• 제목/요약/키워드: FDA approved

검색결과 121건 처리시간 0.025초

Phosphatidylcholine과 Sodium Deoxycholate가 지방세포 생존에 미치는 영향의 비교 분석 (Comparative Analysis about the Effect of Isolated Phosphatidylcholine and Sodium Deoxycholate for the Viability of Adipocyte)

  • 나은영;강조아;이중호;오득영;서제원;문석호;안상태;이종원
    • Archives of Plastic Surgery
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    • 제37권5호
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    • pp.531-534
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    • 2010
  • Purpose: Lipobean$^{(R)}$s, widely used in lipodissolving techniques, contain phosphatidylcholine and sodium deoxycholate as its main substances. They have been approved only as medication for liver disease by the FDA. However, they have been used under various clinical settings without exact knowledge of its action mechanism. The authors designed an in vitro study to analyze the effects of different concentrations of phosphatidylcholine and sodium deoxycholate on adipocytes and other types of cells. Methods: Human adipose-derived stem cell were cultured and induced to differentiate into adipocytes. Fibroblasts extracted from human inferior turbinate tissue, and MC3T3-E1 osteoblast lines were cultured. Phosphatidylcholine solution dissolved with ethanol was applied to the culture medium at differing concentrations (1, 4, 7, 10 mg/mL). The sodium deoxycholate solution dissolved in DMSO applied to the medium at differing concentrations (0.07, 0.1. 0.4. 0.7 mg/mL). Cells were dispersed at a concentration of $5{\times}10^3$ cells/well in 24 well plates, and surviving cells were calculated 1 day after the application using a CCK-8 kit. Results: The number of surviving cells of adipocytes, fibroblasts and osteoblasts decreased as the concentration of sodium deoxycholate increased. However, all types of cells that had been processed in a phosphatidylcholine showed a cell survival rate of over 70% at all concentrations. Conclusion: This study shows that sodium deoxycholate is the more major factor in destroying adipocytes, and it is also toxic to the other cells. Therefore, we conclude that care must be taken when using Lipobean$^{(R)}$s as a method of reducing adipose tissue, for its toxicity may destroy other nontarget cells existing in the subcutaneous tissue layer.

20, 30대 한국 남성의 전두부 모발선의 모양과 위치 (The Shape and the Location of Forehead Hairline of Korean Males in Their 20s & 30s)

  • 윤성원;김정헌
    • Archives of Plastic Surgery
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    • 제38권3호
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    • pp.295-299
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    • 2011
  • Purpose: It is generally believed that alopecia is caused by various factors such as scars, stress, genetical factors, androgens, etc. Androgenic alopecia is one of the most common cause of alopecia and found mainly in males. Propecia (Merck & Co., USA) and Minoxidil (McNEIL-PPC, Inc, USA) were the drugs approved from FDA for treatment of androgenic alopecia. Surgical treatments such as flap, tissue expansion, scalp reduction and hair transplantation can be considered if necessary. Hair micrograft techniques were developed for natural hair shapes and minimal adverse effect. There were attempts to measure the length of the forehead of the Korean young adults. However attempts to classify the shape and location of forehead hairline were rare. This study attempted to find out standard hairlines of young adults in their 20s & 30s and the result would be the guideline of the hairline in hair replacement surgery of male patients in their 40s & 50s. Methods: 200 male adults in 20s and 30s were photographed and measured the length of 11 vertical index lines to determine hairline. The indexes are the distances from hairline to intercanthal midpoint (A), to medial canthus (B), to upper eyelid fissure (C), to lower eyelid fissure (D), to lateral canthus (E) and distance from lateral highest point to medial lowest point, if the hairline is M-shape (F). Additionally, we classified the hairlines into 4 groups, M, horizontal, inverted U and irregular shapes. Results: The most common hairline of male adults in their 20s is inverted U-shape (53.3%), followed by horizontal-shape, M-shape, irregular-shape. In their 30s, inverted U-shape (59%) is followed by irregular-shape, M-shape, horizontal-shape. The M-shape is more frequently found in males in 30s than those in 20s. The mean values of the indexes in their 20s are as follows: A (76.14 mm), B (Rt: 75.78 mm, Lt:76.41 mm), C (Rt: 69.43 mm, Lt: 69.92 mm), D (Rt: 76.92 mm, Lt:77.46 mm), E (Rt: 64.16 mm, Lt: 64.73 mm), F (4.09 mm). Those in their 30s are as follows: A (76.13 mm), B (Rt: 76.114 mm, Lt: 76.02 mm), C (Rt: 69.87 mm, Lt: 70.37 mm), D (Rt: 77.37 mm, Lt: 77.58 mm), E (Rt: 69.63 mm, Lt: 69.85 mm), F (6.14 mm). Conclusion: The knowledge about human body measurement is indispensable to plastic surgeons. In this study, inverted U shape is the most common type of hairline in 30s, and similar distribution is found in 20s. The percentage of M shape in their 30s is elevated more than 10% compared to that in their 20s. The study of hairline shapes and 11 indexes of hairlines can be useful for planning of the hair transplantation and postoperative evaluation. This study being based on photogrammetry, there may be differences between actual distance of curved face and projected distance on flat photographs.

암컷 hGHTg 비만 쥐에서 경신해지환(輕身解脂丸) (GGT1)에 의한 비만관련 유전자 mRNA 발현의 변화 (Changes in mRNA Expression of Obesity-related Genes by GyeongshinhaeGihwan 1 (GGT1) in hGHTg (human growth hormone transgenic) obese Female Rats)

  • 윤기현;윤미정;김훈;신순식
    • 동의생리병리학회지
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    • 제20권2호
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    • pp.383-387
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    • 2006
  • To investigate the effect of GyeongshinhaeGihwan 1(GGT1) frequently used as an anti-obesity herbal medicine in oriental medicine on the expression of obesity-related genes, we measured the changes in mRNA levels of these genes by GGT1 in human growth hormone transgenic (hGHTg) obese female rats, and these effects by GGT1 were compared with those of reductil (RD), an anti-obesity drug approved by FDA. Rats received once daily oral administrations of autoclaved water, RD, or GGT1 for 8 weeks. At the end of study, rats were sacrificed and tissues were harvested. Total RNA from adipose tissue, liver and kidney was prepared and the mRNA levels for LPL (lipoprotein lipase), $PPAR{\gamma}$ (peroxisome proliferator activated receptor-gamma), $PPAR{\delta}$ (peroxisome proliferator activated receptor-delta), leptin, $TNF{\alpha}$ (tumor necrosis factor-alpha), and internal standard G3PDH (glyceraldehyde-3-phosphate dehydrogenase) were analyzed by RT-PCR. Compared with control group, $PPAR{\gamma}$ mRNA levels of liver and kidney were decreased in both RD and GGT1 groups, and the effects were more prominent in GGT1 group than in RD group, suggesting that GGT1 is effective in the inhibition of lipid storage by decreasing the $PPAR{\gamma}$ expression. $PPAR{\delta}$ mRNA levels of adipose tissue were increased by RD and GGT1 compared with DW, and the magnitude of increase were higher in GGT1 group than in RD group, indicating that GGT1 stimulates fatty acid oxidation and energy metabolism by activating $PPAR{\delta}$ expression. GGT1 group had higher concentrations of serum leptin, a well-known inhibitor of appetite, than control and RD groups. However, The mRNA levels of leptin, LPL, and $TNF{\alpha}$ were not changed by GGT1. These results indicate that GGT1 can prevent obesity in hGHTg obese female rats by down-regulating and up-regulating the mRNA expression of $PPAR{\gamma}$ and $PPAR{\delta}$, respectively, and that this anti-obesity effects were more pronounced in GGT1 group compared with RD group. In addition, GGT1 seems to inhibit obesity by increasing the circulating leptin levels.

MR Technology to 4T

  • Vaughan, Thomas
    • 대한자기공명의과학회:학술대회논문집
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    • 대한자기공명의과학회 2003년도 제8차 학술대회 초록집
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    • pp.103-105
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    • 2003
  • After fifteen years of development, Magnetic Resonance (MR) technology for human imaging and spectroscopy is reaching a refined state with FDA approved 3T clinical products from Siemens, GE, and Philips. Broker has cleared CE approval with a 4T system. Varian supports a 4T system platform as well. Shielded magnets are standard at 3T from GE, Oxford, Magnex, and IGC. A shielded 4T whole body magnet is available from Oxford. Stronger switched gradients and dynamic shim coils, desired at any field, areespecially useful at higher static magnetic fields B0. In addition to the higher currents required for higher resolution slice or volume selection afforded by higher SNR, whole body gradient coils will be driven at increasing slew rates to meet the needs of new cardiac applications and other requirements. For example 3T and 4T systems are now being equipped with 2kV, 500A gradient coils and amplifiers capable of generating 4G/cm in 200msec, over a 67+/-cm bore diameter. High field EPI applications require oscillation rates at 1 kHz and higher. To achieve a benchmark 0.2 ppm shim over a 30cm sphere in a high field magnet, at least four stages of shimming need to be considered. 1) A good high field magnet will be built to a homogeneity spec. falling in the range of 100 to 150 ppm over this 30cm spherical "sweet spot" 2) Most modern high field magnets will also have superconducting shim coils capable of finding 1.5 ppm by their adjustment during system installation. 3) Passive ferro-magnetic shimming combined with 4) active, high order room temperature shim coils (as many as five orders are now being recommended) will accomplish 0.2 ppm over the 30cm sphere, and 0.1 ppm over a human brain in even the highest field magnets for human studies. Safety concerns for strong, fast gradients at any B0 field include acoustic noise and peripheral nerve stimulation. One or more of the mechanical decoupling methods may lead to quieter gradients. Patient positioning relative to asymmetric or short gradient coils may limit peripheral nerve stimulation at higher slew rates. Gradient designs combining a short coil for local speed and strength with a longer coil for coverage are being developed for 3T systems. Local gradients give another approach to maximizing performance over a limited region while keeping within the physiologically imposed dB0/dt performance limits.

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Local Drug Delivery System Using Biodegradable Polymers

  • Khang, Gil-Son;Rhee, John M.;Jeong, Je-Kyo;Lee, Jeong-Sik;Kim, Moon-Suk;Cho, Sun-Hang;Lee, Hai-Bang
    • Macromolecular Research
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    • 제11권4호
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    • pp.207-223
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    • 2003
  • For last five years, we are developing the novel local drug delivery devices using biodegradable polymers, especially polylactide (PLA) and poly(D,L-lactide-co-glycolide) (PLGA) due to its relatively good biocompatibility, easily controlled biodegradability, good processability and only FDA approved synthetic degradable polymers. The relationship between various kinds of drug [water soluble small molecule drugs: gentamicin sulfate (GS), fentanyl citrate (FC), BCNU, azidothymidine (AZT), pamidronate (ADP), $1,25(OH)_2$ vitamin $D_3$, water insoluble small molecule drugs: fentanyl, ipriflavone (IP) and nifedipine, and water soluble large peptide molecule drug: nerve growth factor (NGF), and Japanese encephalitis virus (JEV)], different types of geometrical devices [microspheres (MSs), microcapsule, nanoparticle, wafers, pellet, beads, multiple-layered beads, implants, fiber, scaffolds, and films], and pharmacological activity are proposed and discussed for the application of pharmaceutics and tissue engineering. Also, local drug delivery devices proposed in this work are introduced in view of preparation method, drug release behavior, biocompatibility, pharmacological effect, and animal studies. In conclusion, we can control the drug release profiles varying with the preparation, formulation and geometrical parameters. Moreover, any types of drug were successfully applicable to achieve linear sustained release from short period ($1{\sim}3$ days) to long period (over 2 months). It is very important to design a suitable formulation for the wanting period of bioactive molecules loaded in biodegradable polymers for the local delivery of drug. The drug release is affected by many factors such as hydrophilicity of drug, electric charge of drug, drug loading amount, polymer molecular weight, the monomer composition, the size of implants, the applied fabrication techniques, and so on. It is well known that the commercialization of new drug needs a lot of cost of money (average: over 10 million US dollar per one drug) and time (average: above 9 years) whereas the development of DDS and high effective generic drug might be need relatively low investment with a short time period. Also, one core technology of DDS can be applicable to many drugs for the market needs. From these reasons, the DDS research on potent generic drugs might be suitable for less risk and high return.

전남 여자만 해수 및 새꼬막(Scapharca subcrenata)의 세균학적 위생 평가 (Assessment of Bacteriological Safety of the Seawater and Ark shell (Scapharca subcrenata) in Yeoja Bay, Korea)

  • 신순범;오은경;정상현;이희정;김연계;이태식
    • 수산해양교육연구
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    • 제28권5호
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    • pp.1435-1443
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    • 2016
  • 본 연구에서는 우리나라의 새꼬막 주 생산해역인 전남 여자만에 대하여 해수 및 패류의 세균학적 분석결과를 근거로 위생상태를 평가함으로써 동 해역의 위생안전성 확보를 위한 기초자료를 제공하고자 하였다. 또한 본 연구결과를 적용하여 우리나라의 정착성 수산물 등급기준에 따른 해역분류 및 한국패류위생계획에 근거한 '수출용패류생산지정해역'으로의 가능성을 평가하고자 하였다. 2014년 1월부터 2016년 6월까지 여자만에 설정한 50개소의 조사정점별 해수의 위생지표세균 조사결과, 대장균군 및 분변계대장균 수의 범위는 각각 <1.8~5,400 및 <1.8~350 MPN/100 mL으로 분석되었으며 이는 우리나라의 '정착성 수산동식물 생산해역 등급설정 기준'(MOF, 2013a)에 따라 청정해역의 기준에 충족하는 것으로 평가되었다. 수출용패류생산지정해역으로 지정을 위해서는 미국이나 유럽연합 등의 기준을 충족하여야 하며 본 조사결과 미국의 National Shellfish Sanitation program (U.S. FDA, 2016)에 따라 해수의 수질은 허가해역에 적합한 것으로 평가되었으나, 여자만은 주변에 오염원이 산재해 있고 강우의 영향을 받을 수 있으므로 오염원 관리가 수반되어야 하는 조건부 허가해역에 적합한 것으로 평가되었다. 또한, 유럽연합의 Regulation (EC) No 854 (European Commission, 2004)에 근거하여 여자만의 패류(새꼬막)는 계절적 또는 시기적 영향을 받는 것으로 확인되어, 해역 분류기준 중 Class B에 부합하는 것으로 확인 되었으며 시기에 따른 분류(6~10월은 Class B, 11-5월은 Class A)도 가능 할 것으로 평가되었다. 아울러 여자만의 위생안전성을 확보하고 외국으로 패류를 수출하기 위해서는 앞으로 오염원관리계획 수립을 위한 체계적인 오염원 현황파악 및 영향평가가 수반되어야 하며, 패류에 대한 중금속 및 패류독소 등의 추가조사 또한 필요할 것으로 사료된다.

조형가공기술을 이용한 인공지지체의 수산화나트륨 개질 효과 (Effect of Sodium Hydroxide Treatment on Scaffold by Solid Freeform Fabrication)

  • 박수아;이정복;김양은;김지은;권일근;이준희;김완두;김형근;김미은;이준식
    • 폴리머
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    • 제38권6호
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    • pp.815-819
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    • 2014
  • 조직공학에서의 인공지지체는 세포의 부착과 증식 및 분화가 잘 되어야 하고, 우수한 생체친화성 및 생분해성을 지녀야 한다. 다양한 인공지지체 제작 방법이 시도되어지고 있으며, 최근들어 3D 프린팅 기술을 이용한 방식이 활발하게 연구되어지고 있다. 폴리카프로락톤(polycaprolactone, PCL)은 낮은 녹는점을 가지고 있어 3D 프린팅하기에 우수한 생체적합 고분자 합성재료이다. 본 연구에서는 3D 프린팅 기술을 이용하여 3차원 PCL 인공지지체를 제작하였고, 지지체의 표면개질을 위해 수산화나트륨(NaOH)을 이용하였다. 표면개질된 인공지지체의 표면특성을 SEM으로 확인한 결과, 수산화나트륨을 처리한 PCL 인공지지체가 처리하지 않은 PCL 인공지지체에 비해 거칠기가 증가함을 보였으며, 접촉각 측정을 통해 친수성이 증가함을 확인하였다. In vitro 실험결과, 수산화나트륨을 처리한 PCL 인공지지체가 처리하지 않은 PCL 인공지지체에 비해 세포의 증식과 분화가 증가함을 보였고, 세포의 부착 모습은 균일하고 밀집된 형태로 부착됨을 확인하였다. 따라서 조형가공기술을 이용하여 수산화나트륨을 처리한 표면개질된 PCL 인공지지체를 제작하고 분석함으로써, 세포적합성을 통해 체내 인공지지체 개발 적용 가능성을 제시하였다.

경신해지환(輕身解脂丸) (GGT1)이 형질전환 비만모델 hGHTg 수컷 쥐의 비만관련 유전자 발현에 미치는 영향 (Effects of GyeongshinhaeGihwan 1(GGT1) on the Expression of Obesity-related Genes in Obese Male hGHTg Rats)

  • 정양삼;윤미정;김경철;신순식
    • 동의생리병리학회지
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    • 제20권1호
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    • pp.93-97
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    • 2006
  • To investigate whether GyeongshinhaeGihwan 1(GGT1), an anti-obesity herbal medicine widely used in oriental medicine, regulates the expression of obesity-related genes, we measured the changes in mRNA levels of these genes by GGT1 in human growth hormone transgenic (hGHTg) obese male rats, and these effects by GGT1 were compared with those of reductil (RD), an anti-obesity drug approved by FDA. Rats received once daily oral administrations of autoclaved water, RD, or GGT1 for 8 weeks. At the end of study, rats were sacrificed and tissues were harvested. Total RNA from adipose tissue, liver and kidney was prepared and the mRNA levels for LPL (lipoprotein lipase), PPAR $\gamma$ (peroxisome proliferator activated receptor-gamma), PPAR$\delta$ (peroxisome proliferator activated receptor-delta), leptin, TNF$\alpha$ (tumor necrosis factor-alpha), and internal standard G3PDH (glyceraldehyde-3- phosphate dehydrogenase) were analyzed by RT-PCR. PPAR$\gamma$ mRNA levels of liver and kidney were decreased in drug-treated groups compared with control group and the decrease of PPAR$\gamma$ expression was more prominent in GGT1 group than in RD group, suggesting that GGT1 is effective in the inhibition of adipogenesis and lipid storage by decreasing the PPAR$\gamma$ expression. In contrast, PPAR$\delta$ mRNA levels of adipose tissue and kidney were increased by RD and GGT1 , and the magnitudes of increase were higher in GGT1 group than in RD group, indicating that GGT1 stimulates fatty acid oxidation and energy metabolism by activating PPAR$\delta$ expression, Compared with control and RD groups, GGT1 group had higher concentrations of serum leptin, a well-known inhibitor of appetite. However, The mRNA levels of leptin, LPL, and TNF$\alpha$ were not changed by GGT1 and RD, compared with DW. These results demonstrate that GGT1 not only decreases PPAR$\gamma$ expression of liver and kidney, but also increases PPAR$\delta$ expression of adipose tissue and kidney, leading to the regulation of obesity and that these effects were more pronounced in GGT1 group compared with RD group. In addition, GGT1 seems to prevent obesity by increasing the serum leptin levels.

급성신손상으로 인해 발생한 dabigatran 독성 (Dabigatran Toxicity Secondary to Acute Kidney Injury)

  • 문형호;이승은;오동준;조희범;권기환;김윤진;김경수;신성준
    • 대한임상독성학회지
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    • 제12권2호
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    • pp.92-96
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    • 2014
  • Dabigatran is the first oral direct thrombin inhibitor approved by the US Food and Drug Administration (FDA) for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Because dabigatran is excreted mainly by the kidneys, serum levels of dabigatran can be elevated to a supratherapeutic range in patients with renal failure, predisposing to emergent bleeding. We describe the case of a 66-year-old man taking dabigatran 150 mg twice daily for atrial fibrillation and cerebral infarction who presented with hematochezia and disseminated intravascular coagulation. Laboratory evaluation showed a hemoglobin level of 6.3 g/dL, platelets of $138,000/mm^3$, activated partial thromboplastin time (aPTT) of 10 s, and an international normalized ratio (INR) of 8.17. Colonoscopy showed a bleeding anal fissure. Hemostasis was provided by hemoclips and packed red blood cells and fresh frozen plasma were transfused. Since then, there was no further hematochezia, however, bleeding including oral mucosal bleeding, hematuria, and intravenous site bleeding persisted. At presentation, his serum creatinine was 4.96 mg/dL (baseline creatinine, 0.9 mg/dL). Dabigatran toxicity secondary to acute kidney injury was presumed. Because acute kidney injury of unknown cause was progressing after admission, he was treated with hemodialysis. Fresh frozen plasma transfusion was provided with hemodialysis. At 15 days from admission, there was no further bleeding, and laboratory values, including hemoglobin, partial thromboplastin time, and prothrombin time were normalized. He was discharged without bleeding. After 2 months, he undergoes dialysis three times per week and no recurrence of bleeding has been observed.

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별아교세포 선택적 유전자 치료전달을 위한 PLGA 나노입자 개발 (Development of PLGA Nanoparticles for Astrocyte-specific Delivery of Gene Therapy: A Review)

  • 신효정;이가영;권기상;권오유;김동운
    • 생명과학회지
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    • 제31권9호
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    • pp.849-855
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    • 2021
  • 최근에는 나노기술이 다양한 분야에 도입되고 활용되면서 신약개발이 가속화되고 있다. 나노입자는 약물의 단일 투여로 장기간 동안 혈중 약물 농도를 유지하고, 병리학적 부위에만 선택적으로 방출되는 장점이 있어 비병리 주위에 대한 부작용을 줄일 수 있다. Poly (D,L-lactic-co-glycolic acid) (PLGA)는 가장 광범위하게 개발된 생분해성 고분자 중 하나이다. PLGA는 다양한 응용분야의 약물전달에 널리 사용된다. 또한 FAD에 의해 약물전달 시스템으로 승인되었으며, 유전자 치료제와 같은 제어방출제형에 널리 적용된다. PLGA 나노입자는 수동 및 능동 표적화 방법을 사용하여 특정 세포 유형에 고효율의 전달 시스템으로 개발되었다. 이러한 PLGA 나노입자를 이용한 약물전달체 개발 후 표적 부위에 선택적으로 약물을 전달하고 질병에 따라 장기간 유효 혈중 농도를 최적화한다. 이 리뷰논문에서 우리는 유전자 치료를 위한 PLGA 나노 물질을 기반으로 하는 성상 세포 선택적 나노입자의 개발을 조사하여 세포 특이적으로 치료결과를 향상시키는 방법에 중점을 두고자 한다.