• Microbiology and Biotechnology Letters
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• v.9 no.3
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• pp.117-121
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• 1981

Safety of yellow pigment produced by Monascus sp. CS-2 was evaluated. Acute oral toxicity, pyrogen test, and histamine test, as well as antimicrobial activity were determined. The results obtained were; LD oral in mice was 132.5 mg/20 g, pyrogen test in rabbit was 5 mg/kg, and histamine test in cat was 10 mg/kg. Also the pigment was particularly sensitive to Bacillus subtilis (ATCC 6633), Sarcina lutea (ATCC 9341) and Staphylococcus aureus (ATCC 6538 P), whereas not sensitive to Pseudomonas pyosyanea (ACTC 10490), Bacillus var. mycoides (ATCC 11778), Bordetella bronchiseptica (ATCC 4617) and Staphylococcus epidermidis(ATCC 12228).

• The Korean Journal of Nuclear Medicine Technology
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• v.13 no.3
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• pp.156-158
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• 2009

Purpose: Since radiopharmaceuticals are intended for human administration, it is imperative that we should undergo quality control very strictly. Now almost all the PET laboratories have adopted Bacterial Endotoxin Test as the stand quality control method to monitor whether pyrogen is free or not in the product vial containing crude solution. The aim of this study is to find out the reason why false positive result is observed when using commercially available test vial. Materials and Methods: For this experiment, we used commercially available single test kit (Associates of Cape Code. Inc. USA) and we made pH samples by mixing each buffer whose pH ranges are 1.0 to 12.0. Otherwise we made Ethanol samples diluted with distilled water. After making test samples, it added 0.2 mL to the test vial. Assay mixture in the test vial was incubated in a water bath (Chang Shin Co. KOR) for 60 min at $35{\pm}2^{\circ}C$. Results: After incubation period ($60{\pm}1^{\circ}C$), we inverted the test vial about $180^{\circ}$ To know what pH and how many percentage of Ethanol (Fisher Scientific Korea. Ltd) will affect the reaction. With pH buffer, false positive result was observed at pH 1.0 to 5.0 and 7.7 to 12.6 but at pH 5.2 to.7.5, the test results show negative. It's very strange that we couldn't observe negative test result with Tris buffer at pH 8.4, 8.6, 8.8, 9.0. in other case Ethanol, the test result was seen with 5 to 10% Ethanol. But to my surprise we could see very thick gel formation with 100% Ethanol. Conclusions: In this study, we could notice that pH which is too much acidic or alkalic or high concentrated Ethanol would affect Bacterial Endotoxin Test result. As you know, LAL test is sensitive and very reliable method. Therefore, we are needed to elicit the accurate test result as possible as we can.

• Journal of Microbiology and Biotechnology
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• v.6 no.3
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• pp.189-193
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• 1996

Submicron-sized polymeric particles (SSPP) were used to remove nucleic acids and endotoxins from cell lysates. The positively charged SSPP selectively adsorb nucleic acids and endotoxins and form complexes with them. The complexes can be easily removed by sedimentation or centrifugation. The removal of nucleic acids and endotoxins using SSPP also can be accomplished in the presence of cell and cell debris. Therefore, nucleic acids and endotoxins can be removed in an initial step of the down-stream processes. In bakers yeast and E. coli lysate systems, the level of DNA could be reduced more than three orders of magnitudes and endotoxins more than seven orders of magnitudes concurrently willi the cell debris removal process using SSPP.

• Journal of Pharmaceutical Investigation
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• v.10 no.3
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• pp.27-32
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• 1980

This paper was to investigate the biovailability of antipyrine, ampicillin and protein binding in pathological rats and rabbits pretreated with typhoid vaccine. The results are as follows: The absorption of antipyrine and ampicillin respectively were reduced in rats pretreated with typhoid vaccine as compared with those of normal rats. Especially absorption of ampicillin was more decreased than those of antipyrine. The blood level of antipyrine in severe state was decreased but in mild state. Blood level of ampicillin was decreased in mild state as well as in severe state. Relative bioavailability of antipyrine and ampicillin were mostly decreased in rabbits pretreated with typhoid vaccine except that of antipyrine in mild state. Renal clearance of antipyrine was not affected, but that of ampicillin was apt to increase. Protein binding of antipyrine and ampicillin were decreased by high concentration of typhoid vaccine.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.04a
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• pp.12-12
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• 1997

CFC-222 is a novel fluoroqinolone antibacterial agent synthesized and under development by the Cheil Jedang Corporation, Korea. CFC-222 exerts the antibacterial activity by inhibition of bacterial DNA gyrase leading to bactericidal action. In in vitro and in vivo preclinical testing, CFC-222 has been shown to possess a broad spectrum of antibacterial activity. In particular CFC-222 is very potent against Gram-positive bacteria such as Staphylococcus spp., Streptocuccus spp. (in particular penicillin G-resistant and -susceptible S. pneumoniae) and Enterococcus spp. when compared to other quinolones (ciprofloxacin, ofloxacin or lomefloxacin). CFC-222 also showed potent activity against the methicillin resistant clinical isolates of S. aureus (MRSA). Against Gram-negative bacteria (E. coli, Pseudomonas and Sarcina) the activity of CFC-222 was slightly weaker than that of ciprofloxacin, but was more potent than that of ofloxacin or lomefloxacin. In urinary systemic infections caused by both Gram-positive and -negative bacteria, CFC-222 demonstrated a potent therapeutic efficacy in particular against Cram-positive bacteria S. aureus, S. pyrogen 203 and S. pneumonia TypeIII.

• Journal of Environmental Health Sciences
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• v.5 no.1
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• pp.1-9
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• 1978

Biological safety, physico-chemical and microbiological experiments were carried out in order to study the possibility of radiation sterilization on medical products, such as polyethylene and polystyrene bottles, gauze sponges and surgical silk suture. Results are as follows: 1. Biological test on plastic samples as to acute systemic toxicity, eye irritation, skin irritation, pyrogen, haemolysis showed satisfactory results. But physico-chemically, the oxidizable matter, nonvolatile residues, residue on ignition seemed to be increased slightly in irradiated samples, though the experimental results were within the range of U.S.P. 19, N.F. and K.P. III. 2. After irradiation, both plastic and gauze sponges showed considerable decrease in pH. 3. Most medical products were sterilized by 1.5 Mard. For the sterilization of the suigical silk suture, 4.5 Mrad is required dul to its radiation resistant micro-organisms. 4. Biologically, total dose of 2.5 Mrad was safe enough to sterilize the medical products, and physico-chemically the results are acceptable according to U.S.P. 19 and K.P. III. However, better results may be expected when the quality of material and additives are improved.

• Korean Journal of Oriental Medicine
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• v.2 no.1
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• pp.129-145
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• 1996

According to the Medical Product Safety Administration Guidelines for safety assessment guinea pigs, mice and rats were used for antigenicity test, rabbits for pyrogenic test and hymolytic test. The results were summarized as follows; 1. The antigenicity test of Red-ginseng radix extract solution for herb-acupuncture did not show any anaphylatic shock but produced IgE in high dose group. 2. The result of the pyrogen test of Red-ginseng radix extract solution for herb-acupuncture was negative. 3. The result of the hemolytic test of Red-ginseng radix extract solution for herb-acupuncture were negative in low and middle dose group but was positive in high dose group.

• The Microorganisms and Industry
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• v.20 no.2
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• pp.33-40
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• 1994

미생물에 대한 유전자 재조합법 등의 개발로 동물세포에서만 합성되던 단백질들을 미생물을 통하여 생산하는 기술이 확립되어 있으나, 동물 세포내에서만 정확하게 실행되어지는 단백질 분자의 folding과 post-translational modification 등이 미생물에서는 불완전하게 이루어져 활성을 잃게 되는 단점이 있고, pyrogen과 같이 미생물로부터 유래한 endotoxin이 생산물에 섞여 있을수도 있으며, 미생물로부터 생산되는 각종 단백질로부터 원하는 유용 단백질을 분리하기 어려운것 등, 현실적으로 많은 어려움을 가지고 있기 때문에 미생물을 이용하기보다 동물 세포 배양을 통하여 위와 같은 제재들을 생산하려 하고 있다. 유전자 재조합 기술은, 현재 미생물뿐만 아니라, 동,식물 세포에 대하여도 적용되어 있어서 각종 유용생산물을 동,식물세포의 유전자 조작을 통해 얻을 수 있는 단계에 와 있으며, 이는 유전자 치료(gene therapy)와 같은 의료분야에까지 확장될 수 있게 되었다. 표 2에서는 동물 세포를 배양할 때와 미생물을 이용할 때의 각각의 특징을 보여주고 있다.

• Journal of Chest Surgery
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• v.17 no.1
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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.

• Proceedings of the Korean Institute of Surface Engineering Conference
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• 2017.05a
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• pp.77-77
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• 2017

Titanium and its alloys offer attractive properties in a variety of applications. These are widely used for the field of biomedical implants because of its good biocompatibility and high corrosion resistance. Titanium anodizing is often used in the metal finishing of products, especially those can be used in the medical devices with dense oxide surface. Based on SAE/AMS (Society of Automotive Engineers/Aerospace Material Specification) 2488D, it has the specification for industrial titanium anodizing that have three different types of titanium anodization as following: Type I is used as a coating for elevated temperature forming; Type II is used as an anti-galling coating without additional lubrication or as a pre-treatment for improving adherence of film lubricants; Type III is used as a treatment to produce a spectrum of surface colours on titanium. In this study, we have focused on Type II anodization for the medical (dental and orthopedic) application, the anodized surface was modified with gray color under alkaline electrolyte. The surface characteristics were analyzed with Focused Ion Beam (FIB), Scanning Electron Microscopy (SEM), surface roughness, Vickers hardness, three point bending test, biocompatibility, and corrosion (potentiodynamic) test. The Ti-6Al-4V alloy was used for specimen, the anodizing procedure was conducted in alkaline solution (NaOH based, pH>13). Applied voltage was range between 20 V to 40 V until the ampere to be zero. As results, the surface characteristics of anodic oxide layer were analyzed with SEM, the dissecting layer was fabricated with FIB method prior to analyze surface. The surface roughness was measured by arithmetic mean deviation of the roughness profile (Ra). The Vickers hardness was obtained with Vickers hardness tester, indentation was repeated for 5 times on each sample, and the three point bending property was verified by yield load values. In order to determine the corrosion resistance for the corrosion rate, the potentiodynamic test was performed for each specimen. The biological safety assessment was analyzed by cytotoxic and pyrogen test. Through FIB feature of anodic surfaces, the thickness of oxide layer was 1.1 um. The surface roughness, Vickers hardness, bending yield, and corrosion resistance of the anodized specimen were shown higher value than those of non-treated specimen. Also we could verify that there was no significant issues from cytotoxicity and pyrogen test.