[Translation] A single-center, open-label, single-arm study evaluating the drug-drug interactions of fluvoxamine and rifampicin on succinylcholine tablets in healthy adult Chinese volunteers

主要目的：（1）评价琥珀八氢氨吖啶片单独使用和与氟伏沙明合用时在中国成年健康受试者中的药代动力学特征；（2）评价琥珀八氢氨吖啶片单独使用和与利福平合用时在中国成年健康受试者中的药代动力学特征。次要目的：（1）评价琥珀八氢氨吖啶片单独使用和与氟伏沙明合用时在中国成年健康受试者中的安全性和耐受性特征；（2）评价琥珀八氢氨吖啶片单独使用和与利福平合用时在中国成年健康受试者中的安全性和耐受性特征。

[Translation]

Primary objectives: (1) To evaluate the pharmacokinetic characteristics of succinic acid tablets when used alone and in combination with fluvoxamine in healthy adult Chinese subjects; (2) To evaluate the pharmacokinetic characteristics of succinic acid tablets when used alone and in combination with rifampicin in healthy adult Chinese subjects. Secondary objectives: (1) To evaluate the safety and tolerability characteristics of succinic acid tablets when used alone and in combination with fluvoxamine in healthy adult Chinese subjects; (2) To evaluate the safety and tolerability characteristics of succinic acid tablets when used alone and in combination with rifampicin in healthy adult Chinese subjects.

Start Date26 Sep 2022

Sponsor / Collaborator

Changchun Huayang High-Tech Co., Ltd.

[+1]

CTR20202210 / CompletedPhase 1

[14C]琥珀八氢氨吖啶在中国成年男性健康志愿者体内吸收、代谢和排泄临床试验——[14C]琥珀八氢氨吖啶人体物质平衡与生物转化研究临床试验

[Translation] Clinical trial on the absorption, metabolism and excretion of [14C] succinic octahydroaminoacridine in healthy adult male volunteers in China——Clinical trial on the material balance and biotransformation of [14C] succinic octahydroaminoacridine in humans

主要目的：评价中国男性健康志愿者单次口服[14C]琥珀八氢氨吖啶的物质平衡及生物转化途径。次要目的：评价琥珀八氢氨吖啶在人体内的药代动力学整体特征及安全性。

[Translation]

Primary objective: To evaluate the material balance and biotransformation pathway of [14C] succinic acid octahydrogenacridine after a single oral administration in healthy Chinese male volunteers. Secondary objective: To evaluate the overall pharmacokinetic characteristics and safety of succinic acid octahydrogenacridine in humans.

Start Date23 Nov 2020

Sponsor / Collaborator

Changchun Huayang High-Tech Co., Ltd.

[+1]

CTR20200956 / Completed

单中心、随机、双盲、安慰剂对照的评估健康成人单次口服琥珀八氢氨吖啶片4 mg及12 mg对QT间期延长的影响

[Translation] A single-center, randomized, double-blind, placebo-controlled study evaluating the effects of a single oral dose of 4 mg and 12 mg succinylcholine on QT interval prolongation in healthy adults

主要目的：评估中国成年健康志愿者单次口服琥珀八氢氨吖啶片4 mg及12 mg对QT间期延长的影响。次要目的：评估单次口服琥珀八氢氨吖啶片4 mg及12 mg情况下，血药浓度与QTc间期变化的关系；药代动力学（PK）特征；受试者的耐受性；如有主要代谢产物将评价其对QT间期延长的影响。

[Translation]

Primary objective: To evaluate the effect of a single oral administration of 4 mg and 12 mg of succinic acid tablets on QTc prolongation in healthy adult Chinese volunteers. Secondary objectives: To evaluate the relationship between blood drug concentration and QTc interval changes after a single oral administration of 4 mg and 12 mg of succinic acid tablets; pharmacokinetic (PK) characteristics; tolerability of subjects; if there are major metabolites, their effects on QTc prolongation will be evaluated.

Start Date06 Aug 2020

Sponsor / Collaborator

Changchun Huayang High-Tech Co., Ltd.

[+1]

100 Clinical Results associated with Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd.

0 Patents (Medical) associated with Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd.

Literatures (Medical) associated with Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd.

01 Jun 2022·Journal of Ethnopharmacology

Comparative and mechanistic study of pharmacodynamic difference in anti-breast cancer activity between water and liquor extracts of Xiaojin Pills

Article

Author: Cao, Bo ; Li, Chunyu ; Xu, Hong ; Xu, Runchun ; Han, Li ; Lin, Junzhi ; Liu, Huimin ; Zhang, Dingkun

ETHNOPHARMACOLOGICAL RELEVANCEXiaojin Pills was first recorded during the Qing Dynasty and have a history of nearly 300 years. It is the first choice among Chinese patent medicines for the clinical treatment of diseases of the mammary glands in contemporary traditional Chinese medicine. It was also widely used in the treatment of breast cancer, lung cancer, thyroid cancer, and other malignant tumors. Its initial administration method was "taken orally after soaking with Chinese baijiu"; however, the method was changed to "taken orally with water" within the last 40 years. There is no scientific evidence for the difference in efficacy against breast cancer between the two methods of administration.AIM OF THE STUDYIn vitro and in vivo experiments were carried out to confirm the therapeutic advantages of the liquor extract of Xiaojin Pills to improve the efficacy against breast cancer, and the mechanism was explained in terms of metabolomics and molecular biology.MATERIALS AND METHODSIn vitro, a cell counting kit-8 cell activity assay and flow cytometry were used to detect the activity and apoptosis of MCF-7 breast cancer cells. In vivo, pharmacodynamic evaluation was performed by constructing a heterotopic transplantation model of breast cancer in BALB/c-nu mice. TUNEL staining was used to observe the apoptosis of cells in tumor tissues. The expression of proteins associated with the phosphoinositide 3-kinase (PI3K)/Akt pathway in BALB/c-nu mice tissue was investigated by metabolomics analysis, immunohistochemistry and western blotting.RESULTSCCK-8 assay showed that the IC₅₀ of XJP-L for the inhibition of the activity of MCF-7 cells was less than that of XJP-W at different times. Flow cytometry assay suggested that the apoptosis rate in the XJP-L group was higher than that in the normal control group (p < 0.01). Animal experiment results indicated that both XJP-W group and XJP-L group reduced the volume and quality of the tumor after administration, and the reduction was more significant in the XJP-L group (p < 0.01). Metabolomics analysis results demonstrated that there are about 26 different metabolites have been screened in the serum metabolites between the liquor and water extract, mainly involved in glycerophospholipid, glutamic acid, aspartic acid, nitrogen and pyrimidine metabolism. In addition, immunohistochemistry and WB results showed that compared with the model group, the protein expression of PTEN, AKT, BAX and in tumor tissues of XJP-L and XJP-W groups both exhibited an upward trend, while the expression of BCL-2, p-PI3K and p-AKT exhibited a downward trend, which was much more obvious in XJP-L group.CONCLUSIONSThis study demonstrates that the liquor extract of Xiaojin Pills had a stronger anti-breast cancer effect than that of the water extract. The PI3K/Akt signaling pathway might play an important role in the mechanism of the liquor extract of Xiaojin Pills and thus improve the efficacy against breast cancer.

01 Jan 2022·Journal of EthnopharmacologyQ2 · MEDICINE

Fengshi Qutong capsule ameliorates bone destruction of experimental rheumatoid arthritis by inhibiting osteoclastogenesis

Q2 · MEDICINE

Article

Author: Su, Xiaohui ; Miao, Yandong ; Li, Yiqun ; Yang, Chao ; Jia, Kexin ; Jing, Yu ; Ming, Ruirui ; Liu, Chunfang ; Xu, Tengteng ; Wang, Jinxia ; Lin, Na ; Wang, Jingxia

ETHNOPHARMACOLOGICAL RELEVANCEBone destruction plays a key role in damaging the joint function of rheumatoid arthritis (RA). Fengshi Qutong capsule (FSQTC) consisting of 19 traditional Chinese medicines has been used for treating RA in China for many years. Preliminary studies show that FSQTC has analgesic activity and inhibits synovial angiogenesis of collagen-induced arthritis (CIA), but its role on bone destruction of RA is still unclear.AIM OF THE STUDYTo explore the effect of FSQTC on bone destruction of RA and the possible mechanism of osteoclastogenesis in vivo and in vitro.MATERIALS AND METHODSLC-MS system was used to detect the quality control components of FSQTC. The anti-arthritic effect of FSQTC on CIA rats was evaluated by arthritis score, arthritis incidence and histopathology evaluation of inflamed joints. The effect of treatment with FSQTC on bone destruction of joint tissues was determined with X-ray and micro-CT quantification, and on bone resorption marker CTX-I and formation marker osteocalcin in sera were detected by ELISA. Then, osteoclast differentiation and mature were evaluated by TRAP staining, actin ring immunofluorescence and bone resorption assay both in joints and RANKL-induced RAW264.7 cells. In addition, RANKL, OPG, IL-1β and TNFα in sera were evaluated by ELISA. The molecular mechanisms of the inhibitions were elucidated by analyzing the protein and gene expression of osteoclastic markers CTSK, MMP-9 and β3-Integrin, transcriptional factors c-Fos and NFATc1, as well as phosphorylation of ERK1/2, JNK and P38 in joints and in RANKL-induced RAW264.7 cells using western blot and/or qPCR.RESULTSIn this study, 12 major quality control components were identified. Our data showed that FSQTC significantly increased bone mineral density, volume fraction, trabecular thickness, and decreased trabecular separation of inflamed joints both at periarticular and extra-articular locations in CIA rats. FSQTC also diminished the level of CTX-I and simultaneously increased osteocalcin in sera of CIA rats. The effects were accompanied by reductions of osteoclast differentiation, bone resorption, and expression of osteoclastic markers (CTSK, MMP-9 and β3-Integrin) in joints. Interestingly, FSQTC treatment could reduce the protein level of RANKL, increase the expression of OPG, and decrease the ratio of RANKL to OPG in inflamed joints and sera of CIA rats. In addition, FSQTC inhibited the levels of pro-inflammatory cytokines implicated in bone resorption, such as IL-1β and TNFα in sera. When RAW264.7 cells were treated with RANKL, FSQTC inhibited the formation of TRAP + multinucleated cells, actin ring and the bone-resorbing activity in dose-dependent manners. Furthermore, FSQTC reduced the RANKL-induced expression of osteoclastic genes and proteins and transcriptional factors (c-Fos and NFATc1), as well as phosphorylation of mitogen-activated protein kinases (MAPKs).CONCLUSIONFSQTC may inhibit bone destruction of RA by its anti-osteoclastogenic activity both in vivo and in vitro.

01 Oct 2021·Journal of EthnopharmacologyQ2 · MEDICINE

Comparative study on the pharmacodynamic difference of oral administration of Xiaojin Pills accompanied with Chinese Baijiu and water

Q2 · MEDICINE

Article

Author: Lin, Junzhi ; Xu, Runchun ; Song, Jiao ; Qiu, Min ; Zhang, Dingkun ; Cao, Bo ; Ran, Fei ; Han, Li ; Xu, Hong ; Feng, Bi

ETHNOPHARMACOLOGICAL RELEVANCEXiaojin Pills is a classic prescription for the treatment of mammary glands hyperplasia with a history of nearly 300 years, and is also the first choice of Chinese patent medicine for the clinical treatment of mammary glands hyperplasia in contemporary traditional Chinese medicine clinic. Clinical and animal studies have shown that Xiaojin Pills has the effects of anti-mammary glands hyperplasia, promoting blood circulation, anti-inflammation and analgesia. However, its initial administration method was "taking orally after soaked with Chinese Baijiu", the modern method was changed to "taking orally with water" in recent 20 years. Whether there is any difference in the efficacy of the two administration methods is still unknown.AIM OF THE STUDYTo reveal the difference in efficacy and metabolic mechanism of anti-mammary gland hyperplasia between the oral administration of Xiaojin Pills accompanied with Chinese Baijiu (XJP&B) and water (XJP&W).MATERIALS AND METHODSCOX-2 inhibition rate test and anti-platelet aggregation activity test were used to investigate the efficacy difference between the 40 vol% Chinese Baijiu and water extracts of Xiaojin Pills on anti-inflammatory and blood-activating in vitro. Kunming male mice (20 ± 5 g) and SD female rats (200-220 g) were orally treated with XJP&B and XJP&W, respectively. Then the difference in anti-inflammatory and analgesic effects between XJP&B and XJP&W were evaluated via xylene-induced ear swelling test, formaldehyde-induced pain test, and acetic acid-induced writhing test in mice. Determination of nipple diameter, pathological examination of mammary gland tissue, determination of serum E₂, P and FSH content and hemorheological parameters of rats with mammary gland hyperplasia were performed to explore the efficacy difference in anti-mammary gland hyperplasia between XJP&B and XJP&W. Metabolomics was used to study the difference of anti-mammary gland hyperplasia mechanism between XJP&B and XJP&W.RESULTSThe results showed that the effect of XJP&B was superior to that of XJP&W in anti-platelet aggregation, inhibition of inflammation and pain, and anti-mammary gland hyperplasia. Interestingly, the advantages were more significant under low-dose condition. In addition, the mechanism of the two combinations against mammary gland hyperplasia was indeed different. Their common metabolic pathways include tryptophan metabolism and alanine, aspartic acid and glutamic acid metabolism. However, Chinese Baijiu and XJP&B also have additional regulatory effects on linoleic acid metabolic pathway.CONCLUSIONIn brief, this research demonstrated that the efficacy of XJP&B was better than that of XJP&W in activating the blood, anti-inflammation, analgesia and anti-mammary gland hyperplasia, which means that XJP&B has synergistic and superior effects. The special dose-effect relationship under the condition of XJP&B was also found, laying the foundation for clinical treatment to reduce the dosage and shorten the medication cycle, which is beneficial to reduce the economic burden of patients.

100 Deals associated with Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd.

100 Translational Medicine associated with Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd.

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Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

ZhuangGuShenJin	Spondylosis More	Approved
XiaoAiPing	Stomach Cancer More	Approved
ZhiMiKang	Trichomonas Vaginitis More	Approved
Qinwei Granules	Arthritis, Gouty More	NDA/BLA
Octahydroaminoacridine succinate ( AChE x BChE )	-	NDA/BLA

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