• 한국식품과학회지
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• 제37권6호
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• pp.962-969
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• 2005

7주령의 F1B golden Syrian 햄스터에게 동맥경화 유발식이에 녹차추출물, 메밀추출물 및 포도잎 추출물을 함유한 타블렛 제품을 각각 5%와 10%로 첨가하여 7주간 사육하였을 때 햄스터 체내의 지질성분과 대동맥 내에서의 지방의 축적 정도에 미치는 영향을 조사하였다. 실험 결과 녹차, 메밀, 포도잎 추출물을 함유한 타블렛 제품은 동맥경화유발식이를 섭취하는 햄스터의 혈중 중성지방과 총콜레스테롤치를 감소시켰고, 대동맥궁내에서의 지방의 축적을 예방하였고, 간장내 중성지방과 총콜레스테롤치를 감소시키는 것으로 나타났다. 특히 5%를 첨가한 군보다 10%를 첨가한 군에서 더 높은 효과를 나타내어 농도 의존적인 경향을 보였다. 이러한 결과를 통해 녹차, 메밀 및 포도잎 추출물 분말을 이용하여 식이 보조제의 형태로 개발한 타블렛 제품이 동맥경화를 예방하는 식품으로써 효과가 있음을 확인할 수 있었다.

• Journal of Pharmaceutical Investigation
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• 제36권5호
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• pp.343-348
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• 2006

The purpose of the present study was to evaluate the bioequivalence of two zolpidem tartrate tablets, Stilnox tablet(Sanofi-aventis Korea, reference product) and Zanilo tablet(ChoDang Pharm Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration(KFDA). After adding an internal standard(cimetropium), 250 ${\mu}L$ plasma samples were extracted using 1.3 mL of ethyl acetate. Extracted compounds were analyzed by HPLC with triple-quadrupole mass spectrometry. This method for determination of zolpidem is proved accurate and reproducible with the limit of quantitation of 1 ng/mL in human plasma. Twenty-four healthy male Korean volunteers received each medicine at the zolpidem tartrate dose of 10 mg in a $2{\times}2$ crossover study. There was one-week washout period between the doses. Plasma concentrations of zolpidem were monitored for over a period of 8 hr after the administration. $AUC_{0-t}$(the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$(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 $AUC_{0-t}$ and $C_{max}$. No significant sequence effect was found for all of the bio-availability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25(e.g., log 0.92-log 1.06 for $AUC_{0-t}$, log 0.96-log 1.13 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zanilo tablet is bioequivalent to Stilnox tablet.

• Journal of Pharmaceutical Investigation
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• 제30권3호
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• pp.213-218
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• 2000

Ondansetron is a potent, highly selective 5-hydroxytryptamine3(5-HT3) receptor- antagonist, for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiography, and the treatment of post-operative nausea and vomiting. The purpose of the present study was to evaluate the bioequivalence of two ondansetron tablets, $Zofran^{TM}$, (Glaxo Wellcome Korea Ltd.) and Hana ondansetron (Hana Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $23.56{\pm}1.79$ year in age and $67.35{\pm}8.35\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 8 mg of ondansetron was orally administered, blood was taken at predetermined time intervals and the concentrations of ondansetron in serum were determined using HPLC with UV detector. Pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets were 7.53%, -0.23% and -3.92%, respectively when calculated against the $Zofran^{TM}$, tablet. The powers $(1-{\beta})$ for $AUC_t,\;C_{max}\;and\;T_{max}$ were above 99.00%, above 99.00% and 84.99%, respectively. Minimum detectable differences $(\Delta)\;at\;{\alpha}=0.1\;and\;1-{\beta}=0.8$ were all less than 20% (e.g., 12.25%, 10.88% and 18.37% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The 90% confidence intervals were all within ${\pm}20%$ (e.g., $-0.70{\sim}15.76,\;-7.53{\sim}7.08\;and\;-16.27{\sim}8.42\;for\;AUC_t,\;C_{max}\;and\;T_{max}$, respectively). All of the above parameters met the criteria of KFDA for bioequivalence, indicating that Hana ondansetron tablet is bioequivalent to $Zofran^{TM}$, tablet.

• 한국식품영양과학회지
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• 제32권1호
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• pp.15-21
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• 2003

본 연구는 뽕잎을 이용한 고부가가치의 기능성식품의 제조에 적합한 뽕잎 품종을 선별하고자 품종별(YK-209, Cheong il, Yongchon and Kaeryang), 산지별(영천 및 상주), 부위별(상위, 중위 및 하위엽) 및 생육시기별(5월, 6월 및 8월)에 따른 뽕잎의 기능성 지표물질인 DNJ, GABA및 flavonoid의 함량을 HPLC로 정량하였다. 4가지 뽕잎 중 YK-209 뽕잎의 기 능성 물질 (DNJ, GABA 및 flavonoid) 함량이 가장 높았다. 그리고 YK-209 뽕잎으로부터 분리된 4가지 flavonoid 중 rutin 함량이 가장 높았으며, 그 다음으로 isoquercitrin>kaempferol-3-Ο-rutinoside＞astragalin 순으로 나타났으나 그 외 3가지 뽕잎에서는isoquercitrin의 함량이 가장 높았고 그 다음으로 rutin이 차지 하였으나 품종별, 산지별, 부위별 및 성장시기별에 따라 flavonoid구성성분의 함량이 다소 차이가 있었다. 영천지역에서 수확한 YK-209뽕잎의 3가지 기능성물질의 함량이 상주에서 수확한 뽕잎보다 그 함량이 높았다. 한편, YK-209 뽕잎의 부위 중 상위엽이 중위 및 하위엽보다 3가지 기능성물질의 함량이 높았다. 끝으로YK-209뽕잎의 성장시기 중 5월에 수확한 것이 6월 및 8월에 수확한 뽕잎보다 기능성물질의 함량이 높았다. 이러한 연구결과를 미루어 볼 때 3가지 기능성 성분함량이 높은 YK-209 뽕잎(용천뽕과 개량뽕을 교배하여 얻은 것)의 5월산 상위엽을 향후 뽕잎의 이용한 기능성식품의 제조용 원료로 활용할 수 있을 것으로 기대된다.

• 한국임상약학회지
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• 제8권2호
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• pp.107-112
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• 1998

Lovastatin is a lipid lowering agent for the treatment of hypercholesterolemia and belongs to a new class of pharmacologic compounds called the 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors. By competitively inhibiting HMG CoA reductase, lovastatin disrupts the biosynthesis of cholesterol in hepatic and peripheral cells and increases the synthesis of high-density-lipoprotein HDL) receptors. Following oral administration, the lactone ring of lovastatin is hydrolysed to the active inhibitor of HMG CoA reductase, lovastatin acid. Lovastatin is known to have poor oral absorption and wide individual variation. In this study, bioequivalence test of two lovastatin formulations, the test drug ($Lovaload^{TM}$, Chong Kun Dang Pharmaceutical Co.) and the reference drug ($Mevacor^{TM}$, Chung Wae Pharmaceutical Co.) were conducted according to the guidelines of Korea Food and Drug Administration (KFDA). A total of 18 healthy male volunteers, $31.90\pm3.60$ years old and $72.17\;7.88$ kg of body weight in average, were evaluated in a randomized crossover manner with a 2-week washout period. Concentrations of lovastatin acid in plasma were measured upto 12 hours following a single oral administration of eight tablets (20 mg of lovastatin per tablet) by high-performance liquid chromatography with UV detection at 238 nm. The area under the concentration-vs-time curve from 0 to 12 hours $(AUC_{0-12h})$ was calculated by the trapezoidal summation method. The statistical analysis showed that there are no significant differences in $AUC_{0-12h),\;C_{max}\;and\;T_{max}$ between the two formulations ($6.72\%,\;1.52\%,\;and\;0.88\$, respectively). The least significant differences between the formulations at $\alpha$=0.05 were less than $20\%\;(11.65\%,\;19.73\%,\;and\;14.81\%\;for\;AUC_{0-12h},\;C_{max}\;and\;T_{max}$, respectively). The $90\%$ confidence intervals for these parameters were also within $\pm20\%\;(-1.50{\leq}{\delta}{\leq}15.00$, $-12.50{\leq}{\delta}{\leq}15.50,\;and\;-9.64{\leq}{\delta]{\leq}11.40{\leq}\;for\;\;AUC_{0-12h}$ ,$C_{max}\;and\;T_{max}$, respectively). In conclusion, the new generic product $Lovaload^{TM}$ was proven to be bioequivalent with the reference drug.

• 한국임상약학회지
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• 제10권1호
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• pp.13-18
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• 2000

The bioequivalence of two clarithromycin tablets, the $Klaricid^{TM}$ (Ciba-Geigy Korea Ltd.) and the $Pylocin^{TM}$ (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen healthy male volunteers ($20\sim26$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet containing 250 mg of clarithromycin was orally administered, blood sample was taken at predetermined time intervals, and the concentrations of clarithromycin in serum were determined using high-performance liquid chromatographic method with electrochemical detector. The pharmaco-kinetic parameters (area under the concentration-time curve: $AUC_t$, maximum concentration; $C_{max}$ and time to maximum concentration; $T_{max}$) were calculated and analysis of variance (ANOVA) was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on $Klaricid^{TM}$ tablet were $-0.22\%,\;-0.48\%\;and\;-1.63\%$, respectively. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;and\;T_{max}\;were\;99.07\%,\;88.15\%\;and\;99.99\%$, respectively. Detectable differences $(\Delta)\;and\;90\%$ confidence intervals ($\alpha$=0.10) were all less than $\pm20\%$ All the parameters above met the criteria of KGBT 1998, indicating that $Pylocin^{TM}$ tablet is bioequivalent to $Klaricid^{TM}$ tablet.

• 한국임상약학회지
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• 제18권1호
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• pp.38-44
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• 2008

Rebamipide, ($\pm$)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl] propionic acid, is used for mucosal protection, healing of gastroduodenal ulcers, and treatment of gastritis. It works by enhancing mucosal defense, scavenging free radicals and temporarily activating genes encoding cyclooxygenase-2. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{(R)}$ (Korea Otsuca Pharmaceuticals Co., Ltd.) and Mustar (Korean Drug Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of rebamipide from the two rebamipide formulations in vitro was tested using KP VIII Apparatus II method with pH 6.8 dissolution medium. Twenty six healthy male subjects, $23.46{\pm}2.63$ years in age and $66.62{\pm}8.97\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 100 mg as rebamipide was orally administered, blood samples were taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Mucosta^{(R)}$ were -5.08, 3.52 and -9.71 % 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 log 0.8 to log 1.25 (e.g., log 0.84$\sim$log 1.07 and log 0.90$\sim$log 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Mustar tablet was bioequivalent to $Mucosta^{(R)}$ tablet.

• 약학회지
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• 제56권5호
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• pp.288-292
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• 2012

The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

• 한국비블리아학회지
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• 제6권1호
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• pp.47-80
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• 1984

The aim of this paper is to study the classification and arrangement system, the original texts, and the bibliographic deseription of Dae-Jang-Mock-Lock. The results of this study can be summarized as followings; 1. The first carving of Dae-Jang-Mock-Lock was assumed to be completed at latest by 1087 (King Sun-Jong 4, Koryo) when the first carving of Dae-Jang-Kyong, the complete collection of Buddhist Sutra, mas finished. Henee, Dae-Jang-Mock-Lack is safely said to be the oldest catalog in Korea. 2. The major function of Dae-Jang-Mock-Lock mas to facilitate the job of printing, managing, or arranging the Sutra tablets, rather than to serve as its references. 3. Dae-Jang-Mock-Lock mas classified in accordance with the classification sys tern of Gae-Woon-Suck-Kyo-Lock, a chinese Buddhist catalog. This system classified the complete collection of Buddhist Sutra into the three categories of "Mah$\={a}$y$\={a}$na Tripitaka", "Hinayan$\={a}$ Tripitaha", and "collected Biographies of Samgha", at the first gradation. And then the Mah$\={a}$yan$\={a}$ Tripitaka mas divided into the three categories of "Mah$\={a}$y$\={a}$na Sutra", "Mah$\={a}$y$\={a}$na Uparaksa", and "Mah$\={a}$y$\={a}$na Upadesa", at the second gradation. In the same manner the "Hinayan$\={a}$ Tripitaka was divided into "Hinayan$\={a}$ Sutra", "Hinayan$\={a}$ Uparaksa", and "Hinayan$\={a}$ Upadesa". The "Collected Biographies of Samgha" was divided into Brahman Samgha and Chinese Samgha. For this reason we Can name this main classification system as a Tripitaka Classification. 4. The first carving tablets of the Buddhist Sutra from Choen Shelf (天函) to Young Shelf (英函) were the same Sutra that were included in Gae-Woen-Suck-Kyo-Lock (開元釋敎錄), except those 4 omitted sutras of 22 volumes. But the other 7 sutras of 24 volumes were included as an extra addition in "Dae-Jang-Mock-Lock." 5. The 40 shelves and 376 volumes of Buddhist Sutra from the Doo Shelf (杜函) to the Kyong Shelf (輕函) in Dae-Jang-Mock-Lock were copied from the texts of Guran Edition (契丹本) 6. The 36 shelves of Buddhist Sutras from the Bun shelf (磻函) to the Mil shelf (密函) in Dae-Jang-Mock-Lock were the same as those included in Sock-Jung-Woen-Suck-Kyo-Lock (續貞元釋敎錄), except the 3 omitted sutras.

• Journal of Pharmaceutical Investigation
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• 제30권2호
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• pp.133-138
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• 2000

Terbinafine is an orally active antifungal agent as it inhibits the fungal enzyme squalene epoxidase, which is important in the early biosynthetic pathway of ergosterol. This leads to abnormal development of the fungal cell membrane. Bioequivalence of two terbinafine tablets, $Lamisil^{TM}$ (Novartis Korea Ltd.) and $Terbina^{TM}$ (Korean Drug Co., Ltd.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, $23.56{\pm}1.75$ years old and $65.60{\pm}8.54\;kg$ of body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 125 mg of terbinafine was orally administered, blood was taken at predetermined time intervals and the serum concentrations of terbinafine were determined using an HPLC method with UV detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA test was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on $Lamisil^{TM}$, tablet were -2.53%, -2.98% and 8.13%, respectively. The powers $(1-{\beta})$ for $AUC_t,\;C_{max}\;and\;T_{max}$ were 85.21%, 98.21% and 93.11%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.1\;and\;1-{\beta}=0.8$ were all less than 20%. The 90% confidence intervals were all within ${\pm}20%$. All the parameters above met the criteria of KFDA for bioequivalence, indicating that $Terbina^{TM}$ tablet is bioequivalent to $Lamisil^{TM}$ tablet.