• 대한한의학회지
• /
• 제25권3호
• /
• pp.180-190
• /
• 2004

Objectives : To present criteria for acupuncture standardization, which will improve quality of acupuncture and secure safety, through studies of the biocompatibility of acupuncture materials. Methods : Acupuncture needles distributed in Korea were studied. Intracutaneous reaction tests and sterility tests were executed to study the biocompatibility of acupuncture. Results & Conclusions : All 4 kinds of acupuncture needles distributed in Korea were found suitable for medical use, through intracutaneous reaction tests and sterility tests. However, the medical instrument standards of the Korea Food and Drug Administration lack criteria concerning intracutaneous reaction tests and sterility tests. The criteria for these tests should be standardized in order to secure the biocompatibility of acupuncture needles.

• 동의생리병리학회지
• /
• 제27권1호
• /
• pp.26-33
• /
• 2013

The present study explored studies directed at elucidating the effectiveness of Korean medicine in the treatment of sterility and systematically analyzed the trends of studies on sterility. The standardization and objectification based on results for this study may contribute to the development of effective Korean medicine in reducing sterility. In the annual tendency of sterility-related clinical studies, the number of papers began to increase rapidly from 2000, and 15 papers were published from 2000 till 2011. Then, in the technical journals publishing them, The Journal of Oriental Obstetrics & Gynecology published 13 the most papers. In the institutions to which the first authors belonged, Dongguk University Hospital had 5 the most papers. In the number of test subjects was also analyzed and as the result the studies with 1~9 were the most as 10. In the study design analysis, there were 10 case reports, 5 case series and 4 before and after studies. In the analysis of intervention methods, there were 10 papers where only the Korean medicines were given, next 6 papers where the acupuncture and moxibustion were added, and 3 papers where the Korean medical therapies and other subsidiary therapies were used. In the analysis on the existence of pattern identification, there were 12 papers with the pattern identification, 6 without the pattern identification and 1 with the four constitution identification. In the IRB approval, 18 or most papers had not received the IRB approval and just 1 paper got the IRB approval. When the sterility-related clinical studies published in the Korean medical journals were surveyed, it turned out that there are no RCT studies and there is just one study with the IRB approval. And there were 6 papers without the pattern identification of Korean medicine. So, it seems necessary in the future to improve the papers in these respects for the development of Korean medicine sterility treatment with a good basis through the more systematic and accurate study method.

• 핵의학기술
• /
• 제12권1호
• /
• pp.74-77
• /
• 2008

The radiopharmaceuticals are routinely injected to blood vessel for acquiring PET image. For this reason, It is imperative that they undergo strict quality control measures. Especially, Sterility test is more important than any other quality control procedures. According to the FDA guideline, It requires filter integrity test used in the processing of sterile solutions. Among several methods, we can decide to use bubble point test. We usually use vented GS-filters (Millipore co., USA) which are sterilizinggrade (0.22 um pore size) and are placed upper site on product vial. After the synthesis of $^{18}F$-FDG, solutions wet the membrane in filter and then go into the product vial. By all synthesis steps have finished, we can observe the presence of the bubbles in the product vial. Since we have started this study, we have never found any bubbles in the product vial. Because the maximum pressure intensity of the filter which has set by manufacturer is up to 5 bars, but helium gas pressure is up to 1 bar in our module system. So, we can make 5 bars pressure using helium gas bombe and increase pressure up to 5 bars step by step. However, it does not happen to anything in vial.

• Journal of Periodontal and Implant Science
• /
• 제34권2호
• /
• pp.425-448
• /
• 2004

A bioactive and degradable poly(epsilon -caprolactone)/silica nanohybrid(PSH) was synthesized for the application as a bone substitute. PSH was manufactured by using silica and polycaprolacton. PSH was manufactured in some composition after low crystaline apatite had been formed in simulated body fluid and, was used this study. The safety of the PSH was established by test of acute, and subacute toxicity, sensitization cytotoxicity and sterility. In order to assess activity of osteoblast, the test for attaching osteoblast, proliferation test for osteoblast, differentiating gene expression test are performed in vitro. And bone substitutes were grafted in rabbit's calvarium, during 8 weeks for testing efficacy of bone substitutes. Degree of osteogenesis and absorption of substitutes were evaluated in microscopic level. In result, it was not appeared that acute and subacute toxicity, sensitization in intradermal induction phase, topical induction phase and challenge phase. It was shown that the test can not inhibit cell proliferation. adversely, it had some ability to accelerate cell proliferation. The result of sterility test described bacterial growth was not detected in most test tube. The attaching and proliferation test of osteoblast had good results. In the result of differentiating gene expression test for osteoblast, cbfa1 and, alkaline phosphatase, osteocalcin and GAPDH were detected with mRNA analysis. In the PSH bone formation test, ostgeoblastic activity would be different as material constitution but it had good new bone formation ability except group #218. futhermore, some material had been absorbed within 8 weeks. Above studies, PSH had bio-compatibility with human body, new bone formation ability and accelerate osteoblastic activity. So it would be the efficient bone substitute material with bio-active and biodegradable.

• 한국환경과학회지
• /
• 제5권1호
• /
• pp.1-6
• /
• 1996

The genetic variabilities of second chromosomes of Drosophila melanogaster concealed in On-yang natural Population have been analyzed by the Cy/Pm method and an allelism test during two years(1993-1994). The mean frequencies of deleterious(lethal and semilethal) genes in On-yang natural population were estimated to be 23.97% in 1993 and 27.15% in 1994, respectively. The allelism rates between lethal genes in the population were 0.654%(1993) and 1.429%(1994). The mean values of elimination by frequencies of deleterious genes and allelism rates were 0.0004(1993) and 0.0010(1994), respectively. The frequencies of phenotypic sterility of males in 1994 were estimated to be 1.95%, and thoses of genotypic sterility of females and males were estimated to be 1.54% and 2.31%, respectively.

• Clinical and Experimental Reproductive Medicine
• /
• 제39권4호
• /
• pp.161-165
• /
• 2012

Objective: To evaluate the effect of hysterosalpingo-contrast sonography (HyCoSy) on natural conception in the infertile patient. Methods: We conducted a prospective observational study recruiting 180 patients admitted to Infertility Center of Ferrara University from January 2010 to February 2012. The essential inclusion criteria was the couple's desire to perform only diagnostic evaluation on infertility causes and to wait for natural conception before proceeding with further management. Couples were investigated with hormonal profile, semen analysis and HyCoSy. Expected time for spontaneous pregnancy was 180 days from HyCoSy. First datation sonography of pregnancy was used calculating time elapsed from HyCoSy at conception. Results: Forty patients (22.2%) obtained spontaneous pregnancy within 6 months after HyCoSy. The mean of "conception time" was 75 days. The pregnancy rate was significantly higher in the first 30 days (45%) compared to other the months of observation (p<0.0005). Multiple linear regression analysis showed that maternal age and sterility duration proved independent variables in detecting the "conception time" after HyCoSy (t=3.742, p=0.001, t=2.371, p=0.02, respectively). Conclusion: A possible beneficial effect of HyCoSy is feasible especially in the days following its execution. This temporal correlation supports its therapeutic use.

• Journal of Pharmaceutical Investigation
• /
• 제39권4호
• /
• pp.263-267
• /
• 2009

The purpose of this study is to evaluate the efficacy of stipulated cleaning process, and the prohibition of cross-contamination and microbiological contamination, which inadequate cleaning in multi-production could occur, through cleaning validation of multi-purpose facility used to produce five biopharmaceutical products as sterile injection. After production of five biopharmaceutical products such as hGH, rhGCSF, rhEPO, rhFSH and rhIFN using vial filling machine, the cleaning validation such as residual analysis of active ingredients or human serum albumin, measurement of total organic carbon (TOC), residual analysis of detergent and microbiological contamination were carried out. In the case of rhGH and rhGCSF clean validations, drug residues were not detected. Furthermore, in the case of rhEPO, rhFSH and rhIFN clean validations, human serum albumin residues were not detected. At TOC (total organic carbon) analysis, all clean validations gave the TOC of about average 137.93%, not more than 150% of acceptance criteria. At sodium analysis for the checking of residues of cleaning agent, sodium residues were not detected. In sterility test, they showed no microbiological contamination of bacteria and fungi. Thus, this cleaning validation was determined as successful in protection of cross-contamination and induction of safety in multi-purpose facility.

• 한국작물학회지
• /
• 제26권1호
• /
• pp.1-31
• /
• 1981

수도품종들의 저온에 대한 생리생태적 반응특성을 구명하여 내냉성 품종육성과 냉해를 경감 수 있는 재배법개선기술을 확립하고저 1975년부터 1980년에 걸처서, 유일형과 일본형 및 인도형 품종들을 공시하여 그들의 생육시기별 시비조건별 저온반응의 특성을 검토하기 위하여 저온처리를 작물시험장 인공기상실에서 그러고 저수온처리에 관한 시험을 작물시험장 춘천출장소 냉수시험지에서 수행한 바 그 결과를 요약하면 다음과 같다. 1. 15\circ_C 저온하에서 70% 이상의 실용적 발아율 얻을 수 있는 기간은 일본형품종들은 15\circ_C에서 10 일간, 통일형품종들은 15 일간이었다. 통일형품종들의 저온발아성 검정은 저온에서 장기간 실시하는 것 보다 16\circ_C에서 6일간 치상하는 것이 적당하였다. 2. 유묘의 저온저항성은 3.0～3.5 엽기묘가 가장 낮고 묘영이 진전됨에 따라 점차 높아켰으며 3엽기와 6엽기의 저온저항성간에 는 고도의 정상관을 보였다. 3. 주ㆍ야 15～10\circ_C온도에서는 일본형 및 통일형 품종 모두 42일 처리정도에서 식물체가 고사하고 20～15\circ_C에서는 일본형 품종은 분벽이 잘 이루어지나 통일형품종은 약관 억제되며 25～15\circ_C에서는 양품종군 모두 분벽이 촉진되었다. 그러나 초장신장 속도는 저온일 수록 저하되었다. 4. 이삭의 지경 및 영화분화는 출수전 30일부터 출수기까지 주ㆍ야 25～20\circ_C처리와 30～25\circ_C 처리시에는 모든 품종에서 잘 이루어졌으나 20～15\circ_C 처리구에서는 통일형품종은 지경 및 영화 분화수화수가 전자에 비하여 감소하였고 일본형품종은 큰 차이가 없었으나 이삭의 추출은 억제되었다. 5. 저기온에 의한 출종지연은 감수분열기에 저온처리한 것이 분얼최성기에 저온처리한 것 보다도 1～3일 이 지연되였으며 같은 시기에서는 저온처리 일수가 길수록 출수지연도가 컸다. 6. 벼 생육기간별로 17\circ_C냉수를 10일간 처리한 경우에 출수지연도는 분얼기 > 감수분열기 > 수잉기의 순이였고 품종별로는 수원26004 > 수원23005 > Lengkwang의 순이있다 냉수처리에 의한 출수지연도는 간장단축률 및 불임율과 유의한 정의 상관을 보였다. 7. 감수분열기의 저기온(15\circ_C)과 고기온(25\circ_C)처리는 고기온(25\circ_C)과 저기온(17\circ_C) 처리보다 간장단축율이 켰으며 이삭 추출도도 낮았고 장간종인 Lengkwang은 단간종인 수원26004에 비하여 저기온에서의 간장단축율이 낮은 경향이었다 이삭 추출도는 출수기에 저온처리를 하였을 때 가장 낮았으며 통일형품종은 일본형품종보다 이삭 추출도가 현저히 낮았고 저온에 의하여 간장단축도 심한 품종은 이삭 추출도도 매우 낮았으며 이들 간에는 고도의 유의한 정의 상관이 있었다. 8. 분벽기의 냉수처리는 수수를 증대시키고 감수분열기의 냉수처리는 수수를 감소시켰다. 생육시기별로 냉수처리시기가 빠를수록 간장단축율이 크고 이삭 추출도도 낮아졌다. 9. 감수분열기의 17\circ_C 저온처리에 의한 불임유발은 3일간 처리로서는 크게 나타나지 않으나 9 일간처리에서는 심하게 나타났으며 수원26004와 밀양4002가 저온처리에서 불임율이 가장 낮았다. 저온처리가 임실장해를 가장 크게 유발한 것은 출수전 15일부터 출수전 5일까지 사이의 처리였으며 일본형인 진흥은 통일형인 통일, 수원26004보다 임실장해가 현저히 적었다. 그러나 감수분열기의 저온처리에 의한 임실장해정도와 출수기의 저온처리에 의한 임실장해정도간에는 유의한 정의 상관을 보였으며 또한 저온에 의하여 이삭 추출도가 낮거나 간장단축율이 큰 품종은 임실율도 떨어지는 경향이었다. 10. 냉수처리에 의한 임실장해는 감수분열기처리(엽이간장-15～10cm)에서 가장 크고 품종별로는 수원26004, 조생통일 > 농백, Towada > 저온저항성이 강한 Lengkwang순이었다. 냉수처리시의 수심과 유수의 위치는 임실비율과 매우 밀접한 관계가 있으며 수심이 20～40cm로서 유수의 위치가 물속에 있면 수원26004는 불임율이 높았고 유수의 위치가 물위에 있었던 Lengkwang은 불임율이 낮았다. 11. 수전기에 3 일간 15\circ_C의 저온처리를 한 경우 등숙에 큰 영향이 없었으나 6 일간 처리한 경우에는 수원287호와 수원 26004만이 60% 이하의 임실율을 보였으며 9 일간 처리한 경우에는 모든 품종에서 임실율이 60^ 이하로 떨어겼다. 그러나 출수 10일 후부터 17\circ_C로 20일간 처리한 경우에는 등숙장해가 크지 않았다. 12. 질소, 인산, 가리, 칼슘, 마그네지움 및 아연등의 양분흡수는 19$^{\circ}C$ $\pm$ 5보다 $25^{\circ}C$ $\pm$ 5에서 흡수가 증대되었으나 망간은 반대로 평균 25\circ_C보다 19$^{\circ}C$에서 흡수가 더욱 많았다. 13. 냉수답에서 질소, 인산, 규산 및 퇴비시용은 분벽 및 수수를 증가시키고 임실율을 향상시키며 수량을 증대시켰다.

• 한국동물위생학회지
• /
• 제42권4호
• /
• pp.285-288
• /
• 2019

Foot-and-mouth disease (FMD) causes economic problems in livestock industry because of fast spread and inducing low productivity. FMD outbreaks occurred in South Korea over the period from 2000 to 2019. Vaccination is the most practical and effective means of controlling or preventing these outbreaks, and a national vaccination policy has been in place for all FMD-susceptible animals since 2010. To prevent and control of FMD, South Korea has been using vaccines imported from the United Kingdom, Argentina, and Russia. The Animal and Plant Quarantine Agency of South Korea oversees continuous quality control of imported FMD vaccines. FMD vaccines were evaluated characteristics, sterility, pH, inactivation, safety, potency test by Korean FMD vaccine standard assay (Test for National Lot Release). The 6 company vaccines (A~F) were used Test for National Lot Release by each method. We evaluated quality of each FMD vaccine from 2015 to 2019. All batch of vaccine showed good quality control and were passed the Test for National Lot Release. The serotypes of vaccine are increasingly changing to multiple vaccine because the FMD was outbreak by various serotype virus in South Korea. Furthermore, this data may be useful as a basis for ensuring the quality of FMD vaccines and for base data to manage them. Additional study is required to simple approach for rapid evaluation of quality and antigen content identification in vaccines.

• Journal of Acupuncture Research
• /
• 제32권4호
• /
• pp.37-45
• /
• 2015

Objectives : The main aim of this study is to evaluate changes in the microbiological safety of pharmacopuncture exposed to room temperature for an elapsed period of time. Methods : The four most frequently used pharmacopuncture products were stored in syringes at room temperature at three different hospitals for 24 hours and 48 hours respectively, and they were compared with pharmacopuncture products stored in vials through a sterility and microbial limited test. Results : Storage forms and duration of exposure to room temperature did not show significant difference in bacterial or fungal contamination, which was confirmed by the sterility and microbial limited test. Conclusions : Pharmacopuncture products stored in syringes at room temperature for 24 hours and 48 hours demonstrated their safety in terms of lack of microbiological contamination.