• 한국식품위생안전성학회:학술대회논문집
• /
• 한국식품위생안전성학회 1994년도 추계 학술 심포지움
• /
• pp.15-26
• /
• 1994

Bovine somatotropin(bST) or bovine growth hormone (bGH) is a protein of 191 amino acids produced by the anterior pituitary gland of cattle. Recombinant bovine somatotropin(rbST) is biosynthetic versions of the naturally occurring pituitary hormone in cows. The use of rbST in dairy cows promises to improve the efficiency of milk production around the world. Using recombinant DNA technology, bST can now be produced in commercial quantities. The recombinant bST(rbST) is biologically identical to the found in the bovine pituitary. Milk from rbST-treated cows has been found to have the same nutritional value and composition as milk from untreated cows. In November of 1993, rbST finally was approved by the FDA, nearly 10 years after filing a licence applica-tion. rbST has been one of the most extensively studied animal drug products to be reviewed by the agency. Three scientific facts will help to reassure the public about the safety of the milk suppy.: 1. rbST has no biological activity in humans when indigested orally or when given by intramuscular injection. 2. Insulin-like growth factor 1(IGF-1) is not orally active. Any changes in IGF-1 levels in milk are well within normal variation and are lower than those reported in human milk. 3. All cow's milk contains bST, and no significant change in bST levels in milk occurs as a result of giving cows supplemental bST. Based on the scientific evidence, the public can be confident that milk and meat from rbST-treated cows is safe to consumers.

• 대한한의학방제학회지
• /
• 제16권1호
• /
• pp.65-78
• /
• 2008

Objectives : this study was to access the effect of Hyeonggaeyeongyotang water extracts, a polyherbal formula has been used as folk medicine, on the fertility and early embryonic development of male and female Wistar rats when administered by oral gavage. Methods : In male rats, Hyeonggaeyeongyotang extract were dosed 4 weeks before pairing and 2 weeks after mating including the mating periods up to termination after necropsy of the majority of the females. In female rats, they were dosed 2 weeks before pairing, and from Day 0 to Day 7 of gestation. This study was conducted in accordance with the recommendations of the KFDA Guideline [2005-60] for Detection of Toxicity to Reproduction for Medicinal Products. Results: 1. No Hyeonggaeyeongyotang extract treatment-related changes on the clinical signs and mortalities, the Food consumptions, the Body weights and gains were demonstrated in all dosed levels tested in this study except for 500ml/kg-dosing male group in which a significant(p<0.05) increase of body gains was detected during day 0-7 after dosing. 2. No Hyeonggaeyeongyotang extract treatment-related changes on the pre-coital intervals, the estrus cycles, the mating index, conception rate and fertility index were demonstrated in all dosed levels tested in this study. 3. No Hyeonggaeyeongyotang extract treatment-related gross findings on reproductive organs, the weights of reproductive organs, histopathological findings on reproductive organs, the corpora lutea number, implantation site number, live fetus number, number of resorpted embryo and pre-and post-implatation loss were demonstrated in all dosed levels tested in this study. Conclusions : Base on the results, it is considered that the NOAEL (No-Observed-Adverse-Effect Level) for fertility and early embryonic development toxicity of Hyeonggaeyeongyotang extract was under 2000ml/kg/day in Wistar male and female rats because there no treatment-related changes on the fertility and early embryonic developmental index were demonstrated in all dosed levels tested.

• 한국임상약학회지
• /
• 제31권4호
• /
• pp.257-267
• /
• 2021

Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

• Journal of Pharmaceutical Investigation
• /
• 제27권4호
• /
• pp.331-335
• /
• 1997

Xerostomia is caused by organic or functional changes affecting the salivary system at different levels. Patients suffering from xerostomia may also complain of an oral burning sensation, ulceration or soreness, difficulty in swallowing, and poor denture retention. And pilocarpine is administered orally to induce salivary secretion. In Seoul National University Hospital(SNUH) pharmacy, the pilocarpine chewing tablets are prepared and supplied to patients of xerostomia in request of the dental hospital in SNUH. And we tested the salivary flow induction and the dissolution patterns of these products in saliva by a double-blind, sequential cross-over trials to eight healthy human volunteers with placebo. The pilocarpine chewing tablet contained 5 mg of pilocarpine, and placebo consisted of same materials as test drug, but didn't contain pilocarpine. In vivo experiment, all subjects were instructed to chew as 60-80 times/min. Mixed saliva was collected in the ranges of intervals such as 0-2, 2-5, 5-10, 10-15, 15-20, 20-30, 30-45 and 45-60 min after pilocarpine chewing tablet or placebo administration. Saliva volume was measured in each collecting time interval, and saliva pilocarpine concentrations were determined by reversed phase HPLC. The 82.5 percent $(4.13{\pm}0.69\;mg)$ of pilocarpine was extracted from chewing tablets during mastication of 60-80 times per minute for 60 minutes. Among these dissolved amounts, 90 percent was extracted within 20 minutes. The salivary flow rates were more increased in a group who administered pilocarpine chewing tablet at the interval of 5-10, 10-15, 20-30 and 45-60 min rather than a placebo-group, but only extracted amount of pilocarpine at 45-60 min interval is significanly different between two groups (p<0.05). But total amounts of saliva secreted for 1 hour in two group-pilocarpine and placebo treated- were $46.36{\pm}9.72\;ml\;and\;39.09{\pm}7.81\;ml$, respectively, and were not significantly different between two groups.

• 한국축산식품학회지
• /
• 제31권1호
• /
• pp.27-31
• /
• 2011

To differentiate between frozen-thawed and fresh broiler breast fillets, different methods such as optical microscopy and measurement of drip loss, pH, torrymeter and K-value were performed. A total of 10 samples of fresh and frozen-thawed breast fillets were stored in a refrigerator ($4^{\circ}C$) for 5 d. Optical microscopy of the frozen-thawed breast fillets found structural changes caused by ice crystals, which may have significantly increased drip loss compared to fresh breast fillet. The pH and K-value could not be distinguished between the two breast fillets during storage. However, the torrymeter values of the fresh and frozen-thawed breast fillets were significantly different (p<0.05). The results indicate that both optical microscopy and torrymeter measurement can be effective methods for differentiating between fresh and frozen-thawed breast fillets. However, optical microscopy may be difficult to implement in the marketplace since it requires much time and effort. Thus, the determination of the torrymeter value is the easiest and most rapid instrumental method among those tested for the differentiation of frozen-thawed chicken breast fillet from fresh one.

• 대한본초학회지
• /
• 제39권4호
• /
• pp.1-9
• /
• 2024

Objective : In this study, the anti-obesity effect of Fragaria orientalis (FO) on high-fat diet-induced obese mice was investigated. Drug treatment methods are widely used as obesity treatment methods, but research using various natural products is being conducted due to safety concerns. This study aims to evaluate the anti-obesity effect of FO extract, a natural product derived from Mongolia. Methods : C57BL/6 mice were used and divided into three groups, normal diet group, high-fat diet group, and high-fat diet with FO oral treatment group at a dose of 300 mg/kg. Extract was orally provided everyday for 6 weeks. Body Weight and food intake were measured every 2 days and blood lipid profiles and liver function in the sacrificed mice were evaluated. In addition, protein expression in hepatic tissue and histomorphological changes in liver and adipose tissue were observed. Results : Body weight, adipose tissue weight and FER were significantly lower in a high-fat diet with FO treatment than fed only high-fat diet. There was a significant difference between the high-fat diet and the FO-treated high-fat diet mice. As a result of analyzing lipid metabolism-related genes in hepatic tissue, all of p-AMPK, p-ACC, PPAR-α, CPT-1, and UCP-1 showed significant increases, and PPAR-γ also decreased significantly compared to the high-fat diet group. Conclusion : Overall, these results indicate that FO is effectual in improving obesity, suggesting that it can be used as a possible material for anti-obesity agents or functional supplements for weight control.

• Biomolecules & Therapeutics
• /
• 제15권2호
• /
• pp.95-101
• /
• 2007

Resveratrol (3,5,4’-trihydroxy-trans-stilbene), a naturally occurring phytoallexin abundant in grapes and several plants, has been shown to be active in inhibiting proliferation and inducing apoptosis in several human cancer cell lines. On the line of the biological activity of resveratrol, a variety of resveratrol analogs were synthesized and evaluated for their growth inhibitory effects against several human cancer cell lines. In the present study, we found that one of the resveratrol analogs, 3,4,5-trimethoxy-4’-bromo-cis-stilbene, markedly suppressed human colon cancer cell proliferation (EC$_{50}$ = 0.01 ${\mu}$g/ml), and the inhibitory activity was superior to its corresponding trans-isomer (EC$_{50}$ = 1.6 ${\mu}$g/ml) and resveratrol (EC$_{50}$ = 18.7 ${\mu}$g/ml). Prompted by the strong growth inhibitory activity in cultured human colon cancer cells (Col2), we investigated its mechanism of action. 3,4,5-Trimethoxy-4’-bromo-cis-stilbene induced arrest of cell cycle progression at G2/M phase and increased at sub-G1 phase DNA contents of the cell cycle in a time- and dose-dependent manner. Colony formation was also inhibited in a dose-dependent manner, indicating the inhibitory activity of the compound on cell proliferation. Moreover, the morphological changes and condensation of the cellular DNA by the treatment of the compound were well correlated with the induction of apoptosis. These data suggest the potential of 3,4,5-trimethoxy-4’-bromo-cis-stilbene might serve as a cancer chemotherapeutic or chemopreventive agent by virtue of arresting the cell cycle and inducing apoptosis for the human colon cancer cells.

• 대한수의학회지
• /
• 제49권1호
• /
• pp.23-34
• /
• 2009

This study was performed to evaluate repeated-dose oral toxicities of Chelidonium majus extract in Fischer 344/N rats. Chelidonium majus extract was administered orally to rats at dose levels of 0, 25, 74, 222, 666 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Chelidonium majus extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program (issued by National Institute of Toxicological Research) and The Standards of Toxicity Study for Medicinal Products (issued by Korea Food and Drug Administration). In the present study, There were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Chelidonium majus extract. These results suggest that the oral no observed adverse-effect level of the test item, Chelidonium majus extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.

• 의료법학
• /
• 제21권2호
• /
• pp.3-33
• /
• 2020

원격의료가 이미 허용되어 상당히 진행된 국가도 있는 반면, 원격의료가 법률해석상 금지되는 국가들도 있다. 최근까지 한국과 독일은 모두 후자에 속하였다. 독일에서 원격의료가 금지되는 가장 주요한 근거는 독일연방의사협회가 마련한 표준의사직업규정 제7조 제4항이 "상담을 전적으로 인쇄 및 통신매체를 통해 수행해서는 안 된다. 원격의료절차에서도, 의사가 환자를 직접 진료하는 것이 보장되어야 한다."고 규정하고 있었고 각 주(州)의 의사직업규정이 이를 그대로 수용하였기 때문이다. 그렇지만 독일 내에서도 전적인 원격의료가 허용되어야 한다는 논의 및 전자의료(E-Health) 활성화를 위한 인프라와 그를 규제하는 법을 마련해야 한다는 논의가 상당히 오래 전부터 있어 왔다. 2018년 표준의사직업규정이 변경되었고 대부분의 주(州)의사협회가 의사직업규정을 개정하였으므로 이제 독일에서는 원격의료가 대부분 허용된다고 할 수 있다. 아직 우리나라는 원격의료를 허용하지는 않으나, 우리와 같은 입장이었던 독일이 어떤 준비 하에 원격의료 허용 쪽으로 선회하였는지 살펴보는 것은 우리법이 개정될 경우를 대비하여 여전히 중요한 작업이라 할 것이다.

• 문화기술의 융합
• /
• 제7권4호
• /
• pp.833-844
• /
• 2021

코로나 시대에 반려동물은 우리에게 많은 위안을 주고, 가족처럼 반려동물을 여기는 펫팸족이 등장하였다. 그리고 젊은 소비자는 자신에게 소비할 금액을 줄여서 반려동물에게 소비하는 패턴을 보이는 펫푸어도 볼 수 있다. 하지만 이러한 시대적인 변화에도 불구하고 펫푸드를 포함한 반려동물 용품 및 화장품은 여전히 수입 의존도가 높고, 국내의 반려동물 화장품 및 용품에 대한 기준이 설정되어 있지 않아 화장품 안전기준 등에 관한 규정에만 의존하고 있는 실정이다. 또한 국내 반려동물 용품 및 화장품에 관한 용어도 아직 정립되지 않은 상태이다. 현재 국내 법률은 반려동물과 관련한 동물보호법 만이 존재하지만 일본에서는 반려동물 사료안전법이 2009년 6월부터 시행되었고, 미국은 연방식품, 의약품, 화장품 관리법에서 반려동물 화장품 및 용품을 담당하고, 동물보호법이 강력한 독일은 식품 및 사료에 대한 다양한 국가 차원의 법규가 있다. 그리고 식품 안전국 웹 사이트에서도 국가 규정을 정밀하게 확인 가능하다. 따라서 본 연구는 국외의 빠르게 성장하고 안정적인 반려동물 산업처럼 국내에서도 반려 동물 산업을 관리하고 개발을 뒷받침 해주는 국가 정책과 환경 등이 반려동물 용품 및 화장품 그 외 다양한 반려동물 관련 산업을 해외시장으로 수출하는데 기초자료로 반드시 필요할 것으로 사료된다.