Kim, Il-Woung;Hong, Hee-Do;Choi, Sang-Yoon;Hwang, Da-Hye;Her, Youl;Kim, Si-Kwan
Journal of Ginseng Research
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v.35
no.4
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pp.487-496
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2011
Good manufacturing practice (GMP)-based quality control is an integral component of the common technical document, a formal documentation process for applying a marketing authorization holder to those countries where ginseng is classified as a medicine. In addition, authentication of the physico-chemical properties of ginsenoside reference materials, and qualitative and quantitative batch analytical data based on validated analytical procedures are prerequisites for certifying GMP. Therefore, the aim of this study was to propose an authentication process for isolated ginsenosides $Rb_1$ and $Rg_1$ as reference materials (RM) and for these compounds to be designated as RMs for ginseng preparations throughout the world. Ginsenoside $Rb_1$ and $Rg_1$ 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 the isolated ginsenosides was made according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantitation, and mass balance tests. The isolated ginsenosides were proven to be a single compound when analyzed by three different HPLC systems. Also, the water content was found to be 0.940% for $Rb_1$ and 0.485% for $Rg_1$, meaning that the net mass balance for ginsenoside $Rb_1$ and $Rg_1$ were 99.060% and 99.515%, respectively. From these results, we could assess and propose a full spectrum of physicochemical properties for the ginsenosides $Rb_1$ and $Rg_1$ as standard reference materials for GMP-based quality control.
Journal of Information Technology and Architecture
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v.9
no.4
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pp.423-432
/
2012
EA (Enterprise Architecture) is an SI (System Integration) approach, i.e., a comprehensive plan for SI, which shows the elements of SI and the relationships among them. Since EA can be utilized in every stages of SI, the more large-scaled and complicated SI projects are, the more important EA is. Although many central government agencies and wide local governments implemented EA, the current level of EA utilization is still low. One of the reasons is the low level of EA updating. Some reasons of the low level of EA updating are the low frequency of EA updating, and the shortage of workers, as well. In order to improve the frequency of EA updating and alleviate the workloads of SI officers, MLTM (Ministry of land, transport, and maritime affairs) standardized the processes and documents for SI projects, and implemented PMS (Project Management System) that can support the unifying management of SI projects and be connected with EA system. We expect that EA information are updated efficiently, the level of EA utilization is boosted, and the qualities of SI products are improved, by the implementation of the PMS connected with EA system.
This study analyzed an operational concept for the D Information Resource Management Information System (DIRMIS) to manage any IT resources effectively in defense area. We first deduced the concept of the information resource management (IRM) for defense area from the literature review, and we suggested a guideline, which has used in defense area, of the documentation for the operational concept description (OCD). Moreover, we developed the operational concept for the DIRMIS following the guideline. Especially, this study is a practical approach for suggesting of a case, and the share of accumulated cases will contribute to advance in System Integration (SI) industry as well as academic research.
Most publications on friction stir welding describe phenomena or results with given process parameters like feed rate, rotation speed, angle and depth of penetration. But without a complete documentation of tool design, the results under the same process parameters are completely different. For this purpose, the Institute of Cutting and Joining Manufacturing Processes (tff), University of Kassel investigated the influence of tool roughness on the friction stir welding process. Therefore a defined surface finish was produced by turning and die sinking. As basis of comparison the constant parameters were rotation speed, feed rate, tilt angle and a heel plunge depth. Sound butt-welds were produced in aluminium alloy 6082 (AlMgSi1) with 1.5 mm sheet thickness with a turned reference tool with a surface of $Ra=0.575{\mu}m$ in position controlled mode. The surfaces are manufactured from a very fine to a very rough structure, classified by the VDI-classes with differences in the arithmetical mean roughness. It can be demonstrated with the help of temperature measures, that less heat is generated at the surfaces of the shoulder and the pin by the higher roughness due to lower active friction contact surface. This can also be seen in the resulting wormhole defects.
Kim, Il-Woung;Sun, Won Suk;Yun, Bong-Sik;Kim, Na-Ri;Min, Dongsun;Kim, Si-Kwan
Journal of Ginseng Research
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v.37
no.1
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pp.124-134
/
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.
Proceedings of the Korean Powder Metallurgy Institute Conference
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2002.07a
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pp.25-37
/
2002
The most important industrial application of gamma radiation in characterizing green compacts is the determination of the density. Examples are given where this method is applied in manufacturing technical components in powder metallurgy. The requirements imposed by modern quality management systems and operation by the workforce in industrial production are described. The accuracy of measurement achieved with this method is demonstrated and a comparison is given with other test methods to measure the density. The advantages and limitations of gamma ray densitometry are outlined. The gamma ray densitometer measures the attenuation of gamma radiation penetrating the test parts (Fig. 1). As the capability of compacts to absorb this type of radiation depends on their density, the attenuation of gamma radiation can serve as a measure of the density. The volume of the part being tested is defined by the size of the aperture screeniing out the radiation. It is a channel with the cross section of the aperture whose length is the height of the test part. The intensity of the radiation identified by the detector is the quantity used to determine the material density. Gamma ray densitometry can equally be performed on green compacts as well as on sintered components. Neither special preparation of test parts nor skilled personnel is required to perform the measurement; neither liquids nor other harmful substances are involved. When parts are exhibiting local density variations, which is normally the case in powder compaction, sectional densities can be determined in different parts of the sample without cutting it into pieces. The test is non-destructive, i.e. the parts can still be used after the measurement and do not have to be scrapped. The measurement is controlled by a special PC based software. All results are available for further processing by in-house quality documentation and supervision of measurements. Tool setting for multi-level components can be much improved by using this test method. When a densitometer is installed on the press shop floor, it can be operated by the tool setter himself. Then he can return to the press and immediately implement the corrections. Transfer of sample parts to the lab for density testing can be eliminated and results for the correction of tool settings are more readily available. This helps to reduce the time required for tool setting and clearly improves the productivity of powder presses. The range of materials where this method can be successfully applied covers almost the entire periodic system of the elements. It reaches from the light elements such as graphite via light metals (AI, Mg, Li, Ti) and their alloys, ceramics ($AI_20_3$, SiC, Si_3N_4, $Zr0_2$, ...), magnetic materials (hard and soft ferrites, AlNiCo, Nd-Fe-B, ...), metals including iron and alloy steels, Cu, Ni and Co based alloys to refractory and heavy metals (W, Mo, ...) as well as hardmetals. The gamma radiation required for the measurement is generated by radioactive sources which are produced by nuclear technology. These nuclear materials are safely encapsulated in stainless steel capsules so that no radioactive material can escape from the protective shielding container. The gamma ray densitometer is subject to the strict regulations for the use of radioactive materials. The radiation shield is so effective that there is no elevation of the natural radiation level outside the instrument. Personal dosimetry by the operating personnel is not required. Even in case of malfunction, loss of power and incorrect operation, the escape of gamma radiation from the instrument is positively prevented.
Seo, Young-Jin;Song, Si Young;Kim, In Sung;Ahn, Jung Tae;Yoo, Yon-Sik
Journal of the Korean Arthroscopy Society
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v.15
no.2
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pp.99-107
/
2011
Purpose: The purpose of this study was to investigate the clinical results after a anatomical double bundle ACL reconstruction using a longitudinally split tibialis anterior allograft. Materials and Methods: We evaluated 24 patients with a minimum follow-up of 12 months who had undergone anatomical double bundle ACL reconstructions. The grafts utilized in all cases were tibialis anterior allografts which were longitudinally split into two strands. A standard rehabilitation protocol was applied in all patients. The pre- and post-operative data including Lysholm scores, International Knee Documentation Committee (IKDC) scores, Lachman test, pivot shift test and the side-to-side differences of anterior laxity measured by KT-2000 arthrometer were analyzed by use of a statistical method Results: The mean side-to-side instrumented laxity measured by the KT-2000 arthrometer significantly improved to a mean of $1.04{\pm}0.80\;mm$ (P < 0.001). The Lysholm knee scores also improved from $58.34{\pm}15.32$ to $86.25{\pm}6.48$ after surgery (P < 0.001). The patients exhibited improved IKDC scores (A: 15 cases, B; 9 cases) at the final follow-up, compared to preoperative scores (B: 5, C: 10, D: 9). Conclusion: Our data demonstrated that clinical results of anatomical double bundle ACL reconstruction with a split tibialis anterior allograft are encouraging with excellent side-to side laxity, significantly improved Lysholm knee score, IKDC score, Lachman and pivot shift data.
Journal of Korean Society of Archives and Records Management
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v.3
no.1
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pp.69-92
/
2003
Registration and description of records are important elements of processing which provide with the background information of production of records and business-related information. They also enable to search and use the records. In this paper, I examined the Korean registration and description system defined in the Public Records Management Act which directs the records creating agency to register records in creating offices and directs the "professional archives" to make "basic registrations" and "detailed registrations" of the records. In the analysis and comparison of two different registration and description systems with the known international standards of records and archives management, such as ISO15489 and ISAD(G), I intended to evaluate the Korean records and archives management system and suggested recommendations for the renovation of the Korean recordskeeping system. Despite we have unique office business procedures and the culture of officialdom, and despite we have developed our system based on the established business procedures and office culture, it would be preferable to adopt or follow the international standards and established best practices. After the comparative analysis, I recommended some innovations in the filed of registration and description. For instance, in the basic registration. we would better to install an item of "simple contents summary." We may also need the multiple-level description. The fonds level description and the series level description should be introduced to our archival automated management system. We need to establish a Korean standard of description adopting the rules of the ISAD(G) and ISAAR(CPF). Essential requirements for electronic records management, such as contextual and structural information, should be incorporated in the new standard. Documentation of records disposition also should be reinforced to guarantee the authenticity of records and to ensure control of the records. To implement the recommendations for the standard, we need to amend the Public Records Management Act and its Regulations and Rules. Also it is imperative to redesign the GARS integrated archival automated management system.
Chung, Hyun-Min;Seo, Young-Jin;Song, Si Young;Cha, Myoungsoo
Journal of the Korean Orthopaedic Association
/
v.54
no.6
/
pp.537-546
/
2019
Purpose: Anteromedial (AM), posterolateral (PL), anterior, and posterior remnant preserving anterior cruciate ligament (ACL) reconstructions were conducted on patients with partial ACL tears based on the arthroscopic findings. The clinical results of the four groups were compared. Materials and Methods: This study included 98 patients who underwent a remnant preserving ACL reconstruction from January 2013 to June 2016 and could be followed-up for at least two years. The subjects were categorized into four groups according to the selective bundles reconstructed: group A, anteromedial selective bundle reconstruction; group B, posterolateral selective bundle reconstruction; group C, anterior bundle reconstruction; and group D, posterior bundle reconstruction. The preoperative and postoperative anterior translation from the stress X-ray, International Knee Documentation Committee Subjective Knee Form (IKDC SKF) score, Lysholm score, and hospital for special surgery (HSS) score were compared. Results: All four groups showed significant improvement in anterior translation on the stress X-ray conducted with knees at 15° flexion, IKDC SKF score, Lysholm score, and HSS score postoperatively (in all groups, p<0.001). No intergroup differences were observed in terms of the functional outcomes except that preoperative IKDC SKF score was higher in the C group than in the A group (p=0.021), and the preoperative Lysholm score was higher in the B group than in the A group (p=0.03). Conclusion: After the AM, PL, anterior, and posterior remnant preserving ACL reconstructions, all four groups showed satisfactory results in terms of the anteroposterior stability and functional knee scores with no significant intergroup differences.
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