• Journal of Pharmaceutical Investigation
• /
• 제34권6호
• /
• pp.521-527
• /
• 2004

Cimetidine is a histamine $H_2-receptor$ antagonist, used for the treatment of endoscopically or radiographically comfirmed duodenal ulcer, pathologic GI hypersecretory conditions, and active, benign and gastric ulcer. Simple method for determining cimetidine in human plasma has been developed and validated. The analytical procedure for cimetidine showed a linear relationship in the concentration ranges from $0.05\;to\;5\;{\mu}g/ml$. Coefficient of variance (CV, %) for intraday and interday validation and relative error (RE, %) were less than ${\pm}15%$. Based on this analytical method, the bioequivalence of two cimetidine 400 mg tablets, reference (Tagamet 400 mg) and test drug (Sinil CIMETIDINE 400 mg) was evaluated according to the guidelines set by the Korea Food and Drug Administration (KFDA). Release of cimetidine from the tablets in vitro was tested using KP VIII Apparatus II with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). Twenty-four healthy volunteers, $21.38{\pm}1.86$ years in age and $68.71{\pm}8.68\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 400 mg of cimetidine, blood samples were taken at predetermined time intervals and concentrations of cimetidine in plasma were determined using HPLC equipped with UV detector. The dissolution profiles of the two tablet formulations were very similar at all dissolution media. In addition, pharmacokinetic parameters such as $AUC_t$ and $C_{max}$ were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the differences in $AUC_t$ and $C_{max}$ between the two tablets were 4.17 % and 0.97% respectively. At 90% confidence intervals, the differences in these parameters were also within ${\pm}20%$. All of the above mentioned parameters have met the criteria of KFDA guidelines for bioequivalence, indicating that the test drug tablet (Sinil CIMETIDINE tablet) is bioequivalent to Tagamet 400 mg tablet.

• Journal of Pharmaceutical Investigation
• /
• 제37권6호
• /
• pp.397-402
• /
• 2007

To evaluate the bioequivalence of two venlafaxine formulations, a standard 2-way randomized cross-over study was conducted in twenty-four healthy male Korean volunteers. A single oral dose of 75 mg of test formulation Venfaxine $OR^{(R)}$ (tablet) or reference formulation Efexor $XR^{(R)}$ (capsule) was administered with one-week washout period. Plasma concentrations of venlafaxine were assayed for over a period of 72 hours with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS). The $mean{\pm}S.D$. of maximum concentration $(C_{max})$ and elimination half-life $(t_{1/2})$ were $64.7{\pm}28.5$ ng/mL, $9.2{\pm}3.0$ h, and $67.2{\pm}30.2$ ng/mL, $9.9{\pm}3.5$ h for test and reference formulations, respectively. Time to reach maximum concentration $(T_{max})$ expressed in median value (range), for the test and the reference, were 10 h (6-14) and 8h (4-12), respectively. Similarly, area under the plasma concentration-time curve, from time zero to last sampling time $(AUC_t)$ and from time zero to time infinity $(AUC_{inf})$, for test and reference formulations were $1185{\pm}755$, $1326{\pm}896$ and $1124{\pm}737$, $1185{\pm}755$ $ng{\cdot}h/mL$, respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log transformed values of $AUC_t$, and $C_{max}$ were 0.9630 to 1.1383 and 0.8650 to 1.0446, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribe interchangeably.

• Journal of Pharmaceutical Investigation
• /
• 제38권2호
• /
• pp.135-142
• /
• 2008

The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom the plasma 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 Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

• Journal of Biosystems Engineering
• /
• 제34권2호
• /
• pp.127-132
• /
• 2009

In the working population, muscle fatigue and musculoskeletal discomfort are common, which, in the case of insufficient recovery may lead to musculoskeletal pain. Workers suffering from musculoskeletal pains need to be rehabilitated for recovery. Isokinetic testing has been used in physical strengthening, rehabilitation and post-operative orthopedic surgery. Frequency analysis of electromyography (EMG) signals using the mean frequency (MNF) has been widely used to characterize muscle fatigue. During isokinetic contractions, EMG signals present strong nonstationarities. Hilbert-Haung transform (HHT) and autoregressive (AR) model have been known more suitable than Fourier or wavelet transform for nonstationary signals. Moreover, several analyses have been performed within each active phase during isokinetic contractions. Thus, the aims of this study were i) to determine which one was better suitable for the analysis of MNF between HHT and AR model during repetitive maximum isokinetic extensions and ii) to investigate whether the analysis could be repeated for sequential fixed epoch lengths. Seven healthy volunteers (five males and two females) performed isokinetic knee extensions at $60^{\circ}/s$ and $240^{\circ}/s$ until 50% of the maximum peak torque was reached. Surface EMG signals were recorded from the rectus femoris of the right thigh. An algorithm detecting the onset and offset of EMG signals was applied to extract each active phase of the muscle. Following the results, slopes from the least-square error linear regression of MNF values showed that muscle fatigue of all subjects occurred. The AR model is better suited than HHT for estimating MNF from nonstationary EMG signals during isokinetic knee extensions. Moreover, the linear regression can be extracted from MNF values calculated by sequential fixed epoch lengths (p> 0.0I).

• Korean Journal of Acupuncture
• /
• 제26권2호
• /
• pp.15-25
• /
• 2009

Objective: This paper aimed to understand influences on EEG conducting acupuncture stimulation, by comparing the changes in the acupoints on the body before and after normal people are treated with acupuncture at PC9 and TE3, which are referred to as Wood points(木穴), and PC5 and TE1, which are referred to as the Metal points(金穴) among the five shu points of Yin pericardium Meridian and Yang Triple Energizer Meridian. Methods: The study was performed on 30 healthy female volunteers in their 20's. EEG was measured for 5 minutes before acupuncture stimulation was conducted on PC9, TE3, PC5 and TE1. During 20 minutes of acupuncture treatment, the same items were continuously measured to find out whether there were any changes in them, and they were measured for 5 minutes after removing the acupuncture needles in order to implement a comparative analysis. Results: Comparision of EEG data before and after the treatment at PC9 shows no significant differences in all wave. Compared with the pre-acupuncture period at TE3, $\delta-\theta$ wave decreased significantly (P<0.05) during the acupuncture stimulation periods. Compared with the pre-acupuncture period at PC5, $\delta-\theta$ wave and high $\alpha$ wave increased significantly (P<0.05) during the acupuncture stimulation periods. And Mid $\beta$ wave and high $\beta$ wave decreased significantly (P<0.05) during the acupuncture periods and the post acupuncture periods. Compared with the Pre-acupuncture period at TE1, $\delta-\theta$ wave, $\theta$ wave and high $\alpha$ wave increased significantly (P<0.05) during the acupuncture stimulation periods. And Low $\beta$ wave decreased significantly (P<0.05) during the acupuncture periods. Conclusion: When acupuncture stimulation was performed on PC9 and TE3, referred to as the "Wood points", brain waves were stabled, while when acupuncture was performed on PC5 and TE1, called the "Metal points", a brain was waked. From the findings of this study, we hypothesize that the wood properties, from which growing starts in all things, are related with fast waves of EEG, and the metal properties, which stabilize and converge in all things, are related with slow waves of EEG.

• 한국콘텐츠학회논문지
• /
• 제9권9호
• /
• pp.278-286
• /
• 2009

본 연구는 스트레칭이 $\alpha$-운동신경원의 흥분도를 변화시키는지의 여부와 이에 따른 유연성의 변화 정도를 알아보고자 시도되었다. 본 연구에서 $\alpha$-운동신경원 흥분도는 비복근 H-반사의 Hmax/Mmax 비로 측정하였으며 근육의 유연성은 족관절의 능동 배측굴곡 가동 범위를 통해 알아보았다. 스트레칭은 10명의 건강한 피검자를 대상으로 총 4분간(2분간의 스트레칭, 1분의 휴식, 2분간의 스트레칭), 각 시기별로 비복근에 적용하였다. $\alpha$-운동신경원 흥분도와 유연성을 분석하기 위해 본 연구에서는 스트레칭 적용 전, 1차 스트레칭 적용 직후, 2차 스트레칭 적용 직후, 그리고 2차 스트레칭 적용 후 48시간 후 Hmax/Hmax와 족관절의 능동 배측굴곡 각도를 측정하였다. 본 연구의 결과 1차와 2차 스트레칭 적용 후 의미 있는 $\alpha$-운동신경원 흥분도의 감소와 족관절 능동 배측굴곡 각도의 증가가 나타났으나 스트레칭을 소거한 48시간 후에는 $\alpha$-운동신경원 흥분도와 족관절의 능동 배측굴곡 가동 범위가 스트레칭 적용전과 비슷한 상태로 되돌아갔다. 이러한 스트레칭에 의한 비복근 $\alpha$-운동신경원 흥분도 감소와 이에 따른 족관절 배측굴곡 유연성 증가는 족관절 주변의 III형 기계적 수용기와 근육에 위치한 골지건 기관의 활성 결과로 사료된다.

• 한방재활의학과학회지
• /
• 제29권4호
• /
• pp.81-88
• /
• 2019

Objectives This study is a preliminary study for safe and accurate cervical Hyeopcheok acupuncture by comparing the depth of cervical Hyeopcheok acupoint with cervical spine rotation. Methods Researchers took ultrasonographic images of cervical Hyeopcheok acupoint during full rotation of cervical spine, 45 degree rotation and neutral condition in a prone position. 4 healthy volunteers were recruited. Results No significant difference in needling depth of cervical Hyeopcheok acupoint was observed. However, there were a differences in anatomical structures' shape such as muscles. Conclusions There are no significant difference in needling depth, but anatomical structures' shape were changed. This result mean that if patient rotate cervical spine during acupuncture treatment, it can occur complications. Thus, when acupuncture treatment on cervical Hyeopcheok acupoint, practioner should make subject's cervical spine alignment corrected and be careful not to change posture during the procedure.

• 대한화장품학회지
• /
• 제41권4호
• /
• pp.413-420
• /
• 2015

피부는 신체에서 가장 크고 육중한 기관 중 하나로 인간의 생리 및 병리 과정에 참여한다. 피부는 자기 유지 및 치유, 기계적 및 화학적 손상 방어, 자외선 과 외부 병원성 미생물로부터의 방어, 비타민 D 합성 그리고 사회 심리적 기능을 한다고 알려져 있다. 이 연구의 목적은 한국 여성의 부위와 연령에 따라 피부 생물학 인자와 연관된 생물리학 인자의 변화를 평가하는 데 있다. 20 ~ 49세의 약 70명의 건강한 성인 여성이 이 실험에 참여하였다. 측정부위는 하박 내측과 뺨으로 진행하였다. 인체 피부의 생물리학 인자를 측정하기 위하여 여러 가지 비침습적인 방법으로 진행하였다. 피부의 생물학 인자를 분석하기 위하여 코티졸, 파이브로넥틴, 케라틴-1, 10, 11, 인보루크린, 케라틴 6를 인체의 얼굴과 하박내측으로 비교하였다. 또한 비침습적 방법으로 피부 생물리학 인자는 피부 부위와 연령에 따른 차이를 측정하였다. 측정 부위에 따른 결과, 각질층 수분량, 경피수분손실량과 피부색(L과 a값)은 유의적인 차이가 나타났다. 연령에 따른 결과, 오직 피부색에서만 연령에 따른 차이가 유의적으로 나타났다. 코티졸, 케라틴-6, 파이브로넥틴, 케라틴-1, 10, 11 은 연령과 부위간 유의적 차이가 없지만 인볼루크린은 30 ~ 39세 연령대에서 다른 연령대보다 유의적으로 가장 높았다. 이러한 결과는 개인의 피부 환경에 대한 상세한 피부 상태 변화로 설명할 수 있을 것이다.

• Archives of Pharmacal Research
• /
• 제29권4호
• /
• pp.328-332
• /
• 2006

The bioequivalence and pharmacokinetics of alendronate sodium tablets were examined by determining the plasma concentration of alendronate. Two groups, consisting of 24 healthy volunteers, each received a 70 mg reference alendronate sodium tablet and a test tablet in a $2{\times}2$ crossover study. There was a 6-day washout period between doses. The plasma alendronate concentration was monitored for 7 h after the dose, using HPLC-Fluorescence Detector (FD). The area under the plasma concentration-time curve from time 0 to the last sampling time at 7 h $(AUC_{0-7h})$ was calculated using the linear-log trapezoidal rule. The maximum plasma drug concentration $(C_{max})$ and the time to reach $C_{max}(T_{max})$ were derived from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_{0-7h}\;and\;C_{max}$, and untransformed $T_{max}$. For the test medication versus the reference medication, the $AUC_{0-7h}\;were\;87.63{\pm}29.27\;vs.\;102.44{\pm}69.96ng\;h\;mL^{-1}$ and the $C_{max}$ values were $34.29{\pm}13.77\;vs.\;38.47{\pm}24.39ng\;mL^{-1}$ respectively. The $90\%$ confidence intervals of the mean differences of the logarithmic transformed $AUC_{0-7h}$ and $C_{max}$ values were log 0.8234-log 1.1597 and log 0.8222-log 1.1409, respectively, satisfying the bioequivalence criteria guidelines of both the US Food and Drug Administration and the Korea Food and Drug Administration. The other pharmacokinetic parameters for the test drug versus reference drug, respectively, were: $t_{1/2},\;1.87{\pm}0.62\;vs.\;1.77{\pm}0.54\;h;\;V/F,\;2061.30{\pm}986.49\;vs.\;2576.45{\pm}1826.05\;L;\;CL/F,\;835.32{\pm}357.35\;vs.\;889.48{\pm}485.87\;L\;h^{-1}; K_{el},\;0.42{\pm}0.14\;vs.\;0.40{\pm}0.18\;h^{-1};\;Ka,\;4.46{\pm}3.63\;vs.\;3.80{\pm}3.64\;h^{-1};\;and\;T_{lag},\;0.19{\pm}0.09\;vs.\;0.18{\pm}0.06\;h$. These results indicated that two alendronate formulations(70-mg alendronate sodium) were biologically equivalent and can be prescribed interchangeably.

• 한국응용과학기술학회지
• /
• 제35권4호
• /
• pp.1185-1196
• /
• 2018

본 연구는 여성 노인을 대상으로 12주간의 아쿠아로빅 운동이 혈중지질, 동맥경화지수 및 간기능에 미치는 영향을 규명하는데 그 목적이 있으며, 이를 위해 만 65-80세 여성 노인을 대상으로 아쿠아로빅군 13명, 대조군 12명으로 분류하여 아쿠아로빅을 12주, 주 2회, 60분 동안 실시하였다. 본 연구의 운동강도는 운동자각도를 설정하여 1-4주는 RPE 11-12, 5-8주는 RPE 13-14, 9-12주는 RPE 14-15를 유지하였다. 아쿠아로빅 실시 전 후의 항목별 차의 비교를 위해 그룹 내 차이는 대응 t 검정, 그룹 간 차이는 독립 t 검정, 상호작용 검증을 위해 이원 반복측정 분산분석을 사용하였으며, 각 항목별 통계적 유의수준은 .05로 설정하였다. 그 결과 아쿠아로빅군의 LDL-C(p<.05)이 유의하게 감소하였으며, TC, TG, LDL-C에서 상호작용효과가 있는 것으로 나타났다. 동맥경화지수는 LDL-C/HDL-C, TG/HDL-C에서 상호작용효과가 나타났으며, 간 기능은 아쿠아로빅군이 AST(p<.001)의 유의한 감소를 나타냈다. 이상의 결과 노화와 신체활동 부족은 곧 심혈관 질환과 대사기능의 위험요인이라는 점을 감안할 때, 규칙적인 아쿠아로빅은 여성 노인의 혈중지질, 동맥경화지수 및 간 기능을 개선함으로써 노인기의 심혈관건강의 증진과 대사증후군 예방을 위한 효과적인 운동방법으로 권장된다.