主要目的：以保定天浩制药有限公司研发，杨凌步长制药有限公司生产的盐酸伐地那非片（20 mg）为受试制剂（T），以Bayer AG持证、生产的盐酸伐地那非片（Levitra®，20 mg）为参比制剂（R），评估健康研究参与者在空腹状态下单次口服受试制剂和参比制剂的药代动力学特征，评价两种制剂的人体生物等效性。次要目的：考察健康研究参与者口服受试制剂和参比制剂后的安全性。

开始日期2025-05-30

申办/合作机构

保定天浩制药有限公司

CTR20250722

/ Recruiting临床2/3期

评价BC003在急性失代偿性心力衰竭（ADHF）患者中的有效性及安全性的多中心、随机、盲法、阳性药对照的II/III期临床研究

II期——剂量探索阶段：（1）初步评价不同剂量BC003治疗急性失代偿性心力衰竭的有效性和安全性；（2）评价BC003在急性失代偿性心力衰竭（ADHF）患者中的PK特征及暴露-效应关系；（3）进一步探索给药剂量，为确证性阶段给药方案提供依据。 III期——确证性阶段：主要目的：评价BC003与硝酸甘油对比治疗急性失代偿性心力衰竭的有效性。次要目的：评价BC003治疗急性失代偿性心力衰竭的安全性。

开始日期2025-05-26

申办/合作机构

山东丹红制药有限公司

CTR20251412

/ Active, not recruitingN/A

甲苯磺酸索拉非尼片在健康研究参与者中的随机、开放、单剂量、两制剂、三周期、三序列部分重复交叉设计生物等效性研究

主要目的：以山东丹红制药有限公司研发，杨凌步长制药有限公司生产的甲苯磺酸索拉非尼片（0.2 g）为受试制剂（T），以 Bayer AG 持证的甲苯磺酸索拉非尼片（多吉美®，0.2 g）为参比制剂（R），评估健康研究参与者在空腹状态下单次口服受试制剂和参比制剂的药代动力学特征，评价两种制剂的人体生物等效性。次要目的：考察健康研究参与者口服受试制剂和参比制剂后的安全性。

开始日期2025-05-23

申办/合作机构

山东丹红制药有限公司

100 项与山东步长制药股份有限公司相关的临床结果

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0 项与山东步长制药股份有限公司相关的专利（医药）

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项与山东步长制药股份有限公司相关的文献（医药）

2025-09-02·Mitochondrial DNA Part B-Resources

The complete chloroplast genome of Gaillardia pulchella Foug. and its phylogenetic analysis

Article

作者: Yuan, Jicheng ; Li, Hongqin ; Wu, Guiyuan ; Wang, Liqiang

Gaillardia pulchella, an annual Asteraceae herb native to tropical America, is widely cultivated in China for its vibrant blooms and long flowering period. The species exhibited notable biological activities, including antioxidant and anti-inflammatory effects. We presented the first complete chloroplast genome of G. pulchella, spanning 151,778 bp with an overall GC content of 37.7%, and containing 128 genes (85 protein-coding genes, 35 tRNA genes, and eight rRNA genes). Phylogenetic analysis revealed its close relationship with Galinsoga parviflora, Tagetes erecta, and Flaveria bidentis. This study provided valuable genomic insights for evolutionary studies, and potential pharmaceutical applications of G. pulchella.

2025-07-01·PHYTOMEDICINE

Fuling Wenxin formula treats "Qi-Yin deficiency" arrhythmia by regulating the dilated cardiomyopathy and adrenergic signaling pathway in cardiomyocytes

Article

作者: Song, Zhong-Xing ; Liu, Yan-Ru ; Yang, Sheng-Ran ; Wang, Ming-Geng ; Tang, Zhi-Shu

BACKGROUND:

Arrhythmia, a common cardiac disorder, presents a considerable risk to human health, characterized by symptoms including palpitations and chest tightness, and may result in sudden cardiac death. The Fuling Wenxin Formula (FLWXF), an innovative compound originating from traditional Chinese medicine and consisting of various herbs known for their anti-arrhythmic properties, demonstrates an unclear mechanism of action.

OBJECTIVE:

This study aimed to examine the therapeutic effects of FLWXF on "Qi-Yin deficiency" arrhythmia and elucidate the underlying mechanisms involved.

METHODS:

The therapeutic effects of FLWXF were assessed using isoproterenol (ISO)-induced arrhythmia models and models indicative of "Qi-Yin deficiency." To elucidate the molecular mechanisms underlying the effects of FLWXF in "Qi-Yin deficiency" arrhythmia, proteomics and metabolomics techniques were used for predictive analysis, which was subsequently validated through reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and Western blotting.

RESULTS:

Our findings demonstrated that FLWXF could ameliorate electrical signal abnormalities, atypical serum indicators, and myocardial damage induced by ISO. Moreover, FLWXF effectively mitigated electrical signal irregularities and abnormal serum markers associated with "Qi-Yin deficiency" and exhibited therapeutic efficacy in treating "Qi-Yin deficiency" arrhythmia. We identified significant enrichment of dilated cardiomyopathy and adrenergic signaling pathways in cardiomyocytes through integrated proteomics and metabolomics analyses. Additionally, our study revealed that FLWXF can normalize the aberrant elevation of cyclic adenosine monophosphate levels. RT-qPCR and Western blotting assays validated that FLWXF restored the expression of genes and proteins associated with dilated cardiomyopathy and the adrenergic signaling pathway in cardiomyocytes, including ADRB1, GNAS, ADCY1, PKA, CACNA2D1, RYR2, TNNC1, TNNI3, TNNT2, TPM1, ACTC1, and MYL7.

CONCLUSION:

Our research indicates that FLWXF addresses "Qi-Yin deficiency" arrhythmia by modulating the adrenergic signaling pathway in dilated cardiomyopathy and cardiomyocytes. This study offers novel therapeutic options and empirical data to support the treatment of complex arrhythmia.

2024-02-01·Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan

Efficacy of Ganshuang granules on non-alcoholic fatty liver and underlying mechanism: a network pharmacology and experimental verification.

Article

作者: Dong, Wang ; Bingjie, Shao ; Guoguo, Zhi ; Tianyan, Zheng ; Jingwei, L I ; Yanni, Dang ; Shaoxiu, J I ; Feng, Liu

OBJECTIVE:

To investigate the potential pharmacological mechanisms of Ganshuang granules (, GSG) in treating non-alcoholic fatty liver (NAFLD).

METHODS:

All the active components and targets of GSG were retrieved from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform. Protein-Protein interaction network, Kyoto Encyclopedia of Genes and Genomes and Gene Ontology function annotation of common targets were analyzed to predict the mechanisms of action of GSG in the treatment of NAFLD. Then, the mouse models of NAFLD were constructed in a diet-induced manner and treated with GSG. The levels of interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and phosphatidylinositol 3-kinase/protein kinase B (PI3K/AKT) pathway-related proteins in the liver of mice in each group were measured by enzyme linked immunosorbent assay and Western blot, respectively.

RESULTS:

Network pharmacology revealed a total of 159 potential targets of GSG for the treatment of NAFLD. Functional enrichment analysis indicated that the PI3K/AKT signaling pathway may be involved during GSG treatment of NAFLD. Further experiments showed that the significantly decreased alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total cholesterol, triglyceride and low-density lipoprotein cholesterol levels in NAFLD model mice serum after GSG treatment, as well as the expression levels of IL-6 and TNF-α in the liver. Furthermore, drug intervention increased the protein expression levels of phosphorylated-PI3K (P-PI3K) and P-AKT in the liver of the model group mice, and decreased the protein expression level of sterol regulatory element-binding protein 1.

CONCLUSION:

We found that GSG is effective in treating NAFLD and the potential therapeutic targets may be involved in PI3K/AKT signaling pathway.

1,148

项与山东步长制药股份有限公司相关的新闻（医药）

2025-09-09

·同写意

驯鹿生物与赛桥生物达成全球战略合作，携手共拓国产细胞治疗一体化出海丨会员动态

细胞疗法免疫疗法

2025-09-09

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拜耳Co.Lab在华开幕一周年：成立创投联盟，汇聚更多初创企业

细胞疗法引进/卖出

2025-09-08

·同写意

这家CDMO产能逆势增长100%，达10万升

抗体药物偶联物疫苗

100 项与山东步长制药股份有限公司相关的药物交易

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100 项与山东步长制药股份有限公司相关的转化医学

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