• 대한약학회:학술대회논문집
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• 대한약학회 2000년도 춘계총회 및 학술대회
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• pp.198.3-199
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• 2000

• Natural Product Sciences
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• 제15권4호
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• pp.203-207
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• 2009

A homoisoflavanone, 7,4'-dihydroxyhomoisoflavanone (1) and a flavanone, (2S)-7,4'-dihydroxy-5-methoxyflavanone (2), were isolated from the rhizomes of Anemarrhena asphodeloides, together with 4,4'-dihydroxychalcon (3), 2'-O-methylphlorethin (4), 1,3-bis-di-p-hydroxyphenyl-4-penten-1-one (5), and 2,4'-dihydroxy-4-methoxybenzophenone (6) on the basis of spectroscopic and physicochemical analyses including 1Dand 2D- NMR techniques as well as by comparison of their data with the published values. Compounds 1 - 4 were isolated for the first time from this plant source. Among isolates, compound 2 exhibited moderate inhibitory effect on the differentiation of pre-adipocyte 3T3-L1 cells.

• International Journal of Stem Cells
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• 제16권3호
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• pp.281-292
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• 2023

Background and Objectives: Human induced pluripotent stem cell (hiPSC)-derived cardiomyocyte (CM) hold great promise as a cellular source of CM for cardiac function restoration in ischemic heart disease. However, the use of animal-derived xenogeneic substances during the biomanufacturing of hiPSC-CM can induce inadvertent immune responses or chronic inflammation, followed by tumorigenicity. In this study, we aimed to reveal the effects of xenogeneic substances on the functional properties and potential immunogenicity of hiPSC-CM during differentiation, demonstrating the quality and safety of hiPSC-based cell therapy. Methods and Results: We successfully generated hiPSC-CM in the presence and absence of xenogeneic substances (xeno-containing (XC) and xeno-free (XF) conditions, respectively), and compared their characteristics, including the contractile functions and glycan profiles. Compared to XC-hiPSC-CM, XF-hiPSC-CM showed early onset of myocyte contractile beating and maturation, with a high expression of cardiac lineage-specific genes (ACTC1, TNNT2, and RYR2) by using MEA and RT-qPCR. We quantified N-glycolylneuraminic acid (Neu5Gc), a xenogeneic sialic acid, in hiPSC-CM using an indirect enzyme-linked immunosorbent assay and liquid chromatography-multiple reaction monitoring-mass spectrometry. Neu5Gc was incorporated into the glycans of hiPSC-CM during xeno-containing differentiation, whereas it was barely detected in XF-hiPSC-CM. Conclusions: To the best of our knowledge, this is the first study to show that the electrophysiological function and glycan profiles of hiPSC-CM can be affected by the presence of xenogeneic substances during their differentiation and maturation. To ensure quality control and safety in hiPSC-based cell therapy, xenogeneic substances should be excluded from the biomanufacturing process.

• Journal of Pharmaceutical Investigation
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• 제40권5호
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• pp.297-304
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• 2010

The present work focuses on preparation of olanzapine, orally dispersing tablets by direct compression method. Effect of super disintegrant crospovidone, disintegration time, drug content on in vitro release has been studied. A factorial design was employed in formulating a prompt dispersible tablet. The selected independent variables crospovidone and fmelt showed significant effect on dependent variables i.e. disintegration time and percent drug dissolved. Disintegration time and percent drug dissolved decreased with increase in the level of crospovidone. The similarity factor $f_2$ was found to be 97.48 for the developed formulation indicating the release was similar to that of the marketed formulation. Pharmacokinetics of olanzapine after single-dose oral administration of orally disintegrating tablet in normal volunteers were evaluated and the results showed that PK parameters (Cmax, Tmax, AUC) of the designed ODT matrix were similar to those of commercial product, Zyprexa Zydis$^{(R)}$ as a reference.

• 대한의용생체공학회:의공학회지
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• 제31권6호
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• pp.434-437
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• 2010

For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.

• Food Science and Biotechnology
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• 제17권6호
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• pp.1376-1378
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• 2008

Tachioside (4-hydroxy-3-methoxy-phenyl-1-O-glucoside), a known phenolic glycoside, was isolated from various bamboo species. The 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical scavenging activity and Trolox equivalent antioxidant capacity determined a significant antioxidant activity of tachioside which was comparable to L-ascorbic acid. Each culm and leaf extracts were tested and the culm of Phyllostachys bambusoides appeared to contain the highest amount of tachioside.

• Bulletin of the Korean Chemical Society
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• 제34권11호
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• pp.3345-3349
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• 2013

Hsp90 shows great promise as a therapeutic target due to its potential to disable multiple signaling pathways simultaneously. In this study, we discovered that a natural product, butein moderately inhibited the growth of drug-resistant cancer cells (A2780cis and H1975), and brought about the degradation of oncogenic Hsp90 client proteins. The study demonstrated that butein would be a therapeutic lead to circumvent drug-resistance in cancer chemotherapy. The structure-based screening, synthesis, and biological evaluation of butein are described herein.

• Journal of Pharmaceutical Investigation
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• 제37권6호
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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.

• 의료법학
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• 제21권3호
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• pp.77-116
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• 2020

현대 과학의 경험과 성과가 반영된 의약품의 사용으로 인류에게 질병의 치료와 건강 상태의 개선이라는 혜택이 주어지고 있다. 그러나 의약품은 질병의 치료라는 혜택 이외에도 본질적으로 피할 수 없는 부작용도 내포한다. 각국은 부작용으로 인한 피해의 최소화를 위해 시장진입 규제나 시판후조사 등의 조치를 취하고 있으나, 부작용의 발생은 피할 수 없다. 부작용으로 인한 손해의 발생이 불가항력이라도 그 점이 사전에 알려진 것이었다면, 의약품의 종류와 사용 형태에 따라서 처방한 의사나 복약지도를 담당하는 약사 등이 손해를 배상해야 한다. 의약품에 결함이 있어 손해가 발생하는 경우도 있는데, 손해 배상의 일반원칙을 그대로 적용해서는 결함으로 인한 부작용 피해자가 손해를 배상받기 쉽지 않다. 우리나라를 비롯한 여러 나라가 제조물 책임법을 통하여 피해자의 보호를 도모하고 있으며, 의약품도 제조물에 포섭되기 때문에 제조물 책임법을 통한 손해배상을 문의할 수 있는데, 이 때 주로 설계상의 결함이나 표시상의 결함이 문제될 수 있다. 제조물 책임법이 제정·시행되기 이전에도 의약품의 부작용으로 인한 손해는 발생하여왔다. 이러한 경우를 위해서 판례는 제조물 책임법과 유사한 법리를 발전시켜 왔고, 의약품 결함은 혈액제제와 관련하여 판례가 형성되어 왔다. 제조물 책임법 시행 이전에 제조된 의약품으로 인한 손해는 향후에도 발생할 수 있기에 판례 법리는 중요한 검토의 대상이다.

• 약학회지
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• 제18권1호
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• pp.49-58
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• 1974

Tablet product design problem was structured as constrained optimization problem and subsequently solved by multiple regression analysis and Lagrangian method of optimization. Aluminum flufenamate was the drug chosen and microcrystalline cellulose nad starch were the binder and disintegrant, respectivley. The effect of the binder and disintegrant concentration on tablet hardness, friability, volume, in vitro release rate, and urinary excretion rate of drug in human subjects was recorded. Since a reasonably rapid release rate of drug is generally an important objective in the design of solid dosage form, optimization of this parameter was employed in studying the applicability of constrained optimization to a pharmaceutical product design problem. In addition to finding optimal sitivity analysis studies to such problems was also illustratd. It would appear that prediction of the in vivo t$_{50%}$ response from a knowledge of the incitro t$_{50%}$ response can be made fairly accurately for the tablet system used in this study.