• Journal of Pharmaceutical Investigation
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• 제16권2호
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• pp.85-88
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• 1986

To estimate the effect of some injectable antibiotics (ampicillin sodium, cefazolin sodium, cephaloridine, cefuroxime sodium and chloramphenicol sodium succinate) on pyrogen tests, the Limulus amebocyte lysate (LAL) test and an ultrafiltration technique were used. The rabbit pyrogen test was also used in the case of cafazolin sodium. At high antibiotic concentrations, these samples which were artificially contaminated with endotoxin inhibited the gelation reaction of LAL. But the gelation reaction occurred when most of the antibiotic was removed by ultrafiltration. Likewise, cefazolin sodium interfered not only with the LAL test but also with the rabbit pyrogen test. From these results it can be said that special modification to eliminate interference should be taken into consideration for valid method of pyrogen tests in the parenteral products containing these antibiotics.

• Journal of Microbiology and Biotechnology
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• 제16권2호
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• pp.219-225
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• 2006

The rabbit pyrogen test and Limulus amoebocyte lysate (LAL) assay have been used to detect endotoxins present in vaccines. Currently, the rabbit pyrogen test is used to detect endotoxins in hepatitis B (HB) vaccines, even though the HB surface protein, which is the active ingredient, is overexpressed in and purified from eukaryotic cells that lack these endotoxins. Although the LAL clot assay is sensitive and reliable and can be used to replace the rabbit pyrogen test, its reaction is limited by the lack of responsiveness to the Gram-positive bacterial components. Furthermore, aluminum hydroxide in the HB vaccine can interfere with the LAL assay. In contrast, macrophages can detect the endotoxin as well as other pyrogens, and secrete $TNF-{\alpha}$. Therefore, this study was undertaken to examine the possibility of replacing the animal tests with a more efficient $TNF-{\alpha}$ secretion assay. With this in mind, we determined if aluminum hydroxide in the HB vaccines affects the $TNF-{\alpha}$ secretion assay. HB vaccines and the HB protein solutions spiked with lipopolysaccharide (LPS) produced the same level of dose-dependent $TNF{\alpha}$ secretion and temperature increase in rabbits, indicating that aluminum hydroxide in the HB vaccine does not interfere with the pyrogenic response in rabbits, nor does it interfere with $TNF-{\alpha}$ secretion. In addition, the $TNF-{\alpha}$ assay was found to be more sensitive than the LAL assay, and correlated well with the pyrogen test and the LAL assay. These results suggest that the $TNF-{\alpha}$ assay in RAW264.7 cells is a good substitute for the current pyrogen assays that are used for detecting LPS in HB vaccines as well as in other vaccines containing aluminum.

• 약학회지
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• 제43권5호
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• pp.606-613
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• 1999

To survey the possibility of replacing the pyrogen test with Limulus Amebocyte Lysate(LAL) test and to find out a standard methods suitable to our blood products made in Korea, 100 samples of 20% human serum albumin were tested by commercial LAL test kits and results of those were compared with rabbit pyrogen test. The LAL test is used both dinetic-chromogenically and kinetic-turbidimetrically. Both methods equally showed broad detection range (5.0~0.005 EU/ml), excellent sensitivity ($\geq$ 0.005 EU/ml) and predominant recovery rate within valid dilution range, but kinetic-turbidimetric method seemed to be more reproducible than kinetic-chromogenic method(kinetic-chromogenic method : S.D. = 15.88, kinetic-turbidimetric method : S.D. = 8.12). After heating the sample at 75$^{\circ}C$ for 15 min, the results showed a little elevated recovery rate with both methods. After performing the test on 100 albumin samples with both kits, the results were analysed using the USP standard (1.33 EU/ml). 7% of samples in kinetic-chromogenic methods and 1% of samples in kinetic-turbidimetric method exceeded the limit of endotoxin levels regulated for blood products in USA. Because this phenomenon was not observed in both methods at the same time and both methods have high sensitivity ($\geq$0.005 EU/ml), these results seemed to depend on nonspecific reaction. Considering its sensitivity and reproducibility, we could assure that LAL test is proper to detecting pyrogenic with good sensitivity.

• Clinical and Experimental Pediatrics
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• 제50권2호
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• pp.121-126
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• 2007

Fever has been recognized as a cardinal feature of disease since antiquity, but only recently has the pathophysiology of fever come to be understood. It became clear that the ultimate cause of fever is not a bacterial product (a so-called exogenous pyrogen) but a product of host inflammatory cells (i.e., an endogenous pyrogen). Many studies have demonstrated that mononuclear phagocytes are the principal source of endogenous pyrogen and that a variety of mononuclear cell products can mediate the febrile response. Cytokines are also important as mediators of the acute-phase response to infection and inflammation.

• 한국추진공학회:학술대회논문집
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• 한국추진공학회 2008년 영문 학술대회
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• pp.301-306
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• 2008

A pyrogen igniter was designed to satisfy the required condition of kick motor system for the space launch vehicle. We analyzed the ignition characteristics and performed the combustion tests to verify the internal ballistic performance. In the design process, the arc-image test was carried out to find the sufficient heat flux as varying the initial pressure from 10 to 700kPa. The analysis indicated that the initial pressure condition would delay ignition time within a range from 100 to 500ms. The combustion test with an inert chamber was also performed to understand the ignition characteristics with the variation of the initial pressure of free chamber volume. Finally, we confirmed that the igniter could provide the acceptable energy to ignite the propellant of kick motor at the ground test. The result of the ground tests showed that the ignition delay time was within the design range at the atmospheric pressure condition.

• Toxicological Research
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• 제4권2호
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• pp.181-188
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• 1988

This study was carried out to investigate whether the use of the high endotoxin-sensitive or the low endotoxin-sensitive rabbits (New Zealand White strain) are more suited for the pyrogen test regulated by the Korean Pharmacopeia and United State Pharmacopeia. The results obtained were as follows. 1. The ferbrile responese were increased according to increased endotoxin doses used (i.e., 0.1, 1, 5, 10ng/kg) and the febrile responses reached to its maximum between 90 mins and 120 mins after the intravenous injection of endotoxin.

• 대한핵의학회지
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• 제1권1호
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• pp.83-87
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• 1967

$^{131}I$ 및 $^{125}I$를 함유(含有)하는 Hippuran, L-Thyroxine, Triiodothyronine, Rose Bengal, RISA, MAA, Triolein, Oleic acid 및 주사용(注射用) 옥소액(沃素液_의 합성방식(合成方式)과 $^{203}Hg$을 함유(含有)하는 Neohydrine의 합성방식(合成方式)을 각각(各各) 연구(硏究)하여 표지수율(標識收率) $100{\sim}60%$의 좋은 결과(結果)를 얻었다. 합성방식(合成方式)에서는 교환법(交換法), 옥화법(沃化法)을 사용(使用)하였고 특(特)히 Chloramin-T를 이용(利用)한 저온(低溫) 옥화반응(沃化反應)을 이용(利用)하였다. 합성품(合成品)의 제제법(製劑法) 및 pyrogen free 시험결과(試驗結果)를 기술(記述)하였으며 당연구소(當硏究所)에서의 제품분배(製品分配) 상황(狀況)을 보고(報告)하였다.

• 미생물학회지
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• 제11권4호
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• pp.181-188
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• 1973

For the bulk sterilization, there are two traditional methods of autoclaving and exposure to ethylene oxide. However, autoclaving involves high temperatures and pressures and ethylene oxide is chemically highly reactive, so these methods are radiation, we have carried out sterility and safety tests on some medical products irradiated at varying radiation levels. The results obtained were as follows ; 1) The minimum dose of radiation for the sterilization of medical products was 2.5 Mrad. 2) The radiosterilization dose varied depending on the initial population of microorganisms. 3) In transfusion sets, a level of radiation of 2.5Mrad at room temperature produced no pyrogen and they remained bacteriologically sterile.

• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of the Pharmaceutical Society of Korea
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• pp.221.1-221.1
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• 2001

• 대한약학회:학술대회논문집
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• 대한약학회 2000년도 춘계총회 및 학술대회
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• pp.202.2-202.2
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• 2000