人参次苷H滴丸(Ginsenoside h dripping pills) - 在研适应症：肝癌，非小细胞肺癌_专利_临床

概要

基本信息

药物类型

中药

别名-

靶点-

作用机制-

治疗领域

肿瘤消化系统疾病呼吸系统疾病

在研适应症

肝癌非小细胞肺癌

非在研适应症-

原研机构-

在研机构

山东绿叶天然药物研究开发有限公司

非在研机构

Tasly Pharmaceuticals, Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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关联

4

项与人参次苷H滴丸相关的临床试验

CTR20160561 / Recruiting临床2期

以安慰剂对照，中央随机、双盲、多中心方法评价*滴丸治疗晚期非小细胞肺癌(气虚证)有效性及安全性研究

初步评价人参次苷H滴丸治疗晚期非小细胞肺癌的有效性和安全性，并进行剂量探索

开始日期2016-07-29

申办/合作机构

山东绿叶天然药物研究开发有限公司

NCT02714608 / Unknown status临床2期

A PhaseⅡa, Placebo Parallel Control, Central Randomized, Double Blind, Dosage Exploring and Multi-Center Study to Evaluate the Efficacy and Safety of Ginsenoside H Dripping Pills in Patients With Advanced NSCLC (Syndrome Of Qi-Deficiency)

Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency) and explore the optimal dosage

开始日期2016-05-01

申办/合作机构

Tasly Pharmaceuticals, Inc.

CTR20132054 / Active, not recruiting临床2期

人参次苷H滴丸治疗晚期肝癌的开放、无对照、多中心的Ⅱa期临床试验

评价人参次苷H滴丸对于提高晚期肝癌患者生活质量的作用

开始日期2012-07-03

申办/合作机构

山东绿叶天然药物研究开发有限公司

100 项与人参次苷H滴丸相关的临床结果

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100 项与人参次苷H滴丸相关的转化医学

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100 项与人参次苷H滴丸相关的专利（医药）

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3

项与人参次苷H滴丸相关的文献（医药）

2021-06-01·Clinical Pharmacology in Drug Development

Pharmacokinetics of Ginsenoside Rh2, the Major Anticancer Ingredient of Ginsenoside H Dripping Pills, in Healthy Subjects

Article

作者: Qin, Yongping ; Liu, Rui ; Zhou, Mi ; Wang, Huanhuan ; Wang, Yongsheng ; Chen, Li ; Wang, Zhenlei

AbstractGinsenoside H dripping pill (GH) is a novel clinical‐stage adjuvant for the treatment of non‐small cell lung cancer. In this study, the pharmacokinetics of ginsenoside Rh2, the major anticancer ingredient of GH, was investigated in healthy volunteers. Enrolled volunteers were assigned to 3 cohorts—7.8, 15.6, and 31.2 mg—and received single and/or multiple GH orally. Blood samples were assayed by a validated bioanalytical method, and drug concentrations were analyzed using a noncompartmental methodology. The results showed that ginsenoside Rh2 was absorbed with medium speed and reached Cmax a median of 3 hours after administration. The exposure of ginsenoside Rh2 was approximately dose‐dependent in terms of AUC and Cmax. The plasma concentration of ginsenoside Rh2 reached steady state after oral administration of GH twice daily for 5 days. There was no obvious accumulation in exposure parameters in the multiple‐dose study.

2018-12-01·Biomedicine & Pharmacotherapy2区 · 医学

Combination of Ginsenoside H dripping pills and cyclophosphamide improve paraneoplastic syndrome and inhibit postoperative recurrence via the reversion of Th1/Th2 shift

2区 · 医学

Article

作者: Sun, Li ; Ma, Xiaohui ; Wang, Junyi ; Song, Zhaohui ; Yuan, Shengtao ; Li, Xinxin ; Chen, Fengfei

Non-small-cell lung cancer (NSCLC) is recognized as the most common malignant disease worldwide and combination treatment is recommended as its first line therapy. As a Ph2 clinical product, Ginsenoside H dripping pills (GH) is proposed as an adjuvant of chemotherapy. In the present study, we utilized a postoperative model to evaluate the efficacy of GH on the functions of anti-recurrence and improvement of life quality when combined with chemotherapeutic drug cyclophosphamide (CTX). Specifically, the anti-recurrence effect was evaluated by tumor inhibiting rate and the improvement of life quality was evaluated by the remission of splenomegaly and emaciation. The underlying mechanisms were explored via quantitative real time-PCR, Elisa and IHC staining. Results showed that GH had a synergy when combined with CTX against tumor recurrence, significantly improved the life quality of postoperative patients via remitting splenomegaly and emaciation. H&E staining showed that GH could increase the number of splenic T cells, which were inhibited after CTX administration. Furthermore, the reversion of Th1/Th2 shift, which had been verified by different methods, may account for one of the mechanisms of the synergy. All these results indicated Ginsenoside H dripping pills as a promising adjuvant for postoperative chemotherapy of NSCLC.

Frontiers in Pharmacology2区 · 医学

An Integrative Pharmacology-Based Pattern to Uncover the Pharmacological Mechanism of Ginsenoside H Dripping Pills in the Treatment of Depression

2区 · 医学

ArticleOA

作者: Yang, Wenjing ; Song, Zhaohui ; Ma, Xiaowei ; Zhang, Yu ; Lin, Yingxian ; Du, Wuxun ; Zhao, Libin ; Cao, Ningning ; Pei, Shuai ; Liu, Changxiao ; Xiao, Xuefeng ; Guo, Rui ; Li, Yingpeng

Objectives: To evaluate the pharmacodynamical effects and pharmacological mechanism of Ginsenoside H dripping pills (GH) in chronic unpredictable mild stress (CUMS) model rats.Methods: First, the CUMS-induced rat model was established to assess the anti-depressant effects of GH (28, 56, and 112 mg/kg) by the changes of the behavioral indexes (sucrose preference, crossing score, rearing score) and biochemical indexes (serotonin, dopamine, norepinephrine) in Hippocampus. Then, the components of GH were identified by ultra-performance liquid chromatography-iron trap-time of flight-mass spectrometry (UPLC/IT-TOF MS). After network pharmacology analysis, the active ingredients of GH were further screened out based on OB and DL, and the PPI network of putative targets of active ingredients of GH and depression candidate targets was established based on STRING database. The PPI network was analyzed topologically to obtain key targets, so as to predict the potential pharmacological mechanism of GH acting on depression. Finally, some major target proteins involved in the predictive signaling pathway were validated experimentally.Results: The establishment of CUMS depression model was successful and GH has antidepressant effects, and the middle dose of GH (56 mg/kg) showed the best inhibitory effects on rats with depressant-like behavior induced by CUMS. Twenty-eight chemical components of GH were identified by UPLC/IT-TOF MS. Subsequently, 20(S)-ginsenoside Rh2 was selected as active ingredient and the PPI network of the 43 putative targets of 20(S)-ginsenoside Rh2 containing in GH and the 230 depression candidate targets, was established based on STRING database, and 47 major targets were extracted. Further network pharmacological analysis indicated that the cAMP signaling pathway may be potential pharmacological mechanism regulated by GH acting on depression. Among the cAMP signaling pathway, the major target proteins, namely, cAMP, PKA, CREB, p-CREB, BDNF, were used to verify in the CUMS model rats. The results showed that GH could activate the cAMP-PKA-CREB-BDNF signaling pathway to exert antidepressant effects.Conclusions: An integrative pharmacology-based pattern was used to uncover that GH could increase the contents of DA, NE and 5-HT, activate cAMP-PKA-CREB-BDNF signaling pathway exert antidepressant effects.

100 项与人参次苷H滴丸相关的药物交易

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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
肝癌	临床2期	中国	山东绿叶天然药物研究开发有限公司	2012-07-03
非小细胞肺癌	临床2期	中国	山东绿叶天然药物研究开发有限公司	2012-06-21