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Studies on the stability examination of biological products - BCG vaccine

  • Lee, Joo-Hyeun;Shin, Won-Pil;Ahn, Hye-Jeong;Kim, So-Hee;Lee, Gil-Woong
    • Proceedings of the PSK Conference
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    • 2003.10b
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    • pp.180.3-180.3
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    • 2003
  • This study was carried out to examine stability of biological products(BCG vaccine), freeze-dried BCG vaccine for percutaneous use and for interdermal use.1. pH tests of freeze-dried BCG vaccine for percutaneous use and for interdermal use vaccine was suited to basic range with variable temperature. freeze-dried BCG vaccine for percutaneous use was resulted with 6.2-6.7 and for interdermal use was resulted with 6.2-6.7.2. Bacterial concentration test of freeze-dried BCG vaccine for percutaneous use and for interdermal use vaccine was suited to basic range with variable temperature. (omitted)

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ACTIVATION OF P38 MAP KINASE AND AP-1 DURING THE PROMOTION OF NEURITE EXTENSION OF PC-12 CELLS BY 15-DEOXY-$\Delta$12,14-PROSTAGLANDIN J2

  • Song, Y.S.;Oh. J.H.;Park, K.S.;Jung, K.M.;Lee, M.K.;Jung, H.K.;Jung, S.Y.;Hong, J.T.
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2002.05a
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    • pp.110-110
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    • 2002
  • 15-Deoxy-$\Delta$12, 14-prostaglandin J2 (15-deoxy-PGJ2), a naturally occurring ligand activates the peroxisome proliferator-activated receptor-$\gamma$(PPAR-$\gamma$). It was known to have promoting ability of nerve growth factor(NGF)-induced neurite extension. However, it is not clear yet as to what signaling pathway is involved in its promoting ability of neurite extension.(omitted)

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Monitoring of Residual Sulfur Dioxide in Herbal Medicines (유통 한약재의 잔류이산화황에 대한 모니터링)

  • Kim, Mi-Kyeong;Hur, Moon-Hye;Lee, Chang-Hee;Jin, Jong-Seong;Jin, Sun-Kyung;Lee, Young-Ja
    • Korean Journal of Pharmacognosy
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    • v.35 no.4 s.139
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    • pp.276-282
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    • 2004
  • This study has been conducted to investigate the amount of residual sulfur dioxide for herbal medicines of 30 species which are purchased in 13 different regions (Bonghwa, Busan, Chunju, Jecheun, Kwangiu, Keumsan, Seoul, Taeku, Cheungdu, Xian, Beijing, Tokyo and Osaka). The sulfur dioxide residues were determined in the collected 386 samples by the modified Monier-Williams method. The residues of sulfur dioxide in 386 samples ranged from ND (under detection limit) to 2808 ppm. The sulfur dioxide in Cassiae Semon, Cinnamomi Ramulus, Cervi Cornu, Hoelen, Crataegi Fructus, Artemisiae Argyi Herba, Scolopendrae Corpus, Schizandrae Fructus and Cyperi Rhizoma were detected under the detection limit regardless of the collected regions. The sulfur dioxide residues in herbal medicines collected in domestic regions were relatively lower than those in foreign regions. There are no standards for sulfur dioxide residual limits of herbal medicines in Korea. This results will provide the scientific basis for the standardization of sulfur dioxide residues in Korea Pharmacopoeia.

Food-Effect Bioavailability and Fed Bioequivalence Studies (생체이용률에 미치는 음식물의 영향 및 식후 생물학적동등성시험)

  • Choi, Sun-Ok;Kwon, Kwang-Il;Jung, Sung-Hee;Um, So-Young;Jung, Seo-Jeong;Kim, Joo-Il;Chung, Soo-Youn;Kim, Ok-Hee
    • Korean Journal of Clinical Pharmacy
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    • v.15 no.2
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    • pp.82-88
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    • 2005
  • A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

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Chemopreventive Effect of Chitosan on Rat Colon Carcinogenesis Induced by Azoxymethane (실험적 대장암 모델에서 키토산의 발암 억제효과에 관한 연구)

  • Han, Beom-Seok;Kim, Dae-Joong;Ahn, Byeong-Woo;Kim, Ki-Sok;Kang, Jin-Seok;Moon, Ji-Young;Hong, Choong-Man;Jang, Dong-Deuk
    • Korean Journal of Veterinary Pathology
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    • v.5 no.1
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    • pp.29-34
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    • 2001
  • This study was conducted to assess the chemopreventive effects of chitosan in a rat colon carcinogenesis induced by azoxymethane (AOM). Ninety, 5-week-old, male F344 rats were divided into three groups. The animals in group 1 received subcutaneous injections of 15mg/kg AOM three times for two weeks, then were placed on powdered basal diet containing 2% chitosan for 37 weeks from weeks 3 to 40. The animals in group 2 were given AOM alone. The animals in group 3 were given 2% chitosan without prior carcinogen treatment. All animals were sacrificed at week 12 for quantitative analysis of aberrant crypt foci (ACF) and at week 40 fur analysis of tumor induction. Total numbers of ACF and AC per colon of group 1 were not significantly different from those of group 2. Tumor incidences and multiplicities of small intestine in the group 1 were significantly decreased compared with those of the group 2 (P<0.05). According to pathological diagnoses, adenocarcinoma incidence and multiplicity in the small and large intestine in the group 1 were significantly decreased compared with those of the group 2 (p<0.05). No toxic effects were observed in animals given chitosan in terms of body weights, and liver or kidney histology. These results indicate that chitosan may have a potential as chemopreventive agents of colon carcinogenesis during the postinitiation stage.

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Determination of residual flumethrin in honey products by HPLC (HPLC를 이용한 벌꿀 중 플루메쓰린 분석)

  • Won, So-Young;Jeong, Young-Ji;Lee, Hwee-Jae;Chang, Hye-Sook;Bahn, Kyeong-Nyeo;Kang, Ho-Il;Kim, So-Hee
    • Analytical Science and Technology
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    • v.22 no.6
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    • pp.458-463
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    • 2009
  • A new quantitative analytical method has been established for the rapid determination of flumethrin in honey products using high performance liquid chromatography (HPLC). Sample was dissolved and extracted in the mixture of water and acetonitrile (1:2). The extracts were purified with silica cartridge eluted by the mixture of hexane and dichloromethane (55:45) and analyzed at 266 nm using HPLC. The percentage recovery of flumethrin spiked in sample was found to be 90.2-97.8% and the limit of detection is 0.003 mg/kg. We validated the method for the linearity, the precision and the reproducibility. We investigated the residues of flumethrin in honey products retailed in market using the established method. Flumethrin was not detected at all among 130 samples of honey.