• Journal of Pharmaceutical Investigation
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• 제37권4호
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• pp.255-261
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• 2007

A bioequivalence study of $Nimegen^{TM}$ soft capsule (Medica Korea Pharma. Co., Ltd.) to $RoAccutane^{(R)}$ soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48 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 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 $Nimegen^{TM}/RoAccutane^{(R)}$ were $log0.860{\sim}log0.98\;and\;log0.85{\sim}log1.00$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Nimegen^{TM}\;and\;RoAccutane^{(R)}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제39권2호
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• pp.133-139
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• 2009

The purpose of the present study was to evaluate the bioequivalence of two pioglitazone HCl tablets, $Actos^{TM}$, tablets (Lilly Korea. Ltd., Korea) as a reference drug and $Piros^{TM}$, tablets (Reyon Pharm. Co., Ltd., Korea) as test drug, according to the guideline of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet containing pioglitazone HCl 15 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of pioglitazone were monitored for over a period of 36 hr after administration by using a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The area under the plasma concentration-time curve from time zero to 36 hr ($AUC_{0-36hr}$), maximum plasma drug concentration ($C_{max}$) and time to reach $C_{max}$ ($T_{max}$) were complied from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_{0-36hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-36hr}$ ratio and the $C_{max}$ ratio for $Piros^{TM}$/$Actos^{TM}$. were log 0.8753-log 1.1286 and log 0.8669-log 1.1734, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that the $Piros^{TM}$. tablet was bioequivalent to the $Actos^{TM}$. tablet, based on the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제39권6호
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• pp.457-463
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• 2009

The purpose of the present study was to evaluate the bioequivalence of meloxicam capsule, $Mobic^{TM}$ capsule( Boehringer Ingelheim Ltd., Korea) as a reference drug and $Meloxifen^{TM}$ capsule (Kukje Pharma Ind. Co., Ltd., Korea) as a test drug, according to the guidelines of Korea Food and Drug Administration(KFDA). Thirty two healthy male Korean volunteers received capsule containing meloxicam 7.5 mg in a $2{\times}2$ crossover study. There was a one-week above washout period between the doses. Plasma concentrations of meloxicam were monitored for over a period of 72 hr after administration by using a high performance liquid chromatography-tandem mass spectrometer(LC-MS/MS). $AUC_t$(the area under the plasma concentration-time curve from time zero to 72 hr), $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were complied from the plasma concentration-time data. Analysis of variance(ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Meloxifen^{TM}/Mobic^{TM}$ were log 0.8605-log 0.9847 and log 0.9765-log 1.1503, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that $Meloxifen^{TM}$ capsule was bioequivalent to $Mobic^{TM}$ capsule, based on the rate and extent of absorption.

• Journal of Nutrition and Health
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• 제31권1호
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• pp.46-61
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• 1998

This study was carried out to evaluate the effects of vitamin D nutritional status on bone mineral density of adults (21-49 years). To attain the aim, we measured bone mineral density (BMD) of the subjects at distal radius by single-photon absorptiometry (SPA). Serum level of 25-hydroxyvitamin D(25-(OH)D) , known to be the best indicator of indicator of vitamin D status in humans was analyzed . The factors affecting this vitamin D level were also investigated in autumn in 122 young adults. Serum level of 25-(OH)D was measured by high pressure liquid chromatography(HPLC) and biochemical variables, general health status, time spent outdoors, and dietary intakes of the subjects. BMD of the male subjects was significantly greater than that of female subjects. Weight, activity and total energy expediture (TEE) showed a positive correlation with distal BMD. The mean level of serum 25-(OH)D was 24.4$\pm$11.0 ng./ml and by sex, 26.0$\pm$6.8ng/ml for males and 23.3$\pm$12.3ng/ml for females , the level was significantly higher in male (p<0.01). there was significant correlation between BMD at distal-radius and s-25(OH)D levels (p<0.001). The serum level fo parathyroid hormone (PTH) showed a negative correlation with BMD(p<0.05), with the more obvious correlation in females. Vitamin D intake was estimated to be 3.75$\pm$2.19ug/day in average. Among the nutrients studied, protein ,fat, calcium , and vitamin D intake were positively correlated with distal BMD. When food frequencies were concerned , milk and dairy products showed a significant positive correlation with the BMD level, and driedfoods, eggs , fats and oils, and cereals also showed a positive correlation. Time spent outdoors was estimated to be about 70 minutes in average and positively correlated with the distal BMD level(p<0.01). During the day, the specific time between 12 :00pm and 2:00pm showed the most significant correlation with BMD (p<0.001). Multiple regression analysis with the variables showed that distal BMD could be fit 31.9% by the time spent outdoors a day, intake of Ca and vitamin D, and TEE. The standardized estimates were 0.344 for vitamin D intake, 0.284 for Ca intake 0.179 for the time spent outdoors a day and 0.273 for TEE. For males, s-25*OH)D level, TEE and time spent outdoors during a day showed a significant correlation. For females, intake of Ca and vitamin D could fit about 27.1% of the distal BMD.

• 대한화장품학회지
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• 제42권1호
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• pp.65-73
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• 2016

대한민국 식품의약품안전처(식약처)는 포름알데하이드 분석법으로 2,4-dinitrophenylhydrazine(DNPH) 유도체화-고성능액체크로마토그래프법(HPLC)을 고시하고 있다. 본 연구는 고시법의 복잡한 시료 전처리 과정을 개선하여 화장품 분석에 편리하게 사용할 수 있는 유도체화법을 개발하고자 수행되었다. 전처리법을 간단하게 하기 위하여 pH, 시간 및 온도 등 반응조건을 최적화하였다. 이 전처리법은 초산염 완충액(pH 5.0)을 사용한 검액의 pH 조정, 디클로로메탄을 사용한 액-액 분획 그리고 감압농축기를 사용한 증발건조와 같이 식약처 고시법의 복잡한 과정이 필요 없다. 유도체화 과정을 통하여 생성된 formaldehyde dinitrophenylhydrazone(formaldehyde-DNP)는 식약처의 시험방법을 약간 변형한 역상 HPLC법으로 분리하고 정량하였다. 2 ~ 40 ppm 농도 범위의 표준액들을 가지고 수행한 검량선 작성 결과, 본 시험법은 상관계수 값이 0.9999로 좋은 직선성을 보여주었다. 본 실험의 최소검출한계(LOD)와 최소정량한계(LOQ)는 각각 0.2 ppm과 0.5 ppm이었다. 또한 회수율 실험결과는 실험방법이 매우 정확하고 재현성이 높음을 보여주었다. 따라서 본 연구에서 제안된 시험법은 화장품 중 포름알데하이드를 신속하게 분석하는데 적용될 수 있을 것이다.

• 대한수의학회지
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• 제35권4호
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• pp.793-807
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• 1995

This study was carried out to investigate the effects of diethyl maleate(DEM) on the carcinogenesis of forestomach and pyloric glandular stomach in rats caused by N-methyl-N'-nitro-N-nitrosoguanidine(MNNG). A total of 60 male 6-week-old Wistar rats were given twice intragastric injection of MMNG(200mg/kg BW), then were given diets containing 5% NaCl for 3 weeks until 4th week of the experiment. And then the animals of groups of 1 and 2 were placed on diets containing 0.2% DEM for 16 weeks until the end of 20 weeks of the experiment. On the other hand, the animals of groups of 3 and 4 were placed on basal diets for the same periods. The tissues of forestomach and liver of each group were frozen in liquid nitrogen and the activities of quinone reductase(QR) were determined by measurement of the dicoumarol-sensitive reduction of dichloro-indophenol by NADPH at 600nm. All rats were sacrificed at the end of 20 weeks of the experiment. Every animal was fasted for 24 hrs prior to sacrifice. The forestomach was fixed in 10% neutral phosphate buffered formalin for histology and the pyloric gland was fixed in sublimated formalin for immunohistochemistry of pepsinogen 1 altered pyloric gland(PAPG). The final body weight of the group given MNNG and treated with 5% NaCI and DEM was significantly decreased compared with that of the group 4(p<0.05). Food and water consumption rates were not significantly changed. The preneoplastic and neoplastic lesions of the forestomach given MNNG and treated with 5% NaCI and DEM were significantly increased compared to those of the group 4(p<0.0l). The incidence of PAPG in the groups treated with 0.2% DEM was significantly increased compared with that of the group 4(group 1:p<0.01, group 2:p<0.05). The activities of QR of forestomach in the groups treated with 0.2% DEM were significanitly increased compared with those of the group 4(p<0.001), but those of liver were not significant. These results indicate that DEM exert the enhancing effect of forestomach and glandular stomach carcinogenesis in rats pretreated with MNNG and NaCl.

• 대한화학회지
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• 제32권1호
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• pp.65-70
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• 1988

애모무늬잎말이나방의 성 유인물질 (Z)-9-인테트라데센-1-일 아세테이트(1)와 (Z)-11-테트라데센-1-일 아세테이트(2)를 합성하여 생물활성시험을 수행하였다. 1,8-옥탄디올에서 쉽게 얻을 수 있는 8-브로모옥탄-1-올 THP 에테르를 1-헥신의 리튬음이온과 알킬화시켜 9-테트라데신-1-올 THP 에테르를 얻었다. 이를 Pb/BaSO4 촉매하에서 수소환원시킨 후 PPTS로 보호기를 제거하여 (Z)-9-테트라데센-1-올을 얻었으며 이를 아세틸화시켜 (Z)-9-테트라데센-1-일 아세테이트(1)를 합성하였다. 한편 1,10-데칸디올에서 쉽게 얻을 수 있는 10-브로모데칸-1-올 THP 에테르를 아세틸렌나트륨음이온과 알킬화시켜 11-도데신-1-올 THP 에테르를 얻는다. 이를 다시 부틸리튬으로 처리하여 얻어지는 리튬음이온을 브로모에탄과 반응시켜 11-테트라데신-1-올 THP 에테르를 형성시켰다. 이를 Pd/BaS$O_4$ 하에서 수소환원, 보호기제거 후 (Z)-11-테트라데신-1-올을 거쳐, 아세틸화시켜 (Z)-11-테트라데센-1-일 아세테이트 (2)를 합성하였다. 합성된 성 페로몬에 대한 애모무늬잎말이나방 숫컷의 성 유인력을 시험해본 결과 활성이 있음이 밝혀졌다.

• 농업과학연구
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• 제9권1호
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• pp.377-386
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• 1982

고온균(高溫菌)의 생리적(生理的) 특성(特性)과 내열기구(耐熱機構)에 관한 기초자료(基礎資料)를 얻고자 온천토양(溫泉土壤)에서 ${\beta}$-galactosidase를 생산(生産)하는 고온균(高溫菌)을 분리(分離)하여 동정(同定)하고, 몇가지 주요(主要)한 생리적(生理的) 특성(特性)을 검토(檢討)하였으며, 그의 균체지방산(菌體脂肪酸) 조성(組成)을 gas chromatography로 분석(分析)하여 다음과 같은 결과(結果)를 얻었다. 1. ${\beta}$-galactosidase를 생산(生産)하는 공시(供試) 균주(菌株)는 Thermus속(屬)으로 동정(同定)되었다. 2. 분리선정(分離選定)한 균주(菌株)의 최적(最適) 생육온도(生育溫度)는 $65^{\circ}C$이었고, $37^{\circ}C$에서 생육(生育)하지 않는 절대(絶對) 고온균(高溫菌)이었으며 최적(最適) pH는 6.5내외(內外)이었다. 3. NaCl에 대(對)한 내성(耐性)은 NaCl 1% 이상(以上)에서 생육(生育)하지 못했다. 4. 공시균주(供試菌株)의 항생물질(抗生物質) 내성(耐性)은 Penicillin G는 $10{\mu}g/m{\ell}$, Chloramphenicol은 $0.5{\mu}g/m{\ell}$이었다. 5. Vitamin 요구성(要求性)은 Ca-pantothenate와 pyridoxine-HCl을 절대적(絶對的) 생육인자(生育因子)로 요구(要求)하였고 niacin을 자극적(刺戟的) 생육인자(生育因子)로 요구(要求)하였다. 6. 공시균주(供試菌株)는 최대(最大) 흡수파장(吸收波長)이 420nm 부근(附近)의 색소(色素)를 생성(生成)하였고 그의 생성능(生成能)은 약(弱)하였다. 7. 공시균주(供試菌株)의 균체 지방산(脂肪酸) 조성(組成)은 palmitic acid 60.20%, lauric acid 11.80%, myristic acid 7.56%, behenic acid 4.25%, capric acid 1.77%, stearic acid 2.13%, arachidic acid 1.53%이었다.

• 사상체질의학회지
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• 제2권1호
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• pp.149-166
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• 1990

In order to investigate experimented effects of Indongdeung Jigolpi-Tang, which is applied to Soyangin, to diabetes, the measurement, comparison and observation made on the contents of volumes of blood glucose, total cholesterol, triglyceride, phospholipid, total protein and electrolyte($K^+$, $Na^+$) in blood serum by giving a high blood glucose, induced by streptozotocin, to hyperglycemic rats, dosing the cooked liquid of I.J.T., and following conclusion was attained. 1. The volume of glucose urine, induced by streptozotocin to hyperglycemic rats, was shown an increase in comparision to a normal flock when $12.50m{\ell}/kg$ of I.J.T. dosed to the rats and checked after two and four weeks and thereby, a sinificant reduction in the volume of blood glucose was made. 2. The volume of total cholesterol of blood serum in the diabetic rats, induced by streptozotocin, was increased in comparision to the normal flock, and in the fouth week of dosing $1.25m{\ell}/kg$ of I.J.T., a significant reduction of total cholesterol volum was shown in the blood serum. 3. The volume of triglyceride in the blood serum of the diabetic rats, induced by the streptozotocin, was increased in comparision to the normal flock, and with dosing $1.25m{\ell}/kg$ and $12.50m{\ell}/kg$ of I.J.T., a significant reduction of triglyceride volium was shwon in the blood serum after second and fourth week. 4. The volume of phospholipid in the blood serum of the diabetic rats, induced by the streptozotocin, was somewhat reduced in comparision to the normal flock, and with dosing $1.25m{\ell}/kg$ of I.J.T., a significant reduction of phospholipid volium in the blood serum was shown after first and second week. 5. The volume of total protein in the blood serum of the diabetic rats, induced by the streptozotocin, was somewhat reduced in comparison to the normal flock however, with dosing the I.J.T., no significant change on the volium of total protein was made in the blood serum. 6. The volume of potassium in the blood serum of the diabetic rats, induced by the streptozotocin, was increased in comparision to the normal flock however, with dosing the I.J.T., no significant change of potassium content was made in the blood serum. 7. The volume of sodium in the blood serum of the diabetic rats, induced by the streptozotocin, was somewhat reduced in comparision to the normal flock, and with dosing $12.50m{\ell}/kg$ of the I.J.T., a significant increase was shown in the blood serum after first week. Soyangin, accompanying with a middle and upper heat, the I.J.T. - that has a merits of cleaning up fever, solving fever, solving poison, solving thirst and restoring exhaustion - can be proved that it has a blood sugar reduction effect and it is considered that it can be meritorious for strengthening vitality, further, many other exhausting diseases, and can actively used for the cases such as thirst causing disease and a disease that causes an abnormal food hunger, thirst causing and frequent going to pass urine, in particular.

• Parasites, Hosts and Diseases
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• 제22권2호
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• pp.259-266
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• 1984

원발성 아메바성 뇌수막염 (primary amoebic rneningoencephalitis; PAM)을 일으키는 자유생황아메바인 Svaegleria few입번를 사용하여 액체배지에서 무균적으로 배양된 영양형과 실험적으로 감염시켜 얻은 마우스 뇌조직에 존재하는 영 양형의 미세구조를 전자현미경을 이용하여 비교 관찰한 결과 다음과 같은 성적을 얻었다. 1. 마우스 뇌 조직내의 영양형은 다소 등근 모양인데 반해 액체배지에서 무균배양하여 엎은 영양형은 불규칙한 모양을 보였다. 2. 배 양기에서 얻은 아메바 세포질내 mitochondria 는 난원형, 구형 및 원통형 등 형태가 다양한데 마우스 뇌 조직내의 아메바에서는 이러한 형태 이외에 아령 모양이 특이하게 있었고 배양기내 아메바의 mitochondr심는 진하게 염색되나 마우스 뇌 조직내의 아메바에서 는 진한 것과 흐린 것이 모두 있었다. 3. 조면세포질내세망(rER)의 형태에 있어 마우스뇌조직내 아메바에서는 세관(microtubule)모양인데 비해 배 양기내 아에 바에서는 세관모양 이외에도 소낭(vesiole) 모양이 관찰된다. Ribosome은 배양기내 아메바에서는 free ribosome이 많은 반면 마우스 뇌조직내 아메바에서는 polysome이 많았다. 4. 배양기내 아메바에서는 내용물이 없는 액포(vacuole)가 많고 그 안에 미엘린양 구조가 존재함을 보앗다. 이것으로 아메바는 마우스 뇌조직내에서 강한 식작용을 나타냄을 알 수 있다. 5. Naegleria fowleri에 감염된 마우스 뇌조직은 괴사가 심하였다. 침윤된 염증세포로 다핵백혈구가 많았고, 아메바는 혈관 주위에 많았다.