• Journal of Pharmaceutical Investigation
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• 제17권2호
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• pp.89-93
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• 1987

Effects of Ssang Wha Tang (SWT), a blended Chinese traditional medicine, on the pharmacokinetics of sulfobromophthalein (BSP) were studied in the rats. BSP was administered via portal vein to the control and the SWT-treated rats. The in vitro distribution of BSP to blood cells and the hemato-physiological conditions, liver weight, GOT. GPT activity were also examined. The systemic clearance $(CL_s)$ of BSP was increased with the administration of SWT, but no significant differences were observed in the liver weight and in vitro distribution of BSP to blood cells. These results suggest that the intrinsic clearance of free BSP of the liver is increased with the administration of SWT in the rats.

• 한국컴퓨터정보학회논문지
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• 제20권2호
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• pp.197-208
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• 2015

세계적으로 유통되고 있는 가짜의약품으로 인하여 제약사들은 판매수익과 기업브랜드 이미지에 큰 피해를 입고 있는 실정이고, 불법적으로 유통된 의약품이 복용 또는 투약된 환자(소비자)들은 생명에 위협을 받을 가능성이 점점 더 높아지고 있다. 이러한 가짜의약품의 유통을 근절시키기 위하여 세계 각국에서는 의약품의 생산에서부터 소비자에게 판매될 때까지 즉 의약품 유통과정을 추적하여 가시성있는 이력관리를 할 수 있도록 RFID 및 barcode 등 IT기반의 e-Pedigree(electronic pedigree)의 법제화 및 일련번호 관리제도를 도입하고 있다. 따라서, 본 연구에서는 국내 외 의약품 관리체계를 고찰하고 RFID 기반의 e-Pedigree 적용방안을 제시함으로써 국내 제약산업의 유통합리화와 이를 통한 소비자 안전성을 제고시키는데 그 목적이 있다.

• 한국생명과학회:학술대회논문집
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• 한국생명과학회 2006년도 제47회 학술심포지움 및 추계국제학술대회
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• pp.76.2-76.2
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• 2006

• Journal of Biosystems Engineering
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• 제40권4호
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• pp.394-408
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• 2015

Spectroscopy is an emerging technology for the quality assessment of pharmaceutical samples, from tablet manufacturing to final quality assurance. The traditional methods for the quality management of pharmaceutical tablets are time consuming and destructive, while spectroscopic techniques allow rapid analysis in a non-destructive manner. The advantage of spectroscopy is that it collects both spatial and spectral information (called hyperspectral imaging), which is useful for the chemical imaging of pharmaceutical samples. These chemical images provide both qualitative and quantitative information on tablet samples. In the pharmaceutics, spectroscopic techniques are used for a variety of applications, such as analysis of the homogeneity of powder samples as well as determination of particle size, product composition, and the concentration, uniformity, and distribution of the active pharmaceutical ingredient in solid tablets. This review paper presents an introduction to the applications of various spectroscopic techniques such as hyperspectroscopy and vibrational spectroscopies (Raman spectroscopy, FT-NIR, and IR spectroscopy) for the quality and safety assessment of pharmaceutical solid dosage forms. In addition, various chemometric techniques that are highly essential for analyzing the spectroscopic data of pharmaceutical samples are also reviewed.

• 한국해양바이오학회지
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• 제1권4호
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• pp.298-304
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• 2006

In this study, we establish a thin-layer chromatography (TLC) immunostaining method for detecting starfish gangliosides. A new monoclonal antibody (MAb) against AG-2, the major gangliosides molecular species of Acanthaster planci, was produced by fusing hybridoma with splenocytes immunized to liposomal AG-2. BALB/c male mice were injected with liposomal AG-2 antigen, and immunized. Their splenocytos were isolated and fused with hypoxanthine-aminopterine-thimidine (HAT)-sensitive mouse myeloma cells. Hybridomas producing MAb reactive to AG-2 were cloned using the limited dilution method. Established hybridomas were cultured in eRDF medium. Crude MAb produced from clone 8D4 was purified with a magnesium pyrophosphate column. Enzyme immunoassay and TLC immunostaining of AG-2 were performed using the purified MAb. Structurally related gangliosides did not cross-react with anti-AG-2 antibodies. The detection limit of TLC immunostaining was 50 ng of AG-2. The newly established immunostaining method was further developed for detecting AG-2 distribution and qualitative analysis in tissues and/or organs. Our results show that the majority of AG-2 is present in the stomach of male A. planci, while AG-2 is distributed not only in the stomach but also in the the pyloric caeca of female A. planci.

• 유통과학연구
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• 제6권2호
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• pp.41-60
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• 2008

본 연구는 국내 제약 산업의 현황과 유통시스템을 조사하였다. 본 연구에서는 국내 제약 산업 유통시스템의 문제점을 찾아내고 그에 따른 개선점도 동시에 제시하였다. 연구는 국내 제약 산업의 유통시스템을 개선하기 위해서 국내 제약 제조의 선도기업인 'J'기업의 10가지 유통시스템을 대상으로 조사하였으며 그에 따른 유통시스템의 개선점도 찾을 수 있었다. 본 연구는 'J'기업의 2008년 4월 1일부터 7월 31일까지의 내부 보고서를 중심으로 자료를 수집하였으며 또한 지속적인 담당자 면접을 통해 유통시스템의 문제를 밝혀냈다. 그 결과 의약공급 유통시스템의 문제점으로 첫째, 직접 판매 비즈니스의 부정적 효과를 가졌고 둘째, 생계유지형의 영세한 구조였다. 셋째, 도매유통이 넘쳐나고 불법적인 거래가 보편적이었다. 이러한 문제점을 극복하기 위해서는 다음과 같은 몇 가지 대안이 시급히 마련되어야 한다. 첫째, 도매유통시스템의 역할과 기능을 더욱 강화해야 하며 둘째, 도매유통시스템 관리자의 신중한 유통시스템의 재설계가 필요하다. 셋째, 상적 유통이 더 업그레이드(upgrade) 되어야 하며 넷째, 물적 유통 또한 추가적인 업그레이드가 필요하다. 마지막으로 의약공급 유통시스템 문제 해결을 위해서 투명하고 활동적인 정보시스템이 반드시 이루어져야 함을 제시한다.

• 보건행정학회지
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• 제21권1호
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• pp.132-157
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• 2011

The purpose of this article is to examine the cause of policy non-compliance in the case of pharmaceutical rebates from the perspective of rational choice institutionalism. In Korea, there have been rebates practices between pharmaceutical companies and hospitals since the introduction of the Actual Remuneration System for insured medicine in 1999. The government has chosen the policy means of punishment to eliminate pharmaceutical rebates but the illegal practices are still widespread. Institution in rational choice institutionalism usually reflects the incentives and preferences of actors, and the Actual Remuneration System has resulted in a the lack of procedures to ensure savings on drug expenditures. Pharmaceutical rebates are the product of the institutions which reflect their incentives: the Actual Remuneration System, the current pricing policy for generic drugs, the drug distribution system, and so on. In the end, the problem of the rebates is the consequence of policy non-compliance as actors' rational choice because their incentives lead to opportunistic behaviors. We should therefore understand the incentive structure of policy stakeholders, which is derived from the view of new institutionalism; also, the newly designed Korean drug pricing policy reform must be compatible with the incentive structure.

• Mycobiology
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• 제50권6호
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• pp.408-419
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• 2022

Filamentous fungi that could be classified into Aspergillus flavus/oryzae were isolated from traditionally fermented meju commercially available in Korea. The samples were analyzed for aflatoxin B1 and ochratoxin A contamination by HPLC; however, no toxin was detected. In addition, fungal and bacterial metagenomic sequencing were performed to analyze the microbial distribution in the samples. The results revealed that the distribution and abundance of fungi and bacteria differed considerably depending on the production regions and fermentation conditions of the meju samples. Through morphological analysis, ITS region sequencing, and assessment of the aflatoxin-producing ability, a total of 32 A. flavus/oryzae strains were identified. PCR analysis of six regions with a high mutation frequency in the aflatoxin gene cluster (AGC) revealed a total of six types of AGC breaking point patterns. The A. flavus/oryzae strains did not exhibit the high amylase activity detected in the commercial yellow koji strain (starter mold). However, their peptidase and lipase activities were generally higher than that of the koji isolates. We verified the safety of the traditionally fermented meju samples by analyzing the AGC breaking point pattern and the enzyme activities of A. flavus/oryzae strains isolated from the samples. The isolated strains could possibly be used as starter molds for soybean fermentation.

• International Journal of Human Ecology
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• 제12권2호
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• pp.1-12
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• 2011

Many pharmaceutical products are available through prescription (Rx) only status. As a result, access to physicians and insurance coverage play a key role in the use of these products, and therefore may affect the population to whom advertising is targeted at. The movement of pharmaceutical products from prescription (Rx) to Over-the-Counter (OTC), or Rx-to-OTC switch changes the cost of acquiring the drug and therefore may change the incentives manufacturers have at targeting particular population segments. This study examines whether Rx-to-OTC switch changes the frequency and the distribution of who is exposed to pharmaceutical advertising. Using an archive of pharmaceutical advertisements and National Consumer Survey, this study examines how individuals with particular demographic characteristics are exposed to pharmaceutical advertisements before and after drugs are moved from Rx to OTC. The results provide evidence that individual's advertising exposure increases after Rx-to-OTC switch. Moreover, the increase in advertising exposure is greater for the low socioeconomic status (SES) consumers which implies they may get more information about the disease, treatment and product after the Rx-to-OTC switch through advertising. If low SES consumers have more exposure to the advertising after products switched to OTC, then FDA policies regulating this switch should recognize the potential role of advertising providing access to health-related information.

• Journal of Pharmaceutical Investigation
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• 제32권1호
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• pp.41-45
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• 2002

The purpose of this study is to microencapsulate a highly hygroscopic drug, pyridostigmine bromide (PB), with a waterproof wall material, in order to increase the flowability of the drug particles. Polyvinylacetaldiethylaminoacetate (AEA), Eugragit E and Eugragit RS were examined as the wall materials. Microcapsules containing PB were prepared by the evaporation technique in an acetone/liquid paraffin system using aluminum tristearate as a core material, and evaluated for drug encapsulation efficiency, surface morphology, particle size and drug dissolution. The encapsulation of PB in the wall material was almost complete. Among the wall materials examined, AEA exhibited the most excellency in shape, surface texture, flowability, size distribution of microcapsules. Above results suggest that AEA would be a potential wall material for microcapsulation of highly hygroscopic drugs, such as PB. Through microencapsulation with AEA, inconvenience of handling of PB powders encountered in the process of weighing and packing the powders to tableting die or capsule body could be greatly improved.