• 대한안전경영과학회지
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• 제12권3호
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• 한국수정란이식학회지
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• 제22권3호
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• pp.161-165
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• 2007

포유류에서 옥시토신은 다양한 기능을 가지고 있는 신경뇌하수체 호르몬이다. 옥시토신은 주로 젖의 분비를 일으키고 분만 시 자궁의 수축 및 모성 행동과 관계가 있다. 모성 행동은 스트레스에 의해 억압을 받으며 옥시토신에 의해 촉진된다. 본 연구는 제왕절개의 스트레스와 자궁내 옥시투여에 따른 모성 행동의 변화를 알아보기 위해 수행되었다. 본 실험 결과, 자연 분만 예에서 스트레스를 준 개체와 스트레스를 주지 않은 개체에서 새끼의 생존율을 비교한 결과, 스트레스를 준 군에서 새끼의 생존율이 낮아 스트레스가 모성 행동에 영향을 미친다는 것을 확인하였다. 제왕절개 수술을 실시한 예에서 옥시토신을 투여한 군은 마취의 회복 후 일정 시간이 경과한 다음 새끼를 잡아먹는 식자증이 나타난 반면, 옥시토신을 투여한 군에서는 마취에서 회복한 다음 곧바로 새끼를 확인한 다음 살해하는 행동을 보였다. 결과적으로 새끼를 관리하고자 하는 모성 행동을 발현하기 위해서는 말초에 옥시토신을 투여하는 것은 의미가 없다는 것을 확인하였으며, 분만 시 모체에 대한 스트레스는 새끼의 관리에 좋지 않은 영향을 미친다는 것을 확인하였다. 또한, 본 실험은 랫드를 대상으로 제왕절개라는 새로운 스트레스의 실험적 이용, 임상적으로 제왕절개시 수행하는 자궁 내 옥시토신 투여의 임상적 평가, 그리고 제왕절개 수술을 실시한 다음 마취 회복 후 새끼를 탐색하는 모성 행동관찰의 요인을 추가한 새로운 실험이라는데 의의가 있다.

• 대한의용생체공학회:의공학회지
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• 제31권4호
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• pp.280-284
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• 2010

Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

• 한국의학물리학회지:의학물리
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• 제19권4호
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• pp.276-284
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• 2008

전 세계적으로 컴퓨터 단층 촬영 장치(Computed Tomography, CT)의 임상 적용이 환자의 질병의 조기 진단에 매우 중요하게 사용되고 있으며 사용 빈도 또한 매년 급증하고 있다. 새로운 종류의 CT 장치들이 병변을 조기 진단하기 위하여 개발되고 있다. 이 방사선 발생 장치에 의한 환자나 작업 종사자들의 방사선 피폭이 불가피 할 수도 있다. 국내에서는 CT 장치에 대한 구체적인 방사선 방어나 방사선 시설에 대한 구체적인 규정이 확립되어 있지 않다. 본 논문에서는 국내에서의 CT 사용시설에 대한 방사선 방어 시설과 사용 기준에 대한 규정 마련에 토대를 이루기 위하여 외국에서의 CT 장비에 대한 방사선 방어 및 방사선 차폐에 대한 규정을 조사하였다. 조사방법으로는 구글 검색을 이용한 특정 키워드 검색과 방사선 관련 업무를 수행하는 특정 웹사이트를 직접 검색하는 방법을 사용하였다. 검색결과 캐나다, 미국, 영국 등의 국가에서 국가의 실정에 맞는 가이드라인을 사용하고 있었으나, 아직 이중 에너지 CT에 대한 가이드라인은 없는 것으로 나타났다. 한국에서도 국내 실정에 적합한 CT 장비에서의 방사선 방어, 차폐, 환자나 작업종사자 및 일반인에 대한 방사선 피폭에 대한 가이드라인의 설정이 필요하다고 생각된다.

• 응용통계연구
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• 제26권4호
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• pp.675-686
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• 2013

현재 우리나라 식품의약품안전청에서는 $2{\times}2$ 교차설계법을 기초로 제제간의 생물학적 동등성 평가를 수행하도록 규정하고 있다. 하지만 고변동성 제제의 생물학적 동등성 평가에서 $2{\times}2$ 교차설계법에 의한 시험은 지나치게 많은 피험자를 필요로 할 수 있어 윤리적이고 경제적인 고려가 필요하다는 논의가 이루어지고 있다. $2{\times}2$ 교차설계법을 대체할 수 있는 대안으로 $2{\times}4$ 교차설계법은 미국 및 유럽 등에서는 생물학적 동등성 평가에 광범위하게 사용되는 설계 방법이고, $2{\times}3$ 교차설계법도 $2{\times}2$와 $2{\times}4$ 교차설계법의 단점을 개선할 수 있는 효율적인 대안으로 관심이 많다. 본 연구에서는 $2{\times}4$와 $2{\times}3$ 교차설계법의 통계적 모형과 제시된 통계적 모형에 연계된 분산분석표를 유도한다. 현행 국내 생물학적 동등성 시험 규정에 의하면 $2{\times}4$와 $2{\times}3$ 교차설계법의 분산분석표는 반드시 제시되어야 하지만 아직 문헌상에 존재하지 않아 관련 연구에 기여할 것으로 생각된다. 또한 $2{\times}4$와 $2{\times}3$ 교차설계법에 기초한 피험자 계산을 $2{\times}2$ 교차설계법과 비교 제시하여 고변동성 제제의 생물학적 동등성 시험 연구에 적절한 시험 설계 선택에 정보를 제공한다.

• 대한약침학회지
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• 제12권3호
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• pp.61-72
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• 2009

Objectives : This experimental study was performed to investigate the safety and efficacy of Bovis Calculus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. To identify the use of it as eye drop, the eye irritation test of rabbits and the antibacterial test of Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans were performed. Methods : 1. The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Bovis Calculus pharmacopuncture solution was administered in the left eye of the rabbits, eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 2. After administering Bovis Calculus pharmacopuncture solution on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis, MIC(Minimum Inhibition Concentration) and the size of inhibition zone were measured. Anti-bacterial potency was also measured using the size of inhibition zone. Results : 1. After Bovis Calculus pharmacopuncture solution was administered in the left eye of the rabbits, it was found that none of nine rabbits have abnormal signs and weight changes. 2. After Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, no eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 3. There was no response to MIC on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) after Bovis Calculus pharmacopuncture solution was medicated. Conclusions : The present study suggests that Bovis Calculus pharmacopuncture solution is a nontoxic and non-irritant medicine, which does not cause eye irritation in rabbits, but dosen't have antibacterial effects on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis. These study result recommends that more research on other herbal medicines of eye drop for Keratitis are required.

• 대한약침학회지
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• 제15권1호
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• pp.23-28
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• 2012

Objective: This experimental study was designed to investigate the safety and the effectiveness of Samjeong pharmacopuncture solution (SPS) manufactured by using a the lowtemperature extract on process. Methods: To identify the safety and the effectiveness of using SPS as eye drops, we performed applied eye irritation tests on rabbits and antibacterial tests for Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans. The eye irritation test was performed according to the toxicity testing regulation of the Korea Food & Drug Administration (2009. 8. 24, KFDA 2009-116). After SPS had been applied on the left eye of the rabbits, eye irritation in the cornea, iris and conjunctiva was observed on the 1st, 2nd, 3rd, 4th & 7th day. After SPS had been dropped on bacterial species that cause keratitis, the minimum inhibition concentration and the size of the inhibition zone were measured. The anti-bacterial potency was also measured by taking the size of inhibition zone. Results: After SPS had been administered on the left eye of the rabbits, none of nine rabbits were found to show abnormal signs or weight changes. After SPS had been administered on the left eye of the rabbits, no eye irritation in the cornea, iris and conjunctiva was observed on the 1st, 2nd, 3rd, 4th & 7th day. No specific response was detected in MIC for bacterial species Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans after SPS had been applied. Conclusions: This study suggests that SPS is a non-toxic and non-irritant medicine that does not cause any of eye irritation in rabbits, but it has no antibacterial effects on bacterial species that are well known to cause keratitis. These results suggest that more research is required on extracts from herbal medicines for treating keratitis.

• 대한약침학회지
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• 제12권1호
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• pp.21-33
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• 2009

Objective : This experimental study was performed to investigate the safety of Soyeom Pharmacopunture solution manufactured by extraction of alcohol and water. To identify the use of it as eyedrops, the eye irritation test of rabbits and antibacterial test of Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans was performed. Methods : 1. The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Soyeom pharmacopuncture solution was administered in the left eye of the rabbits, eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 2. After administering Soyeom Pharmacopuncture solution on bacterial species (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis, MIC(Minimum Inhibition Concentration) and the size of inhibition zone were measured. Anti-bacterial potency was also measured using the size of inhibition zone. Results : 1. After Soyeom pharmacopuncture solution was administered in the left eye of the rabbits, it was found that none of nine rabbits have abnormal signs and weight changes. 2. After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, no eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 3. There was no response to MIC on bacterial species (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) after Soyeom pharmacopuncture solution was medicated. Conclusions : The present study suggests that Soyeom pharmacopuncture solution is a non-toxic and non-irritant medicine, which does not cause eye irritation in rabbits, but dosen't have anti-bacterial effects on bacterial species which cause Keratitis. These study result recommends that more research on other herbal medicines of eye drop for Keratitis are required.

• 한국약용작물학회지
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• 제18권5호
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• pp.338-344
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• 2010

Our paper shows the results of 302 samples of herb medicines about fungal contamination at Yakyeang markets in Seoul. The sample medicines were treated VICAM pretreatment and analysed by post column derivatisation procedure(PHRED-HPLC) with a fluorescence detector. Aflatoxin B1 was founded from 50.3% of samples, aflatoxin B2 was 39.7%, aflatoxin G1 was 21.2% and aflatoxin G2 was 23.5%. The detected ranges of aflatoxin B1, B2, G1 and G2 were from 0.1 to $57.2\;{\mu}g/kg$, 0.1 to $42.6\;{\mu}g/kg$, 0.1 to $23.5\;{\mu}g/kg$ and 0.1 to $9.5\;{\mu}g/kg$ respectively. Among total samples, 26 samples contained aflatoxin B1 violated the regulation (less than 10 ug/kg) for aflatoxin B1 of KFDA. From the result, we could presumed that more than a half of samples were contaminated by aflatoxins. Therefore, it seems to be necessary that the new safety giudeline will be established aflatoxin B2, G1 and G2 from herb medicines as aflatoxin B1.

• 대한본초학회지
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• 제29권3호
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• pp.35-42
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• 2014

Objectives : Since single extract powders was released at 1987, the insurance fee has not been changed, but the price of raw material has been increasing. According to this, Pharmaceutical company couldn't invest on quality of the product, so, the quality of single extracts went down and lost the consumer's trust. We checked the contents of marker ingredients in single extract thereby to recover the reliability of insurance-covered herbal preparations. Methods : we bought total twelve products of eight different single extracts of two main pharmaceutical companies among total 65 kinds of single extract powder stipulated in KHP (The Korean Herbal Pharmacopoeia) monograph III at Jan. 2013. Assays of selected single extract powders are performed by KHP regulation. And we surveyed price fluctuation of relevant herb raw materials from 2005 to 2012. Results : Among twelve products, eight single extract powders were suitable by the KHP regulation. But four products didn't reach the content amount of KHP. Marker contents in the single extracts product of Pueraria Root, Licorice, Peony root and Scutellaria Root of A company were 70%, 1%, 23.7% and 75.1%, respectively. Conclusions : We can acertain whether there's a quality problem in the insurance-covered single extract powders. But, A company is no longer producing these improper single extract powders. As a medicine, single extract powders needs to be strictly quality controlled by the company, and regularly monitored by the KFDA.