• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.59-88
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• 2021

The National Assembly of the Republic of Korea recently enacted laws to fortify sanctions about data manipulation of pharmaceutical companies. The medicine approval system is the result of legislative efforts to prevent accidents that caused damages to patients' life and health. The medicine approval system is based on the trust that the data submitted by pharmaceutical companies is not manipulated. The Supreme Court of Korea clarified that strict standard shoud be required to secure the medicine safety in Supreme Court Decision 2008Du8628 decided November 13, 2008. We agree. This paper suggest legislation to weaken the economic incentives for pharmaceutical companies to choose data manipulation by minimizing the expected profit. In addition to revoking the marketing authorization of the medicine, the 'unfair' profits the pharmaceutical company has earned must be recovered. In addition, in order to increase the possibility to discover data manipulation, it is necessary to strengthen the review capacity and to activate the whistle-blowing.

• The Journal of Internal Korean Medicine
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• v.43 no.4
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• pp.559-566
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• 2022

Introduction: The aim of this systematic review is to provide evidence confirming the efficacy and safety of herbal medicines used in the treatment of liver cancer. Methods: The review will include randomized clinical trials that compared herbal medicines used as treatments for liver cancer with other therapies, such as placebos and Western medicine. Only randomized controlled trials will be included in this review, and all types of herbal medicine will be evaluated. Eleven electronic databases will be searched from the inception date: the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, AMED, CINAHL, one Chinese database (CNKI), and five Korean databases (OASIS, DBpia, RISS, KISS, and NDSL). The selection of studies, data extraction, and management will be performed independently by four researchers. Methodological quality, including the risk of bias, will be assessed using the Cochrane risk-of-bias assessment tool. Results: The review of current evidence for the effectiveness of herbal medicine for liver cancer will be summarized and quantitatively analyzed. Conclusions: Our systematic review will provide evidence of the efficacy of herbal medicines as treatments for liver cancer. This evidence will provide useful information for practitioners and patients in the fields of oncology and complementary medicine.

• Journal of Life Science
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• v.31 no.12
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• pp.1128-1141
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• 2021

'Angelica' is one of the most traditionally consumed medicinal herbs around Northeast Asia including Korea for treatments of various diseases or health care purposes like hematopoiesis, blood circulation for women, sedative, analgesic, and a tonic medicine etc. Angelica gigas Nakai, a Korean native species of Angelica, is clearly different from the others in containing a high concentration of active ingredients like pyranocoumarines including decursin, decursinol, and decursinol angelate. These compounds have various kinds of positive effects such as anti-tumor activity including the precaution of neutropenia occurred during anticancer drug administration, improvements of metabolic disorders, menstrual irregularity, impairment of renal function, respiration improvement, cognition-enhancement, anti-inflammatory effect, anti-oxidative effect, enhancing fertility and so forth. Thus it implies incredible potentialities in future development for foods and drugs. However, certain purity-related qualities and/or overdose in food products can cause side effects like toxicities; therefore, their safety profiles should also be considered. This review focuses on the positive and negative effects of three pyranocoumarines in Angelica gigas Nakai and some possibilities and considerations for future food and drug products development.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.48 no.4
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• pp.303-312
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• 2022

In this study, Cyperus rotundus (C. rotundus) was fractionated into ethyl acetate to identify α-cyperone, a representative indicator, and its ethyl acetate fraction were evaluated to confirm the possibilityas a functional cosmetic ingredient. As a result of HPLC analysis, it was confirmed that the content of α-cyperone was 5.243%. In order to verify the inflammatory relief effect of the ethyl acetate fraction from C. rotundus (EAFC) and α-cyperone, it was confirmed that nitric oxide (NO) production inhibitory ability in RAW 264.7 macrophages induced an inflammatory reaction with lipopolysaccharide (LPS). Real-time qPCR analysis confirmed inhibition of mRNA expression level of inflammatory factors, IL-1β, IL-6, TNF-α, COX-2 and iNOS. As a results of conducting a clinical study using a simple cosmetic formulation containing EAFC, it was confirmed that the skin irritation stimulated by sodium lauryl sulfate (SLS) was calming and relieving itching. Through these results, it is believed that the C. rotundus can be used as a natural cosmetic ingredient that has the effect of inhibiting inflammation and relieving itching.

• The Korea Journal of Herbology
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• v.36 no.6
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• pp.27-37
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• 2021

Objectives : In the current study, we performed the 13-week repeated oral dose toxicity test and a 4-week recovery test of standardized Cornus officinalis Sieb. et Zucc. and Psoralea corylifolia L. 30 % ethanol extract (SCP) in Sprague-Dawley (SD) rats owing to aims for verifying no observed adverse effect level (NOAEL). Methods : The animal study was performed according to OECD guidelines for the testing of chemicals section 4 health effects test No.408 repeated dose 90-day oral toxicity study in rodents (03 October 2008). In the repeated dose toxicity study, SCP was orally administered to female and male rats at dose levels of 1,000, 2,000, and 4,000 mg/kg/day for 13-week. The control group and high dose (4,000 mg/kg/day) group were then monitored for 4 extra weeks to determine recovery time after the study period. 1) Results : Compared with the control group, there were no treatment-related adverse effects in clinical signs, body weight, hematology, serum biochemistry (Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase, 𝛾-Glutamyl transpeptidase, Blood urea nitrogen, Creatinine, Glucose, Total cholesterol, Total protein, Creatine phosphokinase, Albumin, Total bilirubin, Triglyceride, Inorganic phosphorus, Albumin/Globulin ratio, Calcium ion, Sodium ion, Potassium ion, Chloride ion), necropsy findings and organ weight (Ovary, Adrenal gland, Pituitary, Thymus, Prostate, Testis, Epididymis, Spleen, Kidney, Heart, Lung, Brain, Liver) at any dose tested. Conclusions : Taken together, these results suggest that the NOAEL of SCP in both genders was considered as over 4,000 mg/kg. Results from this study provide scientific evidence for the safety of SCP.

• Journal of Life Science
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• v.32 no.5
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• pp.368-374
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• 2022

In this study, the effects of UV irradiation-enhanced ergocalciferol (vitamin D₂) content containing Lentinula edodes extract on inflammation and allergic responses were investigated in vitro. The anti-inflammatory and anti-allergic effects of the mushroom extract were tested by estimating the cytokine secretions, such as TNF-α, IL-6, and IL-1β in LPS-activated macrophages (RAW 264.7), or histamine release in PMA and A23187-activated mast cells (RBL-2H3). Under the condition of macrophage activation with LPS, mushroom extract significantly reduced the secretions of pro-inflammatory cytokines, TNF-α and IL-6, and their mRNA expression also matched the observation. The current mushroom extract also significantly reduced the amount of mast cell degranulation-induced histamine secretion from PMA- and A23187-treated mast cells as well as the reduced secretion of IL-4. These results suggest that mushroom extract, which has increased ergocalciferol content by UV irradiation, inhibits the expression of cytokines in inflammation and allergic reactions; therefore, it can be used effectively for the prevention and treatment of inflammatory and allergic diseases.

• Journal of Life Science
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• v.33 no.3
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• pp.268-276
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• 2023

This study was conducted to optimize the formulation conditions of the immediate-release layer of carvedilol in the development of a two-layer tablet formulation for carvedilol and ivabradine. Using a 2⁴+3 full-factorial design of experiments, excipients (microcrystalline cellulose, citric acid, and crospovidone) of the carvedilol immediate-release layer (wet granulation part) and process parameters for the tablet compression process (main compression) were optimized, and seven types of each dependent variable (assay, content uniformity, hardness, friability, disintegration, and dissolution [pH 1.2 and 6.8]) were evaluated using design expert software. The analysis of variance results confirmed that the main compression has a significant effect on hardness, friability, and disintegration time and that microcrystalline cellulose has a major effect on friability and dissolution. In addition, it was confirmed that citric acid has a significant effect on friability. Crospovidone affects friability and dissolution. According to the design space from the design of the experiment results, the optimized range is microcrystalline cellulose (~18.0-32.0 mg), citric acid (~0.5-12 mg), and main compression (~615-837 kgf). Consequently, this study confirmed the availability of manufacturing the carvedilol immediate-release layer in which all risk factors evaluated in the initial risk assessment are removed.

• Journal of Life Science
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• v.33 no.9
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• pp.754-765
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• 2023

Exosomes are a type of extracellular vesicle containing proteins and messenger and microRNAs; they are secreted by all cell types. Once released, exosomes are selectively taken up by other cells adjacent or at a distance, releasing their contents and reprogramming the target cells. Since exosomes are natural vesicles produced by cells as small sizes, it is generally accepted that exosomes have a non-toxic nature and non-immunogenic behaviors. Recently, exosomes have elicited scientific attention as drug delivery vehicles to the central nervous system. The central nervous system has a blood-brain barrier that makes it difficult for drugs to penetrate. Thus, the blood-brain barrier has been a major obstacle to the development of drugs for treating neurodegenerative diseases. However, accumulating evidence suggests that exosomes can cross the blood-brain barrier primarily through transcytosis. Consequently, exosomes are expected to become a new delivery vehicle that can cross the blood-brain barrier and deliver drugs into the brain parenchyma. In addition, since different types of exosomes are secreted depending on the cell type and disease state, exosomes can also be utilized as biomarkers for the diagnosis of diseases in the central nervous system. In this review, we summarized recent research trends on exosomes, including clinical trials as biomarkers and treatment options for diseases in the central nervous system.

• Journal of Dental Rehabilitation and Applied Science
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• v.39 no.1
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• pp.1-8
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• 2023

Purpose: The purpose of this study is to analyze the prognostic factors related to tooth loss after 5 years of periodontal surgery in periodontal disease patients. Materials and Methods: From January to December 2017, 22 patients and 124 teeth who underwent periodontal treatment through periodontal surgery were targeted. At the time of treatment, the measured values were evaluated after recording the maximum probing depth, average periodontal probing depth, number of root, furcation involvement, pulp vitality, and prosthesis state on the day of periodontal surgery. Based on the initial records at the time of visit, patient-related factors were gender, age, smoking, tooth loss due to periodontal disease at the time of first visit, diabetes, and maintenance period. The influence of each factor on tooth loss was evaluated. Results: As a result of examining the influence of tooth-related factors on tooth loss, the maximum probing depth depth (P: 0.000), bone loss (P: 0.021) was found to have a significant effect on tooth loss. Conclusion: As a result of examining the influence of patient-related factors on tooth loss, any variables had no significant effect. Bone loss, maximum probing depth acted as statistically significant prognostic factors for tooth loss in patients who underwent periodontal surgery.

• Journal of Convergence for Information Technology
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• v.12 no.3
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• pp.132-140
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• 2022

This study was conducted to identify the optimal lotion manufacturing conditions with decursin and decursinol angelate of Angelica gigas Nakai extraction. Lotion was confirmed that it had viscosity (5,208±112 cPs), assay (99.71±1.01%), and pH (5.62) for 3 months. The optimization of manufacturing conditions of mixing 4 for lotion formulation were made by 22+3 full factorial design. Mixing temperature (40-80℃) and mixing time (10-30 min) were used as independent variables with three responses(assay, pH, and weight variation) as critical quality attributes (CQAs). The model for assay and weight variation identified a proper fit having a determination coefficient of the regression equation (about 0.9) and a p-value less than 0.05. Estimated conditions for the optimal manufacturing process of lotion were 61.93℃ in mixing temperature and 15.85 min in mixing time. Predicted values at the mixing temperature (60℃) and mixing time (20 min) were 100.69% of assay, 5.57 of pH, and 98.07% of weight variation. In the verification of the actual measurement the obtained values showed 100.29±0.98% of assay, 5.57±0.02 of pH, and 98.27±0.89% of weight variation, respectively, in good agreement with predicted values.