• Title/Summary/Keyword: Administration and dosage

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Establishment of Dissolution Specifications for Octylonium Bromide Tablets and Pinaverium Bromide Tablets (브롬화옥틸로늄 정과 브롬화피나베륨 정의 용출규격 설정)

  • Lee, Ryun-Kyung;Lee, Yoon-Ae;Shim, Jee-Youn;Kim, Min-A;Sohn, Kyung-Hee;Park, Hye-Rim;Kim, Hee-Sung;Song, Young-Mi;Lee, Su-Jung;Sah, Hong-Kee;Choi, Hoo-Kyun;Kim, Young-Ok;Kim, Dong-Sup;Cho, Tae-Yong
    • YAKHAK HOEJI
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    • v.55 no.5
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    • pp.419-425
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    • 2011
  • To secure the good quality of pharmaceutical products, dissolution specifications for Octylonium bromide tablets and Pinaverium bromide tablets are needed to be established, which are enrolled in KPC (Korea Pharmaceutical Codex) with having no appropriate specifications. For establishing dissolution specifications, a number of experiments based on the "Guideline of Dissolution Testing for Solide Oral Dosage Forms" were performed. The results of this study will be used for revising KPC and it is expected to contribute to the incessant production of quality ensured drugs.

Residues of ampicillin in blood of cultured olive flounder by oral, injection and dipping administration (Ampicillin의 경구, 주사 및 약욕 투약에 따른 넙치 혈액에서의 잔류량 변화)

  • Jung, Sung Hee;Seo, Jung Soo;Park, Myoung Ae
    • Journal of fish pathology
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    • v.25 no.3
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    • pp.211-219
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    • 2012
  • The residue levels of ampicillin (AM) in cultured olive flounder, Paralichthys olivaceus (average 300g) at $20{\pm}1.0^{\circ}C$ were studied by oral, intramuscular and dipping administration (routes). The concentrations of AM in the plasma were determined by HPLC-UV detector. The average recoveries of AM in spiked samples between 0.01~10 ppm were ranging from 84.45% to 91.26% for plasma. The limit of detection for AM was 0.05 ppm by using this method. Plasma concentrations of AM were determined after oral dosage (10, 20 and 40 mg/kg body weight), intramuscular injection (5, 10 and 20 mg/kg body weight) and dipping (10, 20 and 40 ppm; 1 h). Samples were taken at 1, 3, 5, 10, 15, 24, 30, 48, 96, 144, 216, 264 and 360 h post-administration. In oral dosage of 10, 20 and 40 mg/kg, it's peak concentrations were $3.62{\pm}0.97$, $5.20{\pm}0.70$ and $11.18{\pm}0.87{\mu}g/ml$, respectively at 10 h post-administration, but AM was not measurable at 144, 360 and 360 h post-administration, respectively. In intramuscular injection of 5, 10 and 20 mg/kg, it's peak concentrations were $6.92{\pm}1.29{\mu}g/m1$, $9.89{\pm}2.22{\mu}g/ml$ and $19.85{\pm}2.97{\mu}g/ml$, respectively at 5 h post-administration, but AM was not measurable at 216, 264 and 264 h post-administration, respectively. In dipping of 10, 20 and 40 ppm, it's peak concentrations were $4.39{\pm}1.10$, $9.57{\pm}1.51$ and $11.61{\pm}1.92{\mu}g/ml$, respectively at 3 h post-administration, but AM was not measurable at 264, 264 and 360 h post-administration, respectively. Therefore, the plasma distribution and elimination levels of AM in olive flounder were dosage-dependant manner in all administration routes.

Acute Toxicity of Kami-Okchun-San in ICR-Mice (가미옥천산의 ICR 마우스 경구 투여에 의한 급성 독성시험 연구)

  • Ko Byoung-Seob;Park Min-Jung;Park So-Min;Jeon Won-Kyung;Chun Jin-Mi;Joung Pil-Mun;Park Sun-Min;Choi Soo-Bong;Oh Myung-Sook;Chang Mun-Seog;Park Seong-Kyu
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.19 no.5
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    • pp.1200-1203
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    • 2005
  • Kami-Okchun-San(OCS) is known as an effective herbal medicine on Type 2 diabetes. We peformed to investigate acute toxicity of OCS on ICR mice. ICR mice in acute toxicity experiment were administered orally with dosages of 3,200mg/kg (low dosage group), 4,000mg/kg (middle dosage group), 5,000mg/kg (high dosage group) per single time, respectively. Body weights, clinical signs, motalities and histopathological finding were observed daily for 14 days according to the Regulation of Korean Food and Drug Administration(1999. 12. 22). Single oral administration of OCS with different dosages, no animals died of the test drug. Autopsy of animal revealed no abnormal gross findings. Therefore, LD50 value of OCS for ICR mice was more than 5,000mg/kg on oral route. Normally increasing changes were observed in body weight, drinking water and food intake in every dosage group. Hematological parameters were also observed normally in all animals. No histopathological lesions were observed in both control and treated animals. Above data suggest that no toxic dose level of OCS in ICR mice is considered to be more than 5,000mg/kg. Therefore, it was concluded that OCS have no effect on acute toxicity and side effect in ICR mice.

Antitoxic Effects of Semen Mungo Water Extracts against Cadmium Toxicity in Organs of Rats (녹두(綠豆) 전탕액(煎湯液)의 Rat의 장기(臟器) 조직내(組織內) 카드뮴 독성(毒性) 해독(解毒)에 관한 연구(硏究))

  • Ji Jeong-Ok;Kim Jeong-Pil;Lee Ki-Nam;Lee Jong-Sub
    • Journal of Society of Preventive Korean Medicine
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    • v.2 no.1
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    • pp.175-192
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    • 1998
  • A study on the antitoxic effects of Semen Mungo extracts against Cadmium Chloride Toxicity in Rats This study was performed to find out the effect of Semen mungo against Cadmium toxicity. The experimental rats were divided into 5 groups such as control group, Cadmium alone treatment group, three simultaneous treatment groups of semen mungo and cadmium. Rats were given pellets administration with three dosage of semen mungo glabrae such as 4mg/kg body weight for four weeks. The results were summarized as follows on: ' 1. The simultaneously administration of semen mungo and cadmium significantly more decreased cadmium concentration in liver and kidney tissues compared to the administration of cadmium alone.(p<0.05) 2. The simultaneously administration of semen mungo and cadmium significantly more decreased metallothionein concentration in liver and kidney tissues compared to administration of cadmium alone(p<0.05) 3. When liver and kidney tissues were observed with optical microscope obvious changes were visible in those tissues.1

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Antitoxic Effects of Herba Taraxaci Water Extracts Against Cadmium Toxicity in Rats (포공영(蒲公英) 전탕액(煎湯液)을 이용한 카드뮴 독성 해독(解毒) 효과연구)

  • Park Jae-Soo;Lee Jong-Sub;Lee Gi-Nam
    • Journal of Society of Preventive Korean Medicine
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    • v.1 no.1
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    • pp.76-84
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    • 1997
  • A study on the antitoxic effects of Herba Taraxaci extracts against Cadmium Chloride Toxicity in Rats. This study was performed to find out the effect of taraxacum platy carpum against Cadmium toxicity. The experimental rats were divided into 5 groups such as control group, Cadmium alone treatment group, three simultaneous treatment groups of taraxacum platy carpum and cadmium. Rat were given pellets administration with three dosage of taraxacum platy carpum such as 4 mg/kg body weight for four weeks. The results were summarized as follows on: 1. The simultaneously administration of taraxacum platy carpum and cadmium significantly more decreased cadmium concentration in liver and kidney tissues compared to the administration of cadmium alone. (p<0.05) 2. The simultaneously administration of taraxacum platy carpum and cadmium significantly more increased metallothionein concentration in liver and kidney tissues compared to administration alone. (p<0.05) 3. When liver and kidney tissues were observed with optical microscope obvious changes were visible in those tissue.

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Study on the Estrogenic Activity of Di-(2-Ethylhexyl) Adipate in E-Screen Assay and Uterotrophic Assay (E-screen assay 및 자궁비대반응시험 (Uterotrophic assay)을 이용한 di-(2-ethylhexyl) adipate의 에스트로겐성 작용에 관한 연구)

  • Han, Soon-Young;Kim, Hyung-Sik;Han, Sang-Kook;Lee, Rhee-Da;Yang, Kyu-Whan;Park, Kui-Lea
    • Korean Journal of Food Science and Technology
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    • v.32 no.4
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    • pp.964-969
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    • 2000
  • Di-(2-ethylhexyl) adipate(DEHA) has been used extensively as a plasticizer in the manufacture of plastic products such as PVC films. Though, phthalate esters plasticizers have been known to induce endocrine system-mediated responses, few studies have been conducted for the screening of estrogenic activity of DEHA, an adipate plasticizer. This study was initiated to evaluate the estrogenic activity of DEHA by in vitro E-screen assay and in vivo uterotrophic assay. MCF-7 human breast cancer cells were treated with $DEHA(5{\times}10^{-9}{\sim}5{\times}10^{-4}\;M)$, for 144 hr, and cell proliferation was determined by sulforhodamine B(SRB) assay. DEHA dissolved in corn oil was administered subcutaneously to ovariectomized(OVX) female Sprague-Dawley rats at dosage levels of 0, 2, 20 and 200 mg/kg/day for three consecutive days. Rats were sacrificed 24 hr after final treatment and vagina and uterus(wet and blotted) weights were obtained. E-screen assayed DEHA did not generate cell proliferation at treated concentrations$(5{\times}10^{-9}{\sim}5{\times}10^{-4}\;M)$, whereas 17 ${\beta}-estradiol$(E2), the positive control, induced cell proliferation at low concentrations$(5{\times}10^{-14}{\sim}5{\times}10^{-9}\;M)$. In the uterotrophic assay, DEHA did not change vagina and uterus(wet and blotted) weights at dosage levels up to 200 mg/kg/day treatment. These results demonstrated that DEHA did not exhibit the estrogenic activity as determined by in vitro E-screen assay and in vivo uterotrophic assay.

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Hepatoprotcetive Effects of Oyster (Crassostrea gigas) Extract in a Rat Model of Alcohol-Induced Oxidative Stress (알코올로 유도된 간 손상 동물모델에서 굴 추출물의 간 보호 효과)

  • Osaki, Kenji;Arakawa, Teruaki;Kim, Bumsik;Lee, Minjae;Jeong, Changsik;Kang, Namgil
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.45 no.6
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    • pp.805-811
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    • 2016
  • This study was conducted to investigate the protective effects of water extract from Crassostrea gigas (CGW) against ethanol-induced hepatic toxicity in rats. Seventy-two male Wistar rats (6-week-old) were divided into six groups of 12 animals each: control group (1 mL saline/d), ethanol-treated group, positive control group (ethanol+Hovenia dulcis Thunb extract), CGWL group (ethanol+low dosage of CGW), CGWM group (ethanol+medium dosage of CGW), and CGWH group (ethanol+high dosage of CGW). All groups except the control group received ethanol (40% ethanol 5 g/kg) orally. CGW administration with ethanol resulted in prevention of ethanol-induced hepatotoxicity by increasing levels of serum alanine aminotransferase and ${\gamma}-glutamyltransferase$. CGW supplementation significantly reduced formation of malonaldehyde and inhibited reduction of hepatic glutathione and peroxidase levels, as compared with the ethanol-administration group. Further, CGW suppressed expression of CYP2E1, which was elevated by ethanol administration. Consequently, our results indicate that Crassostrea gigas may exert hepatoprotective effects against alcohol-induced hepatocyte injury by intensifying the anti-oxidative defense system.

Survey and Classification of Pharmaceutical Excipients (국내 의약품 첨가제 정보체계 연구)

  • Park, In-Sook;Park, Sang-Aeh;Kim, Eun-Jung;Park, Hyo-Min;Hong, Chong-Hui;Jnng, Joo-Yeon;Kim, Ho-Jung;Lee, Ji-Hyun;Han, Eui-Sik;Kang, Shin-Jung;Lee, Sun-Hee
    • Journal of Pharmaceutical Investigation
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    • v.36 no.4
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    • pp.239-243
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    • 2006
  • Due to the development of new dosage forms and the improvement or pharmaceutics, the pharmaceutical excipients have become more specified and diverse, and the reclassification on them became necessary. Also with the increasing interests on the kinds and usage amount, related provisions, and evaluation of the pharmaceutical excipients, the systemic and effective control of them was in its demand. Therefore, in this research, we provided the following information on excipients: the type, amount and specification. In order to provide the information, we investigated, analysed and summarized the excipients that are approved by KFDA and published $\ulcorner$Handbook of Pharmaceutical Excipients$\lrcorner$). This handbook is expected to be used as a reference in the development of the pharmaceutics and evaluation in them. As the importance of excipients in pharmaceutics are increasing, IPEC which consist of IPEC-America, IPEC-Europe and JPEC, PDG and ICH have tried to make an international harmonization on excipient. This current status was not an exception to Korea, therefore, the result of this research is expected to make a progress in the evaluation on the excipients to an advanced level.

Studies on Excipients for oral dosage forms of currently marketed drug products

  • Kang, Shin-Jung;Choi, Hyun-Ceol;Kim, Ho-Jeong;Park, Sang-Aeh;Kim, Ji-Sun;Kim, Tae-Hee
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.303.1-303.1
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    • 2003
  • Excipients of the drug products can sometimes affect the rate and extent of drug absorption. The changes in components or composition of them can also affect the pharmacological activity. So the quantity of excipients to be changed, the new excipients and atypically large amount of commonly used excipients should be considered as bioequivalence studies. (omitted)

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TERATOGENICITY STUDY OF FOOD ADDITIVES CHEMICALS IN THE DEVELOPING CHICK EMBRYO

  • Lee, Yong-Soon;Park, Jae-Jun
    • Toxicological Research
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    • v.5 no.1
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    • pp.61-69
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    • 1989
  • To evaluate possible teratogenicity of food additives such as sodium propionate and monosodium glutamate, 300 haching eggs were subjected to potential mutagenicity assay by administration of low and high doses of the materials via york and air sac. The results are summarized as follows: 1. Mortality rate of chick embryo was increased significantly by dosage related in the group of sodium propiorate and monosodium glutamate when compared to placebo and non-treated group. 2. Frequency of embryo with malformation in treated group was not increased significantly when compared to placebo and non-treated group.

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