1.First-in-class drug oroxylin A tablets for treating hepatic and gastrointestinal disorders: from preclinical development to clinical research.
Chengju LUO ; Xuhong LI ; Yuan GAO ; Junyi YANG ; Weiming FANG ; Libin WEI
Chinese Journal of Natural Medicines (English Ed.) 2025;23(7):801-814
Oroxylin A (OA) is a natural flavonoid primarily derived from the plants Oroxylum indicum and Scutellaria baicalensis. Currently, OA is obtainable through chemical synthesis and exhibits polypharmacological properties, including anti-cancer, anti-inflammatory, anti-microbial, and multi-organ protective effects. The first-in-class drug OA tablets are presently undergoing phase Ib/IIa clinical trials for hepatocellular carcinoma (HCC) treatment. Substantial evidence suggests that OA demonstrates therapeutic potential against various hepatic and gastrointestinal (GI) disorders, including HCC, hepatic fibrosis, fatty liver disease, hepatitis, liver injury, colitis, and colorectal cancer (CRC). OA exerts its therapeutic effects primarily by modulating several crucial signaling pathways, including those associated with apoptosis, oxidative stress, inflammation, glucolipid metabolism, and fibrosis activation. The oral pharmacokinetics of OA is characterized by phase II metabolism, hydrolysis, and enterohepatic recycling. This review provides a comprehensive overview of the critical stages involved in the development of OA tablets, presenting a holistic perspective on the progression of this first-in-class drug from preclinical to clinical phases. It encompasses the synthesis of active pharmaceutical ingredients, pharmacokinetics, pharmacological efficacy, toxicology, drug delivery, and recent advancements in clinical trials. Importantly, this review examines the potential mechanisms by which OA may influence the gut-liver axis, hypothesizing that these interactions may confer health benefits associated with OA that transcend the limitations posed by its poor bioavailability.
Humans
;
Flavonoids/pharmacokinetics*
;
Tablets
;
Animals
;
Gastrointestinal Diseases/drug therapy*
;
Liver Diseases/drug therapy*
;
Drug Development
;
Clinical Trials as Topic
;
Scutellaria baicalensis/chemistry*
2.Evaluation of Analytical Performance of an Automated Glycated Hemoglobin Analyzer, HLC-723 G11
Yoo Na CHUNG ; Seung Gyu YUN ; Yunjung CHO
Laboratory Medicine Online 2020;10(1):46-51
Clinical and Laboratory Standard Institute's guidelines. Test results from clinical samples were compared between Tosoh G11 and the routine testing systems, Tosoh G8 and Capillarys 2 Flex Piercing.RESULTS: With respect to the precision of Tosoh G11, the test results for low- and high-concentration controls showed a coefficient of variation of less than 1.1%. Furthermore, the new device exhibited good linearity for HbA(1c) values ranging from 3.4% to 18.8%, and carry-over was not observed. HbA(1c) results for Tosoh G11 (N=143) correlated well with those for Tosoh G8 (r=0.9971) and Capillarys 2 Flex Piercing (r=0.9918).CONCLUSIONS: Tosoh G11 demonstrated reliable analytical performance with good precision and linearity, and no carry-over results. In addition, its results were comparable to those of the existing instruments. Thus, the results of this evaluation suggest that Tosoh G11 is suitable for the routine diagnostic testing of HbA(1c) levels in clinical chemistry laboratories.]]>
Chemistry, Clinical
;
Diagnostic Tests, Routine
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Hemoglobin A, Glycosylated
;
Humans
3.Analysis of Class II Common Problems in the Registration of
Xiaohe YANG ; Qinfang DONG ; Wenwu ZHU ; Hui ZHEN
Chinese Journal of Medical Instrumentation 2020;44(6):537-540
From the perspective of technical review, this paper made statistics on the supplement contents of
Chemistry, Clinical/standards*
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China
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Indicators and Reagents
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Reagent Kits, Diagnostic/standards*
4.A simplified and miniaturized glucometer-based assay for the detection of β-glucosidase activity.
Min-Yi JIN ; Tong ZHANG ; Yi-Shun YANG ; Yue DING ; Jun-Song LI ; Gao-Ren ZHONG
Journal of Zhejiang University. Science. B 2019;20(3):264-272
β-Glucosidase activity assays constitute an important indicator for the early diagnosis of neonatal necrotizing enterocolitis and qualitative changes in medicinal plants. The drawbacks of the existing methods are high consumption of both time and reagents, complexity in operation, and requirement of expensive instruments and highly trained personnel. The present study provides a simplified, highly selective, and miniaturized glucometer-based strategy for the detection of β-glucosidase activity. Single-factor experiments showed that optimum β-glucosidase activity was exhibited at 50 °C and pH 5.0 in a citric acid-sodium citrate buffer when reacting with 0.03 g/mL salicin for 30 min. The procedure for detection was simplified without the need of a chromogenic reaction. Validation of the analytical method demonstrated that the accuracy, precision, repeatability, stability, and durability were good. The linear ranges of β-glucosidase in a buffer solution and rat serum were 0.0873-1.5498 U/mL and 0.4076-2.9019 U/mL, respectively. The proposed method was free from interference from β-dextranase, snailase, β-galactosidase, hemicellulase, and glucuronic acid released by baicalin. This demonstrated that the proposed assay had a higher selectivity than the conventional dinitrosalicylic acid (DNS) assay because of the specificity for salicin and unique recognition of glucose by a personal glucose meter. Miniaturization of the method resulted in a microassay for β-glucosidase activity. The easy-to-operate method was successfully used to detect a series of β-glucosidases extracted from bitter almonds and cultured by Aspergillus niger. In addition, the simplified and miniaturized glucometer-based assay has potential application in the point-of-care testing of β-glucosidase in many fields, including medical diagnostics, food safety, and environmental monitoring.
Animals
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Aspergillus niger
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Calibration
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Cellulase/analysis*
;
Chemistry, Clinical/methods*
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Dextranase/analysis*
;
Enterocolitis, Necrotizing/diagnosis*
;
Equipment Design
;
Flavonoids/analysis*
;
Glucose/analysis*
;
Glucuronic Acid/analysis*
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Glucuronidase/analysis*
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Glycoside Hydrolases/analysis*
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Hydrogen-Ion Concentration
;
Linear Models
;
Multienzyme Complexes/analysis*
;
Plants, Medicinal
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Polygalacturonase/analysis*
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Rats
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Reproducibility of Results
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beta-Galactosidase/analysis*
;
beta-Glucosidase/analysis*
5.Design and Laboratory Implementation of Web Application for Collaboratively Setting Reference Intervals
Byung Ryul JEON ; Yong Wha LEE
Journal of Laboratory Medicine and Quality Assurance 2019;41(3):166-171
BACKGROUND: Although the same equipment and reagents can be employed for inspecting identical samples, the setting and verification methods for the corresponding reference intervals differ from each other, and such methods are not well established. To address the issues associated with establishing and validating reference intervals, a Web-based application is proposed for collaboratively setting reference intervals. METHODS: A Web application was designed for automatically providing the statistical results associated with a reference interval upon receiving the corresponding test results from participating institutions and incorporating the cumulative data. RESULTS: By employing the proposed Web-based application (www.referencerange.org), reference intervals can be collaboratively set based on objective and statistical analyses incorporating clinical chemistry results obtained from Korea Healthcare Association in the years 2016 and 2017. Cumulative data obtained from the existing input peer group associated with an inspection are updated in real time, and the current set reference interval is displayed in real time. CONCLUSIONS: In this study, a Web-based application is designed for collaboratively setting reference intervals whereby all Korean laboratories can easily participate, collectively set reference intervals, and apply the set reference intervals. Hence, the proposed application can aid in providing basic data associated with health information.
Chemistry, Clinical
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Delivery of Health Care
;
Indicators and Reagents
;
Korea
;
Peer Group
6.A Questionnaire Survey on General Status and Opinions about Clinical Mass Spectrometric Analysis in Korea (2018)
Sung Eun CHO ; Hyojin CHAE ; Hyung Doo PARK ; Sail CHUN ; Yong Wha LEE ; Yeo Min YUN ; Sang Hoon SONG ; Sang Guk LEE ; Kyunghoon LEE ; Junghan SONG ; Soo Youn LEE ;
Laboratory Medicine Online 2019;9(3):161-165
The Clinical Mass Spectrometry Research Committee (CMSRC), in affiliation with the Korean Society of Clinical Chemistry (KSCC), conducted a questionnaire survey on opinions about the general status of clinical mass spectrometric analysis in Korea. As a result, we understand that this field has passed through the introductory stage and is settled as a field of clinical laboratory testing in Korea, with the number of new laboratories performing mass spectrometric analysis being low. In spite of the many difficulties in introducing and operating clinical mass spectrometric analysis, there is a strong interest in this field, and even though further expansion is expected, there are still many issues to be resolved. In the future, it will be necessary to make concrete and thorough efforts to further develop the laboratory tests using clinical mass spectrometric analysis in Korea, centering on the CMSRC affiliated with the KSCC.
Chemistry, Clinical
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Korea
;
Mass Spectrometry
7.Iodine Deficiency in Neonates: Where Do We Stand After a Quarter Century of Initiating Iodization Programs?
Lena JAFRI ; Hafsa MAJID ; Sibtain AHMED ; Imran SIDDIQUI ; Farooq GHANI ; Aysha Habib KHAN
Laboratory Medicine Online 2019;9(4):232-235
An observational study was conducted at the Section of Clinical Chemistry, Department of Pathology and Laboratory Medicine, to assess the iodine status using the World Health Organization (WHO), United Nations International Children's Emergency Fund (UNICEF), and the International Council for Control of Iodine Deficiency Disorders (ICCIDD) consensus criteria, which state that >3% prevalence of serum thyroid stimulating hormone (TSH) ≥10 mIU/L in the population is an indicator of iodine deficiency. Serum neonatal TSH was analyzed from January to December 2013. In a period of one year, a total of 11,597 neonates with the mean (25 percentile, 75 percentile value) age of 2.0 days (0.5–3.5) were tested for serum TSH. The overall mean TSH level was 3.38 mIU/L (5.63–1.96), with optimal levels (1–39 mIU/L) in 93%, <1 mIU/L in 6.3%, and ≥40 mIU/L in 0.3% neonates. Of all the neonates, 7.9% (N=916) showed TSH ≥10 mIU/L which is higher than the recommended WHO/UNICEF/ICCIDD criteria for mild endemicity for iodine deficiency in the population. These results suggest that iodine deficiency is still prevalent in our population, indicating a need for effective intervention programs and increasing awareness regarding the use of iodized salt and supplementation in all reproductive-aged women to prevent iodine deficiency in neonates.
Chemistry, Clinical
;
Congenital Hypothyroidism
;
Consensus
;
Emergencies
;
Female
;
Financial Management
;
Humans
;
Infant, Newborn
;
Iodine
;
Observational Study
;
Pathology
;
Prevalence
;
Thyrotropin
;
United Nations
;
World Health Organization
8.Comparison of Method Group Precision in Proficiency Testing of Clinical Chemistry Tests Before and After Two Major Changes: Reorganization of Proficiency Testing and Implementation of the Differential Benefit for the Quality of Laboratory Tests
Annals of Laboratory Medicine 2019;39(3):333-339
No abstract available.
Chemistry, Clinical
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Clinical Chemistry Tests
;
Methods
9.Effectiveness of omega-3 polyunsaturated fatty acids against microbial pathogens.
Warren CHANDA ; Thomson P JOSEPH ; Xue-Fang GUO ; Wen-Dong WANG ; Min LIU ; Miza S VUAI ; Arshad A PADHIAR ; Min-Tao ZHONG
Journal of Zhejiang University. Science. B 2018;19(4):253-262
Microorganisms provide both beneficial and harmful effects to human beings. Beneficial effects come from the symbiotic relationship that exists between humans and microbiota, but then several human illnesses have turned some friendly microbes into opportunistic pathogens, causing several microbial-related diseases. Various efforts have been made to create and utilize antimicrobial agents in the treatment and prevention of these infections, but such efforts have been hampered by the emergence of antimicrobial resistance. Despite extensive studies on drug discovery to alleviate this problem, issues with the toxicity and tolerance of certain compounds and continuous microbial evolution have forced researchers to focus on screening various phytochemical dietary compounds for antimicrobial activity. Linolenic acid and its derivatives (eicosapentaenoic acid and docosahexaenoic acid) are omega-3 fatty acids that have been studied due to their role in human health, being important for the brain, the eye, the cardiovascular system, and general human growth. However, their utilization as antimicrobial agents has not been widely appreciated, perhaps due to a lack of understanding of antimicrobial mechanisms, toxicity, and route of administration. Therefore, this review focuses on the efficacy, mechanism, and toxicity of omega-3 fatty acids as alternative therapeutic agents for treating and preventing diseases associated with pathogenic microorganisms.
Animals
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Animals, Genetically Modified
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Anti-Infective Agents/chemistry*
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Antioxidants/chemistry*
;
Bacterial Infections/microbiology*
;
Cell Membrane/drug effects*
;
Clinical Trials as Topic
;
Docosahexaenoic Acids/chemistry*
;
Drug Resistance, Bacterial
;
Eicosapentaenoic Acid/chemistry*
;
Fatty Acids, Omega-3/chemistry*
;
Fishes
;
Humans
;
Lipids/chemistry*
;
Mice
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Microbiota
;
Rats
;
alpha-Linolenic Acid/chemistry*
10.Usefulness of P(50,std) for the Diagnostic Work-up of Patients with Erythrocytosis.
Journal of Laboratory Medicine and Quality Assurance 2018;40(1):46-49
High oxygen-affinity hemoglobin (Hb) variants and a 2,3-diphosphoglycerate (2,3-DPG) deficiency could cause congenital (familial) erythrocytosis. High oxygen-affinity Hb variants and a 2,3-DPG deficiency might result in low tissue oxygen tension left-shifted oxygen dissociation curves and reduction in the standard P₅₀ value (P(50,std), oxygen tension at which haemoglobin is 50% saturated). Hence, the P(50,std) value is considered while formulating diagnostic strategies for erythrocytosis. In this study, we established a reference range for P(50,std) using an International Federation of Clinical Chemistry and Laboratory Medicine-approved equation (Hill's equation) for individual single venous/arterial blood samples. Blood gas analysis results of 243 samples with oxygen saturation ranging from 40%–90% (Hb < 16 mg/dL) were selected. The reference range of P(50,std) was in the 2.5th–97.5th percentile, and was 25.9–27.3 mm Hg. Hill's equation is a simple approved method for evaluating the P(50,std) values. Only a single sample of venous or arterial blood and a blood gas analyser are required to obtain the P(50,std). Our study provides a useful tool for the diagnostic work-up of patients with erythrocytosis.
2,3-Diphosphoglycerate
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Blood Gas Analysis
;
Chemistry, Clinical
;
Humans
;
Methods
;
Oxygen
;
Polycythemia*
;
Reference Values

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