• YAKHAK HOEJI
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• v.49 no.2
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• pp.140-146
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• 2005

Candida albicans, a polymorphic fungus, causes systemic and local infections. Recent reports show that the fungus is a main etiological agent for the arthritis. For trea tment, antifungal drugs and/or rheumatoid drugs are used, but resistance and side effects limit application of the drugs. In search of new sources for treatment of the fungal arthritis, we choose Egb 761 (extract of Ginkgo leaves 761), one of the most popular over-the-counter herbal medicines. The Egb 761 contains two major ingredients such as terpene and flavonoid. In the present study, we examined if the terpene portion of Egb 761 had anti-inflammatory activity against C.albicans-caused arthritis. The terpene was extracted with combination of methanol and water from the Egb 761, followed by gel-permeation chromatography. Presence of terpene was determined by the Salkowski colorimetric method and HPLC analysis. For an animal model of inflammation induction, mice were given an emulsion form of C.albicans cell wall mixed with Complete Freund's Adjuvant (CFA) by footpad-injection. Results showed that intraperitoneal administration of the water-soluble portion that contained terpene and flavonoid reduced the inflammation. Whereas the terpene had anti-inflammatory activity, flavonoid portion had no such activity, For determination of possible mechanism of the activity, the terpene seemed to be suppression of nitric oxide (NO) production from LPS-treated macrophages. Taken together the Ginkgo terpene may have anti-inflammatory effect against C.albicans-caused arthritis, possibly by blocking NO production.

• Korean Journal of Clinical Pharmacy
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• v.19 no.1
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• pp.50-60
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• 2009

Highly variable drugs (within-subject variability greater than 30%) have been difficult to meet current regulatory acceptance criteria using a reasonable number of study subjects. In this study, we reviewed previous studies presenting alternative approaches for bioequivalence evaluation of highly variable drugs, and focused on an approach for widening the bioequivalence acceptance limits using within-subject variability. We discussed the suggested five solutions for highly variable drug including the deletion of $C_{max}$ of the bioequivalence criteria, direct expansion of bioequivalence limit, multiple dose studies in steady state, bioequivalence assessment on the metabolite, add-on study, and widening the bioequivalence acceptance limits based on reference variability. The methods for widening of bioequivalence limits based on reference variability are scaled average bioequivalence containing within-subject variability on reference drug (${\sigma}_{WR}$), population bioequivalence derived from total variability on reference drug (${\sigma}_{TR}$) and test drug (${\sigma}_{TT}$), and individual bioequivalence derived from subject by formulation interaction variability (${\sigma}_D$) and within subject variability on reference drug (${\sigma}_{WR}$) and test drug (${\sigma}_{TR}$). To apply these methods, the switching variability (${\sigma}_0$) will have to be set by the regulatory authorities. The proposals of bioequivalence evaluation approach for the highly variable in Korea are presented for both of new drug and reevaluation drug.

• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.529-540
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• 2004

After new medical system of separation of dispensary from medical practice was started in 2000 in Korea, to expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drugs are hot issues in Korea. It will be obligatory to submit bioequivalence reports for getting licenses of all generic prescription drugs in the near future. Like other countries such as US and Japan, the KFDA also has a plan to re-evaluate the already approved drugs by bioequivalence studies. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products among already approved drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. The information on Japanese guidance and the guidance's Q&As is already provided in our previous paper. In this paper, we examined the US guideline published in 1995 and compared with the Japanese guideline, which will give a useful information to make a guidance on bioequivalence studies of topical drug products in Korea.

• Journal of Lipid and Atherosclerosis
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• v.7 no.2
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• pp.77-87
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• 2018

Lowering serum low-density lipoprotein cholesterol (LDL-C) is the mainstay for reduction of risk of cardiovascular disease (CVD), the second most common cause of death in Korea. The 2015 Korean guidelines for management of dyslipidemia strongly recommend the use of statins in patients at risk of CVD. Statin therapy, which is the gold standard for CVD, reduces LDL-C level by 40% to 60% and is generally well tolerated. However, many patients are intolerant to statins and discontinue therapy or become nonadherent to therapy because of actual/perceived side effects. The most common of these side effects is the statin-associated muscle symptom (SAMS). Discontinuation and repetitive re-challenge with statins can help identify SAMS. If serum creatinine kinase level is more than 10 times the upper limit of normal, statin therapy must be stopped immediately, and the physician should identify possible causes including rhabdomyolysis and treat appropriately. In other patients, it might help to switch to a less potent statin or to use statins at intermittent non-daily dosing. To achieve target LDL-C level, non-statin lipid-lowering therapies such as dietary modifications, ezetimibe, and bile acid sequestrants may be added. Several new drugs have recently been approved for lowering LDL-C level. Alirocumab and evolocumab are monoclonal antibodies that inhibit proprotein convertase subtilisin/kexin type 9, and both drugs cause large reductions in LDL-C, similar to statins. Lomitapide and mipomersen are orphan drugs used as adjuncts to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia.

• Parasites, Hosts and Diseases
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• v.57 no.1
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• pp.1-8
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• 2019

There is no effective treatment modality available against different forms of leishmaniasis. Therefore, the aim of this study was to improve the penetration and efficacy of selenium and glucantime coupled with niosomes and compared them with their simple forms alone on in vitro susceptibility assays. In this study, the niosomal formulations of selenium and in combination with glucantime were prepared. The size and morphology of the niosomal formulations were characterized and the effectivity of the new formulation was also evaluated using in vitro MTT assay, intra-macrophage model, and gene expression profile. From the results obtained, no cytotoxicity effect was observed for niosomal and simple forms of drugs, as alone or in combination. Niosomal formulations of the drugs significantly showed more inhibitory effects ($P{\leq}0.001$) than the simple drugs when the selectivity index was considered. The gene expression levels of Interleukin (IL-10) significantly decreased, while the level of IL-12 and metacaspase significantly increased ($P{\leq}0.001$). The results of the present study showed that selenium plus glucantime niosome possess a potent anti-leishmanial effect and enhanced their lethal activity as evidenced by the in vitro experiments.

• Journal of Dental Anesthesia and Pain Medicine
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• v.22 no.1
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• pp.49-60
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• 2022

Background: Although dental sedation helps control anxiety and pain, side effects and serious complications related to sedation are gradually increasing. Due to the introduction of new drugs and sedation methods, insurance rates, legal regulations, drugs, and methods used for dental sedation are inevitably changed. In the Republic of Korea, National Health Insurance is applied to all citizens, and this study investigated changes in the use of sedatives using this big data. Methods: This study used customized health information data provided by the Healthcare Insurance Review & Assessment Service of Korea. Among patients with a record of use of at least one of eight types of sedatives for dental sedation between January 2007 and September 2019 were selected; the data of their overall insurance claims for dental treatment were then analyzed. Results: The number of patients who received dental sedation was 786,003, and the number of dental sedation cases was 1,649,688. Inhalational sedation using nitrous oxide (N₂O) accounted for 86.8% of all sedatives that could be claimed for drugs and treatment. In particular, it was confirmed that the number of requests for sedation using N₂O sharply increased each year. Midazolam showed an increasing trend, and in the case of chloral hydrate, it gradually decreased. Conclusion: According to our analysis, the use of N₂O and midazolam gradually increased, while the use of chloral hydrate gradually decreased.

• The Journal of Internal Korean Medicine
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• v.44 no.1
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• pp.35-52
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• 2023

Objective: Internal injuries and consumptive disease have different causes, yet they can affect each other. The relationship and combination of prescription drugs in the clinical practice of internal injuries and consumptive disease were analyzed for various diseases of "Donguibogam" through network analysis. Methods: The prescriptions used in consumptive disease and internal injury were established by conducting a full survey on the papers extracted from Donguibogam. The R version 4.0.3 (2020-10-10) and the igraph and arules package were used to perform network analysis and association rule relationship mining analysis in the first and second prescription compositions. Results: The herb frequently used for internal injury was Glycyrrhizae Radix, while the herb combination frequently used was Citri Pericarpium-Glycyrrhizae Radix. For centrality, the main factor was generally Glycyrrhizae Radix. In the case of consumptive disease, the herb most frequently used was Angelicae Gigantis Radix, and the combination most frequently used was Rehmanniae Radix Preparata-Angelicae Gigantis Radix. In terms of centrality, it was Angelicae Gigantis Radix. As a result of the network analysis of herbal prescription frequency, each group was divided into three. Conclusion: The interrelationship between internal injury and consumptive disease prescription drugs may reveal the differences and similarities between internal injury and consumptive disease and may serve as a basis for the development of new drugs or materials that can enhance mutual effectiveness in the treatment of internal injury and consumptive diseases.

• Analytical Science and Technology
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• v.21 no.2
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• pp.65-83
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• 2008

It is noted that illegal hazardous foods containing unauthorized drugs or synthetic drung analogues are increasing. Especially, reported are unknown compounds that have the modified chemical structures of the anti-impotence drugs such as sildenafil, vardenafil, and tatalafil. In addition, it is very reserved, since illegal synthetic compounds having similar chemical structures modified from anti-impotence drug to avoid the government inspection are not proved their safety at all. This review in ulation to food safety, lists the illegal compounds added to foods and describes about the analytical methods to chanacterize 16 anti-impotence drug analogues such as homosildenafil, hongdenafil, pseudovardenafil, aminotadalafil, hydroxyhomosildenafil, hydroxyhongdenafil, dimethylsildenafil, xanthoanthrafil, hydroxyvardenafil, norneosildenafil, demethylhongdenafil, piperidinohongdenafil, carbodenafil, thiosildenafil, dimethylthiosildenafil, and acetylvardenafil.

• The Korean Journal of Physiology and Pharmacology
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• v.28 no.3
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• pp.229-237
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• 2024

Cough is a common symptom of several respiratory diseases. However, frequent coughing from acute to chronic often causes great pain to patients. It may turn into cough variant asthma, which seriously affects people's quality of life. For cough treatment, it is dominated by over-the-counter antitussive drugs, such as asmeton, but most currently available antitussive drugs have serious side effects. Thus, there is a great need for the development of new drugs with potent cough suppressant. BALB/c mice were used to construct mice model with cough to investigate the pharmacological effects of pectolinarigenin (PEC). Hematoxylin-eosin and Masson staining were used to assess lung injury and airway remodeling, and ELISA was used to assess the level of inflammatory factor release. In addition, inflammatory cell counts were measured to assess airway inflammation. Airway hyperresponsiveness assay was used to assess respiratory resistance in mice. Finally, we used Western blotting to explore the potential mechanisms of PEC. We found that PEC could alleviate lung tissue injury and reduce the release of inflammatory factors, inhibit of cough frequency and airway wall collagen deposition in mice model with cough. Meanwhile, PEC inhibited the Ras/ERK/c-Fos pathway to exhibit antitussive effect. Therefore, PEC may be a potential drug for cough suppression.

• The Korean Journal of Pain
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• v.37 no.3
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• pp.211-217
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• 2024

Background: Tolerance to the analgesic effects of opioids and non-steroidal anti-inflammatory drugs (NSAIDs) is a major concern for relieving pain. Thus, it is highly valuable to find new pharmacological strategies for prolonged therapeutic procedures. Biguanide-type drugs such as metformin (MET) are effective for neuroprotection and can be beneficial for addressing opioid tolerance in the treatment of chronic pain. It has been proposed that analgesic tolerance to NSAIDs is mediated by the endogenous opioid system. According to the cross-tolerance between NSAIDs, especially sodium salicylate (SS), and opiates, especially morphine, the objective of this study was to investigate whether MET administration can reduce tolerance to the anti-nociceptive effects of SS. Methods: Fifty-six male Wistar rats were used in this research (weight 200-250 g). For induction of tolerance, SS (300 mg/kg) was injected intraperitoneally for 7 days. During the examination period, animals received MET at doses of 50, 75, or 100 mg/kg for 7 days to evaluate the development of tolerance to the analgesic effect of SS. The hot plate test was used to evaluate the drugs' anti-nociceptive properties. Results: Salicylate injection significantly increased hot plate latency as compared to the control group, but the total analgesic effect of co-treatment with SS + Met50 was stronger than the SS group. Furthermore, the effect of this combination undergoes less analgesic tolerance over time. Conclusions: It can be concluded that MET can reduce the analgesic tolerance that is induced by repeated intraperitoneal injections of SS in Wister rats.