• Journal of Pharmaceutical Investigation
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• 제41권4호
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• pp.255-262
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• 2011

Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the transitions: m/z 160.1${\rightarrow}$142.2 for pregabalin and m/z 423.2${\rightarrow}$207.1 for losartan (as an internal standard). After cold acetonitrileinduced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to $10{\mu}g$/mL and the correlation coefficients (r) were $\geq0.99$. Intra- and inter-day precisions were $\leq6.02$ and $\leq11.04%$, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Daewoong Pharm. Co., Ltd.) and Lyrica$^{(R)}$ capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized $2{\times}2$ crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters ($AUC_{0-t}$, $C_{max}$ and $T_{max}$) were calculated and statistically analyzed to assess the differences between two formulations. The 90% confidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for $C_{max}$). Thus, $AUC_{0-t}$ and $C_{max}$ met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica$^{(R)}$ capsule.

• Journal of Pharmaceutical Investigation
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• 제34권5호
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• pp.413-418
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• 2004

A bioequivalence of $Melax^{TM}$ capsules (Chong Kun Dang Pharm., Korea) and $Mobic^{TM}$ capsules (Boehringer Ingelheim Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 15 mg dose of meloxicam of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2\;{\times}\;2$ crossover design. Concentrations of meloxicam in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 72 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Melax^{TM}/Mobic^{TM}$ were 0.95 - 1.04 and 0.98 - 1.14, respectively. This study demonstrated a bioequivalence of $Melax^{TM}$ and $Mobic^{TM}$ with respect to the rate and extent of absorption.

• 분석과학
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• 제24권2호
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• pp.142-149
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• 2011

Resveratrol을 GC/TOF-MS를 이용하여 대사체를 확인한 결과, 두 개의 phenyl기를 연결하는 이중결합이 단일결합으로 환원된 구조로 추정되었다. 또한, GC/MSD를 이용하여 resveratrol 및 내인성스테로이드의 분석법에 대한 유효성을 점검한 결과, 회수율은 96.47 - 114.74%의 범위로 나타났으며, intra-day와 inter-day의 정밀도는 1.40 - 10.87%과 1.10 - 10.93% 그리고 정확도는 80.03 - 119.92%과 80.02 - 119.56%로 조사되었고, 모두 0.996이상의 직선성을 나타내어 유효한 분석 방법으로 검증되었다. 한편, 지원자들에게 resveratrol을 경구투여 한 요시료로부터 resveratrol과 그 대사체에 대한 상관성을 조사해본 결과, 요중 최대농도 도달시간이 일반적인 약물(1 - 2시간) 보다 긴 10 - 15시간에 나타났으며, 대사체로의 전환율은 남성보다 여성이 높게 나타났다. 한편, 내인성 스테로이드는 약물 복용 후 20시간 까지는 resveratrol 및 그 대사체와 다소 유사한 분비형태를 나타내었으며, estrone과 estradiol의 경우 여성이 남성에 비해 이 약물에 대한 민감성이 높게 나타났다. 그 외의 내인성 스테로이드는 유의할만한 차별된 분비형태의 변화가 나타나지 않았다. 따라서 resveratrol의 경우 약물의 활성이 남성보다는 여성에게 유의한 영향을 미치는 것으로 추측되었다.

• Journal of Pharmaceutical Investigation
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• 제35권5호
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• pp.323-328
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• 2005

The purpose of the present study was to evaluate the bioequivalence of two torasemide tablets, Torem tablet (Roche Korea Co., Ltd., Korea, reference drug) and Boryung Torsemide tablet (Boryung Pharmaceutical Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (furosemide) to human serum, serum samples were extracted using 5 mL of ethyl acetate. Compounds were analyzed by reverse-phase HPLC method with UV detection. This method showed linear response over the concentration range of 0.05 ug/mL with correlation coefficient of 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ug/mL which was sensitive enough for pharmacokinetic studies. Twenty-eight healthy male Korean volunteers received each medicine at the torasemide dose of 20 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of torasemide were monitored by an HPLC-UV for over a period of 12 hr after the administration. $AUC_{t}$(the area under the serum concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum serum drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{t}$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_{t}$ ratio and the $C_{max}$ ratio for Boryung Torsemide/Torem were log 0.97-10g 1.03 and log 0.93log 1.12, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Boryung Torsemide tablet and Torem tablet are bioequivalent.

• Journal of Microbiology and Biotechnology
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• 제10권2호
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• pp.147-153
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• 2000

This study was conducted to compare probiotic activities and physiological functions of Bifidobacterium longum Mk-G7 with weveral commercial and type strains of bifidobacteria. bif. longum MK-G7 showed the highest acid tolerance against HCl and acetic acid, whereas bif. infantis Y-1 showed the lowest acid tolerance and more than 4 log cycles of viable cell count decreased due to acid injuty. Viable cell counts of bifidobacteria strains decreased more than 1.5 log cycles owing to oxygen toxicity, with the exception of Bif. longum MK-G7, Bif. infantis Y-2, Bif. longum Y-3, Bif. longum Y-6, and Bif. longum RD-13 showed the highest bile tolerance, whereas Bif. longum MK-G7 showed a medium level of bile tolerance. Only Bif. longum MK-G7 howed much higher antibiotic resistance against both tetracycline and penicillin-G in the MIC(minimum inhibitory concentration) level of 24.8 mg/I and 0.52mg/I, respectively. Bif longum Y-6, and Bif. bifidum ATCC 29539 showed more than 80% of anti-mutagenicity against NQO(4-nitroquinolinel-oxide). Since the production of cytokines such as $TNF(tumor necrosis factor)-{\alpha}$ and IL (interleukin)-6, and NO(nitric oxide) in the macrophage cell line Raw 264.7 cells increased as Bif. longum MK-G7 cell concentration increased, ti was suggested that Bif. longum MK-G7 is able to enhance immunopotentiating activity in vitro. When freeze-dred Bif. longum MK-G7 was administered to mice at the dose of 1,2,4, and 6 g/kg of body weight, all of the mice survived in all feeding groups, proving the GRAS(generally recognized as safe) status of Bif. longum MK-G7. When fermented milk containing Bif. longum MK-G7 was administered to human volunteers, viable cell count of total bifidobacteria and anaerobes in the feces increased up to 0.5 log cycles more than before the administration. In particular, Bif. logum MK-G7 ingibited the growth of Bacteroides at the level of 1.0-1.5 log cycles.

• 대한화장품학회지
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• 제38권1호
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• pp.75-82
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• 2012

천연보습인자(NMF, natural moisturizing factor)는 정상 피부 내의 각질층에 존재하는 수용성, 친수성 성분을 총칭하는 말로 외부로부터 수분을 흡수하고 각질층의 수분보유능을 증가시키며 피부가 건조해지는 것을 방지하여 피부의 유연성과 가수성을 유지하는 기능을 한다. NMF는 주로 아미노산과 아미노산의 대사산물로 구성되며 이들은 필라그린(filaggrin)이 분해되면서 생성된다. 본 연구에서는 피부 각질층의 22종의 개별 아미노산의 함량분석을 통하여 피부보습능과 개개의 아미노산과의 상관관계를 연구하였다. 15명의 건강한 지원자들의 전박과 이마로부터 tape stripping한 각질 시료 중 22종의 아미노산 함량을 UPLC-PDA를 이용하여 동시 분석하였다. 그 결과 각질 표면보다는 안쪽에서의 아미노산들의 함량이 높음을 확인하였다. 또한 신체 부위별 비교에서 전박이 이마에 비해 아미노산 함량이 1.5배 정도 높음을 확인하였다. 전박부위의 아미노산 총 함량과 보습능(TEWL)과의 상관 관계분석을 통해서는 보습능이 클수록 총아미노산 함량이 높은 것으로 확인되었으며 특히 Ser, Glu, Gly, Ala 및 Thr은 각질 내 존재하는 주요 아미노산 성분으로 보습에 긍정적인 영향을 주는 성분으로 확인되었다. 이상의 결과로써 NMF의 주성분인 아미노산의 함량은 각질 생리기능과 밀접한 관련을 가지고 있음을 확인할 수 있었으며 본 연구를 통해 얻은 각질층의 아미노산의 통합적인 분석법은 보습, 노화, 미백, 피부 염증질환 등 다양한 피부 상태와 아미노산류들의 변화와의 관계를 깊이 이해하고 피부 기능과 관련된 새로운 분자적 타겟을 발굴하고 증명하는데 기초적인 방법으로써 사용될 수 있을 것으로 사료된다.

• 한국약용작물학회지
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• 제10권4호
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• pp.253-258
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• 2002

We compared the long-term metabolic effects of equal amounts of carbohydrate from potato, rice and buckwheat on glycemic indices and blood lipids in healthy subjects. Nine healthy volunteers-2 men and 7 women were studied. All subjects ate diets based on the same-7-day rotating menu differing only in that the major source of carbohydrate (about 50% of daily total calories) came either from buckwheat, rice or potato. The study was conducted with a triple crossover design over three 7 day periods. On the morning of the 8th day, fasting blood was drawn from each subject to determine serum glucose, insulin, triglycerides, total and HDL-cholesterol. Subjects were then asked to eat breakfast with their respective carbohydrate within a 20 min period. Blood samples were drawn at 30, 60, 120 and 180 min after the start of breakfast to determine glucose and insulin levels. At 30 min the glucose response to the rice meal(7.15mmol/L) and potato meal(6.71mmol/L) were greater than the response to the buckwheat meal(5.855mmol/L) (P < 0.05). The mean area under the glucose response to the curve following the rice meal was greater than that following the buckwheat meal(P < 0.05). The insulin responses to the potato and rice meals at 30 and 60 min were greater than those to the buckwheat meal (P < 0.05). The mean area under the serum insulin response curve after the rice meal was greater than of buckwheat. Blood lipids, uric acid and glycosylated hemoglobin were not affected by the three meals. The study shows that the buckwheat meal has more beneficial effects on glycemic indices than either the rice meal or potato meal in healthy subjects.

• IMMUNE NETWORK
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• 제5권4호
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• pp.205-214
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• 2005

Background: We examined global gene expression profiles of peripheral blood mononuclear cells (PBMCs) in patients with ulcerative colitis (DC), and tested whether the identified genes with the altered expression might be associated with susceptibility to UC. Methods: PBMCs from 8 UC and 8 normal healthy (NH) volunteers were collected, and total RNAs were subjected to the human 8.0K cDNA chip for the micro array analysis. Real time-PCR (RT-PCR) was performed to verify the results of micro array. One hundred forty UC patients and 300 NH controls were recruited for single nucleotide polymorphism (SNP) analysis. Results: Twenty-five immune function-related genes with over 2-fold expression were identified. Of these genes, two chemokines, namely, CXCL1 and CCL20, were selected because of their potential importance in the evocation of host innate and adaptive immunity. Four SNPs were identified in the promoter and coding regions of CXCL1, while there was no significant difference between all patients with UC and controls in their polymorphisms, except minor association at g.57A>G (rs2071425, p=0.02). On the other hand, among three novel and one known SNPs identified in the promoter region of CCL20, g. -1,706 G>A (p=0.000000055), g. -1,458 G>A (p=0.0048), and g. -962C>A (p=0.0006) were found to be significantly associated with the susceptibility of Uc. Conclusion: Altered gene expression in mononuclear cells may contribute to IBD pathogenesis. Although the findings need to be confirmed in other populations with larger numbers of patients, the current results demonstrated that polymorphisms in the promoter region of CCL20 are positively associated with the development of Uc.

• Journal of Periodontal and Implant Science
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• 제34권1호
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• pp.195-204
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• 2004

A novel glucanhydrolase from Lipomyces starkeyi KSM 22 has been suggested as a promising anti-plaque agent because it has been shown to have additional amylase activity and mutanase activity besides dextranase activity and to strongly bind to hydroxyapatite. Mouthrinsing with Lipomyces starkeyi KSM 22 glucanhydrolase solution was comparable to 0.12% chlorhexidine mouthwash in inhibition of plaque accumulation and gingival inflammation and local side effects were less frequent and less intense in human experimental gingivitis. In this study, Lipomyces starkeyi KSM 22 glucanhydrolase mouthrinses (1 and 2 unit/ml) were compared with a control mouthrinse (commercial 0.01% benzethonium chloride mouthrinse, $Caregargle^{(R)}$, Hanmi Pharmaceuticals) in the ability to inhibit plaque formation. A 3-replicate clinical trial using 4-day plaque regrowth model was used. Fifteen volunteers were rendered plaque-free on the 1st day of each study period, ceased toothcleansing, and rinsed 2X daily with allocated mouthrinse thereafter. On day 5, plaque accumulation was scored and the washout periods was 9 days for the next trial. Lipomyces starkeyi KSM22 glucanhydrolase(1 unit and 2 unit)- containing mouthrinse resulted in Significantly lower plaque formation in plaque area and thickness, compared to the control mouthrinse. There was no significant difference in plaque inhibition between enzyme-mouthrinses at 2 different concentrations used. This glucanhydrolase- containing mouthwash resulted in significantly lower plaque area severity index score and tended to have lower plaque thickness severity index score than those of control mouthrinse. But there was no significant difference according to the enzyme concentration. From these results, Lipomyces starkeyi KSM 22 glucanhydrolase-containing benzethonium chloride mouthrinse has greater anti-plaque effect than the commercial mouthrinse alone. Therefore this glucanhydrolase preparation is a promising agent for new mouthwash formulation in the near future.

• 호스피스학술지
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• 제2권1호
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• pp.87-111
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• 2002

The hospice activities in Korea have still stood in the premature stage, although the contemporary hospice program, which professionally accommodates terminally ill patients, appeared in the history 35 years ago. Especially, the availability of the facility hospice is not only poor in number, but also lack of a guideline for the conduct of the facility. Saemmul Hospice has keenly felt the necessity of more facility hospices and has interchanged experiences and informations with people interested in hospice. However, the number of facilities has fallen short of one's expectations, and many problems have been revealed in order to maintain the operation. This paper was written in order to improve these atmospheres and to help more terminally ill cancer patients properly. This paper clarifies in detail the principle of management, the method of practice in each departments of Saemmul Hospice, expected effects and supplemental items. We try to provide concrete and practical informations and to help extensively for all peoples who are to begin or currently working. 1.Facility: It secures, maintain, and manage the hospice environment for all around care of patients effectively. 2.Education and Volunteer: It trains and manages hospice volunteers devoted to hospice. 3.Financial: It manages donation by healthy soul with an effective method. 4.Administration and Organization: It executes the administration efficiently and constitutes the organization to operate. 5.Medical and Nursing: It offers the maximum professional supports to a hospital. 6.Medicine and alternative medicine: It improves the quality of life of patients by medical and pharmaceutical approach and by other possible methods available. 7.Nutrition: It helps patients to have diets in accord with the order of the creation. 8.Belief: It offers spiritual care which allows the profound relationship with God. 9. Funeral ceremonies: Funeral ceremonies may heal grieves of families faced with their deaths. 10. Bereaved families: It supports the families after the deaths of patients. 11.Reception and consultation: It seeks to help the patients who meet the purposes for which Saemmul Hospice is established. 12.Publication: It allows publicity activities for Saemmul Hospice. Facility hospice programs are able to overcome the disadvantages that the other type of the hospice possess, like as the economic burdens of the families, and the patients' losses of comforts of home after being transferred to a hospital. Facility hospice can provide home atmosphere with professional manpower and facilities like hospital to the patients. Therefore, it can also improve patients' qualities of life and make them comfortable death. We anticipate that the hospice program in Korea would be more active to let more people be indebted to maintain the nobel human dignity and to cross beautifully in the most painful process of dying in the journey of their lives.