贯叶连翘提取物(Hypericum perforatum Extract)

概要

基本信息

药物类型

中药

别名

Jarsin、SJW、St. John's Wort extract

+ [4]

靶点-

作用机制-

治疗领域

心血管疾病泌尿生殖系统疾病其他疾病

在研适应症-

非在研适应症

经前综合征子宫出血血管舒缩症

原研机构

Herbarium Laboratório Botânico Ltda

在研机构-

非在研机构

Herbarium Laboratório Botânico Ltda

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

关联

21

项与贯叶连翘提取物相关的临床试验

NCT04558697 / Completed临床4期IIT

Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation

There are more and more herbal preparations that are used for the purpose of treatment and improvement of the clinical picture of vaginitis by patients themselves, but also by healthcare professionals. Plant species, St. John's wort, chamomile, calendula, yarrow, shepherd's purse and tea tree oil are well known for there anti-inflammatory, antimicrobial and wound healing activity. This paper presents the results of a clinical study in which three herbal formulations/vagitories, based on extracts of above mentioned plant species, were investigated for their effectiveness on non-specific vaginitis.
This was randomized controlled clinical study that included 210 women with diagnosed non-specific vaginitis. Patients were divided into two basic groups, women in reproductive stage and postmenopausal stage. Three subgroups, containing approximately 30 patients each, received one of three vagitorie formulations for 5 days during which the effects on subjective and objective symptoms were monitored.

开始日期2019-03-21

申办/合作机构

University of Sarajevo

[+1]

NCT03796377 / Completed临床1期

Effects of Hypericum Perforatum (St. John's Wort) on the Pharmacokinetics and Pharmacodynamics of Rivaroxaban in Humans

Single-center, open-label, sequential treatment study to investigate the influence of the combined P-glycoprotein and CYP3A4 inducer hypericum perforatum on the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy volunteers.

开始日期2019-02-13

申办/合作机构

Insel Gruppe AG

[+1]

NCT03482817 / Unknown status临床1期

Drug Cocktail Interaction Study to Investigate the Effect of St. John's Wort Dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers

This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.

开始日期2018-02-05

申办/合作机构

Max Zeller Söhne AG

100 项与贯叶连翘提取物相关的临床结果

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100 项与贯叶连翘提取物相关的转化医学

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100 项与贯叶连翘提取物相关的专利（医药）

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228

项与贯叶连翘提取物相关的文献（医药）

2024-08-01·Clinical and Translational Science

Dose‐dependent induction of CYP3A activity by St. John's wort alone and in combination with rifampin

Article

作者: Hohmann, Nicolas ; Blank, Antje ; Mikus, Gerd ; Haefeli, Walter E. ; Friedrichs, Anna S. ; Burhenne, Jürgen

AbstractThe dose dependence of the effect of enzyme inducers and the effect of the combined administration of two inducers that exert their effect via the same induction pathway (pregnane X receptor) have not been well studied. Using oral midazolam microdoses (30 μg), we have investigated CYP3A4 induction by St. John's wort (SJW) in 11 healthy volunteers using low (300 mg/day containing 7.48 mg hyperforin), therapeutic (900 mg/day), and supratherapeutic doses of SJW (1800 mg/day) for 14 days. SJW was then co‐administered with rifampin (600 mg/day) for a further 7 days to evaluate the effect of the combined administration of two inducers. In addition, intravenous midazolam microdoses (10 μg) were administered before SJW, at SJW 1800 mg/day, and during administration of the two inducers to assess the hepatic contribution to total induction (semi‐simultaneous administration). Administration of SJW increased oral midazolam clearance 1.96‐fold (300 mg/day), 3.86‐fold (900 mg/day), and 5.62‐fold (1800 mg/day), and 17.5‐fold after the addition of rifampin. Concurrently, the clearance of intravenous midazolam increased 2.05‐fold (1800 mg/day) and 2.93‐fold (SJW + rifampin). These results show that rifampin significantly enhances the induction of the highest SJW doses both hepatically and overall and suggest that these metabolic effects occur predominantly in the gut. These findings also suggest that in drug interactions involving strong and moderate enzyme inducers, the perpetrator effects of the strong inducer are decisive for the interaction.

2024-05-01·Clinical and Translational Science

St. John's wort extract with a high hyperforin content does not induce P‐glycoprotein activity at the human blood–brain barrier

Article

作者: Bamminger, Karsten ; Bauer, Martin ; Jackwerth, Matthias ; Lozano, Irene Hernández ; Mairinger, Severin ; Weber, Maria ; Schindler, Natalie ; Jäger, Walter ; El Biali, Myriam ; Poschner, Stefan ; Wölfl-Duchek, Michael ; Tournier, Nicolas ; Rausch, Ivo ; Zeitlinger, Markus ; Langer, Oliver ; Nics, Lukas ; Hacker, Marcus

AbstractSt. John's wort (SJW) extract, a herbal medicine with antidepressant effects, is a potent inducer of intestinal and/or hepatic cytochrome P450 (CYP) enzymes and P‐glycoprotein (P‐gp), which can cause clinically relevant drug interactions. It is currently not known whether SJW can also induce P‐gp activity at the human blood–brain barrier (BBB), which may potentially lead to decreased brain exposure and efficacy of certain central nervous system (CNS)‐targeted P‐gp substrate drugs. In this study, we used a combination of positron emission tomography (PET) imaging and cocktail phenotyping to gain a comprehensive picture on the effect of SJW on central and peripheral P‐gp and CYP activities. Before and after treatment of healthy volunteers (n = 10) with SJW extract with a high hyperforin content (3–6%) for 12–19 days (1800 mg/day), the activity of P‐gp at the BBB was assessed by means of PET imaging with the P‐gp substrate [11C]metoclopramide and the activity of peripheral P‐gp and CYPs was assessed by administering a low‐dose phenotyping cocktail (caffeine, omeprazole, dextromethorphan, and midazolam or fexofenadine). SJW significantly increased peripheral P‐gp, CYP3A, and CYP2C19 activity. Conversely, no significant changes in the peripheral metabolism, brain distribution, and P‐gp‐mediated efflux of [11C]metoclopramide across the BBB were observed following the treatment with SJW extract. Our data suggest that SJW does not lead to significant P‐gp induction at the human BBB despite its ability to induce peripheral P‐gp and CYPs. Simultaneous intake of SJW with CNS‐targeted P‐gp substrate drugs is not expected to lead to P‐gp‐mediated drug interactions at the BBB.

2024-03-01·Clinical Pharmacology in Drug Development

Effect of Tacrolimus Formulation (Prolonged‐Release vs Immediate‐Release) on Its Susceptibility to Drug‐Drug Interactions with St. John's Wort

Article

作者: Sauter, Max ; Weiss, Johanna ; Czock, David ; Teegelbekkers, Anna ; Meid, Andreas D ; Blank, Antje ; Burhenne, Jürgen ; Haefeli, Walter E ; Gümüs, Katja S

AbstractTacrolimus is metabolized by cytochrome P450 3A (CYP3A) and is susceptible to interactions with the CYP3A and P‐glycoprotein inducer St. John's Wort (SJW). CYP3A isozymes are predominantly expressed in the small intestine and liver. Prolonged‐release tacrolimus (PR‐Tac) is largely absorbed in distal intestinal segments and is less susceptible to CYP3A inhibition. The effect of induction by SJW is unknown. In this randomized, crossover trial, 18 healthy volunteers received single oral tacrolimus doses (immediate‐release [IR]‐Tac or PR‐Tac, 5 mg each) alone and during induction by SJW. Concentrations were quantified using ultra‐high performance liquid chromatography coupled with tandem mass spectrometry and non‐compartmental pharmacokinetics were evaluated. SJW decreased IR‐Tac exposure (area under the concentration‐time curve) to 73% (95% confidence interval 60%‐88%) and maximum concentration (Cmax) to 61% (52%‐73%), and PR‐Tac exposure to 67% (55%‐81%) and Cmax to 69% (58%‐82%), with no statistical difference between the 2 formulations. The extent of interaction appeared to be less pronounced in volunteers with higher baseline CYP3A4 activity and in CYP3A5 expressors. In contrast to CYP3A inhibition, CYP3A induction by SJW showed a similar extent of interaction with both tacrolimus formulations. A higher metabolic baseline capacity appeared to attenuate the extent of induction by SJW.

100 项与贯叶连翘提取物相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	贯叶连翘提取物	-	DB13014

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
经前综合征	临床3期	巴西	Herbarium Laboratório Botânico Ltda	2012-03-01
子宫出血	临床3期	巴西	Herbarium Laboratório Botânico Ltda	2012-03-01
血管舒缩症	临床2期	巴西	Herbarium Laboratório Botânico Ltda	2012-03-01

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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


NCT00048815 (CTgov)	N/A	抑郁症 \| 抑郁	73	Citalopram (Citalopram)	蓋淵淵醖衊製襯夢淵壓(夢構構選網憲網淵襯鹽) = 鑰膚襯餘網餘鬱鹹餘鹹襯窪艱繭構鑰廠艱鏇鏇 (窪齋觸壓齋夢鬱壓齋積, 獵艱簾鑰顧鏇願選醖憲 ~ 簾餘壓鬱繭構觸鏇鑰觸) 更多	-	2018-05-11
				St. John's Wort (St. John's Wort)	蓋淵淵醖衊製襯夢淵壓(夢構構選網憲網淵襯鹽) = 鹽範選顧艱糧鹹鬱鹽艱襯窪艱繭構鑰廠艱鏇鏇 (窪齋觸壓齋夢鬱壓齋積, 繭顧壓構醖蓋鬱構範壓 ~ 鏇觸構網鏇艱獵憲蓋壓) 更多
NCT00110136 (CTgov)	临床2期	潮热 \| 乳腺癌	9	St. John's Wort	鏇觸鑰構壓鏇膚襯鑰窪(夢鹽廠鬱窪製醖衊鬱廠) = 遞遞鬱獵廠鹹築繭醖膚範築網醖選鑰廠齋顧廠 (餘鹹積構醖範醖築餘糧, 鹹襯獵簾鹽壓獵遞繭鏇 ~ 廠壓窪蓋糧鏇齋壓鑰襯) 更多	-	2014-12-29
EASD2012	N/A	-	-	St. John's Wort extract	鏇齋構鏇膚齋觸夢襯鹹(網鑰鏇願壓齋獵憲獵餘) = partially corrected the cytokine-induced unbalance between anti- and pro-apoptotic factors 鏇選願遞鹽簾範艱廠糧 (簾壓顧餘鏇襯淵觸遞選 ) 更多	积极	2012-10-04
				Hyperforin
NCT00587860 (CTgov)	临床2期	肠易激综合征	70	St. John's wort (St. John's Wort)	蓋醖顧淵鏇鹹夢餘觸鹽(餘製構膚網衊夢糧壓餘) = 遞鏇鹽艱艱製淵鹹壓遞願餘齋餘糧糧廠鑰顧選 (鏇醖築壓鑰鑰膚範糧觸, 簾製窪蓋遞夢夢窪觸願 ~ 鬱獵築簾淵繭獵餘鹹顧) 更多	-	2010-03-01
				Placebo (Placebo)	蓋醖顧淵鏇鹹夢餘觸鹽(餘製構膚網衊夢糧壓餘) = 醖獵艱獵窪廠憲壓醖積願餘齋餘糧糧廠鑰顧選 (鏇醖築壓鑰鑰膚範糧觸, 鹹衊糧鏇觸夢窪鹽夢鬱 ~ 醖鹽餘築網鏇觸憲壓蓋) 更多