports

Synergistic inhibitory effect of atmospheric pressure plasma and berberine on non‑small cell lung cancer cells via inducing apoptosis

Article

作者: Ming, Huiyun ; Song, Wencheng ; Zhou, Han ; Dai, Haiming ; Lu, Tingting

BACKGROUNDNon-small cell lung cancer (NSCLC) is a type of lung cancer, the incidence and mortality rate have been high, and the use of monotherapy is easy to make patients develop tolerance. Atmospheric pressure plasma (APP) is an emerging technology for killing cancer cells in recent years, and combination of berberine (BBR) mechanism has not been fully elucidated for NSCLC. The article's primary goal is to investigate the effect of combination on NSCLC and its associated characterization.METHODS AND RESULTSAntiproliferative effects were detected by cell viability assay and colony formation, and flow cytometry analysis of apoptosis and cycling showed that the combination synergistically induced apoptosis. Then, extracellular reactive oxygen species (ROS)levels and DCFH-DA-based kits examined intracellular ROS levels, and their effects on mitochondrial membrane potential were measured. Study reveals that co-induced apoptosis is associated with ROS accumulation. Subsequently, Western blotting (WB) detected the expression of epidermal growth factor receptor (EGFR), and the important signaling pathway proteins Ras/ERK and AKT/mTOR. Results showed that it could downregulation of EGFR protein expression and inhibit of activation of ERK/AKT signaling pathways. Simultaneous wound healing assay and epithelial-to-mesenchymal transition (EMT) marker detection were performed for the assessment of migration and EMT ability of NSCLC cells. Combination therapy inhibited migration and EMT of NSCLC cells.CONCLUSIONThe results of this study show that the combination can synergistically induce apoptosis of NSCLC by regulating ROS production. EGFR downregulation and AKT/ERK signaling pathway inhibition are linked to the synergistic effect.

2025-09-01·Talanta

A novel quality evaluation strategy for natural medicines integrated with HPLC Euclidean quantitative fingerprinting, UV total fingerprint dissolution and in vitro antioxidant activity: A case study of Gegen Qinlian tablet

Article

作者: Hu, Yanlei ; Sun, Guoxiang ; Zhang, Liuwei ; Zhai, Manhuayun

A reliable quality control system is essential for ensuring the clinical efficacy and safety of medicines. However, past work on quality control of natural medicines has been focused mainly on the quantification of indicator components and the characteristic chemical fingerprint which provide qualitative information only and rarely provide quantitative information. Herein, a fusion of the Comprehensive Euclidean quantitative fingerprinting method (CEQFM) and multi-component quantification, on-line UV total dissolution methods based on the Dissolution-systematically quantitative fingerprint method (DSQFM) were developed for quality control of Gegen Qinlian tablets (GQTs). Furthermore, DPPH• was used to evaluate the antioxidant activity of GQTs and construct the spectrum-effect relationship. Based on these strategies, the 22 batches of GQTs were classified into six grades by CEQFM (0.898 ≤ S_m ≤ 0.986, 74.4 % ≤ P_E ≤ 149.7 %) and seven grades by DSQFM (0.978 ≤ S_m ≤ 1.000, 50.64 % ≤ P_m ≤ 142.3 %), and 8 active ingredients were quantified simultaneously, with the total contents of all the 8 components spanned from 66.47 to 120.40 mg/g. In the in vitro dissolution test, the dissolution curves of 10 batches of GQTs were very similar (S_m > 0.9, 70 %< P_m<130 %, f2>50). Furthermore, the spectrum-effect relationship was applied to screen out the potential antioxidant active components, such as puerarin, baicalein, baicalin, berberine hydrochloride, palmatine chloride, etc. This method can quickly evaluate the quality of GQTs from the aspects of quantitative fingerprinting, dissolution, multi-component, and antioxidant efficacy. The study provides a new approach to quality control and quality consistency evaluation of natural medicines.

项与盐酸小檗碱相关的新闻（医药）

2025-04-29

·蒲公英Ouryao

6家药企7个品规被暂停采购

转自：上海阳光医药采购网编辑：水晶4月29日，上海市医药集中招标采购事务管理所发布通知，暂停6家药企7个品规药品的采购资格。7个品规药品：复合维生素B片、盐酸小檗碱片、马来酸氯苯那敏片(4个品规)、复方氨酚那敏颗粒。《通知》中没有明确说明被暂停采购的具体原因。各医药机构、药品生产企业：药事所根据《国家医疗保障局办公室关于全国药品挂网价格一览表复核应用的通知》(医保办函〔2025〕4号)文件精神，暂停江西杏林白马药业股份有限公司生产的复合维生素B片等采购资格，详见下表。上海市医药集中招标采购事务管理所2025年4月28日

带量采购

2025-04-25

·君圣泰

政企同行 · 创新发展｜深圳福田区政协领导带队参访君圣泰医药

NEWS近日，深圳市福田区政协领导组织无锡市滨湖区政协及多位当地企业开展联动交流活动，旨在促进地区间高质量协同发展，实地考察区域创新生态与企业发展实践。君圣泰医药作为深圳高新技术企业代表之一，受邀接待本次考察团。图片来源：君圣泰官方拍摄君圣泰医药是中国创新药领域的先行者之一，是港股18A创新药上市企业中的“深圳第一家”。公司建立起从源头创新到全球开发的完整体系，考察团一行走进君圣泰医药，深入了解中国创新药企业在原研药物开发、国际化临床试验等方面的经验。从中国到世界，中国原创药如何走出新路径公司代表向考察团一行介绍君圣泰医药的全球化发展战略，君圣泰医药立足中国，通过国际化团队和全球智库的支持，在多个国家同步推进临床试验，并多次在国际大会上发布研究进展，获权威专家和同行的广泛关注。核心产品——熊去氧胆酸小檗碱（HTD1801）正是在这一模式下开发的新药，是基于天然产物小檗碱和熊去氧胆酸，构建的全球首个以传统中药活性组分为基础的中国原创的创新分子实体。图片来源：君圣泰官方拍摄考察团强调，当前，“中国药”正加速走出国门，向世界展现东方智慧与科技创新的融合成果。HTD1801正是一款真正意义上由中国原创、走向世界的创新药物，且具有中西合璧的独特属性，它是以现代药物开发理念发掘中国传统医药宝库、将中国传统医药价值“说清楚、讲明白”的样本案例。考察团表示，HTD1801这样一个极具中国特色与文化的原创药物，能在全球多个国家开展临床试验，这不仅展示了中国新药研发的国际化水准，也为国内企业探索“在中国研发、在全球验证、向全球申报”的新路径提供了现实样本。HTD1801有机会成为继青蒿素之后又一个“中国药·世界药”的中国原创典范。参访过程中，多位政协委员对君圣泰医药能够结合本土研发与全球验证的能力表示关注，也就政策如何更好支持此类“走出去”的创新企业展开交流。“治标”更“治本”，是全球代谢病患者综合获益方案的提供者在向考察团详细介绍HTD1801的创新临床成果后，考察团了解到，围绕代谢类疾病这一全球公共健康挑战，君圣泰医药的创新不止于在分子层面的研发，更体现在对疾病谱的拓展上，以“标本兼治、深求治愈”这一DeepCure理念为目标，直指糖脂代谢紊乱、肝脏疾病、心血管病变、慢性炎症等病理网络的交织地带。HTD1801的临床疗效不仅限于降糖降脂，还同时具备抗炎、护肝、改善心血管代谢的多重作用，实现了“一个药，多靶点，多效用”的开发与治疗理念。这种理念的背后，是君圣泰医药对患者整体健康状况的深刻关切，是致力于为全球代谢病患者提供中国解决方案的初衷。在考察团看来，真正具有前瞻性的药物研发，应当从患者的整体福祉出发，回应复杂疾病背后的系统性问题。正是这一坚持，使得君圣泰医药在多项国际临床试验中展现出积极信号，获得国际权威认可，也为未来构建更为成熟的综合治疗模式打下基础。政企联动，共促发展——合力铺就创新快车道此次政协领导及企业家代表的走访，既是一次了解企业真实发展状况的务实之行，也是一场关于科技、产业与政策融合发展的对话。政协委员纷纷表示，像君圣泰医药这样立足本土、面向全球的企业，是深圳“科技创新+产业发展”深度融合的缩影。未来，政协将继续发挥桥梁纽带作用，链接政策、资源与企业，推动区域科技成果加速转化、创新链条更加通畅。关于君圣泰医药君圣泰医药（股票代码：2511.HK）是一家全球一体化的新型生物技术公司，专注代谢性疾病领域的重大未满足临床需求。以“标本兼治、深求治愈”这一DeepCure理念为目标，立足源头创新，开发First-in-Class的原创新药，以期为全球患者提供基于中国智慧的，安全、有效、综合获益的解决方案。基于自主知识产权，公司已构建丰富产品管线，在全球推进多项中、后期临床试验，开发代谢相关脂肪性肝炎（MASH）、2型糖尿病（T2DM）、严重高甘油三酯血症（SHTG）和原发性硬化性胆管炎（PSC）等适应症。作为同类首创的多靶点新分子实体，熊去氧胆小檗碱（HTD1801）被美国FDA授予2项“快速通道资格认定”、1项“孤儿药资格认定”，并获得国家“十三五•重大新药创制”科技重大专项支持。欲知更多资讯，敬请访问 www.hightidetx.com垂询 pr@hightidetx.comEND扫码关注君圣泰医药以不断追求患者的整体最佳获益为使命

医药出海

2025-04-23

·药时空

GLP-1：从肠道激素到多面 “药王” 的逆袭之路

1、GLP-1 概述：GLP-1 是肠道 L 细胞分泌的激素，能调节代谢，维持血糖稳定，还可控制饥饿感和促进饱腹感。基于其作用开发的 GLP-1 受体激动剂（GLP-1RAs）在治疗慢性疾病方面意义重大。 2、生理作用：GLP-1 与 GLP-1R 结合，调节胰腺内分泌功能，还在肠道、肌肉、脂肪、肝脏、肾脏和心血管等器官系统发挥作用，如调节营养吸收、促进脂肪分解、保护肾脏和心脏等。 3、分子机制：GLP-1RAs 通过激活 ERK1/2、AMPK、cAMP、MAPK 和 PKC 等信号通路，促进胰岛素分泌、调节胰高血糖素分泌、参与炎症调节和细胞功能调控。 4、在相关疾病中的作用糖尿病与肥胖：GLP-1RAs 促进胰岛素分泌、增强胰岛素敏感性、延缓胃排空，有助于控制血糖、减轻体重，还能降低心血管疾病风险。其他疾病：在心血管疾病中，GLP-1R 激活可改善心脏功能；对神经系统疾病，能减轻神经炎症；在癌症方面，其作用存在争议，影响因癌种而异。 5、miRNAs 的调节作用：miRNAs 参与调节基因表达，与糖尿病和肥胖相关。多种 miRNAs 如 miR-7、miR-204 等，可靶向不同基因，影响 GLP-1R 的表达和功能，进而调节胰岛素分泌、胆固醇代谢等。 6、天然产物的调节：许多天然产物（如黄连素、姜黄素）可调节 GLP-1 的表达和分泌，来源广泛、安全性高，有望成为替代 GLP-1RAs 的治疗选择。 7、替代疗法及进展：GLP-1RAs 分短效和长效制剂，各有特点和副作用。新型长效制剂（如 EX-LAR、PEX-168）可减少注射频率和副作用。GIPR/GLP-1R 双激动剂和 GIPR/GLP-1R/GCGR 三激动剂等多靶点药物也在研发中，潜力较大。 8、未来展望与挑战：未来需深入研究 GLP-1RAs 与 miRNA 等的相互作用，明确长期安全性和潜在副作用，探索新应用领域，优化药物设计并制定个性化治疗方案。

100 项与盐酸小檗碱相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01250	盐酸小檗碱	J	-

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
腹泻	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1994-07-01
肠道感染	中国	华中药业股份有限公司	1981-01-01
感染	-	-	-

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	临床2期	中国	中国医学科学院医药生物技术研究所	2017-03-22
2型糖尿病	临床2期	中国	东北制药集团股份有限公司	2017-03-22
2型糖尿病	临床2期	中国	中国医学科学院	2017-03-22
家族性高乳糜微粒血症综合征	临床2期	中国	东北制药集团股份有限公司	2017-03-22
家族性高乳糜微粒血症综合征	临床2期	中国	中国医学科学院医药生物技术研究所	2017-03-22
高脂血症	临床2期	中国	中国医学科学院	2017-03-22
IV型高脂蛋白血症	临床2期	中国	东北制药集团股份有限公司	2017-03-22
IV型高脂蛋白血症	临床2期	中国	中国医学科学院医药生物技术研究所	2017-03-22
原发性高脂血症	临床2期	中国	中国医学科学院医药生物技术研究所	2017-03-22
原发性高脂血症	临床2期	中国	东北制药集团股份有限公司	2017-03-22

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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


NCT03909763 (CTgov)	临床2期	免疫性血小板减少症	55	Berberine+danazol	鬱鬱艱衊範鏇網遞餘範(糧膚窪選顧獵鬱襯餘遞) = 糧遞鹹窪選鏇鬱憲簾鏇積夢齋衊獵壓遞簾糧艱 (蓋獵鬱鑰淵構餘願簾簾, 範積鑰廠顧餘構醖膚網 ~ 餘築觸觸範簾蓋壓鬱築) 更多	-	2020-09-25