83 results match your criteria: "Beijing Institute for Drug Control[Affiliation]"

has great value and development prospects in hypolipidemic applications. In this study, we comprehensively screened out multi-index components relevant to the quality of based on the hypolipidemic function of the flavonoid fraction of (FFN) combined with chemical characterizations. Firstly, in vitro antioxidant and cell experiments evaluated the hypolipidemic function of the FFN.

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A read-through circular RNA RCRIN inhibits metabolic dysfunction-associated steatotic liver disease.

J Hepatol

December 2024

Key Laboratory of RNA Science and Engineering, Key Laboratory of Epigenetic Regulation and Intervention, Institute of Biophysics, Chinese Academy of Sciences, Beijing 100101, China; University of Chinese Academy of Sciences, Beijing 100049, China. Electronic address:

Background & Aims: The molecular mechanism underlying metabolic dysfunction-associated steatotic liver disease (MASLD) is elusive and whether non-coding RNAs can serve as biomarkers and therapeutic targets of MASLD is less defined.

Methods: Exon capture RNA sequencing analysis was used to identify read-through circRNAs (rt-circRNAs) in livers from three MASLD patients and three patients without MASLD. Hepatocyte-specific deletion or overexpression of rt-circRNA RCRIN were utilized to study MASLD pathogenesis.

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Article Synopsis
  • This study examines how physiologically based pharmacokinetic (PBPK) models can better predict drug absorption affected by food, specifically for weakly basic, water-insoluble drugs like rivaroxaban and ticagrelor.
  • Researchers developed in vitro absorption models and combined them with disposition models to assess the drugs' systemic exposure in different dietary states, achieving moderate to high predictive accuracy, especially in Caucasian populations.
  • The study emphasizes the significance of accurate permeability measurements to improve predictions and cautions against assuming precipitation behavior in vivo, advocating for evidence-based determination of rate constants to enhance PBPK model reliability.
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Label-Free Quantitative Proteomics Analysis of COVID-19 Vaccines by Nano LC-HRMS.

Vaccines (Basel)

September 2024

NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drugs, Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing Institute for Drug Control, Beijing 102206, China.

Article Synopsis
  • - A new method using nanoliter liquid chromatography and high-resolution mass spectrometry was created for analyzing proteins in COVID-19 vaccine samples, allowing for both qualitative and quantitative analysis of target and host cell proteins.
  • - The method successfully analyzed the proteomes of 15 batches of inactivated vaccines from two companies and 12 batches of recombinant protein vaccines from one company, yielding valuable data.
  • - This approach enhances the ability to compare vaccine batches and manufacturers, improving quality assessments of bio-macromolecular drugs and setting new standards in proteomics analysis for complex samples.
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Objective: Huamaoyan Granules (HMYG) and Huamaoyan Capsules (HMYC) are Chinese patent medicines with different dosage forms of the same prescription. Due to the different preparation process, the chemical composition of these Chinese patent medicines varies greatly among different forms, but there were few studies on the difference comparison and quality control of them. In order to improve the effectiveness and safety in its clinical application, an idea combining high performance liquid chromatography (HPLC) and chemometrics was put forward to study the quality control of Chinese patent medicines in different dosage forms of the same prescription.

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Qualitative and quantitative analysis of major components of Qiye Shen'an tablet by UPLC Q-TOF/MS and UPLC-TQS-MS/MS.

J Pharm Biomed Anal

August 2024

NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing Institute for Drug Control, Beijing, China. Electronic address:

The Qiye Shen'an tablet is formulated using total saponins extracted from Notoginseng stems and leaves. At present, the study on its chemical composition remains scarce and the quality control indicators are limited, which seriously hindering the effective quality control and clinical research. Hence, this study aims to comprehensively identify and characterize the Qiye Shen'an tablet while controlling its main component contents.

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An unexpected role of EasD: catalyzing the conversion of chanoclavine aldehyde to chanoclavine acid.

Appl Microbiol Biotechnol

May 2024

Laboratory for Marine Drugs and Bioproducts, Qingdao National Laboratory for Marine Science and Technology, Qingdao, 266003, People's Republic of China.

Ergot alkaloids (EAs) are a diverse group of indole alkaloids known for their complex structures, significant pharmacological effects, and toxicity to plants. The biosynthesis of these compounds begins with chanoclavine-I aldehyde (CC aldehyde, 2), an important intermediate produced by the enzyme EasD or its counterpart FgaDH from chanoclavine-I (CC, 1). However, how CC aldehyde 2 is converted to chanoclavine-I acid (CC acid, 3), first isolated from Ipomoea violacea several decades ago, is still unclear.

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Microcystins (MCs) are the most widespread cyanobacterial toxins in eutrophic water body. As high toxic intermediate metabolites, linearized MCs are further catalyzed by linearized microcystinase (MlrB) of sp. USTB-05.

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Peripheral T-cell lymphoma (PTCL) is a rare and heterogeneous group of hematological malignancies. Compared to our knowledge of B-cell tumors, our understanding of T-cell leukemia and lymphoma remains less advanced, and a significant number of patients are diagnosed with advanced stages of the disease. Unfortunately, the development of drug resistance in tumors leads to relapsed or refractory peripheral T-Cell Lymphomas (r/r PTCL), resulting in highly unsatisfactory treatment outcomes for these patients.

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An accurate, rapid, and selective quantitative nuclear magnetic resonance method was developed and validated to assess the purity of IMM-H014, a novel drug for the treatment of metabolic-associated fatty liver disease (MAFLD), and four related substances (impurities I, II, III, and IV). In this study, we obtained spectra of IMM--H014 and related substances in deuterated chloroform using dimethyl terephthalate (DMT) as the internal standard reference. Quantification was performed using the H resonance signals at 8.

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To identify the active constituents, core targets, immunomodulatory functions and potential mechanisms of Dizhi pill (DZP) in the treatment of myopia. The active constituents and drug targets of DZP were searched in the TCMSP, Herb databases and correlational studies. The targets of myopia were searched in the TTD, Genecards, OMIM and Drugbank databases.

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Quantification and holistic quality evaluation of Wulingzhi extract by UHPLC-Q-Orbitrap-HRMS coupled with chemometric approaches.

Biomed Chromatogr

November 2023

NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing Institute for Drug Control, Beijing, China.

The excreta of Trogopterus xanthipes ("Wulingzhi" in Chinese, WLZ) is a well-known traditional Chinese medicine. It has been used for centuries to treat amenorrhea, menstruation and postpartum abdominal pain. However, a systematic quality study on WLZ chemical markers has yet to be conducted.

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Identification and Determination of Impurities in a New Therapeutic Agent for Fatty Liver Disease.

J Anal Methods Chem

August 2023

State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China.

Methyl 7,7'-dimethoxy-5'-(morpholinomethyl)-[4,4'-bibenzo[d][1,3] dioxole]-5-carboxylate methanesulfonate (IMM) is an innovative drug for the treatment of nonalcoholic fatty liver disease (NAFLD) owing to its high efficacy and low toxicity. In this study, five minor impurities (I, II, III, IV, and V) were identified and analyzed using spectroscopic evidence, chemical synthetic methods, and liquid chromatography-tandem mass spectrometry (LC-MS/MS). The impurities included hydrolysates and oxidation by-products extracted from both the drug in its final formulation and during synthesis.

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HSK7653, an oral dipeptidyl peptidase-4 inhibitor administered every 2 weeks, is a candidate for the treatment of type 2 diabetes mellitus. The major elimination pathway of HSK7653 in vivo is renal excretion, and hepatic metabolism and fecal excretion of unchanged compound contribute less to the systemic clearance of HSK7653. Considering the disposition characteristics and the potential indication population of HSK7653, evaluating the HSK7653 exposure in patients with renal impairment and geriatric populations is a prerequisite for bringing more benefits to the patients.

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Houtt is an important anti-skin pigmentation herb used in traditional Chinese medicine. However, the molecular basis for this activity is complex and not fully understood. In this study, water and ethanol extracts and polysaccharide extract from (LJPs) were analyzed by LC-MS/MS and HPLC-DAD separately.

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High-fructose corn syrup (HFCS) has been speculated to have stronger negative metabolic effects than sucrose. However, given the current equivocality in the field, the aim of the present study was to determine the impact of HFCS use compared to sucrose on anthropometric and metabolic parameters. We searched PubMed, Scopus, Cochrane Central and web of sciences, from database inception to May 2022.

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Microbial cell factories (MCFs) and cell-free systems (CFSs) are generally considered as two unrelated approaches for the biosynthesis of biomolecules. In the current study, two systems were combined together for the overproduction of agroclavine (AC), a structurally complex ergot alkaloid. The whole biosynthetic pathway for AC was split into the early pathway and the late pathway at the point of the FAD-linked oxidoreductase EasE, which was reconstituted in an MCF () and a four-enzyme CFS, respectively.

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This study evaluates the in vitro antioxidant and immunomodulation activities of essential oils isolated from an anti-upper respiratory tract infection (URTI) formulation with a view to their therapeutic potential. The chemical components of the essential oil were analysed by gas chromatography-mass spectrometry (GC-MS). The antioxidative activity of the oils was investigated with regard to their ability to scavenge DPPH, ABTS, and hydroxyl free radical (•OH).

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A new G-triplex-based strategy for sensitivity enhancement of the detection of endonuclease activity and inhibition.

RSC Adv

August 2021

Beijing Institute for Drug Control, MNPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Medicine), MNPA Key Laboratory for Research and Evaluation of Generic Drugs, Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine Beijing 102206 China

EcoRI is an important biomacromolecule in live cells and protects bacterial cells against foreign DNA. In this work, we developed a simple and convenient G-triplex (G3) (5'-TGGGAAGGGAGGGAATTCCCT-3')-based colorimetric assay for the rapid and selective detection of EcoRI activity and inhibition. The sequence specifically responds to EcoRI in the presence of K and hemin to form a G-triplex/hemin complex.

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Generally, some weakly basic insoluble drugs will undergo precipitate and redissolution after emptying from the stomach to the small intestinal, resulting in the limited ability to predict the absorption characteristics of compounds in advance. Absorption is determined by the solubility and permeability of compounds, which are related to physicochemical properties, while knowledge about the absorption of redissolved precipitate is poorly documented. Considering that biorelevant media have been widely used to simulate gastrointestinal fluids, sufficient precipitates can be obtained in biorelevant media in vitro.

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Objective: Improve the quality of testing in medical device manufacturers clean workshops to ensure the authenticity and reliability of testing data.

Methods: Analyze the problems and influencing factors found in the process of testing of medical device manufacturers clean workshops from 2016 to 2020, and put forward reasonable suggestions to ensure the quality of testing.

Results: In the process of testing, there are six factors that affect the quality of testing, including testing personnel, instruments and equipment, testing consumables, testing methods, testing environment and actual operation.

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Enteric and hydrophilic polymers enhance dissolution and absorption of poorly soluble acidic drugs based on micro-environmental pH-modifying solid dispersion.

Eur J Pharm Sci

January 2022

NMPA Key Laboratory for Research and Evaluation of Generic Drugs, Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing Institute for Drug Control, Beijing 102206, China.

The oral bioavailability of poorly water-soluble active pharmaceutical ingredient (API) is often inadequate for the desired therapeutic effect. Micro-environmental pH-modifying solid dispersion (micro pHm SD) is an effective method for enhancing the dissolution of pH-dependent soluble APIs. However, erratic bioavailability of these drugs was often found when the micro pHm SD of the drugs was orally administrated and passed through the gastrointestinal tract.

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Oxidative hair dye products have always been one of the key concerns in cosmetic supervision. The various aromatic amine and phenol dyes used in such products have different degrees of sensitization and toxicities. Therefore, it is necessary to establish a rapid and accurate method for the determination of various dyes.

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Total saponins from stems and leaves of Panax quinquefolius L. ameliorate podophyllotoxin-induced myelosuppression and gastrointestinal toxicity.

Biomed Chromatogr

February 2022

Beijing Institute for Drug Control, NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing, China.

Podophyllotoxin (POD), a natural lignan distributed in podophyllum species, possesses significant antitumor and antiviral activities. But POD often causes serious side effects, such as myelosuppression, gastrointestinal toxicity, neurotoxicity, hepatic and renal dysfunction, and even death, which not only hinder its clinical application but also threaten the patient's health. Therefore, an effective treatment against POD-induced toxicity is important.

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Article Synopsis
  • Toltrazuril (TOL) is an anticoccidial drug used in poultry and livestock, with new formulations developed for better stability and drug release.
  • A study evaluated the pharmacokinetics of TOL and its metabolites after administering two different suspensions in rabbits (one oral and one injectable).
  • Results showed that both formulations increased drug bioavailability, with oral administration leading to quicker absorption and injectable administration resulting in slower metabolism, indicating potential benefits for coccidian control in animals.
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