• Title/Summary/Keyword: Drug labeling

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Phototoxicity Evaluation of Pharmaceutical Substances with a Reactive Oxygen Species Assay Using Ultraviolet A

  • Lee, Yong Sun;Yi, Jung-Sun;Lim, Hye Rim;Kim, Tae Sung;Ahn, Il Young;Ko, Kyungyuk;Kim, JooHwan;Park, Hye-Kyung;Sohn, Soo Jung;Lee, Jong Kwon
    • Toxicological Research
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    • v.33 no.1
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    • pp.43-48
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    • 2017
  • With ultraviolet and visible light exposure, some pharmaceutical substances applied systemically or topically may cause phototoxic skin irritation. The major factor in phototoxicity is the generation of reactive oxygen species (ROS) such as singlet oxygen and superoxide anion that cause oxidative damage to DNA, lipids and proteins. Thus, measuring the generation of ROS can predict the phototoxic potential of a given substance indirectly. For this reason, a standard ROS assay (ROS assay) was developed and validated and provides an alternative method for phototoxicity evaluation. However, negative substances are over-predicted by the assay. Except for ultraviolet A (UVA), other UV ranges are not a major factor in causing phototoxicity and may lead to incorrect labeling of some non-phototoxic substances as being phototoxic in the ROS assay when using a solar simulator. A UVA stimulator is also widely used to evaluate phototoxicity in various test substances. Consequently, we identified the applicability of a UVA simulator to the ROS assay for photoreactivity. In this study, we tested 60 pharmaceutical substances including 50 phototoxins and 10 non-phototoxins to predict their phototoxic potential via the ROS assay with a UVA simulator. Following the ROS protocol, all test substances were dissolved in dimethyl sulfoxide or sodium phosphate buffer. The final concentration of the test solutions in the reaction mixture was 20 to $200{\mu}M$. The exposure was with $2.0{\sim}2.2mW/cm^2$ irradiance and optimization for a relevant dose of UVA was performed. The generation of ROS was compared before and after UVA exposure and was measured by a microplate spectrophotometer. Sensitivity and specificity values were 85.7% and 100.0% respectively, and the accuracy was 88.1%. From this analysis, the ROS assay with a UVA simulator is suitable for testing the photoreactivity and estimating the phototoxic potential of various test pharmaceutical substances.

Development of Specific Organ-Targeting Drug Delivery System (III)-In Vitro Study on Liver-Targeting Adriamycin Delivery System using Human Serum Albumin Microspheres- (장기표적용 약물수송체의 개발에 관한 연구(제 3보 -알부민 미립구를 이용한 Adriamycin의 간 표적용 수송체에 관한 in vitro 연구-)

  • Kim, Chong-Kook;Hwang, Sung-Joo;Yang, Ji-Sun
    • Journal of Pharmaceutical Investigation
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    • v.19 no.4
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    • pp.195-202
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    • 1989
  • In attempt to improve the chemotherapeutic activity of adriamycin, adriamycin-entrapped HSA microspheres were prepared and investigated by the various in vitro experiments. The shape, surface characteristics and size distribution of HSA microspheres are observed by scanning electron microscopy. The in vitro drug release, albumin matrix degradation by protease of HSA microspheres were studied. The shape of HSA microspheres were spherical and the surface was smooth and compact. The size of HSA microspheres ranged from 0.4 to $2.5\;{\mu}m$ and have average diameters of 0.5 to $0.7\;{\mu}m$. The size distribution of HSA microspheres prepared by ultrasonication was mainly affected by albumin concentration and heating time in the process of hardening. In in vitro, almost all adriamycin was released from HSA microspheres for 8 hr. Analysis of the resulting adriamycin release profiles demonstrated that adriamycin is released from the microspheres in two distinct steps, a fast phase (until 30 min) followed by a much slower sustained release phase. Drug release, which is due to diffusion, was depended on the rate of matrix hydration. Drug release was largely affected by albumin concentration and heating temperature during the process of hardening. Albumin matrix degradation of HSA microspheres was affected by heating temperature and albumin concentration. Higher temperature and longer times generally produce harder, less porous, and slowly degradable microspheres.

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Monitoring of Red Pepper Powder and Seasoned Red-Pepper Sauce using Species-Specific PCR in Conjunction with Whole Genome Amplification

  • Hong, Yewon;Kwon, Kisung;Kang, Tae Sun
    • Journal of Food Hygiene and Safety
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    • v.33 no.2
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    • pp.146-150
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    • 2018
  • Red pepper is one of the most important spices popularly utilized in Korea. Because of the differences in tariff rates between red pepper powder and seasoned red-pepper sauce, seasoned red-pepper sauce is often therefore imported by consumers, then dried, ground, and added to red pepper powder for cost effective purposed to use the product the most effectively. In this study, we combined species-specific polymerase chain reaction (PCR) assays (for red pepper, garlic, onion, spring onion, and ginger) with whole-genome amplification (WGA). Thirty-nine red pepper powders were well in accordance with their labels. However, six red pepper powder and five seasoned red-pepper sauce products failed to meet their compliance requirements. As a consequence, our monitoring results revealed that the overall mislabeling rate detected in this study was identified at 22%. Thus, our findings showed that the species-specific PCR in conjunction with WGA was an ideal method to identify raw materials that are used in the manufacturing of red pepper powder and seasoned red-pepper sauce.

Monitoring of Genetically Modified Soybean and Processed Foods in Korean Market using PCR (PCR을 이용한 국내시장에 유통중인 유전자재조합 콩 및 가공식품의 모니터링)

  • Kim, Myo-Young;Kim, Jae-Hwan;Kim, Hyun-Joong;Park, Sun-Hee;Woo, Geon-Jo;Kim, Hae-Yeong
    • Applied Biological Chemistry
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    • v.46 no.4
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    • pp.344-347
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    • 2003
  • A method using PCR was developed for the monitoring of genetically modified soybean (GMS) and GMS derived foods utilized in the market. We designed 3 pairs of specific oligonucleotide primers based on epsps and pat inserted in GMS and ferritin gene as internal standards. Template DNAs isolated from soybean and processed foods were used for multiplex PCR with 3 primer sets. PCR, used with specific primer sets for GMS detection, showed the amplified DNA fragments with GMS template DNA. In this study, GMS containing epsps was detected from soy processed foods manufactured before GM food labeling system, however, GMS containing epsps or pat was not detected from soy processed foods manufactured after GM food labeling system.

Necessity of Research for Safe Drug use in Pregnant Women (임신부에서 약물의 안전사용을 위한 연구의 필요성)

  • Han, Jung Yeol;Cho, Geum Joon;Oh, Jung Mi
    • Journal of The Korean Society of Maternal and Child Health
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    • v.21 no.3
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    • pp.159-165
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    • 2017
  • The thalidomide tragedy in the 1960s has resulted in a perpetuation of a certain perception amongst physicians and pregnant women that the use of medication during pregnancy is a potential teratogen. Consequently, physicians hesitate in prescribing medication to pregnant women. In addition, pregnant women often refuse medication despite therapeutic necessity because of this existing perception. Recently there have been frequent adverse pregnancy outcomes related to the recurrence of chronic diseases, such as hypertension and diabetes, following pregnancy in older women. And there are lots of unnecessary termination of pregnancy due to the of information of medication exposed to medication following over 50% of unintended pregnancy. In light of this, better dissemination of information regarding the safe usage of medication for pregnant women is required. This would not only be cost-effective in terms of medical expenditure, but also prove beneficial for the treatment of diseases. In addition, Korea needs to adapt to the increasing changes of the international information system regarding supporting the safe usage of medication during pregnancy. An example of this is shown by the recent changes to the labeling of medication by the United States Food and Drug Administration. The new labeling includes information on the risk of usage, rather than just an arbitrary alphabetic classification of B, C, D, or X. Furthermore, this information is limited in Korea because of the lack of research, which in turn is due to several limitations on ethics and methodology, as well as present regulations on the research of pregnant women. From this, we can learn that government support is critical for the establishment of research so that we can alter the perception that all medication is harmful to pregnant women.

Evaluation of Promotional Internet Health Information about Health Functional Foods (주요 건강기능식품 관련 홍보용 인터넷 건강 정보에 대한 평가)

  • Choi, Ji Young;Lee, Jin-Seok
    • Korean Journal of Health Education and Promotion
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    • v.31 no.2
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    • pp.65-78
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    • 2014
  • Objectives: The aim of this study is to evaluate promotional Internet health information on health functional foods with regard to labeling information, website structure, and overall quality. Methods : The websites of 15 producers of three health functional foods (Red ginseng, vitamin, aloe) were selected. Ministry of Food and Drug Safety (MFDS) required labeling information was used to evaluate the integrity of basic information, and the structural properties of the websites were investigated. Moreover, DISCERN instrument was used to evaluate reliability and quality of information. Results : 1) Among MFDS required labeling information, seven items, including 'sell by date', and 'possible side effects' were not fully specified, and only 6.7% of Internet advertisements provided 'possible side effects'. 2) Each of 92.9% of these websites offered 'Introducation to websites and producers', and 'customer service', whereas only 64.3% and 42.9% of these websites offered 'FAQ about website utilization' and 'multilingual support', respectively. 3) The evaluation using DISCERN instrument showed the scores of $2.03{\pm}0.24$ in reliability, $1.87{\pm}0.28$ in quality, and $2.10{\pm}0.55$ in overall quality. Conclusions : Current promotional Internet health information on health functional foods has various weaknesses in terms of reliability and quality that need to be improved.

Modifying Effect of Bisphenol A on the Preneoplastic and Neoplastic Lesions of Rat Liver Treated with Diethylnitrosamine Infusion (화학적 간발암모델에서 Bisphenol A가 간암의 전암성 및 종양성 병변에 미치는 영향)

  • Park, Ki-Dae;Han, Beom-Seok;Rhim, Kook-Hwan
    • Journal of Environmental Health Sciences
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    • v.32 no.1 s.88
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    • pp.60-66
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    • 2006
  • Bisphenol A(BPA) was known as an endocrine disrupting chemical. This study was conducted to assess the effect of BPA, weaker estrogen, on the preneoplastic and neoplastic lesions induced by diethylnitrosamine (DEN). One hundred male F344 rats were divided into four groups which were treated with DEN followed by BPA. To make liver tumor early, we conducted that DEN containing osmotic pump implanted into rat abdominal cavity. Then diet containing BPA were fed to the rats. All animals were sacrificed at 10 and 18 weeks. Body weights were significantly decreased in 4000ppm at 18 weeks. Relative Liver weights of 4000 ppm BPA treated group were significantly increased compared to that of DEN alone group at 18 weeks. There were no significant differences of liver tumor incidences. Sum area of GST-P positive foci and BrdU labeling indices of BPA treated group were not significantly different compared to those of control group. These results suggest that BPA have no effects in preneoplastic and neoplastic lesions on DEN-induced hepatocarcinogenesis.

The total sugar and free sugar content in beverages categorized according to recipes at coffee and beverage stores (커피 및 음료 전문점의 음료 종류별 총당류와 Free Sugar 함량 조사)

  • Yeon, Jee-Young;Lee, Soon-Kyu;Shin, Ki-Yong;Kwon, Kwang-Il;Lee, Woo Young;Kang, Baeg-Won;Park, Hye-Kyung
    • Journal of Nutrition and Health
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    • v.46 no.4
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    • pp.382-390
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    • 2013
  • This study was designed to investigate the amount of free sugar according to each beverage category in coffee and beverage stores. The groups were categorized as 15 groups based on the kind of beverage material. The beverage groups contributing to total sugar per 100 mL were milk + syrup or powder, hot (12.9 g), ade (12.6 g), milk + syrup or powder + crushed ice (11.9 g), and espresso shot + milk + syrup + crushed ice (11.4 g). The beverage groups contributing to free sugar per 100 mL were ade (12.6 g), milk + syrup or powder + crushed ice (10.8 g), espresso shot + milk + syrup + crushed ice (10.3 g), and milk + syrup or powder, hot (9.7 g). The beverage groups contributing to total sugar (energy) per portion size were milk + syrup or powder + crushed ice 56.6 g (332.3 kcal), espresso shot + milk + syrup + crushed ice 49.3 g (333.4 kcal), milk + syrup or powder, hot 46.3 g (372.1 kcal), and milk + syrup or powder, ice 38.1 g (325.9 kcal). The beverage groups contributing to free sugar per portion size were milk + syrup or powder + crushed ice 51.2 g, espresso shot + milk + syrup + crushed ice 44.9 g, ade 37.1 g, milk + syrup or powder, hot 34.6 g, and milk + syrup or powder, ice 30.1 g. The percent of average free sugar per portion size of the WHO recommendation (free sugars <10% of total energy; <50 g/2,000 kcal) was milk + syrup or powder + crushed ice 102.4%, espresso shot + milk + syrup + crushed ice 89.8%, ade 74.1%, and milk + syrup or powder, hot 69.2%. The proportion of beverage in excess of WHO recommendation per portion size was 14.6% in espresso shot + milk + syrup + crushed ice, 22.7% in ade, and 10.9% in milk + syrup or powder, hot. Therefore, in coffee and beverage stores, menu development with reduced sugar content is needed, and nutrition information should be provided through sugar nutrition labeling.

Establishment of Biotin Analysis by LC-MS/MS Method in Infant Milk Formulas (LC-MS/MS를 이용한 조제유류 중 비오틴 함량 분석법 연구)

  • Shin, Yong Woon;Lee, Hwa Jung;Ham, Hyeon Suk;Shin, Sung Cheol;Kang, Yoon Jung;Hwang, Kyung Mi;Kwon, Yong Kwan;Seo, Il Won;Oh, Jae Myoung;Koo, Yong Eui
    • Journal of Food Hygiene and Safety
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    • v.31 no.5
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    • pp.327-334
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    • 2016
  • This study was conducted to establish the standard method for the contents of biotin in milk formulas. To optimize the method, we compared several conditions for liquid extraction, purification and instrumental measurement using spiked samples and certified reference material (NIST SRM 1849a) as test materials. LC-MS/MS method for biotin was established using $C_{18}$ column and binary gradient 0.1% formic acid/acetonitrile, 0.1% formic acid/water mobile phase is applied for biotin. Product-ion traces at m/z 245.1 ${\rightarrow}$ 227.1, 166.1 are used for quantitative analysis of biotin. The linearity was over $R^2=0.999$ in range of $5{\sim}60{\mu}g/L$. For purification, chloroform was used as a solvent for eliminating lipids in milk formula. The linearity was over 0.999 in range of 5~60 ng/mL. The detection limit and quantification limit were 0.10, 0.31 ng/mL. The accuracy and precision of LC-MS/MS method using CRM were 103%, 2.5% respectively. Optimized methods were applied in sample analysis to verify the reliability. All the tested milk formulas were acceptable contents of biotin compared with component specification and standards for nutrition labeling. The standard operating procedures were prepared for biotin to provide experimental information and to strengthen the management of nutrient in milk formula.

Survey Analysis of Familiarity and Willingness of the Use of Auxiliary Label in Community Pharmacists (근린약국약사를 대상으로 실시한 보조라벨의 이해도 및 사용의지에 관한 조사)

  • Choi, Byung-Chul;Hong, Myung-Ja;Choi, Han-Gon;Yong, Chul-Soon;Rhee, Jong-Dal;Yoo, Bong-Kyu
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.1
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    • pp.9-13
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    • 2006
  • Patient counseling is emerging as one of the most important roles of community pharmacists because the information on the standard labeling for the prescription drug is not sufficient to ensure the correct use of the drug. However, excessive workload of the community pharmacists in Korea discourages the provision of the effective patient counseling. The use of auxiliary label may be an efficient tool to help patients correctly use the prescription drug in this situation. As a preliminary study to encourage the use of auxiliary label, we have performed a survey analysis of familiarity and willingness of community pharmacists to use the auxiliary label. About three quarters of the participating community pharmacists have heard of the auxiliary label, however, there was not a single pharmacist who uses the label. Furthermore, only one fifth of the participating pharmacists were willing to use the label if they have to purchase. Therefore, it is recommended that governmental and non-profit organizations such as Korean Pharmaceutical Association educate community pharmacists regarding usefulness of the auxiliary label with focus on enhancing patient compliance and constrainment of healthcare expense.

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