• Title/Summary/Keyword: Drug stability

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음양곽, 백출 및 원지의 독성평가를 위한 성분분석 및 안정성 시험 (Analysis and Stability Test of the Extracts from Epimedii Herba, Atractylodis Rhizoma Alba and Polygalae Radix for Toxicity Study)

  • 금정호;한형윤;석지현;노항식;이종권;정자영;김정아;우미희;최재수;민병선
    • 생약학회지
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    • 제45권2호
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    • pp.135-140
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    • 2014
  • A simple and reliable reverse phase HPLC method was developed to determine pharmacologically active marker compounds of Epimedii Herba, Atractylodis Rhizoma Alba, and Polygalae Radix. The stability test of water-extracts of the three natural medicines has been evaluated for six months. However, no significant changes in the content of the marker compounds of each extract were observed during the time of investigation.

성장호르몬방출펩타이드-6 (GHRP-6)의 경피투과 (Iontophoretic Transport of GHRP-6)

  • 최보경;오승열
    • Journal of Pharmaceutical Investigation
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    • 제31권4호
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    • pp.273-279
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    • 2001
  • The purpose of this study is to characterize the iontophoretic transport of growth hormone releasing peptides (GHRP-6) through hairless mouse skin from aqueous solution. The effect of various factors, such as pH, poloarity, current profile, current density, current duration, ionic strength, drug concentration, and enhancer application was studied to obtain basic knowledge on the transport. We have also studied the stability of GHRP-6 in solution with/without current. The donor chamber was filled with phosphate buffer solution containing GHRP-6 and the receptor chamber was filled with phosphate buffer solution (pH 7.4). Ag/AgCl electrode was used for their stability and reversibility. At a predetermined time interval, sampling was made and the concentration of drug was analysed using HPLC system. The results showed that, compared to passive flux, the total amount of drug transported increased markedly by the application of anodal current. Cathodal flux was similar to passive flux. Flux increased with the current density, the duration of current application and drug concentration. The effect of enhancers on the flux was studied using hydrophilic (5% N-methyl pyrrolidone) and hydrophobic (5% propylene glycol monolaurate, 5% oleic acid) enhancers. Application of enhancer also increased the flux.

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Modernization of Review Process for Generic Drug Products in Korea

  • Chung, Suk-Jae
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.42-42
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    • 2003
  • Recently, Korean Food and Drug Administration (KFDA) has been attempting to modernize the review processes for generic drug products. Obviously, the modernization effort will lead to harmonize the guidelines in the process to the internationally acceptable level. In general, the Korean version of abbreviated new drug application (ANDA) consisted of similarly to those in developed countries (viz, specifications for bulk drug/preparation, bioequivalence, and stability); However, there exists a significant gap in the sophistication of the guidelines between the Korean version and those in the other countries. (omitted)

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Guidance for the Evaluation Method of Drugs of Abused in vitro Diagnostic Devices

  • Kang, Shin-Jung;Choi, Hyun-Ceol;Kim, Ho-Jeong;Park, Sang-Aeh;Chug, Hee-Sun
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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    • pp.291.1-291.1
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    • 2003
  • The purpose of this study is to provide KFDA's guidance for premarket notification submission and labeling for prescription use drugs of abuse in vitro diagnostic devices. To evaluate in vitro diagnostic devices the following performance characteristics should be described in detail within the submission: analytical sensitivity or minimum detection limit, cutoff concentration, specificity and cross reactivity, interference, precision, method comparison and stability. (omitted)

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대구시내 고등학생의 약물남용에 관한 연구 (A Cross-sectional Survey on Drug Abuse among High School Students in Taegu City)

  • 이현숙;김정남;오윤정
    • 지역사회간호학회지
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    • 제8권2호
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    • pp.347-367
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    • 1997
  • The purpose of this study was to investigate drug abuse and to find related factors among high school students. The subjects for this study were 973 students from 10 high schools in Taegu city. The data were collected from September 30, 1996 to October 30, 1996. The questionnaire developed by Kim Soyoaja (1991) surveyed adolescent drug use and questions on smoking and drinking were readjusted and added by the researcher based on review. The data was analyzed using frequency, percentage, $X^2-test$, t -test, Pearson Correlation Coefficient with the SPSS /PC+. The results of this study were summarized as follows: 1. The proportion of students who drank alcohol 1-2 times or more per year was 52.4% and smoked Cigarette 1 -2 times or more per year was 20.8%. The 7 different drugs(Analgetics 5.7%. sleeping pills and sedatives 4.2%, antihistamines 1.1%. stimulants 7.7%, hallucinogens 0.8%, inhalants 3.3%, and narcotics 0.6%) were also evaluated. 2. There was a significant relationship between drinking and type of school($X^2$=62.97, p<.0l), grades($X^2$=33.86, P<.001), school life($X^2$= 19.04, p<.001), and delinquent friends($X^2$= 64.72, P<.001). 3. There was a significant relationship between smoking and type of school($X^2$=153.65, p<.001), grades ($X^2$=67.53, p<.001), their respect for teachers ($X^2$=33.80, p<.001) school life($X^2$ =50.87, p<.001), and delinquent friends($X^2$ =85.28, p<.001). 4. There was a significant relationship between the 7 different kinds of drug abuse and type of school ($X^2$=14.65, p<.01), grades($X^2$=12.89, p<.01), their respect for teachers ($X^2$=8.46, p<.05), and delinquent friends($X^2$=22.42, p<.001). 5. There was a significant relationship between a parent's habitual drug abuse and the 7 different kinds of drug abuse($X^2$=7.78, p<.01), as well as a parent's attitude toward drugs and the 7 different kinds of drug abuse($X^2$=6.33, p<.05). 6. There was a significant difference between drinking(t=-12.53, p<.001), smoking(t=-15.98, p<.001), the 7 different kinds of drug abuse(t=-5.77, p<.001), and the respondant's delinquent experience. 7. There was a correlation between drinking and smoking(r=.4166, p<.001), drinking and the 7 different kinds of drug abuse(r=.2200, p<.001), smoking and the 7 different kinds of drug abuse(r=.1428, p<.05). There was a correlation between drinking and smoking(r=.5977, p<.001), drinking and the 7 different kinds of drug abuse(r=.2849, p<. 001), smoking and the 7 different kinds of drug abuse(r=.1711, p<.05) among male students. There was a correlation between drinking and smoking(r=.4219, p<.001), drinking and the 7 different kinds of drug abuse(r=.2611, p<.001), smoking and the 7 different kinds of drug abuse(r=.1764, p<.001) among female students. 8. There was a correlation between drinking and family stability(r=.0709, p<.05) drinkry and parent -child relationships (r=.1321, p<.01), drinking and mother's rearing attitude(r=.0704, P<.05), smoking and parent -child relationships(r=.0813, P<.05). There was a correlation between drinking and family stability(r=.14S7, p<.01), drinkng and parent-child relationships(r=.2147, p<.001), smoking and family stability(r=.1544, p<.01), smoking and parent. -child relationships (r=. 2018, P<.01) among male students. There was a correlation between drinking and family stability(r=.1l21, p<.05), drinking and mother's rearing attitude (r=.0988, P<.05), smoking and parent -child relationships (r=. 0940, P<.05) among female students. 9. There was a significant difference between the 7 different kinds of drug abuse and family stability (t=2.23, p<.05), parent-child relationships (t=4. 34, p<.001), satisfaction with family (t=4.02, p<.001), father's rearing attitude(t=3.04, p<.01), mother's rearing attitude(t=2.87, p<.01). The distribution channel of drugs including alcohol beverages and cigarettes should be evaluated and restructured to discourage student's temptation and to limit accessibility. The step by step preventive teaching on alcohol drinking and cigarette smoking is needed from middle school to help prevent further drug abuse.

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동결 건조된 리포솜의 안정화에 있어서 말토스의 영향 (Effects of Maltose on the Stability of Freeze-Dried Liposomes)

  • 김윤아;한희동;신병철
    • 대한화학회지
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    • 제48권6호
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    • pp.616-622
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    • 2004
  • 약물 수송체로 사용되는 리포솜은 동결 건조를 통하여 분말화 시키는 방법이 사용되어지고 있다. 리포솜 안정제로서 말토스는 동결건조된 리포솜 분말의 안정성을 향상시키고 약물 봉입률에 영향을 주는 것으로 알려져 왔다. 동결건조 전과 후의 리포솜 입자의 크기를 측정하므로서 리포솜의 안정성을 평가하였고 또한, 약물 봉입률은 모델 약물인 칼세인을 사용하여 조건에 따른 봉입양을 측정하였다. 리포솜 제조 후에 말토스를 첨가한 리포솜은 수화하는 과정에서 말토스를 첨가하여 제조한 리포솜보다 훨씬 더 안정한 것으로 확인되었다. 말토스를 첨가하지 않은 리포솜은 시간이 지남에 따라 입자의 크기가 커지는 반면, 리포솜 제조 후에 말토스를 첨가한 리포솜은 $4{\sim}37^{\circ}C$에서 30일 동안 안정하다. 또한, 말토스/지질의 물농도 비가 3과 6일 때 상대적으로 가장 높은 안정성을 보였다.

O/W 유제의 물리적 안정성에 대한 PVP의 영향 (Effect of PVP on the Physical Stability of O/W Emulsion)

  • 오인준;이미영;이정민;이용복;신상철;최보길;김종국
    • Journal of Pharmaceutical Investigation
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    • 제27권4호
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    • pp.287-293
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    • 1997
  • To make a stable o/w emulsion, the effects of egg lecithin as an emulsifier and polyvinylpyrrolidone (PVP) as an auxiliary emulsifier on the physical stability of emulsion were investigated. The oil-in-water emulsion system was manufactured by microfluidizer and evaluated the physical stability. Average particle size and size distribution of emulsion was measured by dynamic light scattering analyzer and interfacial tension was measured. From the interfacial tension tested, critical micelle concentration of the egg lecithin was 0.1 %w/v and optimal concentration for the preparation of emulsion was 1.0 %w/v. The mean particle size was about $0.2\;{\mu}m$ which was suitable for injections. The short-term accelerated stability studies were conducted by centrifugation, freeze-thaw method and shaking of the emulsion samples. The addition of PVP was caused the reduction in the particle size and improved the physical stability of emulsion. These results suggested that a mixed interfacial film comprising the egg lecithin and PVP was formed at the o/w interface and it was effective in preventing phase separation under thermic or mechanical stress. We used antineoplaston A10 (A10) as a model drug which is peptide and amino acid derivative having a action to the living organism against the development of neoplastic growth by a nonimmunological progress. It has a poor solubility in water and there may be a difficulty in formulation of A10. Emulsion formulation study about A10 was performed. Solubility of A10 in emulsion was about five times as high as that in water. From the results of solubility and partition coefficient, almost A10 molecules in o/w emulsion exist in the interface between oil and water.

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Effect of Drug Loading on the Physicochemical Properties and Stability of Cationic Lipid-based Plasmid DNA Complexes

  • Jeong, Ui-Hyeon;Jung, Ji-Hye;Davaa, Enkhzaya;Park, Se-Jin;Myung, Chang-Seon;Park, Jeong-Sook
    • Journal of Pharmaceutical Investigation
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    • 제39권5호
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    • pp.339-343
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    • 2009
  • Recently, co-delivery of drug and gene has been attempted for higher therapeutic effects of anticancer agents. In this study, cationic liposomes were prepared using 1,2-dioleoyl-3-trimethylammoniopropane (DOTAP) as a cationic lipid to investigate the effect of drug loading on the physicochemical characteristics of cationic liposomes/DNA complexes. The complex formation between cationic liposomes and negatively charged plasmid DNA was confirmed and the protection from DNase was observed. Particle size of complexes was reduced not by drug loading, but by the increased ratio of cationic lipid to plasmid DNA. Meanwhile, zeta potential of complex was increased by the addition of cationic liposomes to complexes and the effect of drug loading on the zeta potential was not much higher than on particle size. Gel retardation of complexes was indicated when the complexation weight ratios of cationic lipid to plasmid DNA were higher than 24:1 for drug free complexes and 20:1 for drug loaded ones, respectively. Agarose gel retardation showed the similar complexation between plasmid DNA and drug free liposomes or drug loaded liposomes. Both complexes protected plasmid DNA from DNase independent of complexation temperature. From the results, drug loading may affect not the complex formation of cationic liposomes and plasmid DNA, but the particle size of complex.

하수오의 독성평가를 위한 성분분석 및 안정성 시험 (Analysis and Stability Test of the Water Extract and Powder from Polygoni Multiflori Radix for Toxicity Study)

  • 트란환뉴엔크한;한강현;김용범;우미희;김정아;민병선
    • 생약학회지
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    • 제51권1호
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    • pp.86-91
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    • 2020
  • For toxicological evaluation, water extracts and powder from Polygoni Multiflori Radix were made and the component analysis was followed by the Korean Pharmacopoeia method. To verify the stability of the water extract and powder from Polygoni Multiflori Radix used for toxic testing, the stability test was examined after storage at room temperature and in the cold room for one year. Water extract and powder from Polygoni Multiflori Radix were found to be stable for one year. Therefore, the use of the specimen of Polygoni Multiflori Radix after preparation during the animal test turned out to be stable.

흰쥐 생체시료 중 5-플루오로우라실 및 테가푸르의 안정성 (Stability of 5-FU and Tegafur in Biological Fluids of Rats)

  • 장지현;박종국;강진형;정석재;심창구;구효정
    • Journal of Pharmaceutical Investigation
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    • 제34권3호
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    • pp.161-168
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    • 2004
  • 5-Fluorouracil (5-FU) is an antimetabolite anticancer agent active against many types of solid tumors. Tegafur (TF), a prodrug of 5-FU, is frequently used in combination with uracil as dihydropyrimidine dehydrogenase (DPD) inhibitory fluoropyrimidine. We studied the stability of 5-FU and TF in biological fluids of rats and determined their bioavailability (BA) and excretion into bile, and urine. The drug concentrations were analyzed by an HPLC method. At room temperature, there was a 14-30% decrease in the concentration of 5-FU and TF in bile, urine, and plasma specimen at 10 and $100\;{\mu}g/ml$ over 240 min. No significant difference was noted among the sample types or between two different concentrations of 10 and $100{\mu}g/ml$. The decrease in drug concentration was significantly less in samples kept on ice (6-12%) for both drugs. These data indicate that biological fluid samples containing 5-FU or TF in plasma, urine, or bile should be placed on ice during the sample collection. Following these storage guidelines, samples were collected after administration 50 mg/kg of each drug via i.v. or oral route. BA was 1.5 folds greater for TF (60%) than that of 5-FU (42%). Approximately 0.52 and 3.3% of the i.v. doses of 5-FU and TF was excreted into bile, respectively. Renal clearance of 5-FU was about 16% of its total body clearance. These results suggest that instability of 5-FU and TF in biological fluids should be considered in pharmacokinetic or pharmacogenomic studies.