1,068 results match your criteria: "Institute for Drug Control[Affiliation]"

A review of L. in the treatment of liver disease: viral hepatitis, liver fibrosis/cirrhosis and hepatocellular carcinoma.

Front Pharmacol

August 2024

NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine, Shenzhen Institute for Drug Control, Shenzhen, China.

Due to the pathological production of liver disease in utility particularly complexity, the morbidity and mortality of liver disease including viral hepatitis, liver fibrosis/cirrhosis and hepatocellular carcinoma (HCC) are rapidly increasing worldwide. Considering its insidious onset, rapid progression and drug resistance, finding an effective therapy is particularly worthwhile. L.

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Medical polyurethanes have emerged as a leading choice for biomedical applications owing to their exceptional biocompatibility and good physical and mechanical properties. Catalysts play a crucial role as additives in the synthesis of medical polyurethanes, enhancing synthesis efficiency and material properties. However, the catalysts used may affect the biocompatibility of polyurethanes and pose potential harm to human health.

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Impact of Physiological Characteristics on Chylomicron Pathway-Mediated Absorption of Nanocrystals in the Pediatric Population.

ACS Nano

August 2024

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Science, Peking University, Beijing 100191, China.

Nanocrystals exhibit significant advantages in improving the oral bioavailability of poorly soluble drugs. However, the complicated absorption properties of nanocrystals and the differences in physiological characteristics between children and adults limit pediatric applications of nanocrystals. To elucidate the absorption differences and the underlying mechanisms between children and adults, the pharmacokinetics and tissue distribution of aprepitant crystals with different particle sizes (NC200, NC500, and MC2.

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PRSS50-mediated inhibition of MKP3/ERK signaling is crucial for meiotic progression and sperm quality.

Zool Res

September 2024

National Engineering Laboratory for Druggable Gene and Protein Screening, Northeast Normal University, Changchun, Jilin 130117, China. E-mail:

Serine protease 50 (PRSS50/TSP50) is highly expressed in spermatocytes. Our study investigated its role in testicular development and spermatogenesis. Initially, PRSS50 knockdown was observed to impair DNA synthesis in spermatocytes.

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Quality evaluation of Qiangli Tianma Duzhong (QLTMDZ) employing UHPLC-MS: A multivariate statistical analysis across multiple dosage forms and manufacturers.

J Pharm Biomed Anal

November 2024

MIIT Public Service Platforms for Industrial Technological Base, NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Sichuan Institute for Drug Control (Sichuan Testing Center of Medical Devices), Chengdu 611731, China. Electronic address:

Traditional Chinese medicine (TCM) and its preparations have become increasingly popular in recent years. Nonetheless, due to the high complexity of the compounds in Traditional Chinese Patent Medicine (TCPM), the quality differences between different dosage forms and products from various manufacturers pose numerous challenges and difficulties in quality evaluation. The Qiangli Tianma Duzhong (QLTMDZ) prescription, comprising twelve TCM, is widely used in China.

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In the current landscape, regulatory agencies face the challenge of reconciling timely authorizations for novel medicines addressing life-threatening conditions with thorough evaluations of their benefits and risks. This challenge is pronounced with advanced therapy medicinal products (ATMPs), where expedited approval mechanisms and orphan drug designations are often applied, making post-authorization measures a crucial mechanism to address uncertainties. We compared post-authorization measures imposed by the U.

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: panoramagram of phytochemical and pharmacological properties, biosynthesis, and regulation and production of ginsenosides.

Hortic Res

August 2024

State Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, No.16 Nanxiaojie, Dongzhimennei Ave., Beijing, 100700, China.

is a famous perennial herb widely used as material for medicine and health-care food. Due to its various therapeutic effects, research work on has rapidly increased in recent years, urging a comprehensive review of research progress on this important medicinal plant. Here, we summarize the latest studies on the representative bioactive constituents of and their multiple pharmacological effects, like cardiovascular protection, anti-tumor, and immunomodulatory activities.

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Triterpenoid saponins from the roots of Panax notoginseng with protective effects against APAP-induced liver injury.

Fitoterapia

October 2024

State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Peking University, 38 Xueyuan Road, Beijing 100191, China; State Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Beijng 100700, China; Peking University-Yunnan Baiyao International Medical Research Center, 38 Xueyuan Road, Beijing 100191, China. Electronic address:

Five previously undescribed protopanaxatriol-type saponins, notoginsenosides Ta-Te (1-5), together with eighteen known triterpenoid saponins (6-23) were isolated from the roots of Panax notoginseng. The structures of new compounds were determined by HRESIMS and NMR spectroscopic analyses and chemical methods. Compounds 1 and 2 were the first examples of ginsenosides featuring a 6-deoxy-β-d-glucose moiety from Panax species.

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Candesartan Cilexetil Formulations in Mesoporous Silica: Preparation, Enhanced Dissolution In Vitro, and Oral Bioavailability In Vivo.

J Pharm Sci

October 2024

School of Chemistry, South China Normal University, Key Laboratory of Process Control and Quality Evaluation of Chiral Drugs, Guangdong Provincial Drug Administration, Guangzhou Key Laboratory of Biomedical Analytical Chemistry, Guangzhou 510006, China. Electronic address:

Candesartan cilexetil (CC) is one of well-tolerated antihypertensive drugs, while its poor solubility and low bioavailability limit its use. Herein, two mesoporous silica (Syloid XDP 3150 and Syloid AL-1 FP) and the corresponding amino-modified products (N-XDP 3150 and N-AL-1 FP) have been selected as the carriers of Candesartan cilexetil to prepare solid dispersion through solvent immersion, and characterized through using powder X-ray diffraction analysis, infrared spectroscopy, differential scanning calorimetry, scanning electron microscopy, and solid-state nuclear magnetic resonance spectroscopy, etc. The state of CC changed from crystalline to amorphous after loading onto the silica carriers, in which no interactions between CC and silica existed.

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A new, selective and simple UPLC-MS/MS method was developed and validated for the determination of lifitegrast in human plasma and tear in order to obtain PK data. Lifitegrast-d4 solutions were added in the samples, and then were extracted and transferred to a UPLC vial. The respective working ranges were 25.

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Thiols-rich peptide from water buffalo horn keratin alleviates oxidative stress and inflammation through co-regulating Nrf2/Hmox-1 and NF-κB signaling pathway.

Free Radic Biol Med

October 2024

National and Local Collaborative Engineering Center of Chinese Medicinal Resources Industrialization and Formulae Innovative Medicine, Jiangsu Collaborative Innovation Center of Chinese Medicinal Resources Industrialization, Key Laboratory of Chinese Medicinal Resources Recycling Utilization under National Administration of Traditional Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, PR China; Animal-Derived Chinese Medicine and Functional Peptides International Collaboration Joint Laboratory, Nanjing 210023, PR China; School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210023, PR China; Jiangsu Key Laboratory of Research and Development in Marine Bio-resource Pharmaceutics, Nanjing University of Chinese Medicine, Nanjing 210023, PR China; State Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs, Beijing, 100700, PR China. Electronic address:

Water buffalo horn (WBH), a traditional Chinese medicine, is known for its antipyretic, anti-inflammatory and antioxidant properties. This study aims to investigate the therapeutic potential of WBH keratin (WBHK) and its derived thiol-rich peptide fractions (SHPF) for oxidative stress and inflammation. WBHK and SHPF were prepared and tested using various models including LPS-induced fever in rabbits, HO-induced oxidative damage in bEnd.

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Deapioplatycodin D promotes cell senescence induced by P21 through the mediation of incomplete mitophagy via BNIP3L.

Biomed Pharmacother

September 2024

National Engineering Laboratory for Druggable Gene and Protein Screening, Northeast Normal University, Changchun 130024, PR China. Electronic address:

Article Synopsis
  • - Deapioplatycodin D (DPD) is a saponin from Platycodon grandiflorum that has shown potential anti-inflammatory and immunity-boosting properties, yet its effects on hepatocellular carcinoma (HCC) cells were previously unknown.
  • - Research indicates that DPD significantly inhibits HCC cell growth by altering autophagy-related protein levels and inducing cell senescence, without affecting apoptosis-related proteins.
  • - Further analysis linked DPD’s impact on HCC to mitochondrial damage and increased reactive oxygen species, with evidence suggesting it promotes cell senescence through specific genes, highlighting DPD's potential as a treatment strategy for HCC.
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This study uncovers the novel heterogeneity of FOXP3 + regulatory T (Treg) cells and their pivotal role in modulating immune responses during drug-induced allergic reactions, employing cutting-edge single-cell transcriptomics. We established a mouse model for drug-induced allergic reactions and utilized single-cell RNA sequencing (scRNA-seq) to analyze the transcriptomic landscapes of FOXP3 + Treg cells isolated from affected tissues. The study involved both in vitro and in vivo approaches to evaluate the impact of FOXP3 expression levels on the immunoregulatory functions of Treg cells during allergic responses.

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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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Bioactive components, pharmacological properties and underlying mechanism of spore oil: A review.

Chin Herb Med

July 2024

Guangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine (Institute of Chinese Medicine), Guangdong Pharmaceutical University, Guangzhou 510006, China.

is a Chinese medicinal fungus with a long history of use in healthcare and disease treatment. spores (GLS) are tiny germ cells released from the mushroom cap during the mature stage of growth. They contain all the genetic active substances of .

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The artificial mucus layer, such as hydrogels, used to repair the damaged intestinal barrier, is a promising treatment for inflammatory bowel disease (IBD). However, the currently reported hydrogel-based artificial barriers are administered via rectal injection, causing unnecessary discomfort to patients. Herein, we report an oral hydrogel precursor solution based on thiol-modified hyaluronic acid (HASH).

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Article Synopsis
  • Decoction (HTD) is a traditional Chinese medicine that has been used for over 2,000 years to treat symptoms of spleen-yang deficiency, but its exact mechanisms for treating chronic diarrhea related to this deficiency are not well understood.
  • This study used a mouse model of chronic diarrhea to examine how HTD affects intestinal bacteria and serum metabolites to improve symptoms.
  • Results showed that HTD significantly reduced weight loss and diarrhea in mice, altered gut bacteria composition, and modulated various metabolic pathways, suggesting it may be effective in managing chronic diarrhea symptoms.
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Oncolytic Activity of Sindbis Virus with the Help of GM-CSF in Hepatocellular Carcinoma.

Int J Mol Sci

June 2024

NMPA Key Laboratory for Research and Evaluation of Viral Vector Technology in Cell and Gene Therapy Medicinal Products, The Brain Cognition and Brain Disease Institute, Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Shenzhen 518055, China.

Hepatocellular carcinoma is a refractory tumor with poor prognosis and high mortality. Many oncolytic viruses are currently being investigated for the treatment of hepatocellular carcinoma. Based on previous studies, we constructed a recombinant GM-CSF-carrying Sindbis virus, named SINV-GM-CSF, which contains a mutation (G to S) at amino acid 285 in the nsp1 protein of the viral vector.

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Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval. However, through virtual bioequivalence (VBE) studies, BCS class II drugs may qualify for biological exemptions if reliable and validated modeling is used. Here, we sought to establish physiologically based pharmacokinetic (PBPK) models, in vitro-in vivo relationship (IVIVR), and VBE models for enteric-coated omeprazole capsules, to establish a clinically-relevant dissolution specification (CRDS) for screening BE and non-BE batches, and to ultimately develop evaluation criteria for generic omeprazole enteric-coated capsules.

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Hydrophilic peptides (HPs) play a critical role in the pathogenesis of hepatocellular carcinoma (HCC). However, the comprehensive and in-depth high-throughput analysis of specific changes in HPs associated with HCC remains unrealized, due to the complex nature of biological fluids and the challenges of mining complex patterns in large data sets. The clinical diagnosis of HCC still lacks a non-destructive and accurate classification method, given the limited specificity of widely used biomarkers.

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Article Synopsis
  • Volatile organic compounds (VOCs) are key contributors to air pollution, and this study investigates their impact on chronic obstructive pulmonary disease (COPD) using various statistical models and machine learning techniques.
  • Conducted on nearly 5,000 participants from the National Health and Nutrition Examination Survey, the research found that higher blood levels of VOCs like benzene and toluene are significantly linked to increased COPD prevalence.
  • The Extreme Gradient Boosting (XGBoost) model proved most effective in predicting COPD risk, highlighting a complex, non-linear relationship between VOC exposure and the disease.
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The microreactor with two types of immobilized enzymes, exhibiting excellent orthogonal performance, represents an effective approach to counteract the reduced digestion efficiency resulting from the absence of a single enzyme cleavage site, thereby impacting protein identification. In this study, we developed a hydrophilic dual-enzyme microreactor characterized by rapid mass transfer and superior enzymatic activity. Initially, we selected KIT-6 molecular sieve as the carrier for the dual-IMER due to its three-dimensional network pore structure.

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Ethnopharmacological Relevance: As a traditional Chinese medicine, the flower of Rhododendron molle G. Don (RMF) is record in the Chinese pharmacopoeia, and is commonly utilized for treating rheumatoid arthritis (RA) in clinical practice. However, its precise mechanisms necessitate further exploration.

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Lipid nanoparticles (LNPs) are emerging as one of the most promising drug delivery systems. The long-circulating effect of intact LNPs (i-LNPs) is the key to efficacy and toxicity . However, the significant challenge is specific and sensitive detection of i-LNPs.

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A Novel Multi-Effect Photosensitizer for Tumor Destruction via Multimodal Imaging Guided Synergistic Cancer Phototherapy.

Int J Nanomedicine

July 2024

Key Laboratory for Green Chemical Engineering Process of Ministry of Education, Hubei Key Laboratory of Novel Reactor and Green Chemical Technology, School of Chemical Engineering and Pharmacy, Wuhan Institute of Technology, Wuhan, People's Republic of China.

Background: How to ingeniously design multi-effect photosensitizers (PSs), including multimodal imaging and multi-channel therapy, is of great significance for highly spatiotemporal controllable precise phototherapy of malignant tumors.

Methods: Herein, a novel multifunctional zinc(II) phthalocyanine-based planar micromolecule amphiphile () was successfully designed and synthesized, in which N atom with photoinduced electron transfer effect was introduced to enhance the near-infrared absorbance and nonradiative heat generation. After simple self-assembling into nanoparticles (NPs), would exhibit enhanced multimodal imaging properties including fluorescence (FL) imaging (FLI) /photoacoustic (PA) imaging (PAI) /infrared (IR) thermal imaging, which was further used to guide the combined photodynamic therapy (PDT) and photothermal therapy (PTT).

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