Journal of Pharmaceutical Analysis最新文献

{"title":"Traditional Chinese Medicine Pien-Tze-Huang ameliorates LPS-induced sepsis through bile acid-mediated activation of TGR5-STAT3-A20 signaling","authors":"Bei Li, Yong Zhang, Xinyuan Liu, Ziyang Zhang, Shuqing Zhuang, Xiaoli Zhong, WenBo Chen, Yilin Hong, Pingli Mo, Shuhai Lin, Shicong Wang, Chundong Yu","doi":"10.1016/j.jpha.2023.12.005","DOIUrl":"https://doi.org/10.1016/j.jpha.2023.12.005","url":null,"abstract":"<p>Pien Tze Huang (PZH), a Class I nationally protected Traditional Chinese Medicine (TCM), has been used to treat liver diseases such as hepatitis; however, the effect of PZH on the progression of sepsis is unknown. Here, we reported that PZH attenuated lipopolysaccharide (LPS)-induced sepsis in mice and reduced LPS-induced production of proinflammatory cytokines in macrophages by inhibiting the activation of mitogen-activated protein kinase (MAPK) and nuclear factor-kappa B (NF-κB) signalling. Mechanistically, PZH stimulated signal transducer and activator of transcription 3 (STAT3) phosphorylation to induce the expression of A20, which could inhibit the activation of NF-κB and MAPK signalling. Knockdown of the bile acid (BA) receptor G protein-coupled bile acid receptor 1 (TGR5) in macrophages abolished the effects of PZH on STAT3 phosphorylation and A20 induction, as well as the LPS-induced inflammatory response, suggesting that BAs in PZH may mediate its anti-inflammatory effects by activating TGR5. Consistently, deprivation of BAs in PZH by cholestyramine resin reduced the effects of PZH on the expression of phosphorylated-STAT3 and A20, the activation of NF-κB and MAPK signalling, and the production of proinflammatory cytokines, whereas the addition of BAs to cholestyramine resin-treated PZH partially restored the inhibitory effects on the production of proinflammatory cytokines. Overall, our study identifies BAs as the effective components in PZH that activate TGR5-STAT3-A20 signalling to ameliorate LPS-induced sepsis.</p>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"3 1","pages":""},"PeriodicalIF":8.8,"publicationDate":"2023-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138574464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Basic Regulatory Science Behind Drug Substance and Drug Product Specifications of Monoclonal Antibodies and Other Protein Therapeutics","authors":"Patanachai K. Limpikirati, Sorrayut Mongkoltipparat, Thinnaphat Denchaipradit, Nathathai Siwasophonpong, Wudthipong Pornnopparat, Parawan Ramanandana, Phumrapee Pianpakt, Songsak Tongchusak, Maoxin Tim Tian, Trairak Pisitkun","doi":"10.1016/j.jpha.2023.12.006","DOIUrl":"https://doi.org/10.1016/j.jpha.2023.12.006","url":null,"abstract":"<p>In this review, we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance. Pharmaceutical specifications comprise a list of important quality attributes for testing, references to use for test procedures, and appropriate acceptance criteria for the tests, and they are set up to ensure that when a drug product is administered to a patient, its intended therapeutic benefits and safety can be rendered appropriately. Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance criteria. Quality attributes are chosen to be tested based on their quality risk, and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the specifications. Acceptance criteria are set forth primarily based on efficacy and safety profiles, with an increasing attention noted for patient-centric specifications. Discussed in this work are related guidelines that support the biopharmaceutical specification setting, how to set the acceptance criteria, and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial monographs. Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.</p>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"172 1","pages":""},"PeriodicalIF":8.8,"publicationDate":"2023-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138574454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Model informed Precision Medicine of Chinese Herbal Medicines Formulas- A Multi-scale Mechanistic Intelligent Model","authors":"Yuanyuan Qian, Xiting Wang, Lulu Cai, Jiangxue Han, Zhu Huang, Yahui Lou, Bingyue Zhang, Yanjie Wang, Xiaoning Sun, Yan Zhang, Aisong Zhu","doi":"10.1016/j.jpha.2023.12.004","DOIUrl":"https://doi.org/10.1016/j.jpha.2023.12.004","url":null,"abstract":"<p>Recent trends suggest that Chinese herbal medicine formulas (CHM formulas) are promising treatments for complex diseases. To characterize the precise syndromes, precise diseases and precise targets of the precise targets between complex diseases and CHM formulas, we developed an artificial intelligence-based quantitative predictive algorithm (DeepTCM). DeepTCM has gone through multilevel model calibration and validation against a comprehensive set of herb and disease data so that it accurately captures the complex cellular signaling, molecular and theoretical levels of traditional Chinese medicine (TCM). As an example, our model simulated the optimal CHM formulas for the treatment of coronary heart disease (CHD) with depression, and through model sensitivity analysis, we calculated the balanced scoring of the formulas. Furthermore, we constructed a biological knowledge graph representing interactions by associating herb-target and gene-disease interactions. Finally, we experimentally confirmed the therapeutic effect and pharmacological mechanism of a novel model-predicted intervention in humans and mice. This novel multiscale model opened up a new avenue to combine “disease syndrome” and \"macro micro\" system modeling to facilitate translational research in CHM formulas.</p>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"8 1","pages":""},"PeriodicalIF":8.8,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138574453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"GLP-1 receptor agonists and myocardial metabolism in atrial fibrillation","authors":"Jiani Zhong, Hang Chen, Qiming Liu, Shenghua Zhou, Zhenguo Liu, Yichao Xiao","doi":"10.1016/j.jpha.2023.12.007","DOIUrl":"https://doi.org/10.1016/j.jpha.2023.12.007","url":null,"abstract":"<p>Atrial fibrillation (AF) is the most common cardiac arrhythmia. Many medical conditions, including hypertension, diabetes, obesity, sleep apnea, and heart failure, increase the risk for AF. Cardiomyocytes have unique metabolic characteristics to maintain adenosine triphosphate production. Significant changes occur in myocardial metabolism in AF. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have been used to control blood glucose fluctuations and weight in the treatment of type 2 diabetes and obesity. GLP-1RAs have also been shown to reduce oxidative stress, inflammation, autonomic nervous system modulation, and mitochondrial function. This article reviews the changes in metabolic characteristics in cardiomyocytes in AF. Although the clinical trial outcomes are unsatisfactory, the findings demonstrate that GLP-1 RAs can improve myocardial metabolism in the presence of various risk factors, lowering the incidence of AF.</p>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"15 1","pages":""},"PeriodicalIF":8.8,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138574841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alginate oligosaccharide-mediated butyrate-HIF-1α axis improves skin aging in mice","authors":"Ting Gao, Yixuan Li, Xiaoyu Wang, Fazheng Ren","doi":"10.1016/j.jpha.2023.12.001","DOIUrl":"https://doi.org/10.1016/j.jpha.2023.12.001","url":null,"abstract":"<p>The “gut-skin” axis has been proved and is considered as a novel therapy for the prevention of skin aging. The antioxidant efficacy of oligomannonic acid (MAOS), make it an intriguing target for use to improve skin aging. The present study further explored whereby MAOS-mediated gut-skin axis balance prevented skin aging in mice. The data indicated there was a skin aging phenotypes, oxidative stress, skin mitochondrial dysfunction and intestinal dysbiosis (especially the butyrate and HIF-1α levels decreased) in aging mice. Similarly, fecal microbiota transplantation (FMT) from aging mice rebuild the aging-like phenotypes. Further, we demonstrated MAOS-mediated colonic butyrate-HIF-1α axis homeostasis promoted the entry of butyrate into the skin, up-regulated mitophagy level and ultimately improving skin aging via HDAC3/PHD/HIF-1α/mitophagy loop in skin of mice. Overall, our study offered a better insights of the effectiveness of AOS, promised to become a personalized targeted therapeutic agents, on gut-skin axis disorder inducing skin aging.</p>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"12 1","pages":""},"PeriodicalIF":8.8,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138555590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anti-inflammatory natural products modulate interleukins and their related signaling markers in inflammatory bowel disease: A systematic review","authors":"Gopalsamy Rajiv Gandhi ,&nbsp;Thiruchenduran Mohana ,&nbsp;Kumaraswamy Athesh ,&nbsp;Varghese Edwin Hillary ,&nbsp;Alan Bruno Silva Vasconcelos ,&nbsp;Mariana Nobre Farias de Franca ,&nbsp;Monalisa Martins Montalvão ,&nbsp;Stanislaus Antony Ceasar ,&nbsp;Gnanasekaran Jothi ,&nbsp;Gurunagarajan Sridharan ,&nbsp;Ricardo Queiroz Gurgel ,&nbsp;Baojun Xu","doi":"10.1016/j.jpha.2023.09.012","DOIUrl":"10.1016/j.jpha.2023.09.012","url":null,"abstract":"<div><p>This review aims to identify in vivo studies investigating the potential of plant substances and their natural molecules in managing inflammatory bowel disease (IBD). Specifically, the objective is to examine the impact of these substances on interleukins and other key inflammatory signaling markers. Relevant articles published up to December 2022 were identified through a search of the PubMed, Scopus, Web of Science, and Embase databases. The search used keywords including “inflammatory bowel disease”, “medicinal plants”, “natural molecules”, “anti-inflammatory”, and “ulcerative colitis”, and identified 1,878 potentially relevant articles, of which 89 were included in this review after completion of the selection process. This study provides preclinical data on natural products (NPs) that can potentially treat IBD, including ulcerative colitis. The main actions of these NPs relate to their effects on nuclear factor kappa B (NF-κB), the Janus kinase (JAK)/signal transducer and activator of transcription (STAT) signaling pathway, the regulation of T helper 17/regulatory T cells balance, and oxidative stress. The ability of these NPs to inhibit intestinal inflammation appears to be dependent on lowering levels of the pro-inflammatory cytokines tumor necrosis factor-alpha (TNF-α), interleukin (IL)-1β, and IL-17, via the Jun N-terminal kinase (JNK)1, NF-κβ-p65, and STAT3 pathways. In addition, NPs were shown to reduce oxidative stress and the severity of ulcerative colitis, as well as increase the activity of antioxidant enzymes. These actions suggest that NPs represent a promising treatment for IBD, and potentially have greater efficacy and safety than current treatments.</p></div>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"13 12","pages":"Pages 1408-1428"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2095177923002502/pdfft?md5=d37cc949ec742bf908aa2b5676379053&pid=1-s2.0-S2095177923002502-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135433644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interactions of naturally occurring compounds with antimicrobials","authors":"Izabela Malczak,&nbsp;Anna Gajda","doi":"10.1016/j.jpha.2023.09.014","DOIUrl":"10.1016/j.jpha.2023.09.014","url":null,"abstract":"<div><p>Antibiotics are among the most often used medications in human healthcare and agriculture. Overusing these substances can lead to complications such as increasing antibiotic resistance in bacteria or a toxic effect when administering large amounts. To solve these problems, new solutions in antibacterial therapy are needed. The use of natural products in medicine has been known for centuries. Some of them have antibacterial activity, hence the idea to combine their activity with commercial antibiotics to reduce the latter's use. This review presents collected information on natural compounds (terpenes, alkaloids, flavonoids, tannins, sulfoxides, and mycotoxins), of which various drug interactions have been observed. Many of the indicated compounds show synergistic or additive interactions with antibiotics, which suggests their potential for use in antibacterial therapy, reducing the toxicity of the antibiotics used and the risk of further development of bacterial resistance. Unfortunately, there are also compounds which interact antagonistically, potentially hindering the therapy of bacterial infection. Depending on its mechanism of action, each compound can behave differently in combination with different antibiotics and when acting against various bacterial strains.</p></div>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"13 12","pages":"Pages 1452-1470"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2095177923002526/pdfft?md5=3f4063f661c001cbfbeaac064bedb2b2&pid=1-s2.0-S2095177923002526-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135434405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrated mass spectrometry imaging reveals spatial-metabolic alteration in diabetic cardiomyopathy and the intervention effects of ferulic acid","authors":"Yanhua Liu ,&nbsp;Xin Zhang ,&nbsp;Shu Yang ,&nbsp;Zhi Zhou ,&nbsp;Lu Tian ,&nbsp;Wanfang Li ,&nbsp;Jinfeng Wei ,&nbsp;Zeper Abliz ,&nbsp;Zhonghua Wang","doi":"10.1016/j.jpha.2023.08.011","DOIUrl":"10.1016/j.jpha.2023.08.011","url":null,"abstract":"<div><p>Diabetic cardiomyopathy (DCM) is a metabolic disease and a leading cause of heart failure among people with diabetes. Mass spectrometry imaging (MSI) is a versatile technique capable of combining the molecular specificity of mass spectrometry (MS) with the spatial information of imaging. In this study, we used MSI to visualize metabolites in the rat heart with high spatial resolution and sensitivity. We optimized the air flow-assisted desorption electrospray ionization (AFADESI)-MSI platform to detect a wide range of metabolites, and then used matrix-assisted laser desorption ionization (MALDI)-MSI for increasing metabolic coverage and improving localization resolution. AFADESI-MSI detected 214 and 149 metabolites in positive and negative analyses of rat heart sections, respectively, while MALDI-MSI detected 61 metabolites in negative analysis. Our study revealed the heterogenous metabolic profile of the heart in a DCM model, with over 105 region-specific changes in the levels of a wide range of metabolite classes, including carbohydrates, amino acids, nucleotides, and their derivatives, fatty acids, glycerol phospholipids, carnitines, and metal ions. The repeated oral administration of ferulic acid during 20 weeks significantly improved most of the metabolic disorders in the DCM model. Our findings provide novel insights into the molecular mechanisms underlying DCM and the potential of ferulic acid as a therapeutic agent for treating this condition.</p></div>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"13 12","pages":"Pages 1496-1509"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2095177923001995/pdfft?md5=6de13216fc9fbadc6b9c60e6b6fe5a75&pid=1-s2.0-S2095177923001995-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48969822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ginsenoside Rc: A potential intervention agent for metabolic syndrome","authors":"Zhengjie Lu ,&nbsp;Tongyun Mao ,&nbsp;Kaiqi Chen ,&nbsp;Longxin Chai ,&nbsp;Yongguo Dai ,&nbsp;Kexin Liu","doi":"10.1016/j.jpha.2023.08.013","DOIUrl":"10.1016/j.jpha.2023.08.013","url":null,"abstract":"<div><p>Ginsenoside Rc, a dammarane-type tetracyclic triterpenoid saponin primarily derived from <em>Panax ginseng</em>, has garnered significant attention due to its diverse pharmacological properties. This review outlined the sources, putative biosynthetic pathways, extraction, and quantification techniques, as well as the pharmacokinetic properties of ginsenoside Rc. Furthermore, this study explored the pharmacological effects of ginsenoside Rc against metabolic syndrome (MetS) across various phenotypes including obesity, diabetes, atherosclerosis, non-alcoholic fatty liver disease, and osteoarthritis. It also highlighted the impact of ginsenoside Rc on multiple associated signaling molecules. In conclusion, the anti-MetS effect of ginsenoside Rc is characterized by its influence on multiple organs, multiple targets, and multiple ways. Although clinical investigations regarding the effects of ginsenoside Rc on MetS are limited, its proven safety and tolerability suggest its potential as an effective treatment option.</p></div>","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"13 12","pages":"Pages 1375-1387"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2095177923002022/pdfft?md5=8c8b3fb575597deb2177c7266dac940d&pid=1-s2.0-S2095177923002022-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43630093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimization of nucleic acid extraction methods for rapid detection in pandemic situations or diseases with high prevalence","authors":"Hesti Lina Wiraswati ,&nbsp;Ilma Fauziah Ma'ruf ,&nbsp;Savira Ekawardhani ,&nbsp;Lia Faridah ,&nbsp;Amila Laelalugina ,&nbsp;Harry Septanto ,&nbsp;Imam Damar Djati ,&nbsp;Shabarni Gaffar ,&nbsp;Asif Awaludin","doi":"10.1016/j.jpha.2023.08.005","DOIUrl":"10.1016/j.jpha.2023.08.005","url":null,"abstract":"","PeriodicalId":16737,"journal":{"name":"Journal of Pharmaceutical Analysis","volume":"13 12","pages":"Pages 1577-1579"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2095177923001958/pdfft?md5=e4526f43562d7c62a65aeef2d75eab04&pid=1-s2.0-S2095177923001958-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54704096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}