• Journal of Pharmaceutical Investigation
• /
• 제34권6호
• /
• pp.529-540
• /
• 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.

• 지질동맥경화학회지
• /
• 제7권2호
• /
• pp.77-87
• /
• 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
• /
• 제57권1호
• /
• pp.1-8
• /
• 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
• /
• 제22권1호
• /
• pp.49-60
• /
• 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.

• 대한한방내과학회지
• /
• 제44권1호
• /
• pp.35-52
• /
• 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.

• 분석과학
• /
• 제21권2호
• /
• pp.65-83
• /
• 2008

식품에 첨가할 수 없는 의약품이나 화학합성물질이 함유된 부정유해식품이 증가하고 있는 실정이다. 특히 발기부전치료제 성분인 실데나필, 바데나필 및 타다라필의 화학구조를 변형한 미지의 물질이 검출되고 있다. 또한 기존 식품의 기준규격 검사에 따른 단속을 피하기 위하여 성기능강화 등 치료효능을 지닌 의약품 성분의 화학구조를 변형한 불법으로 합성한 부정유해물질은 안전성이 전혀 입증되지 않았으므로 그 위해성이 우려되고 있다. 따라서 식품의 안전성을 확보하기 위하여 발기부전치료제의 화학구조를 변형한 호모실데나필, 홍데나필, 슈도바데나필, 아미노타다라필, 하이드록시호모실데나필, 하이드록시홍데나필, 디메틸실데나필, 잔소안트라필, 하이드록시바데나필, 노르네오실데나필, 데메틸홍데나필, 피페리디노홍데나필, 카보데나필, 치오실데나필, 디메틸치오실데나필, 아세틸바데나필의 총 16개의 발기부전치료 성분의 유사물질 관련 자료와 식품 중 부정유해물질의 규명 및 분석 현황을 정리하였다.

• The Korean Journal of Physiology and Pharmacology
• /
• 제28권3호
• /
• pp.229-237
• /
• 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.

• 한국식품위생안전성학회지
• /
• 제17권2호
• /
• pp.61-70
• /
• 2002

1996년부터 2001년까지 서울시내 환자에서 분리된 718주의 살모넬라속균의 균종별 분포 및 항생제 감수성을 조사한 결과 균종별 분포는 Sal. Enteritidis 가 298주(41.5%)로 가장 많이 분리되었으며, Sal. Typhi 218주(30.4%), Sal. Typhimurium 81주(12.1%)이었으며, 총 48종의 살모넬라균종이 분리되었다 살모넬라속균 718주의 16종 항생제에 대한 내성은 tetracycline (Te)에 대한 내성이 32.7%로 가장 높았으며, streptomycin(5) 28.0%, ticarcillin(TIC) 18.1%, ampicillin(AM) 12.4%순이었다. Sal. Enteritidis의 내성은 Te 34.7%, 5 32.3%, TIC 23.2%, AM 13.5%이었으며, Sal. Typhi는 S 13.8%, Te 10.6%이었으며, Sal. Typhimurium은 Te 66.7%, 5 42.5%, TIC 28.7%, AM 26.4%, C 17.2%이었다. 살모넬라속균 718주 중 324주(45.1%)가 1종 이상의 항생제에 내성을 나타내었으며, 단일항생제에 내성을 나타낸 균주가 64주(19.8%), 2제 내성균이 132주(40.7%), 3제 내성균이 50주(15.4%), 4제 내성균이 27주 (8.3%), 5제 내성균 27주(8.35), 6제 내성균 22주(6.8%), 7제 및 8제 내성균이 각각 1주이었다. 다제 내성 양상은 Te-K내성균이 115주(35.5%)로 가장 많았으며, Te-K-TIC내성균 27주(8.3%), Te-K-TIC-AM내성균 24주(7.4%)이었다 항생제 내성율은 Sal. Typhimurium이 73.6V로 가장 높았으며, Sal. Enteritidis 53.7%, Sal. Typhi 19.3%이었으며, Sal. Enteritidis는 단제 및 2제 내성율이 높은 반면, Sal. Typhi과 Sal. Typhimurium은 5제 이상 내성율이 각각 16.7%, 26.6%이었다.

• IMMUNE NETWORK
• /
• 제4권1호
• /
• pp.1-6
• /
• 2004

Transplantation would be the only way to cure the end-stage organ failure involving heart, lung, liver, kidney and pancreas. The replacement of the parts of the body damaged to lose its function or lost to trauma must be a dream of human-being. Human history is replete with chimeras, from sphinxes to mermaids, making one wonder if the ancients might actually have dreamed of what now is called 'xenotransplantation'. In the 20th century, the transplantation of organs and tissues to cure disease has become a clinical reality. The development in the fields of surgical techniques, physiology and immunology attributed to the successful transplantation in human. In the center of the successful transplantation lies the progress in understanding the cellular and molecular biology of immune system which led to the development of immunosuppressive drugs and the invention of the concept of immunological tolerance. The mandatory side effects of immunosuppressive drugs including infection and cancer forced us to search alternative approaches along with the development of new immunosuppressive agents. Among the alternative approaches, the induction of a state of immunologic tolerance would be the most promising and the most generic applicability as a future therapy. Recent reports documenting long-term graft survival without immunosuppression suggest that tolerance-based therapies may become a clinical reality. Last year, we saw the epoch making success of overcoming hyperacute rejection in porcine to primate xenotransplantation which will lead porcine to human xenotransplantation to clinical reality. In this review, I dare to summarize the development of transplantation immunology from the perspective of history.

• IMMUNE NETWORK
• /
• 제15권2호
• /
• pp.58-65
• /
• 2015

Melanoma is the most aggressive skin cancer and its incidence is gradually increasing worldwide. Patients with metastatic melanoma have a very poor prognosis (estimated 5-year survival rate of <16%). In the last few years, several drugs have been approved for malignant melanoma, such as tyrosine kinase inhibitors and immune checkpoint blockades. Although new therapeutic agents have improved progression-free and overall survival, their use is limited by drug resistance and drug-related toxicity. At the same time, adoptive cell therapy of metastatic melanoma with tumor-infiltrating lymphocytes has shown promising results in preclinical and clinical studies. In this review, we summarize the currently available drugs for treatment of malignant melanoma. In addition, we suggest cytokine-induced killer (CIK) cells as another candidate approach for adoptive cell therapy of melanoma. Our preclinical study and several previous studies have shown that CIK cells have potent anti-tumor activity against melanomas in vitro and in an in vivo human tumor xenograft model without any toxicity.