바난 정 ( 세프포독심 프로세틸 100mg ) 에 대한 포독수 정의 생물학적 동등성

조성완(Seong Wan Cho),이지혜(Ji Hye Lee),송일용(Il Yong Song),이상길(Sang Kil Lee),차영주(Young Joo Cha),최영욱(Young Wook Choi) 한국약제학회 1999 Journal of Pharmaceutical Investigation Vol.29 No.3

Bioequivalence study of two cefpodoxime preparations, the test drug (Banan^ⓡ: Hanil Pharmaceutical Co., Ltd.) and the reference drug (Podox^ⓡ: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 23.81±2.13 years old and 63.34 ±4.84 ㎏ of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 200 ㎎ as cefpodoxime proxetil in a 2×2 crossover study. Plasma concentrations of cefpodoxime were analysed by HPLC method for 12 hr after administration. The AUC_(0-12hr) was calculated by the linear trapezoidal rule method, The C_(max) and T_(max) were compiled directly from the plasma drug concentration-time data. Student`s t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there were no differences in AUC, C_(max), and T_(max) between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 4.31, 1.99 and 4.30% for AUC, C_(max), and T_(max), respectively). Minimum detectable differences (%) between the formulations at α = 0.05 and 1-β=0.8 were less than 20% (e.g., 13.89, 13.88, and 16.97% for AUC, C_(max), and T_(max), respectively). The 90% confidence intervals for these parameters were also within ±20% (e.g., -5.58∼14.20, -7.89∼11.88, and -7.78∼16.38% for AUC, C_(max), and T_(max), respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cefpodoxime were bioequivalent.

Nondestructive Quantification of Acetamiophen using Near Infrared Spectroscopy

Seong-Wan Cho(조성완) 한국산학기술학회 2021 한국산학기술학회논문지 Vol.22 No.11

아세트아미노펜은 치료용량으로 투여시 내약성이 우수한 장점을 가진 해열진통제로 가장 널리 사용되고 있는 의약품 중의 하나이나 기존의 분석법인 HPLC 방법으로 분석하였을 때 용매 조성을 맞추어야 하며 분석시간이 상대적으로 길다는 단점이 있었다. 본 연구의 목적은 기존의 HPLC 분석방법 대신에 비 파괴적인 분석법을 가지고 있으며 단시간에 분석이 가능하며 간편함과 재현성의 장점을 가진 근적외선 분광법을 도입하여 그 결과를 상호 비교해 보고 생산 현장에서 적용 가능 여부를 확인 해 보는 것이었다. 제제학적으로 사용되는 다른 첨가제들과 함께 각 함량 별로 준비된 아세트아미노펜 시료를 근적외선으로 분석하였다. 그 결과를 HPLC 방법으로 도출된 분석법 밸리데이션의 데이터와 비교하여 근적외선 분광법으로의 대체 가능성을 확인한 결과 특이성, 정확도, 선형성 등에서 매개 변수를 만족하였으며 적합한 결과를 얻었다. 본 분석방법은 의약품 개발, 공정 모니터링을 위한 생산 또는 품질 관리 검증에서 구현될 수 있으며 향후 많은 응용이 가능할 것이다. Acetaminophen (AAP) is widely used as an antipyretic analgesic and has excellent tolerability when administered in therapeutic doses. This study introduces a non-destructive analytical method using near-infrared spectroscopy (NIR) which has the advantages of being simple, reproducible, and fast. AAP samples were analyzed by NIR and the results were compared to those obtained through the high-performance liquid chromatography (HPLC) method to validate the data and confirm the possibility of replacing HPLC with NIR. The NIR spectrum analysis method satisfied the parameters of method validation like specificity, accuracy, and linearity. In conclusion, NIR can be considered for use during pharmaceutical development, in production for process monitoring, or the validation of quality control for active pharmaceutical ingredients.

방향의 은유적 표현이 소비자 평가에 미치는 영향

조성완(Seong Wan Cho),윤성아(Song Oh Yoon),김희진(Hee Jin Kim) 한국마케팅학회 2012 마케팅연구 Vol.27 No.3

소비자의 선택에 영향을 주는 요소 중 하나가 "거리"이다. 같은 제품이나 상점이라면, 소비자들은 가깝고 쉽게 접근할 수 있는 곳에 위치한 것을, 멀고 접근이 어려운 곳에 위치한 것보다 선호한다. 기존의 심리학, 마케팅연구들은 사람의 "거리"에 대한 인지 (심리적 거리)는 비단 객관적인 물리적 거리뿐 아니라, 시간적, 사회적 거리에 의해서도 결정됨을 보여주었다. 이러한 연구흐름의 일환으로, Nelson과 Simmons(2009)의 최근 연구는 소비자의 거리에 대한 인식이 "은유적 표현"(metaphoric expression)에 의해서도 결정됨을 보여주었다. 구체적으로, 사람들은 북쪽으로 이동하는 것을 ``위로 올라간다``는 은유적 의미로 해석하여, 북쪽에 위치한 상점으로 가는 데 동일 거리의 남쪽에 위치한 상점에 가는 것보다 많은 시간과 노력이 소요될 것이라고 생각하였다. 이러한 인식의 오류는 북쪽 상점에 대한 방문 및 구매의도를 저하시켰다. 본 연구는 개인에게 순간적으로 부여된 상향적 목표 (예: 직장에서의 프로모션을 생각하게 만드는 것)가 어떻게 이러한 은유적 표현 효과를 완화 또는 반전시키는지를 보여주고자 한다. 우리는 상향목표가 제시된 소비자들은 북행을 남행보다 더 가깝고 쉽게 인지하여, 북쪽에 위치한 제품을 더 선호할 것이라고 예측한다. 상향목표(upward goal)가 활성화된 소비자들은 상향이동에 드는 시간/노력의 비용을 짧게 지각하고 상향이동에 대한 가치를 높게 평가하며, 상향이동을 수월하게(fluently) 느껴, 은유적 표현의 효과가 반전 또는 완화될 것 이라고 생각한다. 이들 가설은 두 실증 연구를 통해 검증되었다. 실험 1에서는 피험자의 목표방향이 상향(upward)일 경우, 피험자들은 북쪽 대상물에 도달 시간이 같은 거리에 위치한 남쪽 대상물에 비해 짧을 것으로 예측하여 상향목표가 예열되지 않은 피험자들(즉, Nelson의 실험)과 반대의 결과가 도출되었다. 실험 2 에서는 매장 내 "남"과 "북"에 위치한 제품에 대한 구매의도가 소비자 목적예열(goal priming)여부에 따라 다르게 나타남을 보여주어 본 연구의 마케팅적 시사점을 제시하고 있다. Consumer evaluation is influenced not only by the inherent quality of the marketing stimuli, but also by the contextual factors surrounding that stimuli. One such important factor is "physical proximity", that is, how far or close the stimuli is located from a consumer. In general, consumer prefers a product or a store that he or she has an easy access to. Past studies in psychology and marketing show that human perception of "distance"(i.e., psychological distance) is a function not only of the actual physical proximity, but also of the temporal and social distance. Extending this stream of research, Nelson and Simmons (2009) demonstrated that metaphoric expression can determine consumer`s psychological distance, which in turn affects the subsequent evaluation of an object. In the study, people mistakenly believing that travel to "north" (vs. south) takes longer time and more efforts show less intention to visit stores located in north versus south. The current research proposes and shows the moderating effect of temporally accessible goal in the previously demonstrated metaphoric expression of cardinal direction on consumer evaluation. In particular, we hypothesize that situationally primed upward goal (e. g., thinking about their future promotion in the workplace) makes people perceive the travel to north (vs. south) easier, leading them to prefer a product located in north than the same product located in south. We expect that the following three mechanisms are responsible for the moderating effect of upward goal. First, upward goal evokes a greater motivation for upward movement, rendering upward travel seem shorter and easier. Second, the upward goal leads to increases in the perceived values attached to upward movement. Third, the escalation goal makes upward movement psychologically more fluent, causing people underestimate the travel time. The hypotheses were tested in two laboratory studies. In study 1, the participants were presented with a map showing a hypothetical city located either north or south to their current place. Then they estimated the time, efforts, and difficulty of traveling to the designated place. Prior to the estimation, a half of the participants was given a chance to think about the process which they have to go through in order to promote to the top rank in their desired work place (upward goal priming condition). The other half of the participants was given a filler task (control condition). The estimation of time, efforts, and difficulty of moving to north and south differed significantly by the goal priming condition. In the control condition, participants estimated the travel to the north (vs. south) longer, more effortful and difficult. However, as expected, the opposite pattern emerged in the upward goal priming condition. Study 2 shows the marketing implication of our research by testing the hypothesis in a consumer purchase setting. In particular, we attempted to show that consumer`s intention to purchase a product is a simultaneous function of the cardinal direction of the product and a primed direction of the goal. In this study, we compared participants` willingness to purchase a product when it is located in north versus south in a store and when participants are primed with upward goal versus no such goal. The results show partial support for our hypothesis. When there was no goal priming, participants were more inclined to purchase the product located in south versus north. However, although the preference for south versus north was attenuated by primed goal (i. e, people equally liked south and north), there was no overriding effect of goal priming in purchase intention. This research is the first study that investigates the potential condition under which the effect of metaphoric expression on consumer evaluation is moderated. Also, we add to the goal priming literature by demonstrating that nonconscious pursuit of goal in a domain irrelevant to the target evaluation can have a

시호추출물 (SHI-1909)의 염증성 대장염 실험동물 모델에 대한 치료효과

조성완(Cho, Seong-Wan),김영권(Kim, Young-Kwon) 한국산학기술학회 2009 한국산학기술학회논문지 Vol.10 No.3

SHI-1909를 초산과 TNBS에 의해 rat에 유발된 염증성 대장염 모델에서 5일 동안 경구 투여 하여 대조약인 프레드니솔론과 그 치료 효능을 비교 조사하였다. 7% 초산과 5% TNBS 용액을 polyethylene 튜브로 rat의 항문에 점적하여 염증성 대장염을 유발하였으며 점적 후 초산과 TNBS 대조군은 말단의 대장부위에서 궤양과 염증 증상 같은 병적인 소견을 보여 염증성 대장염이 잘 유발되었음을 확인할 수 있었다. 약물의 투약기간 중 염증 치유 변수인 실험동물의 중량과 식이 섭취량 변화를 관찰하였으며 실험이 종료된 후에는 실험동물을 희생시킨 후 대장의 길이와 궤양, 병적인 소견을 조사하였다. SHI-1909의 투여는 중량변화와 식이 섭취량 등에서 대조약과 필적할 만한 결과를 나타내었으며 특히 대장의 손상 정도 평가에서 대조약물인 프레드니솔론보다도 더 우수한 효과를 나타내었다. 이러한 결과로부터 SHI-1909는 IBD의 치료에 가능성이 있는 치료 약물이 될 수 있을 것으로 사료된다. The Efficacy of SHI-1909 was investigated in comparision with predinisolone in acetic acid and Picrylsulfonic acid solution (TNBS)-induced rat inflammatory bowel disease (IBD) for 5 days. 7% Acetic acid and 5% TNBS solution were administered with polyethylene (P.E) tube inserted to rats intracolon, which causing colitis to the rats. The acetic acid and TNBS control group (the saline treated colitic rat) exhibited ulceration and inflammation of the distal colon with formation of granuloma and pathologic connections. We checked the inflammatory parameters like rat’s weight, food intake quantity change during administration. After 5 days, we sacrificed the rats and checked the colon’s length, ulcer and pathologic condition. Oral treatment with SHI-1909 resulted in significant recovery of macroscopic parameters like weight and diet intake change. Especially, SHI-1909 had a more potent effect than prednisolone on macroscopic colonic damage score. We can suggest that SHI-1909 could be a promising drug in the treatment of IBD.

수용성 약물인 세파클로를 함유하는 젤라틴 마이크로캅셀의 제조 및 약물 방출특성

조성완(Seong Wan Cho),박종화(Jong Hwa Park),박준상(Jun Sang Park),장정수(Joung Soo Jang),최영욱(Young Wook Choi) 대한약학회 1997 약학회지 Vol.41 No.1

In order to formulate a controlled release system for oral drug delivery, the microcapsules were prepared in w/o emulsion containing cefaclor as a water-soluble model drug by the method of interfacial polycondensation. Gelatin wis selected as a suitable polymer for interfacial polycondensation. Gelatin solution containing drug was emulsified in an organic phase under mechanical stirring. After emulsification, terephthaloyl chloride was added as cross linking agent, followed by mechanical stirring, washing and drying. Physical characteristics of microcapsules were investigated by optical microscopy, scanning electron microscopy and particle size analysis. Mean particle sizes of gelatin microcapsules were, in the range, of about 20~50mcm. The microcapsules were in good apperance with spherical shapes before washing, but were destroyed partially after washing and drying, even though some microcapsules were still maintained in their shapes. Contents of cefaclor in the microcapsules were calculated by UV spectrophotometry after 3 days extraction with pH 4 carbonate buffer solution. The effects of cross linking time. pH. concentration of cross-linking agent, and temperature on drug release kinetics have been discussed extensively.

액상 콜린알포세레이트의 고형 제제화 연구

최성업(Choi, Sung-Up),조성완(Cho, Seong-Wan) 한국산학기술학회 2013 한국산학기술학회논문지 Vol.14 No.12

본 연구에서는 액상 형태인 콜린알포세레이트를 알루미늄마그네슘규산화합물에 흡착시켜 고형의 제형화가 가능한 콜린알포세레이트를 함유하는 정제의 제조하고 평가하였다. 정제는 콜린알포세레이트 대비 흡착제의 비율을 달리하여 제조하고, 물리적 특성 및 용출률을 조사하였다. 정제의 타정성과 용출률을 고려할 때 흡착제는 주성분 대 비 50∼75%가 적절하였다. 주성분 대비 62.5%의 흡착제를 사용한 제제에서 정제의 경도, 붕해, 마손도 시험, 용출곡 선하면적 비율 결과가 가장 우수하였다. 알루미늄마스네슘규산화합물은 액상 약물의 고형화 설계 시 좋은 소재가 될 수 있을 것이다. The aim of this study was to prepare and evaluate tablets containing liquid choline alphoscerate, which is capable of being formulated as a solid dosage form by the adsorption of magnesium aluminum silicate. The tablets were prepared with various absorbent to choine alphoscerate ratios. The physical properties and the dissolution rate were investigated. Considering the tabletting and dissolution rate, the formula scontaining 50-75% absorbent were adequate in the tested formulations. The 62.5% absorbent formula showed superior results with the tests of hardness, friability, disintegration time, and the ratio of dissolution area under the curve. Overall, magnesium aluminum silicate can be an alternative additive to a liquid drug.

코지산을 함유한 폴록사머 겔 제제의 약물방출 및 피부자극성

박은우(Eun Woo Park),조성완(Seong Wan Cho),김동섭(Dong Sup Kim),최기환(Ki Hwan Choi),최영욱(Young Wook Choi) 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.3

N/A Low toxicity, reverse thermal gelation and high drug loading capabilities suggest that poloxamer 407 gels have great potential as a topical drug delivery system. Kojic acid (KA) is an antimelanogenic agent which has been widely used in cosmetics to whiten the skin color. However, it has the drawbacks of skin irritancy due to its acidic pH. Poloxamer gels of different polymer contents were formulated to overcome the problem and compared to the cream type formulations of either w/o/w multiple emulsion cream or o/w type emulsion cream. Using Franz diffusion cells mounted with a synthetic cellulose membrane (MWCO 12.000), drug release characteristics of the formulations were evaluated by the HPLC assay of KA concentration in the receptor compartment of pH 7.4 phosphate buffered saline solutions. Drug release from w/o/w multiple emulsion cream was controlled by oil membrane, showing the apparent zero order release kinetics. The KA release from the poloxamer gels was also controlled by the gel matrix, showing that drug release increased linearly as KA contents increase, but decreased exponentially as the polymer contents increase. In the skin irritancy test, the primary irritancy index(PII) of poloxamer gel base was lower than those of multiple emulsion cream base and o/w cream. Depending on KA contents or polymer contents in the gel, PII values in poloxamer gels were ranged from 1.3 to 2.0, which are interpreted as low or negligible irritation on skin. There was a good correlation between the log value of flux in drug release and PII value in skin irritation. It was possible to conclude that the poloxamer gels containing KA might be a good candidate for an antimelanogenic topical delivery system by virtue of the controlled release of the drug and the reduced skin irritancy.

폴리락티드 - 글리콜리드 마이크로피어에 봉입된 단백질의 항원성 평가

송세현(Seh Hyon Song),조성완(Seong Wan Cho),신택환(Taek Hwan Shin),윤미경(Mi Kyoung Yoon),최영욱(Young Wook Choi) 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.3

N/A Biodegradable polymeric microspheres were studied for their usefulness as carriers for the delivery of vaccine antigens. However, protein antigen could be denatured during microencapsulation processes due to the exposure to the organic phase and stress condition of cavitation and shear force. Therefore this study was carried out to re-evaluate the degree of protein denaturation during microencapsulation with poly(lactide-co-glycolide) (PLGA) copolymer. PLGA microspheres containing ovalbumin (OVA), prepared by W/O/W multiple emulsification method, were suspended in pH 7.4 PBS and incubated with shaking at 37.5℃. Drug released medium was collected periodically and analyzed for protein contents by micro-BCA protein assay. In order to evaluate the protein integrity, release medium was subjected to the analyses of SDSPAGE and size exclusion chromatography (SEC). And enzyme-linked immunosorbent assay (ELISA) was introduced to measure the immunoreactivity of entrapped OVA and to get an insight into the three-dimensional structure of epitope. The structures of entrapped protein were not affected significantly by the results of SDS-PAGE and SEC. However, immunoreactivity of released antigen was varied, revealing the possibility of protein denaturation in some microspheres when it was evaluate by ELISA method. Therefore, in order to express the degree of protein denaturation, antigenicity ratio (AR) was obtained as follows: amount of immunoreactivity of OVA/total amount of OVA released × 100(%). ELISA method was an efficient tool to detect a protein denaturation during microencapsulation and the comparison of AR values resulted in more accurate evaluation for immunoreactivity of entrapped protein.

SMEDDS를 이용한 naproxen의 용출률 개선 및 in vivo 효능 평가

변재혁(Jae-Hyuk Byun),조성완(Seong-Wan Cho) 한국산업기술융합학회(구. 산업기술교육훈련학회) 2024 산업기술연구논문지 (JITR) Vol.29 No.1

Naproxen은 비스테로이드성 진통소염제로, 통증, 염증, 해열제로서 사용되고 있다. 반감기가 길어서 효능이 오래 지속되어 환자들의 만족도가 높지만 용해도가 매우 낮다(in water 15.9mg/L). 용해도와 용출률을 높이기 위해 self-microemulsifying delivery system (SMEDDS)을 이용하여 가용화 시켰다. 주로 사용된 oil은 Labrasol ® 이고, 계면활성제로는 Labrafil ® M1944, Cremophor ® RH-40을 사용하였다. 선택한 oil과 계면활성제의 비율을 상평형도로 용해도가 좋은 영역을 도출하였다. 그 다음 적용 가능한 범위 내에서 효능을 확인하였다. 본 실험에서 만든 SMEDDS 로 naproxen을 가용화한 제제는, naproxen에 염을 붙인 정제 제품보다 용출률이 높았고, naproxen emulsion이 봉입된 연질캅셀 제품보다 위염 동물모델에서 위염 개선 능력 또한 뛰어난 것을 확인하였다. 본 연구 에서 naproxen의 SMEDDS의 적절한 oil과 비율을 제시하고, 효능, 용출률 및 안정성을 확인함으로써, 앞으로 naproxen 연구 및 제조의 방향성에 도움을 줄 것이다. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) administered to reduce pain, inflammation, and fever. The extended half-life of naproxen enables prolonged efficacy, leading to symptom relief and high patient satisfaction. However, naproxen has notably low solubility in water (15.9 mg/L). The present study aimed to enhance the solubility and dissolution rate of naproxen by using a self-microemulsifying delivery system (SMEDDS). Labrasol® was used as the primary oil and Labrafil® M1944 and Cremophor® RH-40 as the surfactants in the SMEDDS. The ratio of the selected oil to the surfactant was determined to identify the equilibrium range with good solubility. Subsequently, the efficacy was confirmed to be within the applicable range. The results indicated that the SMEDDS formulation showed higher dissolution rates than the salt-formulated purified naproxen product. Furthermore, the efficacy was compared with that of commercially available naproxen emulsion-filled soft gel capsules in an animal model of gastric ulcers, showing the excellent gastro-protective abilities of the naproxen SMEDDS. This study provides an appropriate oil and ratio for a naproxen SMEDDS, confirming it sefficacy, dissolution rate, and stability. These results will guide future directions in naproxen research and manufacturing.

2. 수용성 약물인 cefaclor 를 함유하는 확산제어형 지속성제제의 설계

박준상(Jun Sang Park),조성완(Seong Wan Cho),유성운(Seong Un Yu),석창현(Chang Hyun Suk),최영욱(Young Wook Choi) 한국약제학회 1996 한국약제학회 총회 및 학술대회 요지집 Vol.- No.26

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