[Translation] A multicenter, randomized, open, parallel controlled phase IIa clinical study to evaluate the efficacy and safety of Danshensu sodium injection in the treatment of coronary microvascular disease

评价丹参素钠注射液治疗冠状动脉微血管疾病的有效性及安全性

[Translation]

To evaluate the efficacy and safety of Danshensu sodium injection in the treatment of coronary microvascular disease

Start Date16 May 2024

Sponsor / Collaborator

Shenzhen Gaoyingtai Technology Development Co., Ltd.

[+1]

CTR20201177 / CompletedPhase 1

丹参素钠注射液在中国健康志愿者中多次给药的安全性、耐受性和药代动力学I期临床研究

[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of multiple-dose danshensu sodium injection in Chinese healthy volunteers

（1）评价丹参素钠注射液在中国健康志愿者中多次静脉滴注的安全性和耐受性，确定丹参素钠注射液的安全剂量范围，为后续临床开发提供参考；（2）评价丹参素注射液在中国健康志愿者中多次静脉滴注的药代动力学特征。

[Translation]

(1) To evaluate the safety and tolerability of multiple intravenous infusions of Danshensu sodium injection in healthy Chinese volunteers, determine the safe dosage range of Danshensu sodium injection, and provide a reference for subsequent clinical development; (2) To evaluate the pharmacokinetic characteristics of multiple intravenous infusions of Danshensu sodium injection in healthy Chinese volunteers.

Start Date03 Aug 2020

Sponsor / Collaborator

Shenzhen Gaoyingtai Technology Development Co., Ltd.

[+1]

CTR20160945 / CompletedPhase 1

丹参素钠注射液在中国健康志愿者中单次给药的安全性、耐受性和药代动力学I期临床研究

[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of single-dose danshensu sodium injection in Chinese healthy volunteers

主要目的： 1）评价丹参素钠注射液在健康受试者中单次给药的安全性和耐受性，确定最大耐受剂量，为多次给药耐受性试验提供依据。 2）考察丹参素钠注射液在健康受试者中单次给药的药代动力学特征。次要目的：为后期的临床试验推荐剂量；安全和合理的静滴速度。

[Translation]

Main objectives: 1) To evaluate the safety and tolerability of single-dose danshensu sodium injection in healthy subjects, determine the maximum tolerated dose, and provide a basis for multiple-dose tolerance tests. 2) To investigate the pharmacokinetic characteristics of single-dose danshensu sodium injection in healthy subjects. Secondary objectives: To recommend doses for later clinical trials; safe and reasonable intravenous drip rates.

Start Date18 Oct 2018

Sponsor / Collaborator

Shenzhen Gaoyingtai Technology Development Co., Ltd.

[+1]

100 Clinical Results associated with Salvianic Acid A Sodium

100 Translational Medicine associated with Salvianic Acid A Sodium

100 Patents (Medical) associated with Salvianic Acid A Sodium

Literatures (Medical) associated with Salvianic Acid A Sodium

01 Dec 2024·Journal of Biotechnology

Structure-guided engineering of 4-coumarate: CoA ligase for efficient production of rosmarinic acid in Saccharomyces cerevisiae

Article

Author: Zhu, Jinyuan ; Du, Jiayan ; Zhou, Xiuqi ; Zhou, Pingping ; Pang, Xueqing ; Yin, Xinjian

The utilization of genetically modified microbial cells for rosmarinic acid (RA) production is gaining increased attention as a cost-effective and sustainable approach. However, the substrate promiscuity of 4-coumarate: CoA ligase and RA synthase has been considered as a critical factor for low RA yields. In this study, we rationally engineered the substrate preference of 4-coumarate: CoA ligase (OPc4CL2) from Petroselinum crispum, resulting in a significant enhancement in RA production. Particularly, the introduction of the Y240C mutation led to a remarkable 176% increase in RA yield. Subsequent enzymatic analysis of OPc4CL2 variants revealed diminished activity towards p-coumaric acid, resulting in insufficient time for the transformation of p-coumaric acid to 4-coumaroyl CoA to generate byproduct. Furthermore, to minimize the formation of undesired byproducts, the overexpression of 4-hydroxyphenylacetate 3-monooxygenase (OHpaB) and NADPH-flavin oxidoreductase (HpaC) was carried out to facilitate the conversion of p-coumaric acid to caffeic acid and 4-hydroxyphenyllactate to salvianic acid A, thus achieving a significant increase in RA yield of up to 329.9mg/L (16.5mg/g yield on glucose) in shake-flask cultivation. Finally, the engineered strain YRA113-24BHM achieved a notable RA production of 3.6g/L (about 20.2mg/g yield on glucose) by fed-batch fermentation. This study serves as a foundation for the sustainable biosynthesis of RA and other caffeic acid derivatives.

01 Nov 2024·Journal of Separation Science

Advanced Bionic Technology Combining Online Electrochemistry‐Mass Spectrometry and Offline Electrochemistry‐Liquid Chromatography‐Mass Spectrometry for Simulating and Characterizing Metabolic Processes of Bioactive phenolic acids in Natural Products

Article

Author: Sun, Huihui ; Li, Jin ; Chang, Yanxu ; Ma, Wentao ; Liu, Tianyu ; Yang, Man ; Huang, Tengteng ; Du, Kunze

ABSTRACTThe metabolism research of bioactive phenolic acids widely found in natural products is of great significance for elucidating pharmacologic mechanisms and screening lead compounds. However, it is time‐consuming and vulnerable to interference to conduct the traditional metabolism approach by applying organisms or biomaterials. Herein, a bionic technology was established by combining online electrochemistry‐mass spectrometry (EC‐MS) with offline electrochemistry‐liquid chromatography‐mass spectrometry (EC‐LC‐MS) to investigate the oxidative transformation and metabolic processes of the active phenolic acids (including salvianolic acid A, caffeic acid, 3, 5‐O‐dicaffeoylquinic acid, ferulic acid, salvianic acid A, and protocatechuic acid). Phase I metabolism of the phenolic acids were simulated by applying a three‐electrode controlled potential electrochemical reactor with a boron‐doped diamond electrode, with glutathione mixed into the oxidative products simultaneously for obtaining the phase II metabolites. Finally, structural characterization of the simulated metabolites of the phenolic acids was achieved successfully, including hydroxylation, methylation, demethylation, decarboxylation, etc. It was revealed that the simulated metabolism process based on an electrochemical system was effective in yielding a wide variety of metabolites for these compounds, which was also compared with the metabolism results applying rat liver microsomes. Consequently, this bionic technology is expected to be a powerful tool to investigate the material basis for the efficacy of active ingredients of natural products.

01 Sep 2024·Biomedical Chromatography

Development and validation of a liquid chromatography–tandem mass spectrometry method for simultaneous quantification of eight Xiakucao Oral liquid–related compounds in rat plasma and its application in pharmacokinetic study

Article

Author: Yan, Dongming ; Qiu, Furong ; Chen, Biao ; Wang, Xinwei ; Xu, Xiaoqing ; Jin, Jingyi ; Chen, Zhongguo ; Miao, Yingying

AbstractXiakucao Oral Liquid (XKCOL) has been widely used for treating mammary gland hyperplasia and goiter in China. However, its pharmacokinetic data have been missing to date. To conduct its pharmacokinetic study, we established an LC–tandem mass spectrometry method for the simultaneous determination of eight XKCOL‐related compounds in rat plasma. Liquid–liquid extraction was used for the sampling process. Chromatographic separation was performed on a Phenomenon Luna C18 column with a mobile phase of methanol and 2 mM ammonium acetate, using gradient elution at a flow rate of 0.8 mL/min. Detection was performed in the multiple reaction monitoring mode using negative electrospray ionization (ESI−) with optimized MS parameters. Endogenous substances and carryover did not interfere in the detection of analytes. The calibration curves showed a good linear relationship within the linear ranges. The intra‐ and inter‐batch accuracy and precision were 94.8%–110.0% and ≤11.2%, respectively. There was no significant matrix effect and the recovery was reproducible. The dilution of samples did not affect the accuracy and precision. The solution and plasma samples were stable under the various test conditions. The major components of XKCOL absorbed into the blood were salvianic acid A and rosmarinic acid. They demonstrated linear kinetics over the dose range used in this study.

100 Deals associated with Salvianic Acid A Sodium

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Angina Pectoris	Phase 2	CN	Shenzhen Gaoyingtai Technology Development Co., Ltd.	16 May 2024
Angina Pectoris	Phase 2	CN	The Second Military Medical University	16 May 2024
Coronary Artery Disease	Phase 2	CN	Shenzhen Gaoyingtai Technology Development Co., Ltd.	16 May 2024
Coronary Artery Disease	Phase 2	CN	The Second Military Medical University	16 May 2024
Angina, Stable	Preclinical	CN	The Second Military Medical University	18 Oct 2018
Angina, Stable	Discovery	CN	Shenzhen Gaoyingtai Technology Development Co., Ltd.	18 Oct 2018

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