• Title/Summary/Keyword: pharmacy law

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Spectrophotometric Determination of Reducing Drugs (Ascorbic Acid, Potassium Antimonyl Tartrate, Isonicotinic Acid Hydrazide) with $Bis(2,4-diaminophenyl)phosphonate-KIO_3$ ($Bis(2,4-diaminophenyl)phosphonate-KIO_3$에 의한 환원성의약품(Ascorbic Acid, Potassium Antimonyl Tartrate, Isonicotinic Acid Hydrazide)의 분광광도정량)

  • Suh, Jung-Hyun;Kam, Sang-Kyu
    • YAKHAK HOEJI
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    • v.34 no.1
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    • pp.22-33
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    • 1990
  • Aqueous solution of bis(2,4-diaminophenyl)phosphonate(APP) was very stable, especially below pH 2.0 and the red-color compound formed by the reaction of APP and $IO_3-$ was stable at room temperature. A simple and rapid spectrophotometric method for the determination of ascorbic acid, potassium antimonyl tartrate (PAT), and isonicotinic acid hydrazide (INAH) was established by the reaction of $IO_3-$ and these reducing drugs, and the absorbance measurements were made at 500 nm. In the reaction of $IO_3-$ and each of the reducing drugs, the conditions of pH were suitable below 2.5 for ascorbic acid, below 2.0 for PAT, and below 1.5 for INAH. Beer's law did hold in the range of $17.6{\sim}1549.9\;ug$ for ascorbic acid, $33.4{\sim}2871.8{\mu}g$ for PAT,and $6.9{\sim}548.6\;{\mu}g$ for INAH. Many common ingredients present in pharmaceutical dosage forms did not interfere. The average recoveries for ascorbic acid and INAH in pharmaceutical formulations were 99.8 $-100.3\;{\pm}\;0.2{\sim}0.4%$, $99.8\;{\pm}\;0.3%$, respectively.

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Comparative Analysis on The Great Three Books of Oriental Medicines (한의약학(韓醫藥學)의 삼대원전(三大原典)에 대한 비교 분석)

  • Choi, Myung-Sook;Yim, Dong-Sool;Lee, Sook-Yeon
    • Korean Journal of Pharmacognosy
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    • v.39 no.4
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    • pp.271-289
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    • 2008
  • In the Oriental Medicine field the great three reference books are Hwantienaekyung(黃帝內徑, HJNK), Sihnnongbonchokyung(神農本草經, BCK) and Shanghanlun(SHR). HJNK has been a theory book regarded as a bible of the Oriental Medicine, BCK, a herbal book with 365 species of red letters noticed from Bonchokyungjipjoo(本草經集註) and SHR, very important clinical book with concrete prescriptions for the therapy of patients. Though these books were written by Chinese people ca. 2000 years ago, yet they are no doubt very important and effective ones in these days. Unfortunately they are handed down to all transmitted books for a long times because original ones were destroyed by fire and another troubles. In this study we have tried to extract three common terminological words and common theories from the prescription law by theoretical principles(理法方藥, clinical therapeutic mechanism) acquired through the comparative analysis of these three books. They are qi(氣), cold or heat(寒熱) and yin & yang(陰陽), and their practical basic theories have been evidenced through exterior & interior of body(表裏) and deficiency or exessiveness(虛實) by the heat of Sun. Also we would have realized that Oriental Medicine should be analyzed through various scientific techniques and clinical experiences, and necessarily unified to yin & yang monism from qi theory of the Sun in all human's life cycle(生老病死).

Normalization and Search of the UV/VIS Spectra Measured from TLC/HPTLC (TLC/HPTLC에서 측정된 자외/가시부 스펙트럼의 표준화 및 검색)

  • Kang, Jong-Seong
    • YAKHAK HOEJI
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    • v.38 no.4
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    • pp.366-371
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    • 1994
  • To improve the identification power of TLC/HPTLC the in situ reflectance spectra obtained directly from plates with commercial scanner are used. The spectrum normalization should be carried out prior to comparing and searching the spectra from library for the identification of compounds. Because the reflectance does not obey the Lambert-Beer's law, there arise some problems in normalization. These problems could be solved to some extent by normalizing the spectra with regression methods. The spectra are manipulated with the regression function of a curve obtained from the correlation plot. When the parabola was used as the manipulating function, the spectra were identified with the accuracy of 97% and this result was better than that of conventionally used the point and area normalization method.

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Opportunistic Insights into Occupational Health Hazards Associated with Waterpipe Tobacco Smoking Premises in the United Kingdom

  • Al-Bakri, Ali;Jawad, Mohammed;Salameh, Pascale;al'Absi, Mustafa;Kassim, Saba
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.2
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    • pp.621-626
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    • 2015
  • Background: Smokefree laws aim to protect employees and the public from the dangers of secondhand smoke. Waterpipe premises have significantly increased in number in the last decade, with anecdotal reports of poor compliance with the smokefree law. The literature is bereft of information pertaining to waterpipe premise employees. This study aimed to opportunistically gather knowledge about the occupational health hazards associated with working in waterpipe premises in London, England. Materials and Methods: Employees from seven convenience-sampled, smokefree-compliant waterpipe premises in London were observed for occupational activities. Opportunistic carbon monoxide (CO) measurements were made among those with whom a rapport had developed. Observations were thematically coded and analysed. Results: Occupational hazards mainly included environmental smoke exposure. Waterpipe-serving employees were required to draw several puffs soon after igniting the coals, thereby providing quality assurance of the product. Median CO levels were 27.5ppm (range 21-55ppm) among these employees. Self-reported employee health was poor, with some suggestion that working patterns and smoke exposure was a contributory factor. Conclusions: The smokefree law in England does not appear to protect waterpipe premise employees from high levels of CO. Continued concerns surrounding chronic smoke exposure may contribute to poor self-reported physical and mental wellbeing.

How to establish the definition of Conventional medicine and Korean herbal medicine? (한약과 양약의 개념 설정 어떻게 할 것인가?)

  • Yin, Chang Shik;Lee, Seung-Woo;Kim, Yun-Kyung
    • Herbal Formula Science
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    • v.20 no.2
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    • pp.187-197
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    • 2012
  • Objectives : The purpose of this study is to find a reasonable solution to a current status of drug classification between the drugs of western conventional (allopathic) medicine and Korean medicine. A clear and distinct concept on the drugs of allopathic medicine and Korean medicine based on reasonable concepts and broad consensus is a pressing issue in Korea, and will facilitate the development of herbal medicinal products and pharmaceutical industry. Methods : Considering the issue of drug classification from domestic and international regulations, we reviewed the current Drug Law of Korea and China, Guidance for Industry, Botanical Drug Products of USA, Directive 2004/24/EC of the European parliament and of the council. Results : In Korea, the drug classification of allopathic medicine and Korean medicine is quite vague even though differential licensure system is enforced for the clinicians of allopathic medicine and Korean medicine field. According to the definition in the Drug Law, the scope of Korean medicine drug is so broad that even a drug made of single-compound material, as well as herbal extract of crude mixture, is regarded as a drug of Korean medicine, as long as the material may be separated from medicinal herbs, animal tissues, or mineral resources. Only new compound not found in natural resources are outside of the scope of Korean medicine drug. In USA and EU, medicinal products manufactured from herbs are approved by separate regulations for the herbs with special waivers. In China, the category of new medicine and the definition of allopathic medicine and traditional chinese medicine are clearly specified and classified. Conclusions : As medicines are validated therapeutic materials for efficacy and toxicity, we suggest that generally the concept of conventional medicines is based on a single compound that has been synthesized and individually validated and that of Korean medicines is based on a compound extracted from natural materials or a complex of compounds that has been validated as a whole in its totality.

Estimation of Physical-Chemical Property and Environmental Fate of Benzoyl peroxide Using (Q)SAR

  • Kim, Mi-Kyoung;Kim, Su-Hyon;Heekyung Bae;Sanghwan Song;Hyunju Koo;Jeon, Seong-Hwan;Na, Jin-Gyun;Park, Kwangsik;Lee, Moon-Soon
    • Proceedings of the Korea Society of Environmental Toocicology Conference
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    • 2002.10a
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    • pp.154-154
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    • 2002
  • Benzoyl peroxide is a High Production Volume Chemical, which is produced about 1,375 tons/year in Korea as of 2001 survey. The substance is mainly used as initiators in polymerization, catalysts in the plastics industry, bleaching agents for flour and medication for acne vulgaris. The substance is one of seven chemicals of which human health and environmental risks are being assessed by National Institute of Environmental Research (NIER) under the frame of OECD SIDS Program. In this study, Quantitative Structure-Activity Relationships (QSAR) is used for getting adequate information on the physical-chemical property and the environmental fate of this chemical. For the assessment of benzoyl peroxide, models such as MPBPWIN for vapor pressure, KOWWIN for octanol/water partition coefficient, HENRYWIN for Henry's Law constant, AOPWIN for photolysis and BCFWN for bioconcentration factor (BCF) were used. These (Q)SAR model programmes were worked by using the SHILES (Simplified Molecular Input Line Entry System) notations. The physical-chemical properties and the environmental fate of benzoyl peroxide were estimated as followed : vapor pressure =0.00929 Pa, Log Kow = 3.43, Henry's Law constant = 0.00000354 atm-㎥/mole at 25 $^{\circ}C$, the half-life of photodegradation = 3 days, bioconcentration factor (BCF) = 92

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The Meaning and the Legislative Suggestion about Data Manipulation of Pharmaceutical Companies in the Aspect of the Medicine Approval System (의약품 품목허가 제도에서 제약기업 자료조작의 의미와 입법 개선 방안-대법원 2008. 11. 13. 선고 2008두8628 판결을 중심으로-)

  • Park, Sungmin;Shin, Youngkee
    • The Korean Society of Law and Medicine
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    • v.22 no.4
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    • pp.59-88
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    • 2021
  • The National Assembly of the Republic of Korea recently enacted laws to fortify sanctions about data manipulation of pharmaceutical companies. The medicine approval system is the result of legislative efforts to prevent accidents that caused damages to patients' life and health. The medicine approval system is based on the trust that the data submitted by pharmaceutical companies is not manipulated. The Supreme Court of Korea clarified that strict standard shoud be required to secure the medicine safety in Supreme Court Decision 2008Du8628 decided November 13, 2008. We agree. This paper suggest legislation to weaken the economic incentives for pharmaceutical companies to choose data manipulation by minimizing the expected profit. In addition to revoking the marketing authorization of the medicine, the 'unfair' profits the pharmaceutical company has earned must be recovered. In addition, in order to increase the possibility to discover data manipulation, it is necessary to strengthen the review capacity and to activate the whistle-blowing.

Effective Components of Bovine Colostrum and Its Applications (소 초유의 유효성분과 산업적 활용)

  • Seo, Sang-Ah;Seo, Hye-Ryoung;Heo, Young-Tae
    • Journal of Embryo Transfer
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    • v.33 no.3
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    • pp.159-168
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    • 2018
  • Bovine colostrum is necessary for newborn calves to survive, grow and receive immunity from their mother. Cows in Korea produce about 35kg of colostrum, 4Kg of which is fed to the calf, and the rest is discarded. The bovine colostrum causes the harmful side effects to human, such as allergies and digestive problems; so, it is prohibited by law to consume colostrum itself as a food. However, many scientific research data have suggested that components in the colostrum can improve human health and has the ability to help treat diseases. In line with the trend of food and pharmacy industries using natural product materials, which attract positive attention, recently, some ingredients in colostrum have been used in the production of food supplements, and it has been used in its raw form in some cosmetics. This review introduces the active ingredients and physiologically active substances contained in bovine colostrum, summarizes the efficacy of physiological enhancement of the colostrum, which has been proven by scientific methods to date, and also suggests the possibility of industrial applications of colostrum as an animal-derived natural material.

A Study on Improving Korea's Regulatory System for Pharmaceutical Safety Management (의약품 안전성 관리를 위한 연구 - 의약품 안전관리 제도개선 방안을 중심으로 -)

  • Chae, Gyu Han;Cho, Gi Won;Nagata, Ryuji;Park, Ji Sun;Hong, Chong Hui;Kang, Jong Seong
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.173-186
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    • 2013
  • To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

A Proposal to Change Welfare Policy Principles for Agent Orange Exposed Korean Veterans (고엽제 피해자에 대한 국가 보상 현황 및 보훈 정책 원리 수정 제안)

  • Chung, Injae
    • Journal of Environmental Health Sciences
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    • v.40 no.2
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    • pp.157-170
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    • 2014
  • Objectives: Agent Orange TCDD has been related to serious diseases among Korean veterans who were exposed to it. Decades after the end of the war, however, its effects are still being debated. The object of this study was to examine various unmet needs raised among Agent Orange exposed veterans and their families and to find grounds of a new welfare policy for providing alternative legislation. Methods: Literatures concerning Agent Orange, TCDD, the associated diseases, compensation for veterans and Supreme Court sentencing were searched using PubMed, ProQuest, press news and relevant homepages. Results: Agent Orange exposed veterans are eligible for various benefits from the government, including disability compensation for diseases associated with exposure. The Ministry of Patriots and Veterans Affairs has classified certain diseases into two categories, Agent Orange sequela diseases and sequela suspect diseases and has provided differential benefits based on separated laws. Big differences exist in benefits to veterans and their families between the two laws. The absence of definite standards to classify the Agent Orange associated diseases was confirmed by recent Supreme Court sentencing which ruled in favor of US manufacturers. Conclusion: It appears that the evidence for cause and effect of Agent Orange related diseases would never be perfect. The results suggest a need to change welfare principles from presumptive or indefinite disease basis to exposure experiences combined with integrated disability evaluation. We propose to extend eligibility by enacting a new law for Agent Orange exposed Korean veterans.