• 한국문헌정보학회지
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• 제43권3호
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• pp.355-377
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• 2009

공공기록관리 혁신의 일환으로 표준화 정책이 수립된 이후 지난 4년간 기록관리 전 영역에 걸쳐 55개의 표준화 과제가 추진되었다. 이 연구는 그동안 추진된 기록관리 표준화 정책과 추진내용을 평가하여 중장기 표준화 전략 재구축에 시사점을 제공하고자 한다. 평가는 표준화 관련 정책 문서와 중앙행정기관 기록관리 실무자들과의 면담을 기반으로 수행하였다. 표준화 대상 선정의 적절성, 표준의 질적 수준, 표준화 절차, 표준화 정책 등 4개 영역으로 범주화하여 평가 기준을 설정하고 이에 따라 정성적 평가를 실시하였다.

• Journal of Pharmaceutical Investigation
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• 제34권5호
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• pp.427-433
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• 2004

With the Sunshine policy, exchange of materials and cultures inter Koreas has been broadened and expectancy of reunification is getting higher. Especially, medical supplies and medicines are one of the biggest parts in the exchange goods. So, preparing an unified official drug standard preparing new medical administration system is required. We compared the Korean pharmacopoeia with North Korean Pharmacopoeia. Two pharmacopoeias have been developed in different direction and have many differences in the nomenclature and format. In this study, we compared general notices, general rules for preparations and crude drugs, monographs, general tests, processes and apparatus.

• Journal of Ginseng Research
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• 제46권2호
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• pp.255-265
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• 2022

Background: Ginsenoside Rb1, a bioactive component isolated from the Panax ginseng, acts as a remedy to prevent myocardial injury. However, it is obscure whether the cardioprotective functions of Rb1 are related to the regulation of endogenous metabolites, and its potential molecular mechanism still needs further clarification, especially from a comprehensive metabolomics profiling perspective. Methods: The mice model of acute myocardial ischemia (AMI) and oxygen glucose deprivation (OGD)-induced cardiomyocytes injury were applied to explore the protective effect and mechanism of Rb1. Meanwhile, the comprehensive metabolomics profiling was conducted by high-performance liquid chromatography and quadrupole time-of-flight mass spectrometry (HPLC-Q/TOF-MS) and a tandem liquid chromatography and mass spectrometry (LC-MS). Results: Rb1 treatment profoundly reduced the infarct size and attenuated myocardial injury. The metabolic network map of 65 differential endogenous metabolites was constructed and provided a new inspiration for the treatment of AMI by Rb1, which was mainly associated with mitophagy. In vivo and in vitro experiments, Rb1 was found to improve mitochondrial morphology, mitochondrial function and promote mitophagy. Interestingly, the mitophagy inhibitor partly attenuated the cardioprotective effect of Rb1. Additionally, Rb1 markedly facilitated the phosphorylation of AMP-activated protein kinase α (AMPKα), and AMPK inhibition partially weakened the role of Rb1 in promoting mitophagy. Conclusions: Ginsenoside Rb1 protects acute myocardial ischemia injury through promoting mitophagy via AMPKα phosphorylation, which might lay the foundation for the further application of Rb1 in cardiovascular diseases.

• Journal of Pharmaceutical Investigation
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• 제30권3호
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• pp.223-228
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• 2000

Testing the volume of injection in container is to ensure that the nominal content of a container can be administered to the patient. The method to test the volume of injection in container is described in European Pharmacopeia (EP) and United States Pharmacopeia (USP). However there is no method to test the volume of injection in Korean Pharmacopeia (KP). So we surveyed the method practiced by 53 pharmaceutical companies in Korea by a questionnaire and tested commercially available injections by discharged volume. As the result, we agreed with the International Conference on Harmonization (ICH) test method for discharged volume. It was suggested that the ICH test method for discharged volume of injection in container would be adopted.

• Journal of Pharmaceutical Investigation
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• 제33권1호
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• pp.67-71
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• 2003

Drug excipients are material used in the formulation of pharmacologically active drugs. They have a variety of roles including dilutents/fillers/bulking agents, binders/adhesives, propellant, disintegrants, lubricants/dlidants, colors, flavors, coating agents, polising agents, fragrance, sweeteening agent, polymers and waxes. Excipient should be inert or inactive and does not interfere with the test. Nowadays within industry there has been a recent surge of interest in novel excipient for novel dosage forms. The purpose of the review is to introduce the administration systems of drug excipient about kinds, matters to be attended to change of excipients.

• 대한한의학회지
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• 제37권3호
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• pp.97-111
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• 2016

Objectives: This study aims to investigate the policy status of traditional medicine standardization between Korea and China as well as to derive a strategic development plan for Korean medicine standardization. Methods: The existing national plans and preceding studies on traditional medicine standardization in Korea and China were reviewed, and scope of the study was categorized as having three main aspects: infrastructure; standard development and standardization activities; and application and diffusion. Results: Nine development plans for Korean medicine standardization derived under the study were as follows: With regard to infrastructure of standardization, 1) standardization plan of Korean medicine shall be established based on involvement of multi-government ministries. 2) It shall be set with a consistent cooperation process among standardization-related organizations, as well as 3) encourage the industry to participate in standardization activities. To activate standards development, 4) launching the R&D-standardization-industrialization linked project, 5) supporting Korean medicine society and the mirror committee for motivation, and 6) planning the international joint research for development of standard and expanding standardization activities are recommended. In the aspect of application, there is a need for 7) expanding certification systems for the industry and 8) evaluation and feedback on the life-cycle of standardization. Lastly, 9) educational programs for training experts of standardization shall be developed and implemented. Conclusions: In order to invigorate standardization activities for Korean medicine, enhancement of planning and evaluation capacity, ensuring the strategic development of standards, broadening boundaries of international standardization activities, and training professionals are required.

• 대한안전경영과학회:학술대회논문집
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• 대한안전경영과학회 2003년도 춘계학술대회
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• pp.115-120
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• 2003

The purpose of this study is to carry out comparative analysis of the differences between the trend of biometrics-related test St evaluation standardization in the world and that of Korea, and to suggest ideal directions and building plans for domestic biometrics industry. Its purpose also includes constructing promptly a standardization of domestics biometrics industry based on the suggested standards.

• Journal of Ginseng Research
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• 제42권3호
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• pp.270-276
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• 2018

Background: Notoginsenoside Ft1 is a promising potential candidate for cardiovascular and cancer disease therapy owing to its positive pharmacological activities. However, the yield of Ft1 is ultralow utilizing reported methods. Herein, an acid hydrolyzing strategy was implemented in the acquirement of rare notoginsenoside Ft1. Methods: Chemical profiles were identified by ultraperformance liquid chromatography coupled with quadruple-time-of-flight and electrospray ionization mass spectrometry (UPLC-Q/TOF-ESI-MS). The acid hydrolyzing dynamic changes of chemical compositions and the possible transformation pathways of saponins were monitored by ultrahigh-performance LC coupled with tandem MS (UHPLC-MS/ MS). Results and conclusion: Notoginsenoside Ft1 was epimerized from notoginsenoside ST4, which was generated through cleaving the carbohydrate side chains at C-20 of notoginsenosides Fa and Fc, and vinaginsenoside R7, and further converted to other compounds via hydroxylation at C-25 or hydrolysis of the carbohydrate side chains at C-3 under the acid conditions. High temperature contributed to the hydroxylation reaction at C-25 and 25% acetic acid concentration was conducive to the preparation of notoginsenoside Ft1. C-20 epimers of notoginsenoside Ft1 and ST4 were successfully separated utilizing solvent method of acetic acid solution. The theoretical preparation yield rate of notoginsenoside Ft1 was about 1.8%, which would be beneficial to further study on its bioactivities and clinical application.

• Journal of Pharmaceutical Investigation
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• 제32권4호
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• pp.331-337
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• 2002

Nonproprietary name may be used without restriction by the public at large and can be called common name, generic name. Nomenclature agencies exist in US, Great Britain, Japan and so on. The agencies maintain liaison with onε another in an effort to secure the wide adoption of thε most appropriate and universally acceptable designation for each drug. To prevent the confusion which arises when several nonproprietary names are used for a single drug, either in the same country or in several different countries, the WHO has assumed the responsibility of coordination existing nomenclature at the international level. In this study, the nomenclature for new drugs and the terminology to harmonize specifications for revision of Korean Pharmacopoeia (KP) were established.

• Journal of Pharmaceutical Investigation
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• 제39권2호
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• pp.127-131
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• 2009

Hydrogels for medical devices such as hydrophilic dressing, moisturizing healing band, hydrophilic intravenous catheter and soft contact lens were evaluated for their cytotoxicity according to the International Organization for Standardization (ISO) procedures. To test indirect cytotoxicity of hydrogel products, dissolution medium and dissolution condition were selected based on the guideline for medical devices. Cytotoxicity was low in all the case of hydrogel products. Soft contact lens showed no significant difference in dissolution between complete medium and saline. Currently, there is no specific guidelineto test hydrogel for medical devices in Korea with consideration of characteristics of hydrogel. Thus, proper method of cytotoxicity evaluation should be selected depending on the characteristics and usages of hydrogels for medical devices.