• Title/Summary/Keyword: Drug storage

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Statistical Inference of Shelf -life in Drug's Stability Study (의약품 안정성 연구에서의 사용기간에 관한 통계적 추론)

  • Kim, Tai-Kyoo;Park, Sang-Gue
    • Journal of Korean Society for Quality Management
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    • v.36 no.1
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    • pp.1-6
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    • 2008
  • The purpose of stability study of pharmaceutical products is to establish the shelf life based on the change of the quality with time. Stability study generally consists of a random sample of dosage units from a batch or several batches placed in a storage room and periodically assayed for their drug content. The statistical methods of assessing the shelf-life of drug in the market is considered with the current KFDA regulations. An illustrated application to some stability data from the pharmaceutical industry is also presented with the discussion.

Effect of Curing and Compression Process on the Drug Release of Coated Ion-Exchange Resin Complexes

  • Jeong, Seong-Hoon;Wang, Hun-Sik;Koo, Ja-Seong;Choi, Eun-Joo;Park, Ki-Nam
    • Journal of Pharmaceutical Investigation
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    • v.41 no.2
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    • pp.67-73
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    • 2011
  • Ion exchange resins can be one of the good carriers for sustained drug release. However, the sustained release may not be enough only with themselves and hence film coating with rate controlling polymers can be applied to have a further effect on the drug release. Due to the environmental and economic issues of organic solvent for the polymer coating, aqueous polymeric systems were selected to develop dosage forms. Among the many aqueous polymeric dispersions for the film coating, EC (ethylcellulose) based polymers such as Aquacoat$^{(R)}$ ECD and Surelease$^{(R)}$ were evaluated.A fluid-bed coating was applied as a processing method. The drug release rate was quite dependent on the coating level so the release rate could be modified easily by changing different levels of the coating. The drug release rate in the Aquacoat$^{(R)}$ coated resin particles was strongly dependent on curing, which is a thermal treatment to make homogeneous films and circumvent drug release changes during storage. After dissolution test using the compressed tablets in which the coated resin particles are contained, inhomogeneous coating and even pores could be observed showing that the mechanical properties of EC were not resistant to granulation and compaction process. However, when tablets were prepared in different batches, the release profiles were almost identical showing the feasibility of the coated resin particle as incorporated into the tablet formulation.

Cell Death and Stress Signaling in Glycogen Storage Disease Type I

  • Kim, So Youn;Bae, Yun Soo
    • Molecules and Cells
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    • v.28 no.3
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    • pp.139-148
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    • 2009
  • Cell death has been traditionally classified in apoptosis and necrosis. Apoptosis, known as programmed cell death, is an active form of cell death mechanism that is tightly regulated by multiple cellular signaling pathways and requires ATP for its appropriate process. Apoptotic death plays essential roles for successful development and maintenance of normal cellular homeostasis in mammalian. In contrast to apoptosis, necrosis is classically considered as a passive cell death process that occurs rather by accident in disastrous conditions, is not required for energy and eventually induces inflammation. Regardless of different characteristics between apoptosis and necrosis, it has been well defined that both are responsible for a wide range of human diseases. Glycogen storage disease type I (GSD-I) is a kind of human genetic disorders and is caused by the deficiency of a microsomal protein, glucose-6-phosphatase-${\alpha}$ ($G6Pase-{\alpha}$) or glucose-6-phosphate transporter (G6PT) responsible for glucose homeostasis, leading to GSD-Ia or GSD-Ib, respectively. This review summarizes cell deaths in GSD-I and mostly focuses on current knowledge of the neutrophil apoptosis in GSD-Ib based upon ER stress and redox signaling.

Comparative Study of Terminology for Identification of the Chinese Herbal Materia Medica (초본류 한약재 감별을 위한 용어의 비교연구)

  • Shin, Yong-Wook
    • The Korea Journal of Herbology
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    • v.29 no.3
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    • pp.43-50
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    • 2014
  • Objectives : To investigate terminology of Herbal drug discrimination commonly used in China, and it was translated into Korean. It also has been modified to fit the circumstances of the Korean for easier understand for Korean student. Methods : First,Terminology for Identification of the Chinese Herbal Materia Medica (TICHMM) was classified by the appearance, cut surface, material, processing and storage of Herb. Chinese commentary of TICHMM was translated into Korean. Comparative Study was performed based on the Pharmacopoeia of Korea and China. Depending on the meaning of the word, TICHMM was modified to revised Korean expression or remain chinese expression or suggest new Korean expression Result : In the 28 TICHMM terms that describes the shape properties of herbal medicine, 5 was remained in Chinese expression, 22 was modified to revised Korean expression and 1 was suggested in new Korean expression. 8 terms that describes the Section properties of herbal medicine, 6 was modified to revised Korean expression and 2 was suggested in new Korean expression. 3 terms that describes the Material properties of herbal medicine, 1 was remained in Chinese expression, 2 was modified to revised Korean expression. 3 terms that describes the processing and storage properties of herbal medicine, 2 was modified to revised Korean expression and 1 was suggested in new Korean expression. Conclusion : By comparative Study of TICHMM, commonly used in China, it will contribute new guideline on the Visual Examination of Herbal Medicine for Korean student.

Stability Study for Herbal Drug According to Storage Conditions and Periods (탕약의 실온과 냉장보관 및 기간별 안정성에 대한 실험적 연구)

  • Son, Jin-Young;Shin, Jang-Woo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.30 no.2
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    • pp.127-132
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    • 2009
  • Objectives: This study aimed to investigate the stability of a decoction using three herbal plants and their major components according to the storage conditions and periods. Materials and Methods: A three-herb mixture (1:1:1) of Glycyrrhiza uralensis Fischer, Artemisia capillaris Thunberg, and Poncirus trifoliata Rafinesqui was decocted and kept at room temperature ($25{\pm}2^{\circ}C$) or cold temperature ($4^{\circ}C$) for 0, 2, 4 or 8 weeks in liquid form in a plastic pack under dark conditions. At time points given, they were lyophilized. 200 mg of powdered samples were dissolved in 1 mL of 90% methanol and then applied to a high performance thin layer chromatography (HPTLC) with glycyrrhizin, 6,7-dimethoxycoumarin or poncirin for quantitative or qualitative analysis. Results: There were no gross changes in HPTLC-based compositional band-patterns of the three herbal mixture according to the storage conditions and period. The major components of each herb, glycyrrhizin, 6,7-dimethoxycoumarin and poncirin, showed slight time-dependent reduction in their contents both at room and cold temperature for 8 weeks. Conclusion: We could conclude that the current herbal decoction is generally safe for the stability at both RT or CT for at least 8 weeks. Nevertheless, we proposed that further advanced studies are required for more multiple herbal mixtures and longer storage periods.

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Characterization of Protein L-isoaspartyl Methyltransferase Purified from Porcine Testis

  • Kikyung Jung;Mihee Shin;Hyungmee Han;Seogyeon Kang;Kim, Taegyun;Sungryoul Hong;Kim, Seunghee;Lee, Youngkeun
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1998.11a
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    • pp.136-136
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    • 1998
  • L-asparaginyl and L- aspartyl residues in proteins are subject to spontaneous degradation reactions generating isomerized and racemized aspartyl derivatives. Proteins containing L-isoaspartyl and D-aspartyl residues usually have altered structures and diminished biological activities. These residues can be recognized and be repaired to normal L-aspartyl residues by protein L-isoaspartyl methyltransferase(PIMT), which is present at high levels in testis. Although testicular PIMT have been shown to be involved in either sperm motility or sperm maturation, it may play an important role in the repair of damaged sperm proteins during the prolonged period of epididymal transport and storage. In the present study, as a initial step toward elucidating the function of protein carboxylmethylation in testis, we purified PIMT from porcine testicular cytosol as a momeric 27,000 Da species by ammonium sulfate precipitation, DEAE-sephacel chromatography, SAH-liganded affinity chromatography, and gel filtration chromatography. The optimum pH for the reaction was 6.0. $K_{m}$ values of the enzyme for the S-adenosyl-L-methionine (SAM), synthetic oligopeptide(VYP-L-isoD-HA) and histone type II-As were 1.0 ${\mu}$M, 33.2 ${\mu}$M and 276 ${\mu}$M respectively. Consequently, properties of the porcine testicular PIMT is similar to that of other mammalian PIMTs.

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Medication Counseling and the Patient Customers' Demands (복약지도 실태와 환자 소비자 요구에 대한 조사 - 간호과 학생에 의한 간접경험을 중심으로 -)

  • Cho Won Sun
    • Journal of Korean Public Health Nursing
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    • v.19 no.1
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    • pp.117-128
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    • 2005
  • Purpose: The study examines the condition of medication counseling to determine the patient customers' demands, with the purpose of providing a basic data to improve the condition of medication counseling for phamacists and clinical nurses. Method: Questionnaire was completed by 150 nursing students. For data analysis, the SPSS win 10.0 program was used. Result: The contents of medication counseling given by the pharmacists in order of frequency were($100\%$ means 'always'): way of use$(78.7\%)$, period of taking medicine $(63.3\%)$, dosage$(46.7\%)$, effect$(27.3\%)$, drug name$(18.7\%)$, diet$(12.7\%)$, question of taking other drug$(12.7\%)$, giving a notice$(12.0\%)$, way of storage$(7.3\%)$, side effects$(6.0\%)$, drug interaction$(3.3\%)$' The needs and demands desired by the patients in order of frequency were('the most important' is given 10 points, followed by the others in numerically decreasing order until 0): effect(8.68), way of use(7.60), side effect(7.20), giving a notice(6.38), dosage (5.95), drug name(5.67), a period of taking medicine(5.60), drug interaction(4.37), diet(3.63), the way of storage(3.03). Most of the respondents were satisfied with the pharmacists' kindness$(62.7\%)$. Some recognized the medication counseling was quite good$(16.7\%)$, but the majority felt it was modest$(50.8\%)$' Nearly half of them felt the medication counseling time was quiet short$(47.3\%)$' The communication was mostly oral$(83.3\%)$, while others used sticker$(6.0\%)$ or leaflet$(6.0\%)$ additionally. There was a significant correlation between pharmacists' kindness and medication counseling content(p<,01), and also recognition(p<.001). The correlation between the number of medication counseling which gave to the patient customer and the recognition was also significant (p<.001). As the number of medication counseling increased, the patient felt the medication counseling time was adequate(p<.05). The correlation between the medication counseling recognition and the adequate time was also very significant(p<.001). Conclusion: These results revealed the situation of medication counseling to be poor and to be differ from the patient customers' demands. Therefore optimal medication counseling, especially regarding possible side effects and drug interaction should be emphasized. Pharmacists and clinical nurses should give qualitative medication counseling which reflects the patients' demands.

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Study of Stability in the Riboflavin Content of Dietary Supplements on Storage Conditions (국내유통 비타민보충용제품의 저장조건에 따른 비타민 $B_{2}$의 안정성에 관한 연구)

  • Kim So-Hee;Kim Ji-Yeon;Lee Young-Ja
    • Journal of Food Hygiene and Safety
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    • v.20 no.4
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    • pp.225-231
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    • 2005
  • This study was carried out to observe the stability of riboflavin in dietary supplements. Dietary supplements were in the type of tablet, powder, capsule and liquid. Various factors on the stability of riboflavin such as effect of light, storage temperature and time were examined using HPLC method. Samples were exposed to various temperatures (-9, 4, $30^{\circ}C$) and light at room temperature far 9 months. As well as storage period became longer, reduction rate constant of riboflavin increased. Riboflavin reduction rate constants were higher during storage with light than without light. And there was a significant difference of reduction rate constants in types of dietary supplement. In other words, riboflavin in tablet types was significantly more stable than the others, and liquid type was the most unstable. Therefore, type, light, and packing container of dietary supplements containing riboflavin would be considered in order to establish their appropriate shelf lives. In consideration with riboflavin decrease in dietary supplements, riboflavin would be appropriate for the nutritional labelling guide when predicting them at the end of shelf lives.

Effect of Storage Conditions on the Chemical Characteristics of Traditional Kochujang (저장조건에 따른 전통고추장의 성분 특성 변화)

  • Kim, Dong-Han;Lee, Jung-Seung;Lee, Sang-Bok
    • Korean Journal of Food Science and Technology
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    • v.34 no.3
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    • pp.466-471
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    • 2002
  • Effect of anti-microbial agents, such as alcohol, garlic, chitosan, K-sorbate, mustard, or pasteurization on the quality of traditional kochujang was investigated during storage at $30^{\circ}C$ for 24 weeks. The pH of kochujang decreased during storage and titratable acidity changed little in the group of mustard and garlic addition. Reducing sugar increased during storage, with higher values for K-sorbate of alcohol added groups than the other groups. Alcohol contents increased during storage with higher values in control or chitosan added group. Amino nitrogen contents of kochujang decreased gradually during storage and were lower in control or chitosan added group. Ammonia nitrogen contents were lower in alcohol, garlic, K-sorbate or mustard added kochujang. The content of total free amino acid increased slightly during storage and were higher in pasteurized, garlic or alcohol added kochujang. After 24 weeks of storage, the results of sensory evaluation showed K-sorbate, garlic or alcohol added kochujang were more acceptable than control in the sense of taste.

Quinetides: diverse posttranslational modified peptides of ribonuclease-like storage protein from Panax quinquefolius as markers for differentiating ginseng species

  • Zhao, Qiang;Bai, Yunpeng;Liu, Dan;Zhao, Nan;Gao, Huiyuan;Zhang, Xiaozhe
    • Journal of Ginseng Research
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    • v.44 no.5
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    • pp.680-689
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    • 2020
  • Background: Peptides have diverse and important physiological roles in plants and are ideal markers for species identification. It is unclear whether there are specific peptides in Panax quinquefolius L. (PQ). The aims of this study were to identify Quinetides, a series of diverse posttranslational modified native peptides of the ribonuclease-like storage protein (ginseng major protein), from PQ to explore novel peptide markers and develop a new method to distinguish PQ from Panax ginseng. Methods: We used different fragmentation modes in the LTQ Orbitrap analysis to identify the enriched Quinetide targets of PQ, and we discovered Quinetide markers of PQ and P. ginseng using ultrahigh-performance liquid chromatography-quadrupole time-of-flight mass spectrometry analysis. These "peptide markers" were validated by simultaneously monitoring Rf and F11 as standard ginsenosides. Results: We discovered 100 Quinetides of PQ with various post-translational modifications (PTMs), including a series of glycopeptides, all of which originated from the protein ginseng major protein. We effectively distinguished PQ from P. ginseng using new "peptide markers." Four unique peptides (Quinetides TP6 and TP7 as markers of PQ and Quinetides TP8 and TP9 as markers of P. ginseng) and their associated glycosylation products were discovered in PQ and P. ginseng. Conclusion: We provide specific information on PQ peptides and propose the clinical application of peptide markers to distinguish PQ from P. ginseng.