• Journal of Ginseng Research
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• 제37권1호
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• pp.124-134
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• 2013

The authentication of the physico-chemical properties of ginsenosides reference materials as well as qualitative and quantitative batch analytical data based on validated analytical procedures is a prerequisite for certifying good manufacturing practice (GMP). Ginsenoside Rb1 and Rg1, representing protopanaxadiol and protopanaxatriol ginsenosides, respectively, are accepted as marker substances in quality control standards worldwide. However, the current analytical methods for these two compounds recommended by Korean, Chinese, European, and Japanese pharmacopoeia do not apply to red ginseng preparations, particularly the extract, because of the relatively low content of the two agents in red ginseng compared to white ginseng. In manufacturing fresh ginseng into red ginseng products, ginseng roots are exposed to a high temperature for many hours, and the naturally occurring ginsenoside Rb1 and Rg1 are converted to artifact ginsenosides such as Rg3, Rg5, Rh1, and Rh2 during the heating process. The analysis of ginsenosides in commercially available ginseng products in Korea led us to propose the inclusion of the (20S)- and (20R)-ginsenoside Rg3, including ginsenoside Rb1 and Rg1, as additional reference materials for ginseng preparations. (20S)- and (20R)-ginsenoside Rg3 were isolated by Diaion HP-20 adsorption chromatography, silica gel flash chromatography, recrystallization, and preparative HPLC. HPLC fractions corresponding to those two ginsenosides were recrystallized in appropriate solvents for the analysis of physico-chemical properties. Documentation of those isolated ginsenosides was achieved according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantification, and mass balance tests. The isolated ginsenosides showed 100% purity when determined by the three HPLC systems. Also, the water content was found to be 0.534% for (20S)-Rg3 and 0.920% for (20R)-Rg3, meaning that the net mass balances for (20S)-Rg3 and (20R)-Rg3 were 99.466% and 99.080%, respectively. From these results, we could assess and propose a full spectrum of physico-chemical properties of (20S)- and (20R)-ginsenoside Rg3 as standard reference materials for GMP-based quality control.

• 한국응용과학기술학회지
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• 제25권4호
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• pp.539-555
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• 2008

It is well understood that developing new drugs is one of the highest value-added businesses in a country; however, the current governments' spending in pharmaceutical research and development(R&D) is minimal in Korea. This paper suggests that different governmental bodies should take in charge of different stages of the R&D process in order to maximize the use of limited government research funding. First, during the initial phase of the drug development, including clinical trials, the Ministry of Education, Science and Technology is the most appropriate governmental organization to support the research. For later procedures such as supporting the industries for exporting developed drugs, legislative approvals, and building infrastructure for future clinical trials should be supported by the Ministry of Knowledge and Economy and the Ministry of Health and Welfare along with the Korea Food and Drug Administration(KFDA). The KFDA, which is the main governmental agency approving newly developed drugs in the market, will need to take a crucial responsibility in the initial phase of the pharmaceutical R&D by guiding the industries with timely and proper information. As a first step, it is recommended to set up and operate a center for supporting new drugs, so that the industries can facilitate the development of marketable drugs which meet customers' needs. Later, in order to expedite the process of exporting and getting approvals of the newly developed drugs from foreign countries, it is necessary to develop new approval system, which includes introduction of the Good Manufacturing Practice (GMP), mandatory validation system, and education program for supporting expertise. Lastly, the KFDA needs to take an active role in developing Korean pharmaceutical industries by communicating with other foreign governments with regards to the globalization of the Korean pharmaceutical industries. For example, as a follow up after the Free Trade Agreement(FTA), active discussion on GLP of Mutual Recognition Agreement(MRA) with the United States of America, should be seriously considered.

• 대한한의학원전학회지
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• 제23권4호
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• pp.63-102
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• 2010

Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

• 한국식품위생안전성학회지
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• 제19권4호
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• pp.185-192
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• 2004

빵류 제품의 HACCP적용을 용이하게 하기 위해서는 HACCP 일반 모델 개발이 필요하다. 제빵 공정이 소성과정 중 제품의 내부온도가 $85^{\circ}C$ 이상 유지되어 호화되는 것을 감안하면 병원성 미생물의 사멸이 베이킹 중에 일어나므로 일반 위생관리가 안전성 확보를 위한 주된 타겟이 되며, 일반위생관리규정은 적정제조기준(GMP : Good manufacturing practice) 함께 HACCP 시스템을 적용하기 위한 보조 프로그램으로서 반드시 확립되고 관리되어야 할 프로그램이다. 이에 본 연구에서는 빵류 제품을 생산, 가공, 포장하여 시판하는 제빵업체에 HACCP시스템을 적용시키고자 빵류 제품을 대상으로 하여 생산 제품의 안전성 및 위생 상태를 미생물학적 방법을 평가하고, 원료의 공정에 따른 위생분석을 행하여 CCP및 CL을 결정하여 빵류제품의 HACCP일반 모델을 제시하였다. 이러한 일반위생관리기준과 HACCP일반모델은 빵류 제품의 안전성 확보 및 HACCP적용에 도움이 될 것으로 판단된다.