• 약학회지
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• 제56권5호
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• pp.288-292
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• 2012

The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

• 분석과학
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• 제35권3호
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• pp.93-115
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• 2022

의약품의 제조, 유통, 보관 과정에서 발생할 수 있는 잠재적 불순물은 의약품의 품질과 안전에 영향을 미치며 반응성이 높은 불순물의 경우 인체에 대한 발암성(변이원성)을 나타내기도 한다. 이를 위해 국제의약품규제조화위원회(International Conference on Harmonisation, ICH)에서는 "잠재적 발암 위해를 제한하기 위한 의약품 중 DNA 반응성(변이원성) 불순물의 평가 및 관리"에 대한 내용을 담은 M7(R1) 가이드라인을 제공하여 채택을 권고하였다. 하지만 가이드라인에서도 잠재적 불순물에 대한 분류, 섭취 허용량, 관리방안 등과 대표적인 불순물 14 종에 대한 가이드라인 적용을 소개하는데 그치고 있어 제약회사와 규제 당국에서 실제 관리를 위한 의약품 중 잠재적 불순물의 분석에 어려움을 겪고 있다. 이에 따라 본 총설에서는 비의도적 변이원성 불순물의 정의와 ICH M7(R1) 가이드라인에 소개된 내용을 간략하게 살펴보는 한편 현재까지 보고된 주요 잠재적 불순물의 분석 동향을 살펴보고자 한다. 이를 통해 식약처를 비롯한 감독 기관과 제약회사 등에서 의약품 중 잠재적 불순물 관리에 조금이나마 도움이 되고자 한다.

• Journal of Microbiology and Biotechnology
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• 제9권4호
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• pp.386-392
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• 1999

A large-scale culture of hepatitis A virus in human diploid MRC-5 cells was conducted. In a roller bottle culture, the virus was grown to a maximum titer in 3 weeks after infection. Over 95％ of the cell-associated virus was excreted after culturing the infected cells in suspension media without fetal bovine serum for 3 days. The cultured virus was inactivated with formalin, concentrated by ultrafiltration, and partially purified by ultracentrifugation in a non-ionic gradient medium of Renocal. Two separate peak fractions showing high anti-HAY ELISA titer were pooled and about 40％ of HAV antigen was recovered by this purification procedure. Of the partially purified vaccine, the protein pattern in SDS-PAGE and immunogenicity in mice were compared with a commercial HAV vaccine. In SDS-PAGE, the purified vaccine in this study and the commercial vaccine showed almost the same protein pattern. The seroconversion rate of the purified vaccine in mice was not different from that of the commercial vaccine. Therefore, we could prepare a good grade of HAV vaccine by a simple purification procedure although the purification itself was not completed.

• Journal of Preventive Medicine and Public Health
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• 제41권2호
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• pp.69-73
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• 2008

To curb a rapid increase in expenditures for pharmaceuticals, the Korean government introduced a positive list system and a negotiation process for drug prices at the end of 2006. Economic evaluation of pharmaceuticals has begun to have a pivotal role in the listing and pricing of drugs for the Korean National Health Insurance. There are some points to discuss regarding the use of economic evaluation in the listing and pricing in the context of the Korean system. First, the listing and pricing processes have been fragmented, evoking complaints from pharmaceutical companies and delaying the access of new drugs to patients. Second, there is a concern that the positive list system may limit the range and availability of drugs for patients to choose for treatment. Third, the time schedule for de-listing of existing drugs may not be realistic. Fourth, it is not always easy to provide reliable evidence of cost-effectiveness due to a lack of materials. Fifth, there is no consensus on the range of the ICER (incremental cost-effectiveness ratio) acceptable to the Korean society. In conclusion, in the near future, it will be necessary to evaluate the achievements that the economic evaluation has provided to the Korean society.

• Journal of Microbiology and Biotechnology
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• 제28권4호
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• pp.613-621
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• 2018

In this study, interface-assembled carbonyl reductase (IACR) was prepared and used in the synthesis of S-licarbazepine in a toluene/Tris-HCl biphasic system. The carbonyl reductase (CR) was conjugated with polystyrene to form a surfactant-like structure at the interface of the toluene/Tris-HCl biphasic system. The interface-assembled efficiency of IACR reached 83% when the CR (180 U/mg) and polystyrene concentration were $8{\times}10^2g/ml$ and $3.75{\times}10^3g/ml$, respectively. The conversion reached 95.6% and the enantiometric excess of S-licarbazepine was 98.6% when $3.97{\times}10^6nmol/l$ oxcarbazepine was converted by IACR using 6% ethanol as a co-substrate in toluene/Tris-HCl (12.5:10) at $30^{\circ}C$ and $43{\times}g$ for 6 h. IACR could be reused efficiently five times.

• 한국환경농학회지
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• 제30권1호
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• pp.68-75
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• 2011

최근, 동물 및 인체용 의약품류는 환경 중 새로운 오염물질로 부각되고 있다. 특히, 우리나라는 동물용의약품에 대한 수의사 처방제 미정착, 집약적 축산환경, 최근의 대규모 지속적 동물 전염병의 발생, 단위 육류 생산량 증대를 위한 동물용의 약품의 남용, 축산분뇨의 해양투기 전면 금지 등 축산분야의 위협적 요소와 함께 환경 중 동물용의약품의 잔류성 문제가 향후 식품오염 및 항생제 내성 유발 등의 요인으로 확대 될 우려가 크다. 그러므로 동물용의약품의 주된 환경배출 매개인 분변을 통한 토양 잔류성 검토는 지하수 오염과 지하수 또는 분변 중 잔류량의 흡수, 이행과정을 통한 농경지 작물의 오염 예방을 위해서도 동물용의약품의 인허가 단계 중 토양 잔류성을 환경 위해성 평가자료로 검토하는 것은 중요한 의의를 갖는다. 본 연구는 VICH, OECD 등의 국제적 기구에서 그 동안 제안하였거나, 검토 중인 동물용의약품의 환경위해성 평가 가이드 라인과 오랫동안 우리나라, 미국, 유럽 등지에서 정착되어 온 농약의 토양 중 잔류성 시험법, 그리고 문헌을 토대로 기 수행한 동물용의약품의 토양잔류성 시험 결과를 바탕으로 하여 동물용의약품의 환경 중 위해성 평가를 위한 토양 잔류성 시험법 가이드라인을 제안하였다. 시험법 가이드라인은 크게 실내, 실외 시험 방법과 잔류소실기의 예측으로 구성되어 있으며, 농경지토양 내 분변을 통한 노출 경로를 주안으로 하여 우리나라 환경에 적합토록 구성하였다.

• 대한의용생체공학회:의공학회지
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• 제31권2호
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• pp.123-128
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• 2010

The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.

• 한국산학기술학회논문지
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• 제14권11호
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• pp.5809-5818
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• 2013

본 논문에서는 '파이프라인 건전도(Pipeline Soundness)와 특허유효성(Patent Validity)개념을 적용하여 제약기업이 적합한 기술 아웃소싱 대상기업을 선정하기 위한 기술 포트폴리오 방법을 제시하고자 한다. 또한 이를 최근 발표한 Amgen의 Onyx Pharmaceuticals 인수사례에 적용하여 개발된 포트폴리오 분석방법의 실제 적용 가능성을 검토하고 사례기업의 기술아웃소싱 타당성을 분석하기로 한다. 본 연구를 통해 제시된 기술포트폴리오의 사례 적용 분석 결과 Amgen은 주력분야인 Cancer 분야의 특허유효성 개선이 시급한 것으로 분석되었으며 Onyx Pharmaceuticals의 인수를 통해 Cancer 분야의 기술포트폴리오를 안정적인 영역에 도달시킬 것으로 기대된다. Amgen의 실제 Onyx Pharmaceuticals 인수 이유 또한 Cancer 분야의 파이프라인 강화와 의약품 도입이라는 점을 고려할 때 새롭게 개발된 기술포트폴리오 분석방법이 실제사례에 잘 적용됨을 알 수 있었으며, 본 연구를 통해 개발된 기술포트폴리오 분석 방법이 제약기업의 기술현황 파악 및 인수대상기업 선정을 위한 도구로 충분히 활용 가능할 수 있을 것으로 판단된다.

• 환경분석과 독성보건
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• 제21권4호
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• pp.243-251
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• 2018

Pharmaceuticals in wastewater effluents have been recognized as emerging pollutants threatening freshwater organisms. To extend understanding for bioaccumulation and toxicity in those organisms, information on biotransformation products (or metabolites) and their metabolic pathway are crucial. The aim of the present study is to identify and elucidate metabolites of pharmaceuticals formed in exposed organisms using suspect and nontarget screening approach using LC-HRMS. As the target pharmaceuticals, carbamazepine, ketoprofen, metoprolol, propranolol, and verapamil were selected whereas Daphnia magna and Gammarus pulex were used as test organisms. After 24h exposure, metabolites formed in the organisms were identified using LC-HRMS. The structures of metabolites were elucidated via analysis of MS/MS fragment pattern and the comparison with fragment database. As the results, a total of 10 metabolites were identified for 5 parent compounds (C253/C356 for carbamazepine, K211 for ketoprofen, M256 for metoprolol, P218/P276/P306 for propranolol, V196/V291/V441 for verapamil). Among them, the presence of C253 and V291 was confirmed using standard materials. Most of the identified metabolites were formed through oxidative reactions such as hydroxylation, N-demethylation, and dealkylation. Cysteine conjugation (phase II reaction) metabolite (C356) for carbamazepine was found in daphnia. The metabolic pathway of verapamil showed similar metabolic pathways and metabolic pathways for both species. Although the toxicological information on the identified metabolites could not be confirmed, the molecular structure information of the proposed metabolites can be used for future evaluation and prediction of toxicity.

• 대한예방한의학회지
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• 제26권2호
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• pp.69-74
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• 2022

Objective : This study was aimed to review the Act on the Promotion of Korean Medicine and Pharmaceuticals. Method : We searched document about the Act on the Promotion of Korean Medicine and Pharmaceuticals. We used Korean Law Information Center(https://www.law.gov.kr) to find the revision of the act. Results : We looked at the current status of the revision of the Act on the Promotion of Korean Medicine and Pharmaceuticals, and the law was revised four times in total. Through the revision of the law, the definition of Korean medical practice was not only expanded, but also the establishment and role of National Institute of Korean Medicine Development were extended. Specific descriptions of Korean medicine technology will be needed in the future, and laws that are less effective should be revised and the role of National Institute of Korean Medicine Development should be further strengthened. Conclusion : For the future of Korean medicine, in-depth consideration is needed on how to foster oriental medicine.