• Title/Summary/Keyword: control drug

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Bioequivalence Study of Toriem® Tablet to Motilium-M® Tablet (Domperidone Maleate 12.72 mg) Evaluated by Liquid Chromatography/Tandem Mass Spectrometry

  • Ryu, Ju-Hee;Choi, Sang-Jun;Lee, Myung-Jae;Lee, Jin-Sung;Kang, Jong-Min;Tak, Sung-Kwon;Seo, Ji-Hyung;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.39 no.1
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    • pp.65-71
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    • 2009
  • The aim of the present study was to evaluate the bioequivalence of two domperidone maleate tablets, Motilium-$M^{(R)}$ Tablet (Janssen Korea Ltd., reference product) and $Toriem^{(R)}$ Tablet (Daewon Pharm. Co., Ltd., test product). Domperidone was extracted by liquid-liquid extraction using tert-butyl methyl ether and separated in less than 3 min on $C_{18}$ reverse-phase column using an isocratic elution. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z $426.1{\rightarrow}119.1$ and the m/z $837.4{\rightarrow}158.2$ transitions for domperidone and the internal standard (roxithromycin), respectively. Calibration curves, from $0.05{\sim}50$ ng/mL of domperidone, showed correlation coefficients (r) higher than 0.9941. Intra day and inter day precision (C.V. %) for quality control were ranged from 10.04 to 16.09% and from 10.87 to 18.69%, respectively. The lower limit of quantification (LLOQ) of domperidone was 0.05 ng/mL. The method described is precise and sensitive and has been successfully applied to the study of bioequivalence of domperidone in 24 healthy Korean volunteers. Twenty-four healthy male Korean volunteers received a single dose of each medicine ($2{\times}12.72\;mg$ domperidone maleate) in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of domperidone were monitored for over a period of 24 hr after the administration. $AUC_{0-t}$ (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. The 90% confidence intervals for the log transformed data were within acceptable range of log 0.8 to log 1.25 (e.g., $log\;0.92{\sim}log\;1.05$ for $AUC_{0-t}$, $log\;0.81{\sim}log\;1.05$ for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that $Toriem^{(R)}$ tablet is bioequivalent to Motilium-$M^{(R)}$ tablet.

Combined Effects of Antibacterial Film and Storage Temperature on Shelf-life and Microbiological Safety of Mackerel (항균 필름과 저장 온도의 고등어 저장성 및 미생물학적 안정성에 대한 병행 효과)

  • Ha, Ji-Hyoung;Lee, Yu-Si;Heo, Sun-Kyung;Bae, Dong-Ho;Park, Sang-Kyu;Hwang, Sun-Soon;Ha, Sang-Do
    • Journal of Food Hygiene and Safety
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    • v.22 no.4
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    • pp.317-322
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    • 2007
  • The purpose of this study was to investigate the antibacterial effect of films on shelf-life and microbiological safety of mackerel. Effects of antimicrobial films against total aerobic bacteria, Escherichia coli O157:H7, Listeria monocytogenes, Vibrio parahaemolyticus in mackerel were evaluated during storage of 5-14 days at $5^{\circ}C,\;10^{\circ}C\;and\;15^{\circ}C$. Antimicrobial films were developed with addition of a natural substance, wasabi extracts (Wasabia japonica). At $5^{\circ}C$ storage, growth of total aerobic bacteria, Escherichia coli O157:H7, Listeria monocytogenes were inhibited higher than at 10 and $15^{\circ}C$. Especially, the numbers of V. parahaemolyticus were decreased gradually at $5^{\circ}C$ even in the control sample, and about $1\;log_{10}cfu/g\;and\;1.8\;log_{10}cfu/g$ reductions were observed at 1 and 4 days, respectively. After 7 days, V. parahaemolyticus in all samples were not detected. There is a limit of a single treatment of antimicrobial film to prolong shelf-life of mackerel. The synergistic effect of antimicrobial film were shown by addition of $5^{\circ}C$ refrigeration.

Effects of Increasing Level of Dietary Rice Straw on Chewing Activity, Ruminal Fermentation and Fibrolytic Enzyme Activity in Growing Goats

  • Wanga, M.;Zhaoa, X.G.;Tan, Z.L.;Tang, S.X.;Zhou, C.S.;Sun, Z.H.;Han, X.F.;Wang, C.W.
    • Asian-Australasian Journal of Animal Sciences
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    • v.23 no.8
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    • pp.1022-1027
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    • 2010
  • Effects of increasing dietary rice straw on chewing activity, ruminal fermentation, and fibrolytic enzyme activity in growing goats were investigated in a $4{\times}4$ Latin Square experiment. The goats were offered four diets with an increasing proportion of rice straw (i.e. 0.05, 0.10, 0.15 and 0.20, respectively, on dry matter basis). Increasing level of rice straw increased ($P_{linear\;effect}$ <0.05) the time spent on eating, ruminating, and chewing. The ruminal pH and acetate: propionate ratio were increased ($P_{linear\;effect}$ <0.05), while the $NH_3$-N concentration was decreased ($P_{linear\;effect}$ <0.01). Increasing level of rice straw in the diet increased ($P_{linear\;effect}{\leq}0.01$) molar proportion of acetate and isovalerate, and decreased ($P_{linear\;effect}$ <0.01) molar proportion of propionate. The CMCase, xylanase and cellobiase activities in the rumen were decreased ($P_{linear\;effect}$ <0.05) with increasing level of dietary rice straw, whereas the avicelase activity was increased ($P_{linear\;effect}$ <0.01). In summary, increased level of rice straw elevated the dietary neutral detergent fibre (NDF) content in the diet and had a great impact on chewing activity and ruminal fermentation.

Korean research project on the integrated exposure assessment of hazardous substances for food safety

  • Lim, Ji-Ae;Kwon, Ho-Jang;Ha, Mina;Kim, Ho;Oh, Se Young;Kim, Jeong Seon;Lee, Sang-Ah;Park, Jung-Duck;Hong, Young-Seoub;Sohn, Seok-Joon;Pyo, Heesoo;Park, Kyung Su;Lee, Kwang-Geun;Kim, Yong Dae;Jun, Sangil;Hwang, Myung Sil
    • Environmental Analysis Health and Toxicology
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    • v.30
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    • pp.4.1-4.11
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    • 2015
  • Objectives: This survey was designed to conduct the first nationwide dietary exposure assessment on hazardous substances including the intakes of functional food and herbal medicine. In this paper, we introduced the survey design and the results of the dietary exposure status and internal exposure levels of lead (Pb), cadmium (Cd), and mercury (Hg). Methods: We selected 4867 subjects of all ages throughout Korea. We conducted a food survey, dietary survey, biomonitoring, and health survey. Results: Pb and Cd were the highest (median value) in the seaweed ($94.2{\mu}g/kg$ for Pb; $594{\mu}g/kg$ for Cd), and Hg was the highest in the fish ($46.4{\mu}g/kg$). The dietary exposure level (median value) of Pb was $0.14{\mu}g/kg$ body weight (bw)/d, $0.18{\mu}g/kg$ bw/d for Cd, and $0.07{\mu}g/kg$ bw/d for Hg. Those with a blood Pb level of less than $5.00{\mu}g/dL$ (US Centers for Disease Control and Prevention, reference value for those 1 to 5 years of age) were 99.0% of all the subjects. Those with a blood Cd level with less than $0.30{\mu}g/L$ (German Federal Environmental Agency, reference value for non-smoking children) were 24.5%. For those with a blood Hg level with less than $5.00{\mu}g/L$ (human biomonitoring I, references value for children and adults, German Federal Environmental Agency) was 81.0 % of all the subjects. Conclusions: The main dietary exposure of heavy metals occurs through food consumed in a large quantity and high frequency. The blood Hg level and dietary exposure level of Hg were both higher than those in the European Union.

Beneficial effects of natural Jeju groundwaters on lipid metabolism in high-fat diet-induced hyperlipidemic rats

  • Wang, Yan-Chao;Lu, Jin-Miao;Jin, Hui-Zi;Ma, Ai-Niu;Zhang, Jin-Yang;Gong, Nian;Xiao, Qi;Zhu, Bin;Lv, Ying-Fang;Yu, Na;Zhang, Wei-Dong;Wang, Yong-Xiang
    • Nutrition Research and Practice
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    • v.8 no.2
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    • pp.165-171
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    • 2014
  • BACKGROUND: Groundwater is believed to possess many beneficial effects due to its natural source of various minerals. In this study, we examined the effects of natural Jeju groundwater S1 (Samdasoo$^{TM}$), S2 and S3 pumped up from different locations of Jeju Island, Korea, along with local tap water, on body weight gain, serum lipids and lipoproteins, and liver histopathology in high-fat diet-induced hyperlipidemic rats. MATERIALS/METHODS: Rats were randomly and equally divided into 6 groups. Different water samples were supplied to the hyperlipidemic rats as their daily drinking water and the widely-used anti-hyperlipidemic drug simvastatin was used as a positive control. Body weight, serum lipids and lipoproteins were measured weekly. Liver weight, liver index and liver histopathology were examined after the execution of the rats. RESULTS: After drinking Jeju groundwaters for two months, S2 but not S3 significantly reduced weight growth and serum triglycerides levels and increased high density lipoprotein-C (HDL-C) without affecting total cholesterol or LDL-C. S1 and particularly S2 significantly reduced the severity of liver hypertrophy and steatosis. All Groundwaters had much higher contents of vanadium (S3>S2>S1>>tap water) whereas S1 and S2 but not S3 markedly blocked autoxidation of ferrous ions. CONCLUSION: Jeju Groundwater S1 and particularly S2 exhibit protective effects against hyperlipidemia and fatty liver and hypothesize that the beneficial effect of Jeju Groundwaters may be contributed from blockade of autoxidation of ferrous ions rather than their high contents of vanadium.

miR-340 Reverses Cisplatin Resistance of Hepatocellular Carcinoma Cell Lines by Targeting Nrf2-dependent Antioxidant Pathway

  • Shi, Liang;Chen, Zhan-Guo;Wu, Li-li;Zheng, Jian-Jian;Yang, Jian-Rong;Chen, Xiao-Fei;Chen, Zeng-Qiang;Liu, Cun-Li;Chi, Sheng-Ying;Zheng, Jia-Ying;Huang, Hai-Xia;Lin, Xiang-Yang;Zheng, Fang
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.23
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    • pp.10439-10444
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    • 2015
  • Many chemotherapeutic agents have been successfully used to treat hepatocellular carcinoma (HCC); however, the development of chemoresistance in liver cancer cells usually results in a relapse and worsening of prognosis. It has been demonstrated that DNA methylation and histone modification play crucial roles in chemotherapy resistance. Currently, extensive research has shown that there is another potential mechanism of gene expression control, which is mediated through the function of short noncoding RNAs, especially for microRNAs (miRNAs), but little is known about their roles in cancer cell drug resistance. In present study, by taking advantage of miRNA effects on the resistance of human hepatocellular carcinoma cells line to cisplatin, it has been demonstrated that miR-340 were significantly downregulated whereas Nrf2 was upregulated in HepG2/CDDP (cisplatin) cells, compared with parental HepG2 cells. Bioinformatics analysis and luciferase assays of Nrf2-3'-untranslated region-based reporter constructor indicated that Nrf2 was the direct target gene of miR-340, miR-340 mimics suppressing Nrf2-dependent antioxidant pathway and enhancing the sensitivity of HepG2/CDDP cells to cisplatin. Interestingly, transfection with miR-340 mimics combined with miR-340 inhibitors reactivated the Nrf2 related pathway and restored the resistance of HepG2/CDDP cells to CDDP. Collectively, the results first suggested that lower expression of miR-340 is involved in the development of CDDP resistance in hepatocellular carcinoma cell line, at least partly due to regulating Nrf2-dependent antioxidant pathway.

Clinical Course according to Antipsychotics Prescription Pattern in Delirium (섬망 환자에서 항정신병약물 처방 유형에 따른 임상 경과의 차이)

  • Park, Jaesub;Kim, Jae-Jin;Park, Sungjong;Kim, Sungmin;Park, Jin Young
    • Korean Journal of Psychosomatic Medicine
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    • v.25 no.2
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    • pp.120-128
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    • 2017
  • Objectives : Although antipsychotics are commonly used to control symptoms of delirium, there is a lack of research on the prescription pattern and its clinical effects. The purpose of this study was to investigate the effect of antipsychotics prescription pattern on clinical course of delirious patients consulted to psychiatry. Methods : During the period from July 2016 to February 2017, 212 patients who were referred for delirium were reviewed for their medical records. The duration of delirium was monitored using CAM-ICU, and duration of admission, mortality, and delirium at discharge were reviewed. Clinical course was compared among three groups according to the antipsychotic drug administration pattern: Continuous use group, optimal use group and PRN use group. Results : The pattern of taking antipsychotic medication longer than duration of delirium did not associated with better clinical course compared with the pattern of adapting to the period of delirium and rather increased the risk of taking antipsychotic medication at discharge. When used for a shorter period than the delirium period, it was associated with poor clinical course. Conclusions : The results of this study suggest that a strategy to administer antipsychotics for a minimum period, according to periods of delirium, is appropriate. Also, efforts are needed to minimize the use of antipsychotic drugs after recovery from delirium.

Evaluation of Medicinal Activity on Isolated Inhibitory Compounds against Helicobacter pylori from Cheongmoknosang Mulberry Leaves (청목노상 뽕잎에서 분리한 Helicobacter pylori 저해물질에 대한 약효평가)

  • Kim, Byong-O;Cho, Young-Je
    • Journal of Applied Biological Chemistry
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    • v.54 no.4
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    • pp.265-269
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    • 2011
  • Inhibitory effect of useful components from Cheongmoknosang mulberry leaves extracts against Helicobacter pylori were investigated to develope them to a health functional food. It was confirmed that H. pylori bacterial infection occurred after 6 weeks over in C57BL/6 mouse which was caused the infection, and the average number of pathogens was $8{\times}10^5$ CFU/mL. Effects of the prevention and cure against H. pylori were tested by the mouth administration with Cheongmoknosang mulberry leaves extracts include the active ingredient, and number of H. pylori colony in stomach of drug groups were decreased more than control group. The result of testing immuno-glogulin isotype from the separated serum from a mouse, IgG1, IgA produced more in administered group, and it is expected to inhibit the H. pylori infection because of increasing antibody production in the mixture. These results suggest that caffeic acid, rosemarinic acid and chlorogenic acid in Cheongmoknosang mulberry leaves extracts are very effective to prevent or cure against H. pylori infection. So the ratio of infection is increasing and it is regarded to be able to prevent and cure the disease like gastritis, gastric ulcer and gastric cancer which are caused by H. pylori.

Immediate Drug Release Enhancement of Nateglinide Using Fumaric Acid (푸마르산을 이용한 나테글리니드 함유 속방출형 제형의 약물방출 개선에 관한 연구)

  • Lee, Sung-Hoon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.18 no.1
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    • pp.506-512
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    • 2017
  • The purpose of this study was to improve release rate and bioavailability of nateglinide formulation. Polymorphism selection and particle size control were performed to enhance formulation dissolution rate, and a pH modifier was included in the formulation to overcome pH-dependent solubility of nateglinide. The enhanced dissolution rate was characterized by using a dissolution test. The results showed that H-type raw material had a higher dissolution rate than that of B-type raw material. There was 6.2% difference in dissolution between the two materials at 60 min. With regard to particle size, raw material with a $1.13{\mu}m$ particle size showed a 20% faster release rate than that of raw material with a $2.28{\mu}m$ particle size. Furthermore, fumaric acid was included in formulation as a pH modifier. That addition produced a greater than 50% improvement in dissolution rate. In conclusion, dissolution rate of nateglinide can be enhanced by optimizing its polymorphism and particle size; moreover, a synergistic effect on the enhancement of dissolution rate is obtained by including fumaric acid, a pH modifier, in the formulation.

Comparison of Pectin Hydrogel Collection Methods in Microfluidic Device (미세유체 장치에서 수거 방법에 따른 펙틴 하이드로겔 입자의 특성 비교)

  • Kim, Chaeyeon;Park, Ki-Su;Kang, Sung-Min;Kim, Jongmin;Song, YoungShin;Lee, Chang-Soo
    • Korean Chemical Engineering Research
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    • v.53 no.6
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    • pp.740-745
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    • 2015
  • This study investigated the effect of different collection methods on physical properties of pectin hydrogels in microfluidic synthetic approach. The pectin hydrogels were simply produced by the incorporation of calcium ions dissolved in continuous mineral oil. Then, different collection methods, pipetting, tubing, and settling, for harvesting pectin hydrogels were applied. The settling method showed most uniform and monodispersed hydrogels. In the case of settling, a coefficient of variation was 3.46 which was lower than pipetting method (18.60) and tubing method (14.76). Under the settling method, we could control the size of hydrogels, ranging from $30{\mu}m$ to $180{\mu}m$, by simple manipulation of the viscosity of pectin and volumetric flow rate of dispersed and continuous phase. Finally, according to the characteristics of simple encapsulation of biological materials, we envision that the pectin hydrogels can be applied to drug delivery, food, and biocompatible materials.