• The Journal of Korean Medicine
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• v.21 no.2
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• pp.14-24
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• 2000

Objectives : To direct methods of management and development of herbs and their derived products, and at the end of this study to inform the process of making new herbal drug regulations in Korea. Methods : This study analyzed the regulations and laws of western medicine drugs. Results : We have got some herbal prescriptions which are not in the eleven books of oriental medicine now in use but which have proved effective. We need to establish standards for permissions to produce medical products through those prescriptions. Besides, we need the special permissions to produce herbal products through prescriptions, especially those which have been used to treat incurable diseases. And, we can contribute to globalization of oriental medicine and to well situating of herb products and medicinal acupunctures if we produce them according to international standards. It is thought that herbal medicine has no side effect in the medical society in Korea. But, it is getting popular to administer herbal medicine and western medicine together. Thus, the side effects of taking both medicines at the same time should be documented. Conclusions : Herbal medicines and herbal products should be under the control over the whole process of production, circulation, and sales. Now, it is time for herbal medicine to be known to all over the world. Therefore, herbal medicine must meet and adhere to the standards set by the western society and WHO.

• Journal of Pharmacopuncture
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• v.23 no.2
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• pp.54-61
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• 2020

Inflammation is an immune response of the human body but excessive inflammation is taken as a major factor in the development of many diseases including autoimmune disorders, cancer and nerve disorders etc. In this regards the need is to suppress the inflammatory response. Suppression of extra or imperfect inflammatory response is not a big deal provided there is an exact knowledge of particular target in the body. Recent advancements in Pharmacological aspect made the therapy with improved outcomes in number of patients. Anticytokine therapy might be one of the important and novel approaches for inflammation and Arthritis. This can be achieved only when we go through the pathophysiology of expression and identification of mediators. Let's take an example of cytokine like interleukins (IL), chemokines, interferons (INF), tumor necrosis factors (TNF-α), growth factors, and colony stimulating factors) release pathway which is a major signalling protein in inflammatory response. In the present study we have reviewed the recent pharmacological therapeutic advancement, inflammatory mediators, receptors, and major signalling pathways. Such information will not only provide the idea about the mechanism of action of Pharmaceuticals and molecular targets but also it provides a new aspect for drug designing and new corrective approaches in existing clinical medicines. This study will be a source of good information for the researchers working in the area of drug designing and molecular Pharmacology especially in anti-inflammatory and anti arthritic medicines for target based therapy.

• Proceedings of the Ginseng society Conference
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• 1990.06a
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• pp.29-35
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• 1990

Using an ethopharmacological technique, we demonstrated that saponin fraction from red ginseng root possessed a potent psychotropic actions on either intermale or maternal aggression models. A series of experiments clearly indicated that one of psychoactive ingredient is ginsenoside Rbl. Although a drug-induced debilitation of motor performance remains a possible cause of the antiaggressive effect of the drug, ginsenoside Rb 1 did not alter the locomotor activity of the mice during agonistic confrontations. Thus, one can eliminate the possibility that the psychoactive effect of ginsenoside Rbl might be concealed by a drugindulced impairment of motor performance. More recently, we developed a new model for copulatory disorder and introduced into the behavioral analysis of drug action. Male mice which has been housed individually from weaning for 5 weeks failed to manifest copulatory behavior when they encountered with the sexually-receptive females. Daily administration of crude ginseng saponin during isolation housing period prevented the development of copulatory disorder, whereas both ginsenoside Rbl and Rgl were ineffective. A further experiment may be needed to explore active ingredient of ginseng saponins. Keywords Panax ginseng, Korean red ginseng, psychotropic action, saponin, ginsenoside Rb1

• Biomolecules & Therapeutics
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• v.17 no.1
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• pp.1-11
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• 2009

Since the Committee for Proprietary Medicinal Products (CPMP) of the European Union issued in 1997 a "points to consider" document for the assessment of the potential for QT interval prolongation by non-cardiovascular agents to predict drug-induced torsades de pointes (TdP), the QT liability has become the critical safety issue in the development of pharmaceuticals. As TdP is usually linked to delayed cardiac repolarization, international guideline (ICH S7B) has advocated the standard repolarization assays such as in vitro IKr (hERG current) and in vivo QT interval, or in vitro APD (as a follow up) as the best biomarkers for predicting the TdP risk. However, the recent increasing evidence suggests that the currently used above biomarkers and/or assays are not fully predictive for TdP, but also does not address potential new druginduced TdP due to the selective disruption of hERG protein trafficking to the cell membrane or VT and/or VF with QT shortening. There is, therefore, an urgent need for other surrogate markers or assays that can predict the proarrhythmic potential of drug candidate. In this review, we provide an ideal pre-clinical strategy to predict the potentials of QT liability and lethal arrhythmia of the drug candidates with recent issues in this field in mind, not at the expense of discarding therapeutically innovative drugs.

• Design & Manufacturing
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• v.14 no.2
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• pp.1-6
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• 2020

Recently, research and commercialization related to the field of cell-based therapeutic drug development has been actively conducted. In order to maintain cell viability and prevent contamination, refrigeration preservation devices, such as CRF (controlled rate freezer) or vapor type LN2 tanks have been developed. On the other hand, the storage container for liquid nitrogen tanks currently on sale minimizes the flow structure to prevent structural defects when stored in a liquid nitrogen tank having a high thermal conductivity than vapor nitrogen. If the cell-based treatment drug is stored in the gaseous LN2 tank as it is, the cell survival after thawing is greatly reduced. It was estimated that the existing storage container structure was a factor that prevented the rapid entry and circulation of gaseous nitrogen into the container. Therefore, this study intends to propose a new supercellular storage container model that can maintain the mechanical strength while maximizing the fluid flow structure. To this end, we estimated that the structural change of the storage container effects on the equivalent stress formed around the through-holes of them when exposed to a cryogenic environment using thermal-structural coupled field analysis. As a result of storage experiments in the gas phase tank of the cell-based therapeutic agent using the developed storage container, it was confirmed that the cell growth rate was improved from 66% to 77%, which satisfied the transportation standards of the FDA(Food and Drug Administration) cell-based therapeutic agent.

• Journal of Pharmaceutical Investigation
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• v.37 no.6
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• pp.329-338
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• 2007

The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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• pp.373-386
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• 2022

Purpose: This study proposes the application of Six Sigma management innovation method for more systematically enhanced execution of Quality by Design (QbD) activities. QbD requires a deeper understanding of the product and process at the design and development stage of the drug, and it is very important to ensure that no fault is fundamentally generated through thorough process control. Methods: Analyzing the background and specific procedures of quality improvement based on the drug design basis, and analyzing the key contents of each step, we have differentated and common points from the 6 Sigma methodology. We propose a new model of Six Sigma management innovation method suitable for pharmaceutical industry. Results: Regulatory agencies are demanding results from statistical analysis as a scientific basis in developing medicines to treat human life through quality improvement activities based on drug design. By utilizing the education system to improve the statistical analysis capacity in the Six Sigma activities and operating the 6 Sigma Belt system in conjunction, it helped systematically strengthen the execution power of quality improvement activities based on pharmaceutical design based on the members of the pharmaceutical industry. Conclusion: By using QbD Six Sigma, which combines quality enhancement based on pharmaceutical design basis and Six Sigma methodology suitable for pharmaceutical industry, it is possible to obtain satisfactory results both by pharmaceutical companies and regulators by using appropriate statistical analysis methods for preparing scientific evidence data required by regulatory.

• Clinical and Experimental Vaccine Research
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• v.12 no.1
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• pp.70-76
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• 2023

Purpose: Typhoid remains a major health problem, especially in the developing world. Furthermore, the emergence of multidrug-resistant and extensively drug-resistant strains of Salmonella typhi added a sense of urgency to develop more effective typhoid vaccines, one of which is bacterial ghosts (BGs), prepared by both genetic and chemical means. The chemical method includes incubation with numerous agents for a short time at their minimum inhibitory or minimum growth concentrations. This study included the preparation of BGs by a sponge-like reduced protocol (SLRP). Materials and Methods: Critical concentrations of sodium dodecyl sulfate, NaOH, and H₂O₂ were used. Moreover, high-quality BGs were visualized by scanning electron microscope (SEM). Subculturing was used to confirm the absence of vital cells. Besides, the concentrations of the released DNA and protein were estimated spectrophotometrically. In addition, the integrity of cells was proved by visualizing Gram-stained cells using a light microscope. Furthermore, a comparison between the immunogenicity and safety of the prepared vaccine and the available whole-cell killed vaccine was established. Results: Improved preparation of high-quality BGs of S. typhi, visualized by SEM, revealed punctured cells with intact outer shells. Moreover, the absence of vital cells was confirmed by subculturing. At the same time, the release of respective amounts of proteins and DNA is another evidence of BGs' production. Additionally, the challenge test provided evidence that the prepared BGs are immunogenic and have the same efficacy as the whole cell vaccine. Conclusion: The SLRP provided a simple, economical, and feasible method for BGs preparation.

• Korean Journal of Pharmacognosy
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• v.51 no.2
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• pp.122-130
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• 2020

To investigate the anti-inflammatory effect on Degenerative Osteoarthritis, Male sprague-Dawley rats were randomized and classified into three different concentration groups. We measured weekly weight change, dietary intake, drinking water intake, blood analysis like TNF-α (tumor necrosis factor-α), IL-6 (interleukin 6), TIMP-1 (tissue inhibitor of metalloprotease-1), MMP-2 (matrix metalloprotease-2), MMP-9 (matrix metalloprotease-9) and micro CT analysis. The results suggest that the treatment with herbal complex HP-04 improved the Monosodium iodoacetate (MIA) induced degenerative osteoarthritis and it could be applicable for the improvement of arthritic symptoms as a new therapeutic agent.

• Journal of Pharmaceutical Investigation
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• v.41 no.2
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• pp.59-65
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• 2011

Nanotechnology for cancer therapy is playing a pivotal role in dramatically improving current approaches to cancer detection, diagnosis, and therapy while reducing toxic side effects associated with previous cancer therapy. A widespread understanding of these new technologies will lead to develop the more refined design of optimized nanoparticles with improved selectivity, efficacy and safety in the clinical practice of oncology. This review provides an integrated overview of applications and advances of nanotechnology in cancer therapy, based on molecular diagnostics, treatment, monitoring, target drug delivery, approved nanoparticle-based chemotherapeutic agents, and current clinical trials in the development of nanomedicine and ultimately personalized medicine.