[Translation] An open, single-center study of the pharmacokinetics and safety of single and multiple intravenous infusions of hydroxysafflor yellow A in healthy subjects

以健康成年受试者为对象，评价单次静脉滴注注射用羟基红花黄色素A 50mg、75mg和100mg后的药代动力学特性，以及75mg连续7天给药的药代动力学特征。

[Translation]

The pharmacokinetic characteristics of hydroxysafflor yellow A for injection after single intravenous infusion of 50 mg, 75 mg and 100 mg, as well as the pharmacokinetic characteristics of 75 mg administered for 7 consecutive days were evaluated in healthy adult subjects.

Start Date19 Jun 2023

Sponsor / Collaborator

Jilin Tiansanqi Phamarceutical Co. Ltd.

ChiCTR2300072306

/ SuspendedPhase 1IIT

Pharmacokinetic profile and safety of hydroxysafflor yellow A following single and multiple intravenous administration in healthy Chinese volunteers: an open-labeled, single-center study

Start Date09 Jun 2023

Sponsor / Collaborator

Peking University Third Hospital

CTR20221803

/ CompletedPhase 1

一项评价健康受试者连续 14 天静脉滴注注射用羟基红花黄色素 A 的药代动力学及耐受性和安全性的单中心、单臂研究

[Translation] A single-center, single-arm study to evaluate the pharmacokinetics, tolerability, and safety of hydroxysafflor yellow A for injection given intravenously for 14 consecutive days in healthy subjects

以健康成年受试者为对象，评价连续 14 天，每天静脉滴注注射用羟基红花黄色素 A 75mg 后的药代动力学特性

[Translation]

To evaluate the pharmacokinetic properties of 75 mg of hydroxysafflor yellow A for injection after daily intravenous infusion for 14 consecutive days in healthy adult subjects.

Start Date11 Jul 2022

Sponsor / Collaborator

Jilin Tiansanqi Phamarceutical Co. Ltd.

100 Clinical Results associated with Hydroxysafflor Yellow A

100 Translational Medicine associated with Hydroxysafflor Yellow A

100 Patents (Medical) associated with Hydroxysafflor Yellow A

259

Literatures (Medical) associated with Hydroxysafflor Yellow A

01 May 2025·Talanta

An AI-driven strategy for active compounds discovery and non-destructive quality control in traditional Chinese medicine: A case of Xuefu Zhuyu Oral Liquid

Article

Author: Cao, Guiyun ; He, Qiuxia ; Meng, Zhaoqing ; Lu, Qingqing ; Feng, Tingting ; Gao, Lele ; Nie, Lei ; Zang, Hengchang ; Li, Lian ; Lin, Guimei ; Liu, Kechun ; Zhong, Liang ; Yue, Jianan ; Wu, Aoli

The modernization and globalization of traditional Chinese medicine (TCM) face challenges such as unclear active compounds and inadequate quality control. Taking Xuefu Zhuyu Oral Liquid (XZOL) as an example, this study proposed an artificial intelligence (AI) -driven strategy for active compounds discovery and non-destructive quality control. Firstly, the multi-wavelength fusion high-performance liquid chromatography (HPLC) fingerprints were constructed to comprehensively characterize the chemical composition of XZOL. Secondly, the pro-angiogenesis effects of XZOL were evaluated in a PTK787-induced intersegmental vessels (ISVs) injury zebrafish model. Then, spectrum-effect relationship models, incorporating gray relational analysis (GRA), partial least squares regression (PLSR), backpropagation artificial neural networks (BP-ANN), and convolutional neural networks (CNN), discovered seven pro-angiogenesis active compounds (Hydroxysafflor Yellow A, Paeoniflorin, Ferulic Acid, Narirutin, Naringin, Hesperidin, and Neohesperidin). Furthermore, the efficacy of these compounds was further validated through network pharmacology, molecular docking, and zebrafish. Finally, a rapid and non-destructive quality control system based on near infrared spectroscopy (NIRS) was established. This system effectively distinguished expired and normal samples by combining Hotelling T² and Distance to Model X (DModX) statistics of multivariate statistical process control (MSPC), and accurately predicted the content of above active compounds by CNN model integration with bidirectional long short-term memory (Bi-LSTM) and multi-head self-attention (MHSA) networks. This study underscores the potential of AI-driven strategy to enhance TCM standardization and global recognition by providing an active compounds-based holistic quality control strategy of TCM.

01 Jan 2025·Clinical Pharmacology in Drug Development

The Safety, Tolerability, and Pharmacokinetics of Active Ingredients From Hydroxysafflor Yellow A in Healthy Chinese Volunteers

Article

Author: Zhao, Xiuli ; Cai, Yefeng ; wang, Xia ; Zhou, Ziyi ; Gu, Shanye

AbstractHydroxysafflor yellow A (HSYA), an active ingredient extracted from Carthami flos, shows potential for treating ischemic stroke. This phase 1 study assessed the safety, tolerability, and pharmacokinetic (PK) properties of HSYA in healthy Chinese volunteers who received intravenous infusions of pure HSYA powder. The study comprised 2 parts. Part A was a randomized, double‐blind, placebo‐controlled dose‐escalation study that evaluated safety and tolerability. This included a single‐dose study with 7 dose levels of HSYA (6.25, 12.5, 25, 50, 75, 100, and 125 mg) in 52 volunteers, and a multidose study (100 and 125 mg) in 16 volunteers. Part B was an open‐label study where 12 volunteers received 75 mg of HSYA once daily for 14 consecutive days to examine PKs. There were no adverse events (AEs) leading to treatment discontinuation by HSYA throughout the treatment period. All reported AEs were mild and did not require special treatment. PK analysis revealed rapid absorption (median Tmax of 1.1 hours) and elimination (median t1/2 4.0 and 4.7 hours) of HSYA. Total body clearance on the 1st and 14th days was 1.7 and 1.6 L/h, respectively.

01 Jan 2025·Journal of Ethnopharmacology

Buyang Huanwu Decoction prevents hemorrhagic transformation after delayed t-PA infusion via inhibiting NLRP3 inflammasome/pyroptosis associated with microglial PGC-1α

Article

Author: Nie, Linlin ; Wan, Ting ; Wang, Qi ; Guan, Danni ; Li, Yongyi ; Zhuang, Lixing ; Zhang, Yifan ; Pan, Yaru ; Chen, Weitao ; Li, Weirong ; Yang, Cong ; Duan, Lining ; Lai, Jianbo

ETHNOPHARMACOLOGICAL RELEVANCEDelayed tissue-type plasminogen activator (t-PA) thrombolysis, which has a restrictive therapeutic time window within 4.5 h following ischemic stroke (IS), increases the risk of hemorrhagic transformation (HT) and subsequent neurotoxicity. Studies have shown that the NLRP3 inflammasome activation reversely regulated by the PGC-1α leads to microglial polarization and pyroptosis to cause damage to nerve cells and the blood-brain barrier. The effect of Buyang Huanwu Decoction (BHD), a traditional Chinese medicine prescription widely used in the recovery of IS, on HT injury after delayed t-PA treatment had been found with clinical studies, while the underlying mechanisms are reminded to be further clarified.AIM OF THE STUDYThis study sought to investigate the therapeutic effect and the underlying mechanisms of BHD in ischemic rat brains with delayed t-PA treatment.MATERIALS AND METHODSThe components of BHD extracts were identified by High Performance Liquid Chromatography (HPLC) and the effective components in the rat brains from BHD were analyzed by liquid chromatography-mass spectrometry (LC-MS). In vivo experiment was carried out by 5 h of middle cerebral artery occlusion (MCAO) following by t-PA infusion for 0.5 h plus reperfusion 19 h, while the in vitro BV2 cells were stimulated by lipopolysaccharide (LPS)-adenosine triphosphate (ATP) to activate microglia pyroptosis, of which the MCC950 (NLRP3 inhibitor) and NSA (GSDMD inhibitor) were adopted as reverse validation. PGC-1α siRNA was utilized to study the mechanisms of BHD against microglial polarization and pyroptosis in BV2 cells.RESULTSHPLC analysis demonstrated the fingerprint of BHD with six reference standards (Hydroxysafflor yellow A, Calycosin-7-glucoside, Paeoniflorin, Formononetin, Ferulic acid and Amygdalin), the last two of which can be found in rat brains by LC-MS analysis. In the following experiments, we found the major discoveries as follow: (1) BHD improved the neurological outcomes, the structural integrity of the blood-brain barrier and the neuronal structure in HT rats with MCAO following by delayed t-PA infusion; (2) the presence of t-PA promoted the suppression of PGC-1α and the activation of microglial NLRP3 inflammasome and pyroptosis in the HT rats; (3) BHD promoted the transformation of microglia from M1 to M2 type for inhibiting inflammatory response; (4) BHD restrained NLRP3 inflammasome/pyroptosis activation in microglia, prevented the translocations of NF-κB into the nucleus, as well as enhanced microglia-specific PGC-1α in ischemic rats following t-PA delayed thrombolysis; (5) BHD suppressed NLRP3 inflammasome assembly and increased PGC-1α expression in the LPS-ATP-induced BV2 cells; (6) PGC-1α silencing withdrew the protective role of BHD against NLRP3 inflammasome/pyroptosis.CONCLUSIONMechanistically, BHD existed the protective effect against HT injury after delayed t-PA treatment through up-regulating microglial PGC-1α to inhibit NLRP3 inflammasome and pyroptosis, and serves as a potential adjuvant therapy for HT injury.

100 Deals associated with Hydroxysafflor Yellow A

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Brain Infarction	Phase 1	China	Jilin Tiansanqi Phamarceutical Co. Ltd.	05 Nov 2015
Thrombotic cerebral infarction	Phase 1	China	Jilin Tiansanqi Phamarceutical Co. Ltd.	05 Nov 2015
Stroke	Preclinical	China	Ruiyang Pharmaceutical Co., Ltd.	19 Jan 2015
Acute Ischemic Stroke	Discovery	China	Jilin Tiansanqi Phamarceutical Co. Ltd.	18 Feb 2021

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