• 제목/요약/키워드: sterile preparation

검색결과 12건 처리시간 0.019초

유산균(乳酸菌) 혼합(混合) 제제(製劑)의 안정성(安定性) 및 분리(分離) 정량(定量)에 관한 연구 (Studies on Stability and Quantitation of a Mixed Preparation of Lactic Acid Bacteria)

  • 김정우;최응칠;김병각
    • 생약학회지
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    • 제15권1호
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    • pp.39-42
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    • 1984
  • To examine stability and a separate quantitative method of a mixed preparation of lactic acid bacteria, a capsule containing Lactobacillus acidophilus, Lactobacillus bulgaricus and Streptococcus thermophilus was suspended and diluted in sterile water. After the diluted suspension was spread on three media of tryptone glucose extract agar, MRS agar and MRS-sucrose agar, their colonies appeared and were counted. The viable counts exceeded the minimum number of the three bacteria and showed that the mixed preparation was stable at least for 18 months. The results also showed that a separate quantitation of viable cells of the each strain was feasible.

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정맥영양의 조제와 감염관리 (Infection Control in Parenteral Nutrition Preparation and Compounding)

  • 최지형;백진희;조윤희;조윤숙
    • Journal of Clinical Nutrition
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    • 제10권2호
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    • pp.31-37
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    • 2018
  • Recently, in Korea, the importance of preparation and use of injectable drugs has been emphasized due to successive fatal accidents caused by injection infections. Parenteral nutrition (PN) has also been identified as a cause of infection. Cases of infection due to PN have been reported not only in Korea, but also abroad, and contamination occurs mainly during the preparation of PN. Because sterile preparation and compounding of injections are very important for infection control and patient safety, this article reviews the major guidelines outlined thus far. The Korea Ministry of Food and Drug Safety in 2006 published guidelines and the KSHP (Korean Society of Health-System Pharmacists) recently issued guidelines for the aseptic preparation of injections. In addition, as US guidelines, the ASHP (American Society of Health-System Pharmacists) guidelines and United States Pharmacopeia (USP) <797> are also reviewed. The recent guidelines published by the KSHP have significance in that they were adopted in accordance with the domestic reality, even though they conform to foreign guidelines, and are expected to be guidelines for hospital pharmacists performing aseptic preparation work. In addition, the Korea Ministry of Health and Welfare is considering appropriate guidelines for the safe management of medications, training staff for infection prevention and strengthening staff capacity. Furthermore, the gradual expansion of aseptic compounding facilities and human resources, as well as the provision of adequate medical costs are also considered. Based on the establishment and standardization of injectable drugs compounding guidelines for Korean hospitals, it is believed that if human resources and facilities are supported and medical charges are improved, it will be possible to expect the safer preparation and use of injections.

N-13 암모니아 주사액 제조 시 멸균필터의 흡착율 차이에 관한 비교 평가 (Studies on sterile filters in the preparation of N-13 ammonia injection)

  • 오창범;김시활;차민정;신진;지용기;최성욱
    • 핵의학기술
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    • 제23권1호
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    • pp.64-68
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    • 2019
  • 기존에 Millex GS 멸균 필터를 사용하여 방사성 의약품 N-13 암모니아 주사액 제조 시 많은 양의 방사성 의약품이 멸균 필터에 흡착되어 있었다. 이에 Satorious의 Minisart 멸균 필터를 사용하여 흡착률의 차이를 확인하고 합성 수율을 증가시키고자 하였다. 실험 대상은 Millex GS 필터와 Satorious Minisart 필터를 대상으로 하였으며 제조된 N-13 암모니아를 각각의 멸균 필터에 통과시킨 후 선량계를 이용하여 흡착률을 구하였다(n=10). 그리고 품질 관리 시험을 시행하여 본원 기준에 적합한지 확인하였다. 실험 결과 Millex GS와 Sartorious Minisart 필터에 각각 $71.0{\pm}17.6%$$19.1{\pm}3.2%$ 흡착되었다. 필터를 제거한 product vial에는 Millex GS와 Sartorious 각각 $29.0{\pm}17.6%$$80.9{\pm}3.2%$ 여과되었다. 여과된 암모니아 주사액의 양은 GS 필터보다 Minisart 필터를 사용할 때 약 2.8배 더 많이 획득할 수 있었다. 각 멸균 필터를 통과한 N-13 암모니아 주사액의 방사화학적 이물, 화학적 이물, 이 핵종, pH, 엔도톡신, 무균 시험 등 품질 관리 시험 결과 본원 기준에 적합하였다. Millex GS 필터의 얇은 막은 mixed cellulous easter(MCE)로써 acetic acid, sulfic acid, anhydride에 추가로 Nitrocellulose가 약 80%의 비중을 차지하고 있는 필터이다. 때문에 Nitrocellulose가 포함되지 않은 CA계열인 Sartorious Minisart 필터보다 여과할 수 있는 성능은 Millex GS가 우수하나, 품질시험의 평가상 Satorious Minisart 필터를 사용하여도 문제가 없을 것이다. 따라서 N-13 암모니아 주사액 제조 시, Satorious Minisart 필터를 사용함으로써 필터 흡착으로 인한 손실을 최소화하고, 비용도 절감 할 수 있으며, 보다 안정적으로 N-13 암모니아 주사액을 제조 할 수 있을 것으로 생각한다.

수동과 엔진구동형 기구를 이용한 난원형 근관의 형성에 관한 주사전자현미경적 관찰 (A SEM OBSERVATION ON THE EFFICIENCY PREPARATION OF OVAL CANALS USING HAND AND ENGINE-DRIVEN INSTRUMENTS)

  • 송욱;허복;이희주
    • Restorative Dentistry and Endodontics
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    • 제29권2호
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    • pp.141-146
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    • 2004
  • The purpose of this study was to evaluate the efficiency of the preparation of oval canals using hand and engine-driven instruments with SEM observation. Thirty single-rooted teeth with oval canal were used in this study. The teeth were divided into 3 groups. In group A the teeth were instrumented up to a size 35 K-file using RC-prep and irrigated with 5% NaOCl between each file size. In group B. the teeth were instrumented with Profile according to the manufacture's instructions using RC-Prep and irrigated with 5% NaOCl between each file size. In group C. the teeth were instrumented with GT file according to the manufacture's instructions using RC-prep and irrigated with 5% NaOCl between each file size. Then. in all teeth. a final flush of 5ml of distilled water delivered for 30s. Canals were dried with sterile standardized paper points. After preparing the canals, the teeth were sectioned along their mesial and diatal surfaces by using low-speed diamond disc. chisel and mallet. Each root section was then dehydrated in graded concentration of alcohol (70, 80, 90, 100%). mounted on an aluminum stub. sputter-coated with gold-palladium and observed with scanning electron microscope (HITACHI S-4200) in middle and apical area. The results of this study were as follows: 1. In the middle area. group B and group C showed less smear layer than group A and it was statistically significant (p < 0.05). 2. In the middle area. group B showed greater smear layer than group C. but it was not statistically significant (p > 0.05). 3. In the apical area, group C showed less smear layer than group A. and it was statistically significant (p < 0.05). 4. In the apical area. group A showed greater smear layer than group B. but it was not statistically significant (p > 0.05). 5. In the apical area. group B showed greater smear layer than group C. but it was not statistically significant (p > 0.05). 6. In all groups. the middle area was less smear layer than the apical area. and it was statistically significant (p < 0.05).

기본간호실습 교육 현황 및 실습교육 필요도 (Content and Educational Needs for Fundamental Nursing Practice)

  • 김경희;장성옥;강현숙;김금순;김종임;김화순;박진희;엄미란;윤미선;이옥철;원종순
    • 기본간호학회지
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    • 제18권4호
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    • pp.506-519
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    • 2011
  • Purpose: The purpose of this study was to identify content of Fundamental Nursing Practice (FNP) and the educational needs for nursing practice items in schools of nursing. Methods: Participants were 81 professors who were teaching FNP and 166 clinical nurses. The research questionnaire included 148 practice items, which were selected by content analysis of 7 FNP textbooks. Data were collected from May 20 to July 27, 2011 and analyzed using descriptive statistics and t-test with SPSS 17.0. Results: The research findings showed that : 1) the seven items included in the education content of all schools of nursing were putting on sterile gloves, checking radial pulse, checking blood pressure in the arm, Foley catheterization, injection preparation with ampule, intramuscular injection in the buttocks, and mixing intravenous fluid. Fifty items were included in the content in more than 80% of the schools. 2) Educational domains needing emphasis were medication, infection control, health assessment, oxygenation, urinary elimination, activity/positioning, and nutrition. There were significant differences in reported educational needs between professors and clinical nurses for 62.8% of practice items. Conclusions: Results indicated that standardization of FNP education contents using the findings of this study should lead to improvement in quality of FNP education.

병원약국 대상으로 정맥영양제 조제 실행에 관한 연구-2009 (Survey of Pharmacy Practice for Compounding Parenteral Nutrition in Hospital Setting - 2009)

  • 신혜연;정기화
    • 약학회지
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    • 제54권4호
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    • pp.244-251
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    • 2010
  • Standardized parenteral nutrition is required to improve patient's safety, clinical appropriateness and to increase uniformity between institution and institutions. We assessed the consistency with the American society for parenteral and enteral nutrition (A.S.P.E.N.) practice guideline for PN by evaluating current practice process for parenteral nutrition formulation in inpatients pharmacies in Korea. Each question in this survey was based on 2007 A.S.P.E.N. recommendations of standard parenteral nutrition formulation, the American society of health-system pharmacists (ASHP), and the United State Pharmacopoeia (USP) Chapter 797 guideline for compounding parenteral nutritions. All 90 Korean society of hospital pharmacist (KSHP) member directors of pharmacy were requested to respond to the survey in order to compare the survey results to ASHP national survey of pharmacy practice in hospital settings (2002) in compliance with A.S.P.E.N. guideline. We had final response rate of 35.6%. 25 (100%) hospitals complied with this Garb guideline (response rate was 84.4%) which was the highest compliance. Only 17.9% of hospital pharmacies were actively involved in complications monitoring. Monitoring complications and efficacy were least in compliance with the A.S.P.E.N. guideline. 69.0% of Korean pharmacists adjusted medication dosage based on disease state or monitoring laboratory data in compliance with the A.S.P.E.N. guideline. Over 50% of the hospital pharmacies failed to provide and evaluate staff training in aseptic manipulation skills periodically. Korean hospital pharmacies need to comply with the standard practice guideline for compounding sterile preparation in order to provide better quality of parenteral nutrition service for specific patient population.

Cytotoxic, Antioxidative, and ACE Inhibiting Activities of Dolsan Leaf Mustard Juice (DLMJ) Treated with Lactic Acid Bacteria

  • Yoo Eun-Jeong;Lim Hyun-Soo;Park Kyung-Ok;Choi Myeong-Rak
    • Biotechnology and Bioprocess Engineering:BBE
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    • 제10권1호
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    • pp.60-66
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    • 2005
  • This study was performed to know whether there is any change of physiological activity in DLMJ which is inoculated by lactic acid bacteria. Lactic acid bacteria were isolated from Dolsan leaf mustard Kimchi (DLMK) at $20^{\circ}C$. In the optimum ripening period, the population of Leuconostoc and Lactobacilli in the DLMK were found to be high. The Leuconostoc, Lactobacilli and Lactococci strains were identified as Leuconostoc mesenteroides, Leuconostoc gelidum, Weissella confusa, Lactobacillus plantarum, Lactobacillus raffinolactis, Lactococcus lactis and Weissella confusa using the Biolog system. The most predominant strain which was isolated from DLMK was Weissella confusa. As the results of the phylogenetic analysis using 16s rDNA sequence, the Weissella confusa turned out to be Weissella kimchii, with 99.0% similarity. To investigated the change of physiological activity in DLMJ by lactic acid bacteria, 7 predominant strains inoculated to DLMJ (Dolsan Leaf Mustard Juice). The cytotoxicity was found to be under $19.55\%$ all cases. Also, the antioxidative activity of the DLMJ treated with lactic acid bacteria was very low, which might have been due to the reduced antioxidative phytochemicals during the preparation of the sterile sample. The ACE inhibiting activity of DLMJ by inoculation with Weissella kimchii was shown to be the highest ($94.0\%$). This could be that the degradation of sulfur containing materials in DLMJ by Weissella kimchii gave rise to ACE inhibiting activity.

Experimental development of caprine enterotoxaemia with Clostridium perfringens type D whole culture in natural host and its treatments

  • Islam, Kbms;Rahman, Md Sidiqur;Ershaduzzaman, Md.;Taimur, Mjfa;Song, Hee-Jong
    • 한국동물위생학회지
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    • 제30권2호
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    • pp.219-231
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    • 2007
  • The effects of intraduodenal administration of Clostridium perfringens type D whole culture in goats were evaluated to develop a reliable experimental model of enterotoxemia in this species and the eventual evaluation of treatment with different drug preparations was also carried out. A total of 28 conventionally reared healthy unvaccinated black bangle goat kids of 6-12 months of age were dosed intraduodenally with whole cultures of C peliringens type D. Four kids were used as controls and received sterile, nontoxic culture medium intraduodenally. All animals received starch solution into the abomasum. The clinical signs developed within 12 hours of post inoculation that were similar to those observed in naturally occurring cases. Among the clinical signs, diarrhea was most common (96.43%) followed by dyspnea (53.57%) and central nervous system (CNS) signs (25.0%). The most striking postmortem findings consisted of necrotizing pseudomembranous colitis (100.0%), lung edema (69.23%) and fluid filled intestines (61.53%). The protocol thus provided a reasonable model of naturally occurring enterotoxemia in goats, producing a range of clinical signs and postmortem changes similar to those observed in the natural disease. Beside this, treatment trial with different drug preparations showed penicillin combined with antitoxin was most effective (100.0%), followed by combination of oxytetracyclin with antitoxin, and combined preparation of antitoxin and sulfur drugs both showed 75% recovery rate. On the other hand, treatment with antitoxin, penicillin and oxytetracycline singly could protect goat enterotoxaemia only 25.0%, 50.0% and 50.0%, respectively. Thus in the present study, it eas observed that antisera in combination of antibiotics gave better recovery rate than the antitoxin or antibiotics alone.

한국산 P.V.C.의 생물학적 안정도 및 적합성에 대한 실험적 고찰 (An experimental study on the biological safety and compatability of P.V.C. made in Korea)

  • 선경
    • Journal of Chest Surgery
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    • 제17권1호
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    • pp.157-166
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    • 1984
  • These biologic test procedures are designed to test the suitability of P.V.C. made in Korea intended for parenteral preparation, which were based on the U.S. Pharmacopeia XIX "Biologic Test-Plastic Container", Official from July 1, 1975. Healthy adult human blood and rabbits weighing 2\ulcorner.2Kg were used for test materials. Sample P.V.C. were sampled from the medical equipments made in Korea randomly and Control P.V.C. were sampled from the standardized Cobe and Polystan P.V.C. tubes. P.V.C. extract was prepared from a homogeneous P.V.C. samples by incubating 60 square centimeters of the sample per 20 millimeters of sterile pyrogen-free saline at 70\ulcorner for 72 hours or autoclaving at 120\ulcorner for 1 hour. The Implantation Test was designed to evaluate the reaction of living tissue to the plastic by the method of the implantation of the Sample itself into animal tissue. The Systemic Injection Test, the Intracutaneous Test, and the remainders were designed to determine the biological response of animals to plastics by the single-dose injection of specific extracts prepared from a Sample. The results are as follows; 1.Implantation Test - No significant difference for reactions was noted between the Sample treated animal and the Control after 72 hours of implantation. 2.Systemic Toxicity Injection Test - No sign of toxicity and/or death immediately after injection and at 4, 24, 48 hours respectfully after injection. 3.Intracutaneous Test - None of the animals treated with the Sample showed a significantly greater reaction than the observed in the animals treated with Blank. 4.Pyrogen Assay-Only one animal treated with the Sample showed the maximal rise of rectal temperature about 0.2\ulcorner after 3 hours of injection, but remainders showed no change. 5.Hemolytic Index - The positive Control tube of distilled water exhibited complete hemolysis while the negative Control tube and P.V.C. extract were negative demonstrating no hemolysis. 6.Cell Morphology of Erythrocytes and Leukocytes on Stored, Heparinized Human Blood -- There was no significant difference in the morphology of either the Control or Sample extract. 7.Clotting Mechanism of Human Blood in vitro - After allowing to the P.V.C. extract at room temperature for 5 Hours and at 10\ulcorner for 24 hours, there was no appreciable difference in Prothrombin Time under these conditions. 8.Clotting Mechanism of Rabbit in vivo - At the termination of 5 days after intraperitoneal injection of the P.V.C. extract, no significant changes in Clotting Time were observed. According to the above results, it could be concluded that the P.V.C. made in Korea was acceptable for parenteral preparation, especially treated with physiologic saline and/or human blood.man blood.

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점봉산 거제수나무에서 분리한 차가버섯의 배양특성 (Cultural characteristics of Inonotus obliquus isolated from Betula costata at Mt. Jumbong in Korea)

  • 박현;이봉훈;박원철
    • 한국버섯학회지
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    • 제3권2호
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    • pp.71-74
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    • 2005
  • 차가는 배양균사로부터 위염, 위궤양 및 여러 가지 암에 효력을 나타내는 것으로 알려진 베풍긴(befungin) 약제의 생산을 위하여 사용되고 있다. 차가는 자작나무 줄기에서 주로 생산되는 것으로 알려져 있는데, 우리나라의 경우 자작나무 자생지는 해발고도 1,100m 이상에만 나타난다. 하지만, 우리는 점봉산의 거제수나무에서 차가버섯을 채집할 수 있었으며, 스트렙토마이신을 첨가한 PDA 배지를 이용하여 균주를 분리할 수 있었다. 차가 균은 5개 부위 중 차가 균으로 만연된 나무조직에서 분리될 뿐 다른 부분에서는 분리가 어려웠다. 균핵에서 확인한 포자는 $6.0{\sim}10.0{\times}4.5{\sim}6.0{\mu}m$ 크기를 나타내었고, 균사 굵기는 $2.5{\sim}5.0{\mu}m$ 이었다. 실내 배양에서 균총은 불규칙한 모양을 띄며, 시간이 경과할수록 균총의 중간 중간이 노란색으로 변색되었다. 약 20일이 경과하면 노란색으로 변색된 부분에서 적갈색의 강모(setae)를 확인할 수 있으며, 강모의 크기는 $4{\sim}6{\times}100{\sim}420{\mu}m$ 이었다. 차가의 균사생장에 가장 좋은 배지는 OA(oatmeal agar)이었다. 적합한 온도 범위는 $25{\sim}30^{\circ}C$이었으며, 균사생장에 적합한 pH는 8.0~9.5로 비교적 높은 산도를 좋아하는 것으로 나타났다.

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