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Purge & Trap-GC를 이용한 의약품 필름코팅 정제 중 잔류용제에 관한 연구
장준식,이명자,소유섭,문춘선,이주헌,박희라,김진숙,강경모,이선옥,방성연,유미자,유문균,금오성,이병욱 식품의약품안전청 2000 식품의약품안전청 연보 Vol.4 No.-
의약품은 약물을 생체에 적풋하기 위하여 유효성분의 효과가 언제나 일정하게 확보되고 사응에 편리하도록 만들어지는 것이므로 유효썽분 이외에 약효에 영향을 주지 않는 성분이 첨가되는 경운가 많다. 이 때 사용되는 용매들은 제피의 광택 및 건쪼시간의 단축 등을 위하여 휘발점이 낮을 용매들이 주로 사용되어진다. 본 연구는 의약품 필름코팅정제 중 잔류용매 4종(chlorofonr benzen, trichloro ethylen, 1,4-dioxane)에 대한 변형된 pirge & trap-GC 장치를 이용한 동시분석방법을 개발하였으며, 각 표준품의 RSD 값은 chloroform 3.03%, benzen 3.17%, trichloroethylen 3.69% and 1,4-dioxane 3.41%였다. 또한 시중 유통중인 의약품 50종에 대하여 잔류웅매 양을 측정하였으며, 검출되는 잔류용매는 한 건도 없었다. This study nras carried out to develope the analytical method for the mixture of chlorefonn, benzen, trichloroethylen and 1,4-dioxane simultaneously and determine the remainingorgauic solvents in coating tablets by Purge & Trap-GC. The results were as follouFs ; 1. Chloroform, benzen, trio:tloroethylen and 1,4-dioxane separated by tenax #5 trap by HP-624GC column by terrlperature programming. The peaks were separated completely at retentiontime of 6.88min for chloroform, 8.21min for benzen, 10.38miu for trichloroethylen and 11.95minfor 1,4-dioxane. 2. Standard RSD were individually chloroform 3.03%, benzen 3.17%, trichloroethylen 3.69%and 1,4-diorane 3.41%. 3. 60 samples were not detrcted chloroform, benzen, trichloroethylen and 1,4-dioxane.
폴록사머 및 프로필렌글리콜을 이용한 클로트리마졸 고형 좌제의 물리화학적 특성
현경희,오유경,김정애,공경환,김지현,양준호,배명수,김호동,이종달,장현욱,용철순,최한곤 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.2
To develop a clotrimazole-loaded solid suppository with poloxamer and propylene glycol, the melting points of various formulations composed of poloxamer 188 (P 188) and propylene glycol were investigated. The dissolution study of clotrimazole delivered by the suppository composed of P 188 and propylene glycol was performed. The mixtures composed of P 188 and propylene glycol were homogeneous. Propylene glycol affected the melting points of poloxamer mixtures. In particular, the mixture [P 188/propylene glycol (70/30%)] with the melting point of about 32°C was a solid form at room temperature and instantly melted at physiological temperature. Furthermore, propylene glycol affected greatly the dissolution rates of clotrimazole from the suppository. Dissolution mechanism analysis showed the dissolution of clotrimazole was proportional to the time. Our results indicated that the solid suppository with P 188 and propylene glycol would be a candidate of rectal dosage form for clotrimazole.
Effects of silver nanoparticles on pregnant dams and embryo-fetal development in rats
Yu, Wook-Joon,Son, Jung-Mo,Lee, Jinsoo,Kim, Sung-Hwan,Lee, In-Chul,Baek, Hyung-Seon,Shin, In-Sik,Moon, Changjong,Kim, Sung-Ho,Kim, Jong-Choon Informa UK Ltd. 2014 Nanotoxicology Vol.8 No.1
<P>Although the potential risk of silver nanoparticles (AgNPs) to humans has recently increased due to widespread application, the potential effects of AgNPs on embryo-fetal development have not yet been determined. This study investigated the potential effects of AgNPs on pregnant dams and embryo-fetal development after maternal exposure on gestational days (GD) 6-19 in rats. AgNPs were administered to pregnant rats by gavage at concentrations of 0, 100, 300, and 1000 mg/kg/day. All dams were subjected to Cesarean section on GD 20 and the fetuses were examined for signs of embryotoxic and teratogenic effects. Examinations of hepatic oxidant/antioxidant balance and serum biochemistry were also added to the routine developmental toxicity study. Treatment with AgNPs caused a decrease in catalase and glutathione reductase activities at ≥100 mg/kg/day and a reduction in glutathione content at 1000 mg/kg/day in maternal liver tissues. However, no treatment-related deaths or clinical signs were observed in any of the animals treated with AgNPs. No treatment-related differences in maternal body weight, food consumption, gross findings, serum biochemistry, organ weight, gestation index, fetal deaths, fetal and placental weights, sex ratio, or morphological alterations were observed between the groups. The results show that repeated oral doses of AgNPs during pregnancy caused oxidative stress in hepatic tissues at ≥100 mg/kg/day, but did not cause developmental toxicity at doses of up to 1000 mg/kg/day. The no-observed-adverse-effect level of AgNPs is considered to be <100 mg/kg/day for dams and 1000 mg/kg/day for embryo-fetal development.</P>
4-Week repeated oral dose toxicity study of 1,4-dichlorobutane in rats
Wook-Joon Yu,In-Chul Lee,Jinsoo Lee,Sang-Min Lee,Sung-Hwan Kim,Hyung-Seon Baek,Changjong Moon,Sung-Ho Kim,Yong-Hyun Chung,Jong-Choon Kim 한국실험동물학회 2013 Laboratory Animal Research Vol.29 No.1
The present study investigated the potential subacute toxicity of 1,4-dichlorobutane by a 4-week repeated oral dose in Sprague-Dawley rats. The test article was administered once daily by gavage to male rats at dose levels of 0, 100, 300, and 1,000 mg/kg/day for 4 weeks. All rats were sacrificed at the end of the treatment period. During the test period, clinical signs, mortality, body weight, hematology, serum biochemistry, gross findings, and organ weight were examined. At 1,000 mg/kg/day, an increase in the clinical signs and weights of the liver and kidneys was observed in the male rats. Serum biochemical investigations revealed an increase in alanine aminotransferase, alkaline phosphatase, total cholesterol, total bilirubin, phospholipids, blood urea nitrogen, and gamma glutamyl transferase levels. There were no treatment-related adverse effects in the low and middle-dose groups. In the present experimental conditions, the target organs were determined to be liver and kidney. The no-observed-adverse-effect level was considered to be 300 mg/kg/day in rats.
( Joon Yeul Nam ),( Yun Bin Lee ),( Jeong-hoon Lee ),( Su Jong Yu ),( Hyo-cheol Kim ),( Jin Wook Chung ),( Jung-hwan Yoon ),( Yoon Jun Kim ) 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Aims: Transarterial radioembolization (TARE) has been one of the treatment options for hepatocellular carcinoma (HCC). However, the indication of TARE was not well-established and prognosis after TARE still remains difficult to predict among individual patients. The aim of this study was to develop a prognostic scoring model to guide TARE initiation. Methods: A total of 174 consecutive patients who underwent TARE for HCC as an initial treatment in Korea were included. The primary outcome was overall survival (OS) from the date which TARE was performed. We developed a prediction model using independent risk factors for OS and conducted a validation with bootstrap. Results: Median maximal tumors size was 8.15 cm (interquartile range (IQR), 5.8-12.0) and median tumor number was 2 (IQR, 1-3). Median albumin level was 4.0 g/dl (IQR, 3.6-4.2). Portal vein invasion was found in 80 patients [46%, Vp1-3 (39.7%) and Vp4 (6.3%)]. Using four independent risk factors associated with OS (maximal tumor Size, tumor Number, serum Albumin, and Portal vein invasion), a scoring system (SNAP-HCC) was developed. Harrell C-index values for OS were 0.756 (95% confidence interval: 0.729-0.783) in validation using bootstrap. The patient group according to SNAP-HCC score (0-5) were well-discriminated and showed significantly different OS among each group (all P<0.001). Patients with SNAP-HCC<3 showed significantly longer OS than patients with SNAP-HCC≥3 (P<0.001) (Figure). The expected survival probabilities at years 1, and 3 were 0.81 and 0.73 in the low-risk group (SNAP<3); and 0.32 and 0.14 in the high-risk group (SNAP≥3), respectively. Conclusions: SNAP-HCC score system could predict a prognosis of HCC patients who underwent TARE as an initial treatment. This model could be helpful for making a decision for selecting HCC treatment.
Clinical outcomes of salvage chemoradiotherapy for locally recurrent biliary tract cancer
Yu, Jeong Il,Park, Hee Chul,Lim, Do Hoon,Park, Joon Oh,Park, Young Suk,Kim, Seung Tae,Choi, Seong Ho,Choi, Dong Wook,Han, In Woong,Heo, Jin Seok CASA EDITRICE AMBROSIANA 2017 TUMORI Vol.103 No.4
<P>Conclusions: CCRT for locally recurrent BTC showed promising outcomes as a salvage modality, but LP was still frequent. The pre-CCRT CA 19-9 level and the chemotherapy regimen were prognostic factors for LPFS and PFS.</P>