Integrated analysis of metabolome, lipidome, and gut microbiome reveals the immunomodulation of Astragali radix in healthy human subjects.

Background: As a typical medicinal food homology species, Chinese herbal medicine Astragali radix (AR) has been widely used to regulate the human immune system worldwide. However, the human immunomodulation of AR and its corresponding mechanisms remain unclear.

Methods: First, following a fortnight successive AR administration, the changes in immune cytokines and immune cells from 20 healthy human subjects were used as immune indicators to characterize the immunomodulatory effects of AR.

Broad range lipidomics and metabolomics coupled with 16S rRNA sequencing to reveal the mechanisms of Huangkui Capsule against cisplatin-induced nephrotoxicity.

Ethnopharmacological Relevance: Huangkui Capsule (HKC) is a traditional Chinese medicinal preparation. Numerous clinical studies have reported that HKC has a good nephroprotection effect. The clinical application of cisplatin is greatly limited by its nephrotoxicity, and HKC shows promise in preventing cisplatin-induced nephrotoxicity (CIN).

Integrating lipidomics, 16S rRNA sequencing, and network pharmacology to explore the mechanism of Qikui granule in treating diabetic kidney disease mice.

Qikui granule (QKG), a hospital preparation of traditional Chinese medicine, has been widely used for diabetic kidney disease (DKD) in clinical practice. However, its holistic therapeutic effects and the underlying therapeutic mechanisms remain unclear. In the present study, the integrated analysis of network pharmacology, 16S rRNA sequencing, and non-targeted lipidomics was performed to explore the anti-DKD effects of QKG and the underlying mechanisms in db/db mouse DKD model.

Chemical Screening, Identification, and Comparison of Tripterygium Hypoglaucum Hutch Preparations by Ultra-High-Performance Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometry Combined With Multivariate Statistical Analysis.

Colquhounia root tablets (CRT) and Tripterygium hypoglaucum hutch tablets (THHT), two major Tripterygium hypoglaucum hutch (THH) commercial preparations, have been used to treat chronic kidney diseases or rheumatic diseases. However, there have been no reports on the chemical comparison between CRT and THHT, greatly hindering the understanding of their pharmacological difference as well as their rational application in clinical practice. In the present study, ultra-high-performance liquid chromatography coupled with quadrupole time-of-flight tandem mass spectrometry combined with automated data analysis by MS-DIAL software and MS-FLO website was employed to systematically screen and characterize the components in CRT and THHT.

A mathematical multiple-dimensional strategy for Q-markers identification based on "five principles": Tianshu Capsule for migraine treatment as an example.

Ethnopharmacological Relevance: Quality control is a critical element for Traditional Chinese medicine (TCM). Due to the varied chemical components, mechanisms of action, and pharmacological functions in TCM, ensuring quality is more challenging compared to chemical drugs. Then, the concept of quality markers (Q-markers) was proposed and ideal Q-markers for TCM prescriptions need to compliant with "five principles", including pharmacological effectiveness, specificity, transfer and traceability, measurability, and prescription compatibility.

Exploring the mechanism of Si-Ni-San against depression by UPLC-Q-TOF-MS/MS integrated with network pharmacology: experimental research.

Background: Depression is becoming an urgent mental health problem. Si-Ni-San has been widely used to treat depression, yet its underlying pharmacological mechanism is poorly understood. Thus, we aim to explore the antidepressant mechanism of Si-Ni-San by chemical analysis and in-silico methods.

An integrated approach of high-performance liquid chromatography-mass spectrometry-based chemical profiling, network pharmacology, and molecular docking to reveal the potential mechanisms of Qishen Gubiao granules for treating coronavirus disease 2019.

Qishen Gubiao granules, a traditional Chinese medicine preparation composed of nine herbs, have been widely used to prevent and treat coronavirus disease 2019 with good clinical efficacy. In the present study, an integrated strategy based on chemical profiling followed by network pharmacology and molecular docking was employed, to explore the active components and potential molecular mechanisms of Qishen Gubiao granules in the therapy of coronavirus disease 2019. Using the ultra-high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry technique, a total of 186 ingredients corresponding to eight structure types in Qishen Gubiao preparation were identified or structurally annotated with the elucidation of the fragmentation pathways in the typical compounds.

In vitro inhibitory effects of components from Salvia miltiorrhiza on catalytic activity of three human Arachidonic acid ω-hydroxylases.

CYP4 enzymes are involved in the metabolism of xenobiotics and endogenous molecules. 20-Hydroxyeicosatetraenoic acid (20-HETE), the arachidonic acid (AA) ω-hydroxylation metabolite catalyzed by CYP4A/4F enzymes, is implicated in various biological functions. The goal of this investigation is to examine the inhibitory effects of components from Salvia miltiorrhiza(Danshen) on AA ω-hydroxylation using recombinant CYP4A11, CYP4F2, CYP4F3B, and microsomal systems.

Simultaneous determination of nicotinamide and N -methylnicotinamide in human serum by LC-MS/MS to associate their serum concentrations with obesity.

A rapid and sensitive LC-MS/MS method was developed and validated for the simultaneous determination of nicotinamide and its metabolite N -methylnicotinamide in human serum. Serum samples were prepared by protein precipitation with acetonitrile. The chromatographic separation was performed on a Waters Spherisorb S5 CN microbore column (2.

Absolute protein assay for the simultaneous quantification of two epoxide hydrolases in rats by mass spectrometry-based targeted proteomics.

Epoxide hydrolases catalyze the hydrolysis of both exogenous and endogenous epoxides to the corresponding vicinal diols by adding water. Microsomal and soluble epoxide hydrolase are two main mammalian enzymes that have been intensely characterized. The purpose of this investigation was to develop and validate a proteomics assay allowing the simultaneous quantification of microsomal and soluble epoxide hydrolase in rats.

Randomised clinical trial: Efficacy and safety of Qing-Chang-Hua-Shi granules in a multicenter, randomized, and double-blind clinical trial of patients with moderately active ulcerative colitis.

Qing-Chang-Hua-Shi (QCHS) is a Chinese herbal formula, which is composed of 11 herbs. Studies have also shown that QCHS granules can alleviate colitis in animal models by preventing inflammatory responses and suppressing apoptosis through the MEK/ERK signaling pathway. To determine the efficacy and safety of QCHS granules in patients with moderately active UC.

Chinese herbal extract granules combined with 5-aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo-controlled trial.

Background: Ulcerative colitis (UC) is an intestinal inflammatory disease characterized by inflammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients with moderately active UC, several therapies (e.

[Safety and Tolerance of Healthy People to Injection of Astragalosides-a New Drug for Coronary Heart Disease].

Objectives: To assess the safety and tolerance of healthy volunteers to as tragalosides injection (AGI), and to determine a safe dose range for phase II clinical trial.

Methods: A total of 62 healthy volunteers participated in this study, with 26 being given a single AGI of 100 mL, 200 mL, 300 mL, 400 mL, 500 mL, or 600 mL and 36 subjects being given 500 mL, 400 mL, 200 mL or 300 mL of AGI once a day for 7 d. Discomfortsymptoms, vital signs and safety problems were recorded 3 d and 7 d after the administration of AGI.

Pharmacokinetic profiles of hydroxysafflor yellow A following intravenous administration of its pure preparations in healthy Chinese volunteers.

Ethnopharmacological Relevance: Hydroxysafflor yellow A (HSYA), the major active marker compound isolated from Carthamus tinctorius L., has been demonstrated to possess various attractive pharmacological activities. However, there is a lack of information about the complete clinical pharmacokinetic profiles of HSYA following the administration of its pure preparations.

Expert consensus for postmarketing Chinese medicine intensive hospital safety monitoring.

It is of vital significance to conduct active postmarketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China Food and Drug Administration. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The expert consensus for postmarketing surveillance focuses on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.

[Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments)].

It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs).

A correlative study of polymorphisms of CYP2C19 and MDR1 C3435T with the pharmacokinetic profiles of lansoprazole and its main metabolites following single oral administration in healthy adult Chinese subjects.

Considering that the genotypes of CYP2C19 and MDRI C3435T are two major factors attributed to the inter-individual pharmacokinetic variability of lansoprazole (LSZ), the aim of the study was to simultaneously elucidate the effects of CYP2C19 and MDRI C3435T polymorphisms on the pharmacokinetics difference of LSZ and its metabolites 5'-hydroxy lansoprazole (HLSZ) and lansoprazole sulphone (LSZS) following oral administration of LSZ tablets in healthy Chinese subjects. Plasma concentration of LSZ, HLSZ and LSZS were quantified by a sensitive and specific LC-MS/MS method, while the genotypes of CYP2C19 and MDRI C3435T for each subject were identified by a direct sequencing method. Statistical analysis was performed in the pharmacokinetic parameters including Cmax, t1/2, Tmax, MRTo_-, AUCO-2 and AUCo_r among different genotype groups of CYP2C 19 and MDRI C3435T.

Pharmacokinetics and tolerance of toal astragalosides after intravenous infusion of astragalosides injection in healthy Chinese volunteers.

Total astragalosides (TA) are the principal active constituents isolated from Radix Astragali, which has been extensively used in the traditional Chinese medicine for hundreds of years. However, few detailed pharmacokinetic studies about TA or its main component in human have been done to date. The aim of this study was to investigate the pharmacokinetic (PK) characteristics of astragaloside IV (AGS-IV), the primary ingredient of TA, and tolerance of TA after single- and multi-intravenous infusion of astragalosides injection (AI) in healthy Chinese volunteers.