• Journal of Pharmaceutical Investigation
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• 제32권2호
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• pp.119-125
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• 2002

A rapid, selective and reproducible high-performance liquid chromatographic method has been developed for the determination of terazocin in human plasma. Terazocin plus the internal standard, prazocin hydrochloride, were extracted from alkalified plasma with tert-butylmethyl ether, back-extracted into 0.05% phosphoric acid. Fifty ${\mu}l-portions$ of extract were injected onto a octadecylsilane column and eluted with a mixture of acetonitrile, water and triethylamine (30 : 70 : 0.1 v/v, adjusted to pH 5.0 with dilute phosphoric acid) at a flow rate of 1.0 ml/min. The fluorescence intensity of column eluents was monitored at excitation wavelength of 250 nm and emission wavelength of 370 nm. No interference peaks were observed. The practical limit of quantitation was 5 ng/ml for terazocin. The average intraday and interday coefficients of variation were 4.15 and 3.54%, respectively. Also intraday and interday precisions over the range $5{\sim}60\;ng/ml$ were $0.49{\sim}2.92\;and\;0.38{\sim}5.12%$, respectively. The bioequivalence of two terazosin tablets, the $Hytrine^{\circledR}$ (Il Yang Pharmaceutical Co., Ltd.) and the $Teratonin^{\circledR}$ (Sam-A Pharmaceutical Co., Ltd.), was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers $(24.6{\pm}2.0\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in plasma was determined with a HPLC method using spectrofluorometric detector. AUC was calculated by the linear trapezoidal method. $C_{max}\;and\;T_{max}$ were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between the two preparations were 0.21 %, 5.53% and 8.82%, respectively. The powers $(1-{\beta})\;for\;AUC_t,\;C_{max}\;and\;T_{max}$ were >99%, 97.49%, and 33.26%, respectively. Minimum detectable differences $({\Delta},\;%)\;at\;{\alpha}=0.1\;and\;1-{\beta}=0.8$ and the 90% confidence intervals were all less than ${\pm}20%$ except for $T_{max}.\;AUC_t\;and\;C_{max}$ met the criteria of KDFA for bioequivalence, indicating that $Teratonin^{circledR}$ tablets are bioequivalent to $Hytrine^{circledR}$ tablets.

• Journal of Pharmaceutical Investigation
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• 제41권5호
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• pp.317-322
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• 2011

Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

• Journal of Pharmaceutical Investigation
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• 제41권2호
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• pp.117-123
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• 2011

Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

• 한방비만학회지
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• 제9권2호
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• pp.47-56
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• 2009

Objectives The purpose of this study was to investigate the progress of weight and waist circumference(WC) through oriental obesity treatment and clarify the correlation between weight loss and WC change. Methods The subjects were treated from January 2007 to September 2009 in J Oriental Medical Center. Herbal medicine, electroacupuncture, oriental obesity physiotherapy were performed for a month. We checked the change of weight and WC at every treatment. We classified the WC into upper, middle, lower parts specifically and measured them individually. Measurements were analyzed by using one-way repeated measures ANOVA and we also investigated correlation between weight loss and WC change. Results (1) During the first and second treatment sessions, the weight loss was the highest, $0.96{\pm}0.86\;kg$($1.46{\pm}1.32\;%$) and during the 5th and 6th treatment sessions, the lowest $0.37{\pm}0.616\;kg$. The final weight loss was $3.71{\pm}1.476\;kg$($5.51{\pm}2.12\;%$). (2) After 8 treatment sessions, the reductions of upper, middle and lower WC were $3.59{\pm}2.26\;%$, $5.93{\pm}2.75\;%$, $5.51{\pm}3.22\;%$, respectively. As the patients received more treatment, there was a progressive decline in the variation of weight and middle WC. However, the decline rate of upper and middle WC fluctuated during the treatments, forming a W-shaped curve. (3) Analysis of the correlation between the weight loss and WC change shows that the reduction of middle WC was most closely associated with the weight loss. Conclusions This study indicated that the rate of weight loss and WC reduction showed stagnation during the 5th and 6th treatment sessions, and the reduction of middle WC was most closely associated with the weight loss. Since the progress of weight and WC change is an important field of research on obesity, further systemic studies would be needed for the foundation of a clinical guideline.

• 한국동물위생학회지
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• 제31권3호
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• pp.347-356
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• 2008

The purpose of this study was to evaluate the efficacy and cross-protection of serovar 12 against serovar 4 or 5 of H parasuis with M+$Parapac^{(R)}$. A total of 141 piglets from 2(A and B) farms were used and divided into experimental group and control group in each farm. Farm A has been detected H parasuis serovar 12, whereas farm B has been detected H parasuis serovar 4 or 5 from post-weaned pigs with PMWS. The piglets were vaccinated intramuscularly with 2.0ml of M+$Parapac^{(R)}$ in experimental group or normal saline in control group at 1 week of age. A same booster dose was given at 3 weeks of age. In order to value the antibody titer to H parasuis using by tube agglutination test, blood samples were collected from piglets at the aged of 1 week, 6 and 14 weeks. In experimental group and control group, the average antibody titers were $32.5{\pm}21.0,\;114.5{\pm}34.0,\;98.1{\pm}55.4$ and $32.9{\pm}18.6,\;25.8{\pm}36.9,\; 746.7{\pm}1,215.8$ at the aged of 1 week, 6 and 14 weeks, respectively. The cumulative clinical sign indexes by standard guideline of Schering-Plough Animal Health Corp were 486 and 1,069, respectively. The average daily gains and feed conversion rates were $0.553{\pm}0.016kg$ and $0.492{\pm}0.004kg$, and 1.99 and 2.24, respectively. The average gross lesion scores were $1.0{\pm}0.8$ and $1.9{\pm}0.6$, respectively. According to these results, the M+$Parapac^{(R)}$ containing H parasuis serovar 12 may be induce circulating antibodies that cross-react with serovar 4 or 5 and have a protection of PMWS with H parasuis.

• 한국병원경영학회지
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• 제23권1호
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• pp.87-106
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• 2018

Purpose: 본 연구는 미국 캘리포니아와 플로리다에 위치한 의료기관을 대상으로 급성심근경색증, 심부전, 폐렴을 주진단으로 받은 메디케어 입원환자들에게 제공된 의료서비스의 과정적 질과 잠재적으로 예방이 가능한 30일 이내 위험 보정 재입원율과의 관계를 살펴보았다. Methods: 본 연구의 종속변수는 잠재적으로 예방이 가능한 30일 이내 위험 보정 질환별 재입원율이며 3M PPR 소프트웨어를 이용하여 재입원의 예방 가능 여부를 결정하였다. 미연방 의료 비용 및 이용 프로젝트 데이터베이스, 미국병원협회의 병원조사 자료, 미연방 보건복지부소속 메디케어 및 메디케이드 서비스 센터의 병원비교 자료를 이용하였다. 자료의 위계적 구조를 고려하여 다수준 로지스틱 회귀분석을 이용하여 분석하였다. Findings: 의료서비스의 과정적 품질과 퇴원 후 30일 이내 잠재적 예방 가능 위험도 보정 재입원율과의 관계는 질환별로 차이를 보였다. 폐렴의 경우 의료서비스의 과정적 질은 30일 이내 잠재적 예방 가능 보정 재입원율과 유의한 부(-)의 관계를 보였으나, 급성심근경색증과 심부전의 경우 대체로 유의한 관계를 관찰할 수 없었다. Practical Implications: 잠재적으로 예방 가능한 급성심근경색증, 심부전 재입원율을 줄이기 위해서는 의료기관에서 가이드라인으로 따를 수 있는 더욱 다양한 근거 중심의 과정적 질 지표의 개발에 대한 정부와 보건의료계의 노력이 필요하다.

• 생명과학회지
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• 제19권10호
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• pp.1389-1395
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• 2009

천연물 신약으로 응용 가능성이 있는 목초액을 산화응집반응과 활성탄 등을 첨가하여 증류하는 방법으로 제조하였으며, 장기보존과 가속 저장 조건에서 목초액의 이화학적 변화(pH, 비중, 굴절률 및 용해 타르), 유해물질(카르보닐기, 벤조피렌 및 잔류용매) 그리고 유기산(개미산, 초산 및 프로피온산)의 변화를 검토하여 안정성을 평가하였다. 또한, 발모 모델로서 C57BL/6 마우스를 이용하여 모발 성장 효과를 살펴보았다. 보관 기간 중에 어떤 화학 결합이 일어나거나 또는 분해반응이 반복적으로 일어나지 않았다. 또한, 유해성분이나 주성분이 일정하게 유지되었고 특히 발암물질인 벤조피렌은 검출되지 않았다. 정제된 목초액 또는 미녹시딜을 2주 동안 등에 도포한 후, 어떤 임상 증상 없이 음성 대조군인 생리식염수보다 모발 성장을 촉진하였다. 따라서 화장품이나 천연물 신약으로 응용가능성이 높은 목초액을 함유한 제품 개발 시 일정한 양으로 유지되는 주성분을 함유하면서 페놀과 같은 유해물질을 줄일 수 있는 방법이 가능할 뿐만 아니라 모발 성장 촉진 효과가 있어 탈모환자에도 유용하게 사용될 것으로 기대되어진다.

• 한국컴퓨터정보학회:학술대회논문집
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• 한국컴퓨터정보학회 2017년도 제55차 동계학술대회논문집 25권1호
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• pp.235-238
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• 2017

This study was to develop a portable digital radiography (PDR) system with a function measuring the X-ray source-with-detector angle (SDA) and to evaluate the imaging performance for the diagnosis of chest imaging. The SDA device consisted of an Arduino, an accelerometer and gyro sensor, and a Bluetooth module. According to different angle degrees, five anatomical landmarks on chest images were assessed using a 5-point scale. Mean signal-to-noise ratio and contrast-to-noise ratio were 182.47 and 141.43. Spatial resolution (10% MTF) and entrance surface dose were 3.17 lp/mm ($157{\mu}m$) and 0.266mGy. The angle values of SDA device were not significant difference as compared to those of the digital angle meter. In chest imaging, SNR and CNR values were not significantly different according to different angle degrees (repeated-measures ANOVA, p>0.05). The visibility scores of the border of heart, 5th rib and scapula showed significant differences according to different angles (rmANOVA, p<0.05), whereas the scores of the clavicle and 1st rib were not significant. It is noticeable that the increase in SDA degree was consistent with the increase of visibility score. Our PDR with SDA device would be useful to be applicable to clinical radiography setting according to the standard radiography guideline at various fields.

• 대한임상독성학회지
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• 제8권1호
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• pp.16-23
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• 2010

Purpose: Organophosphate insecticide poisoning is common in Korea, but there is no definitive guideline for determining the severity of the poisoning and the predictive factors. Therefore, we evaluated the organophosphate poisoned patients and we divided them into two groups, the survivors and the dead, and the results might be useful for treating organophosphate poisoning patients. Methods: We performed a retrospective analysis of 68 organophosphate poisoned patients who visited the Chosun University Hospital Emergency Medical Center during a 24-month period from January, 2007 to December, 2008. We made a work sheet of the patients' characteristics and the collected data was analyzed and we compared this data between the survivor group and the dead patient group. Results: There were significant differences between the survivor group and the dead patient group for the mean age, the alcohol intake state and the typically expressed signs. The dead patients had lower blood pressure, tachycardia and a lower Glasgo Coma Score (GCS) score than the survivor group. On the arterial blood gas analysis, the dead patients had more severe acidemia and they had lower saturations. Increased serum amylase levels were found in the dead patients. The survivors'initial and follow up serum pseudocholinesterase activity (after 6~8 days) was significantly higher than that of the dead group. The total amount of atropine injected to patient was less in the survivors than that in the dead patients. Conclusion: Old age and expressing the typical intoxication signs, a lower GCS score and blood pressure, showing acidosis on the gas analysis and low serum cholinesterase activity may be useful as poor prognostic indicators for patients with organophosphate poisoning. We suggest that physicians must pay careful attention to the signs and prognostic factors of organophosphate insecticide poisoned patients.

• 핵의학기술
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• 제13권1호
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• pp.30-34
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• 2009

목적 : 현재 신속한 검사 및 환자의 대기 시간 단축에 따른 제한적인 영향을 가지고 있는 whole body bone scan의 단점을 보완하기 위한 다양한 프로그램들이 개발되어 사용되고 있다. 본 연구는 스캔속도와 알파 값에 따른 FWHM를 이용하고 영상의 육안평가를 통해서 우수한 영상의 질을 얻을 수 있는 매개변수로 임상의 유용성을 얻고자 한다. 실험재료 및 방법 : Siemens (e.cam)사의 감마카메라에서 spatial resolution phantom과 four quadrant bar phantom을 이용하였다. spatial resolution phantom을 가지고 scatter와 non scatter로 Onco Flash를 적용해서 스캔속도 15, 20, 25, 30, 35, 40 cm/min으로 FWHM을 비교하였다. 또한 Onco Flash의 알파값 (0~100%)에서 10%씩 증가하여 스캔속도 30 cm/min 기준으로 계수율과 bar phantom 영상을 얻어 육안적 평가를 하였다. 결과 : Onco Flash를 적용한 scatter에서 스캔속도에 따라 FWHM은 9.37, 9.40, 9.28, 9.30, 9.31, 9.53 mm이고, non scatter에서는 스캔속도에 따라 FWHM은 8.42, 8.32, 8.2, 8.25, 8.35, 8.52 mm이었다. 알파 값은 10%씩 증가할수록 계수율도 증가하고, 육안적 평가는 40% 이상에서 인공물이 나타나기 시작하기 때문에 알파 값은 30% 이하에서 적합하였다. 따라서 Onco Flash를 사용한 스캔속도가 25~35 cm/min에서 알파값 30% 적용 시 FWHM이 평균 9.3 mm로서 15~40 cm/min를 벗어나는 값 보다 공간분해능이 향상되었다. 결론 : Whole body bone scan의 영상을 향상시킬 수 있는 적정 매개변수를 알 수 있었으며 검사 시간을 단축하면서 영상의 질을 향상 할 수 있도록 매개변수들을 적용해 보아 임상적용에 적합한 범위를 얻어 검사자에게 유용한 지표가 될 것이라 사료된다.