• 한국한의학연구원논문집
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• 제16권2호
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• pp.143-157
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• 2010

Objectives : The objective of this study was to access the effect of Artemisiae capillaris herba Extracts on the organogenetic reproductive toxicity of New Zealand White rabbits when administered by oral gavage. Methods : Gestational New Zealand White rabbits were dosed from 6 days of gestation to 18 days of gestation. It was conducted in accordance with the recommendations of the KFDA Guideline for Detection of Toxicity to Reproduction for Medicinal Products. In addition, serum AST, ALT, LDH and ALP levels were detected with their necropsy and histopathological observation Results: No significant changes of body weights, gains and food consumption were demonstrated in all dosed groups compared to those of vehicle control group except for 2,000mg/kg-dosing group, which showed significantly increase of body weight compared to that of vehicle control group. Normal gross findings were demonstrated in all tested groups. No significant changes of number of corpora lutea, implantation, implantation rate, number of fetal death, loss rate of post-implantation, number of live youngs at C-section, survival rate of post-implantation, number of male live youngs at C-section, number of female live youngs, sex ratio of live young, external anomalies of live youngs and body weight of live youngs were demonstrated in all dosed groups compared to those of vehicle control group. Although some visceral variations such as thymic reminant in the neck, dilation of renal pelvis, dilated ureter and malpositioned left common carotid artery, no significant changes were demonstrated in all dosed groups compared to that of vehicle control group. Some malformations and variation were demonstrated with retardations. However, no significant changes were demonstrated in all dosed groups compared to that of vehicle control group. In addition, similar ossification numbers were detected in sternebrae, metacarpals, metatarsals, phalanges, cervical vertebrae, and sacral and caudal vertebrae. No Artemisiae capillaris herba Extracts treatment-related changes of serum AST, ALT, LDH and ALP levels were demonstrated in all dosed levels in this study. Conclusions : We could conclude that oral administration of Artemisiae capillaris herba Extracts hasn't an influence on the organogenetic reproductive toxicity.

• 대한한방내과학회지
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• 제26권2호
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• pp.369-378
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• 2005

An herbal water extract of Bojungikkeehapdaechilkitang(BDT) was prepared to test it for single-dose and repeated-dose toxicity, genotoxicity and reproductive toxicity, and to obtain a 50% lethal dose$(LD_{50})$, approximated lethal dose(ALD), and approximated target organs for BDT. The extract was tested on female and male ICR mice according to KFDA Guideline 1999-61 at doasge level of 2000, 1000, 500, 250 and 125mg/kg/10mL In this study, clinical signs, mortalities and gross findings of principal organs were observed for 14 days of single dosing, and afterwards in some cases. The ALD and $LD_{50}$ of BDT extract obtained in this study was>2000mg/kg for both male and female ICR mice. Also, any possible digestive toxicity of BDT extract was found to be above 1000mg/kg in both male and female ICR mice. The results of this study strongly suggest that BDT extract has no toxic effect at dosage level below 500mg/kg.

• Fisheries and Aquatic Sciences
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• 제7권3호
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• pp.141-147
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• 2004

Sixteen polycyclic aromatic hydrocarbons (PAHs) were analyzed in seventy marine organisms (40 species) from the Korean coast. PAHs were present in all the organisms. The level of total PAHs in the organisms varied from 0.45 to 224 ng/g dry weight and the carcinogenic PAHs varied from 0.05 to 49.8 ng/g dry weight. The PAHs residues according to the marine organisms showed a highest content in bivalve species, and followed by crustaceans, cephalopods, fish and gastropods. Human dietary intake of total PAHs through marine organism in Korea was estimated to be 4.12 ng/kg body weight/day and 0.67 ng/kg body weight/day for carcinogenic PAHs. The relative contributions of individual species to the total dietary intake of PAHs were in the order of bivalves $(53.4{\%})$, fish $(21.9{\%})$, crustaceans $(15.3{\%})$, cephalopods $(8.8{\%})$ and gastropods $(0.6{\%})$. Daily dietary intake of $PAH_{TEQ}$ expressed as a TEQ value was estimated to be 0.13 pg TEQ/kg body weight/day, which did not exceed a tolerable daily intake (TDI) proposed by the KFDA and the WHO as well as the UK toxicity committee. Lifetime cancer risk due to ingestion of marine species by the Korean adult was evaluated using the equation estimating exposure of food ingestion. Although approximately $23{\%}$ of cumulative frequency of the sampled marine species exceeded the cancer risk guideline, lifetime cancer risk associated with marine organism consumption was negligible. Results indicate that dietary intake of PAHs through the consumption of the Korean marine organisms seems to be safe for human ingestion with negligible cancer risk.

• Journal of Acupuncture Research
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• 제24권6호
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• pp.195-206
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• 2007

Objectives : The aim of this study is to investigate the safety of Acupuncture needles made from duplex stainless steel. Methods : In order to check the safety concern of the DSS Acupuncture needle, we employed biochemical measures, DSS and SS304 Acupuncture needles were tested for pH level, heavy metals and UV absorbance spectrum along with cytotoxicity and hemolysis. As a guideline, we have referred to the 'standards for acupuncture needles', 'standards for disposable needles' and 'standards and experimental procedures for stents' for the Korean Food & Drug Administration(KFDA). Results & Conclusions : The DSS Acupuncture needle extract satisfied these requirements. There was no significant difference between the DSS and SS304 Acupuncture needle extract. In conclusion, the DSS Acupuncture needle displayed biochemical safety.

• 한국식품영양학회지
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• 제26권4호
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• pp.655-662
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• 2013

This study was carried out to investigate the changes in the quality properties of red pepper Yukwa (red pepper liquid fermented with lactic acid bacteria was added to the Yukwa) during the storage period. To determine the shelf life of red pepper Yukwa, the rice Yukwa (control) and red pepper Yukwa were stored at 15, 25, and $35^{\circ}C$ for 70 days. Also, the quality properties of red pepper Yukwa, such as acid value, peroxide value, texture, color, and sensory evaluation were measured. Although the acid value of rice Yukwa and red pepper Yukwa increased during storage, the red pepper Yukwa showed a lower acid value score (1.09mg KOH/g) than that (1.19mg KOH/g) of the rice Yukwa. Nevertheless, these values did not exceed the guideline maximum values of 2.0 g KOH/g specified in the Korean Food Code. The peroxide values of samples had significantly increased after 42 days. Especially, the peroxide value scores for the rice Yukwa and red pepper Yukwa were the highest at 146.49 and 126.79 meq/kg at $35^{\circ}C$, respectively. Hardness and brittleness in textural properties increased up to 70 days. The sensory values for the red pepper Yukwa for overall acceptance, taste;texture and appearance were the highest. The results indicated that by using the 'Visual Shelf life Simulator for foods' of the Korea Food and Drug Administration (KFDA) the shelf life of red pepper Yukwa is estimated to be 274.78 days.

• 대한본초학회지
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• 제30권3호
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• pp.19-24
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• 2015

Objectives : HPL-1, a novel herbal medicine which is composed of five herbs such as Kalopanacis Cortex, Chaenomelis Fructus, Raphani Semen, Atractylodis Rhizoma and Pulvis Aconiti Tuberis Purificatum, was developed for treatment of osteoarthritis. This study is aimed to develop analytical method for consistent quality control of HPL-1 and validate chromatographic method. Methods : Chromatographic analysis was performed using ultra-high performance liquid chromatography - diode array detector (UHPLC-DAD) equipped with RP-amide column, column oven, and auto sampler. Marker compounds [protocatechuic acid, chlorogenic acid, liriodendrin, 3,5-dicaffeoylquinic acid, ${\beta}$-D-(3-O-sinapoyl)-fructofuranosyl-$\alpha$-D-(6-O-sinapoyl)glucopyranoside and benzoylmesaconine] were separated by step gradient elution of acetonitrile and 0.1% phosphoric acid/water. The method validation was evaluated by quantitative validation parameters of linearity, accuracy, precision, limit of detection (LOD) and limit of quantification (LOQ) according to KFDA guideline.Results : An optimized method for six marker compounds in HPL-1 was established by UHPLC-DAD. The correlation coefficient (R²) with each calibration curve was greater than 0.99. The LOD and LOQ were within the range of 0.008-0.090 and $0.023-0.274{\mu}g/mL$, respectively. The relative standard deviation (RSD) of intra- and inter-day variability were less than 4.0%. The result of recovery test was range from 93.3-106.3% with RSD < 4.0%.Conclusions : These results suggest that the quantitative UHPLC method is precise, accurate, effective for quality evaluation of HPL-1. The method may also contribute to improve quality of crude drug preparations used for treatment of various diseases.

• 대한화장품학회지
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• 제39권2호
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• pp.105-115
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• 2013

국내의 주름개선 혹은 미백 효능을 평가하기 위한 인체시험 방법은 식약청 가이드라인에 근거하여 시행 되어왔으며, 인체시험에서 육안평가 및 기기평가 결과에 대해 시험군과 대조군 간의 효과를 비교하기 위해서 unpaired t-test를 주로 이용하였고, 시술 전후의 효과를 비교하기 위해서 paired t-test를 이용하였다. 설문평가 결과에 대해서는 빈도분석을 이용한 기술통계법이 이용되고 있다. 미국 및 유럽의 임상 평가기관에서도 이와 유사한 시험법 및 통계분석 방법을 이용하고 있다. 그러나 동일 개체에 대하여 처치를 반복 적용하여 얻은 자료는 서로 관련성이 높아 이를 감안한 분석법을 적용해야 한다. 따라서 본 연구에서는 화장품 분야에서는 처음으로 기능성 화장품 중 주름 개선 및 미백 효능 시험의 육안평가 및 기기평가 자료에 대해 repeated measures ANCOVA (RM ANCOVA)와 repeated measures ANOVA (RM ANOVA)를 적용하여 통계 방법의 타당성 여부를 검증함으로서 현재의 인체시험 방법에 적합한 새로운 통계분석 방법을 제시하였다.

• Journal of Pharmaceutical Investigation
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• 제34권4호
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• pp.311-317
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• 2004

A bioequivalence study of $Gomcillin^{TM}$ capsules (DAEWOONG Pharmaceutical Co., Korea) to $Famoxin^{TM}$ capsules (Dong Wha Pharm. Ind. Co., Korea) was conducted according to the guideline of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the amoxicillin dose of 500 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of amoxicillin were monitored by a high-performance liquid chromatography for over a period of 8 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 8 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 $Gomcillin^{TM}/Famoxin^{TM}$ were $log0.91\;{\sim}\;log1.03$ and $;log0.93\;{\sim}\;log1.10$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80\;{\sim}\;log1.25$. Thus, our study demonstrated the bioequivalence of $Gomcillin^{TM}$ and $Famoxin^{TM}$ with respect to the rate and extent of absorption.

• 한국자원식물학회지
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• 제31권6호
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• pp.652-659
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• 2018

In this study, baicalin, as a marker substance of Scutellariae Radix, was quantitatively analyzed by a high performance liquid chromatography-photodiode array detector (HPLC-DAD). We identified wogonoside, baicalein, and wogonin in the Scutellariae Radix by a high performance liquid chromatography-electrospray ionization-mass spectrometer (HPLC-ESI-MS). The baicalin was separated on a Xterra C18 column ($5{\mu}m$, $4.6{\times}250mm$) using mobile phase consisting of 38% acetonitrile in 0.68% phosphoric acid. The baicalin spectrum in the Scutellariae Radix extracts was coincided by comparing with UV-visible spectrum (200-550 nm) of baicalin standard in the library. The amount of baicalin in Scutellariae Radix was 10.46%, which is higher than KFDA's guideline. The marker substances of Scutellariae Radix showed a strong base peak $[M]^+$ in the positive detection mode following as; baicalin (m/z; $271[MH^+-sugar]^+$, $447[M+H]^+$), wogonoside (m/z; $285[MH^+-sugar]^+$, $461[M+H]^+$), baicalein (m/z; $271\;[M+H]^+$), wogonin (m/z; $285[M+H]^+$). These results are consistent with the fragment pattern and molecular weight of standard components from literature.

• 한국환경농학회지
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• 제28권4호
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• pp.412-418
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• 2009

This study is conducted in order to know the residue patterns of insecticide cypermethrin and fungicide diethofencarb in ginseng sprayed by various application methods. Two pesticides were sprayed separately on ginseng using traditional, soil and vinyl mulching applications. The vinyl mulching application was that head part of ginseng protected from pesticides. When cypermethrin was sprayed on ginseng by traditional application, its residue amount in ginseng was 0.25 mg/kg which exceeded 0.1 mg/kg, maximum residue limit(MRL) established by Korea Food & Drug Administration(KFDA). But in case of vinyl mulching and soil application, its residue amounts were 0.04 and 0.07 mg/kg, respectively. The residue amount of diethofencarb in ginseng was 3.01 mg/kg which exceeded the MRL, 0.3 mg/kg. Further, in case of vinyl mulching and soil application, its residue amounts were 1.71 and 9.39 mg/kg which exceeded the MRL 0.3 mg/kg. Although the residue amounts of both pesticides exceeded the MRLs for ginseng, we can explain that pesticides remained in head part of ginseng is probably the reason why higher pesticides residue levels were observed.