• Title/Summary/Keyword: clinical chemical parameters

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Bioequivalence of LG Cilostazol Tablet to Pletaal Tablet (Cilostazol 100 mg) (프레탈 정(실로스타졸 100 mg)에 대한 엘지실로스타졸 정의 생물학적 동등성)

  • Cho, Hea-Young;Lim, Dong-Koo;Shin, Sang-Chul;Moon, Jai-Dong;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.11 no.1
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    • pp.7-12
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    • 2001
  • Cilostazol has both antithrombotic and cerebral vasodilating effects, and one of the mechanism is the selective inhibition of platalet cyclic AMP phosphodiesterase. Bioequivalence of two cilostazol tablets, the $Pletaal^{TM}$ (Korea Otsuka Pharmaceutical Co.) and the LG $Cilostazol^{TM}$ (LG Chemical Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers ($20\sim29$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After oral administration of $Pletaal^{TM}$ or LG $Cilostazol^{TM}$ tablet (100 mg cilostazol), blood samples were taken at predetermined time intervals and the serum cilostazol concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in AUCt, C_{max} and Tmax between two tablets based on the $Pletaal^{TM}$ tablet were $-5.39\%,\;2.32\%\;and\;4.26\%$, respectively. The powers (1-${\beta}$) for $AUC_t,\;C_{max}\;and\;T_{max}\;were\;83.81\%,\;96.02\%\;and\;91.04%$, respectively. Minimum detectable differences ($\Delta$) and $90\%$ confidence intervals were all less than $\pm20\%$. All these parameters met the criteria of KFDA for bioequivalence, indicating that LG $Cilostazol^{TM}$ tablet is bioequivalent to $Pletaal^{TM}$ tablet.

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Characterization of Plasma Carnitine Level in Obese Adolescent Korean Women

  • Yoo, Hye-Hyun;Yoon, Ho-Joo;Shin, Hye-Jung;Lee, Sang-Hyup;Yoon, Hye-Ran
    • Biomolecules & Therapeutics
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    • v.17 no.2
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    • pp.181-187
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    • 2009
  • Carnitine is known to be involved in lipid metabolism and affects body composition as well as energy metabolism of the whole body. Improvement of obesity by L-carnitine supplement suggests that obesity can be related with the abnormality of carnitine metabolism and therefore, plasma carnitine level in normal and obesity groups was investigated. For the characterization of plasma carnitine level in obese people, 60 plasma samples collected from Korean women subjects were analyzed using LC/MS and plasma fatty acid level was also determined using GC/MS. Additionally, several clinical chemical parameters including fasting glucose, cholesterol, AST, and ALT level were measured. All the data obtained were combined and pattern recognition analysis was carried out with the dataset. Obese group showed a different metabolic pattern compared with normal group. Plasma acylcarnitine level of the obese group was found to be $11.7{\mu}g/ml$, which was higher than that of normal group ($8.0{\mu}g/ml$). Statistically significant differences in plasma fatty acid level were not observed between the two groups. Other clinical parameters for the obese group were within normal ranges but AST and ALT levels were slightly elevated compared to normal group. The obese group showed elevated plasma acylcarnitine level.

Immunomodulating and Antitumor Activities of Exo-secretion from Phellinus linteus (상황버섯(Phellinus linteus) 자실체 분비물의 면역활성 및 항암효과)

  • Maeng, Eun-Ho;Lee, Yun-Tai;Cho, Kyu-Bong;Hong, Seung-Hee
    • IMMUNE NETWORK
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    • v.2 no.2
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    • pp.115-124
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    • 2002
  • Background: The chemical characteristics of the exo-secretion from Phellinus linteus (referred to as exo-secretion) including the compositions of amino acids and monosaccharides were investigated. In addition, cytotoxicity of the exo-secretion on 5 tumor cell lines derived from human cancers and its antitumor activity against ascitic sarcoma-180 cells were examined. Methods: The antitumor activity of exo-secretion from Phellinus linteus was determined by measuring parameters including tumor weight, life span of mice, chemotatic activity of leukocytes, counts of immune cells, and activity of cytokines. Results: The exo-secretion from Phellinus linteus showed no direct cytotoxicity to the five tumor cell lines tested, but it had a strong antitumor activity against sarcoma-180 cells in ICR mice as measured by tumor weight and life span of mice. The exo-secretion stimulated the chemotaxis of leukocytes and production of immune cells and cytokines. Conclusion: These results suggest that the exo-secretion from Phellinus linteus do not act as a direct cytotoxic substance to cancer cells but as an immunomodulator.

A Study on the Measurements of Optical Parameters in Photosensitizer by Light Scattering (농도가 진한 매질에서 광증감제에 의한 광학적 파라미터측정에 관한 연구)

  • Kim, Ki-Jun;Lee, Jou-Joub
    • Journal of the Korean Applied Science and Technology
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    • v.28 no.1
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    • pp.102-108
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    • 2011
  • The study of wave propagation and scattering in biological media has become increasingly important in recent years. The propagation of light within tissues is an important problem that confronts the dosimetry of therapeutic laser delivery and the development of diagnostic spectroscopy. In the clinical application of photodynamic therapy(PDT) and in photobiology, the photon deposition within a tissue determines the spatial distribution of photochemical reactions. Scattered light is measured as a function of the distance (r) between the axis of the incident beam and the detection spot. Consequently, knowledge of the photosensitizer(Chlorophyll-a) function that characterizes a phantom is measured. To obtain the results of scattering coefficients(${\mu}s$) of a turbid material from diffusion described by experimental approach. It was measured the energy fluency of photon radiation at the position of penetration depth. From fluorescence experimental method obtained the analytical expression for the scattered light as the values of $(I/I_o)_{wavelength}$ vs the distance between the center of the incident beam and optical fiber in terms of the condition of "in situ spectroscopy(optically thick)" and real time by fluorometric measurements. The result was compromised with transport of intensities though a random distribution of scatters.

Single Oral Dose Toxicity Test and Four Weeks Repeated Oral Dose Determination Test of GST in Sprague-Dawley Rats (GST의 Sprague-Dawley Rat를 이용한 단회 경구투여 독성시험 및 4주 반복 경구투여 용량결정시험)

  • Han, Jong-Min;Hong, Jee-Hee;Lee, Hye-Yeong;Jung, In-Chul;Jin, Mi-Rim;Kim, Seong-Hyeong;Park, Yang-Chun
    • The Journal of Internal Korean Medicine
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    • v.34 no.4
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    • pp.349-361
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    • 2013
  • Objectives : This study aimed to evaluate the single oral dose toxicity and four weeks repeated dose determination of Gamisasangja-tang (GST) in male and female Sprague-Dawley rats. Methods : In the single oral toxicity study, rats were orally administered a single dose of 0 and 5,000 mg/kg GST. There were 5 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological finding were observed for 14 days. In the 4-weeks repeated oral dose determination study, rats were orally administered a single dose of 0, 1,250, 2,500 or 5,000 mg/kg GST. There were 5 rats in each group. Mortality, clinical signs, body weight changes, food consumption and gross pathological finding were observed for 28 days. Organ weight, clinical chemistry and hematology were tested after 28 days. Results : There was no mortality in either of the two studies. There were also no significant differences in clinical sign, body weight, organ weights, hematological or serum chemical parameters between the GST and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of GST is over 5,000 mg/kg, so this finding would be expected to provide scientific evidence for the safety of GST.

Long-term Intra-individual Variations and Critical Differences of Clinical Chemical Parameters in Dogs (개 혈청화학검사항목의 장기간의 개체 내 변이와 Critical Difference)

  • Choi Eun-wha;Shin Il-seob;Bhang Dong-ha;Kim You-seok;Hwang Cheol-yong;Youn Hwa-young;Lee Chang-woo
    • Journal of Veterinary Clinics
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    • v.22 no.3
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    • pp.198-201
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    • 2005
  • The purpose of this study was to assess intra-individual variations of clinicochemical parameters and calculate critical differences in healthy dogs during long-term periods. To calculate the critical difference of clinicochemical parameters, blood samples from 20 apparently clinically healthy dogs were collected once weekly for eight consecutive weeks. The critical difference was calculated as 9.01 mg/dl for urea, 0.52 mg/dl for creatinine, 0.99 g/dl for total protein, 0.39 g/dl for albumin, and 20.64 mg/dl for glucose. If two consecutive results differ by less than the critical difference value, it can be concluded that the difference is probably due to physiological variation. However, when the difference is greater than the critical value, other factors, either related to progression of the disease or the presence of concurrent disease, are more likely to be involved.

Effect of Saponin Fraction from Platycodon grandiflorum on Clinical Chemical Changes in TCDD (2,3,7,8-Tetrachlorodibenzo-ρ-dioxin)-induced Rat Toxicity

  • Kwak, Yi-Seong;Moon, You-Jin;Kyung, Jong-Soo;Kim, Tae-Hwan;Rhee, Man Hee
    • Biomedical Science Letters
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    • v.26 no.2
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    • pp.66-74
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    • 2020
  • This study was carried out to investigate the protective effect of crude saponin from Platycodon grandiflorum on Clinical chemical parameters in male rats acutely exposed to 2,3,7,8-tetrachlorodibenzo-ρ-dioxin (TCDD). Crude saponin was prepared from Korean Platycodon grandiflorum with Diaion HP-20 adsorption chromatography after extraction of 80% ethanol at 75℃. The crude saponin was confirmed by thin layer chrmatography. When compared with ginseng saponins, the crude saponin had both a few number of saponins and a broad distribution. Forty male rats (200±20 g) were divided into 4 groups. Normal control (NC) group received vehicle and saline; TCDD-treated (TT) group received TCDD (40 ㎍/kg, single dose) intraperitoneally; Platycodon grandiflorum saponin (PG5 and PG10) groups received crude saponin 5 mg/kg and 10 mg/kg (p.o), respectively, for 2 weeks before 1 week of TCDD-exposure. Increase of body weight was retarded greatly by TCDD-exposure. Body weight of animals in TT group was significantly decrease after 2 days of TCDD-exposure. However, body weights of animals in PG groups increased through the experimental perimental period, although the increasing rate was slower than that of NC group. Increases in contents of blood glucose, total cholesterol and triglyceride (TG) and activities of amylase, lipase, AST, ALT and LDH by toxic action of TCDD were significantly attenuated by crude saponin from Platycodon grandiflorum (P<0.05). In conclusion, these results suggest that crude saponin prepared from Korean Platycodon grandiflorum might be a member of useful protective agents against TCDD, which is one of the environmental hormones.

Protective Effect of Panax ginseng on TCDD-induced Liver Toxicity in Male Guinea Pigs

  • Hwang, Seock-Yeon;Wee, Jae-Joon;Kim, Si-Kwan;Youn, Nae-Young
    • Biomedical Science Letters
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    • v.9 no.1
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    • pp.51-58
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    • 2003
  • This study was carried out to investigate the preventive and therapeutic effect of Panax ginseng water extract (PG-WE) on the toxicity induced by 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD), one of the most notorious toxic environmental pollutants belonging to the group of polyhalogenated aromatic hydrocarbons. Normal control (NC) group guinea pigs (180~200 g) received vehicle and saline, and TCDD-treated (TT) group was given TCDD and saline. P100 and P200 group animals received PG-WE for 28 days since 1 week before TCDD exposure at daily doses of 100 mg/kg b.w. and/or 200 mg/kg b.w., respectively. C100 and C200 group received PG-WE for 14 days starting 1 week after TCDD-exposure. Toxicity was induced by a single intraperitoneal injection of TCDD (1 $\mu\textrm{g}$/kg b.w.). Abnormal increase in AST and ALT activities in TT group was significantly improved by the administration of PC-WE. Microscopically, there were mild to moderate swelling of hepatocytes, hyperchromatism of individual cells, acidophilic cytoplasm and cytoplasm vacuolation of some hepatocytes, slight to moderate variations of staining density, occasional single cell necrosis, variable size and shape of some hepatocytes, small groups of degenerating hepatocytes surrounded by mononuclear cells, dilated sinusoids of centrilobular zone and some loss of lobular architecture in TT group liver. From these results, we could find the protective and therapeutic role of PG-WE in TCDD-induced liver toxicity by examining the blood chemical parameters and histopathological observation.

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Inhalation Toxicity of Bisphenol A and Its Effect on Estrous Cycle, Spatial Learning, and Memory in Rats upon Whole-Body Exposure

  • Chung, Yong Hyun;Han, Jeong Hee;Lee, Sung-Bae;Lee, Yong-Hoon
    • Toxicological Research
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    • v.33 no.2
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    • pp.165-171
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    • 2017
  • Bisphenol A (BPA) is a monomer used in a polymerization reaction in the production of polycarbonate plastics. It has been used in many consumer products, including plastics, polyvinyl chloride, food packaging, dental sealants, and thermal receipts. However, there is little information available on the inhalation toxicity of BPA. Therefore, the aim of this study was to determine its inhalation toxicity and effects on the estrous cycle, spatial learning, and memory. Sprague-Dawley rats were exposed to 0, 10, 30, and $90mg/m^3$ BPA, 6 hr/day, 5 days/week for 8 weeks via whole-body inhalation. Mortality, clinical signs, body weight, hematology, serum chemistry, estrous cycle parameters, performance in the Morris water maze test, and organ weights, as well as gross and histopathological findings, were compared between the control and BPA exposure groups. Statistically significant changes were observed in serum chemistry and organ weights upon exposure to BPA. However, there was no BPA-related toxic effect on the body weight, food consumption, hematology, serum chemistry, organ weights, estrous cycle, performance in the Morris water maze test, or gross or histopathological lesions in any male or female rats in the BPA exposure groups. In conclusion, the results of this study suggested that the no observable adverse effect level (NOAEL) for BPA in rats is above $90mg/m^3$/6 hr/day, 5 days/week upon 8-week exposure. Furthermore, BPA did not affect the estrous cycle, spatial learning, or memory in rats.

Hepatic and Renal Safety of Concurrent Use of Conventional and Herbal Medications for Musculoskeletal Disorders: A Retrospective Observational Study (근골격계 질환에 대한 양약 및 한약 병용의 간과 신장에 대한 안전성: 후향적 관찰 연구)

  • Kim, Se-Yoon;Kim, Hyungsuk;Kang, Doyoung;Ko, Junhyuk;Kim, Jongyeon;Kim, Koh-Woon;Kim, Bo-Hyung;Cho, Jae-Heung;Song, Mi-Yeon;Chung, Won-Seok
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.3
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    • pp.131-140
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    • 2022
  • Objectives This study aimed to investigate whether the concurrent use of conventional and herbal medications affects liver and kidney function, by examining blood test data. Methods We retrospectively reviewed the electronic medical records of 590 inpatients with musculoskeletal diseases between 2013 and 2017. We investigated cases of drug-induced liver injury (DILI) according to the Roussel Uclaf Causality Assessment Method criteria and cases of drug-induced kidney injury (DIKI) based on the Kidney Disease Improving Global Outcomes definition. Results One case (0.17%) of DILI and one case (0.17%) of DIKI were identified. Significant improvements in serum laboratory data were observed after the concurrent use of both types of medications (p<0.05). The kappa coefficients ranged from 0.26 to 0.72, indicating that the values after the concurrent use of conventional and herbal medications showed a fair similarity to the baseline values of the patients. The linear regression test showed that female sex and high body mass index (BMI) were risk factors for an increase in the serum blood levels of liver function parameters. Conclusions The concurrent use of conventional and herbal medications for musculoskeletal disorders is relatively safe; however, clinicians should exercise caution when prescribing these medications to female patients and patients with a high BMI because of their potential effect on hepatic function.