초록 ▼

필요성 및 목표
○ 기술발달, 현장여건 등을 반영한 대한민국약전 의약품 각조 유연물질시험법 및 확인시험법에 대한 체계적이고 효율적인 검토, 재정비 필요
○ 유연물질 표준품은 별도 합성을 해야 하는 등 확보에 장애(예산,시간)가 크므로 대체시험법의 개발이 필요
○ 일본, 영국약전 등 외국약전에서는 확인시험을 위한 UV, IR표준스펙트럼을 제공하고 있음
○ 대한민국약전 등재 의약품 각조 확인시험법 및 유연물질시험법 개선

방 법 및 결 과
○ 대한민국약전 의약품 각조 유연물질시험법 대체시험법 개발(

필요성 및 목표
○ 기술발달, 현장여건 등을 반영한 대한민국약전 의약품 각조 유연물질시험법 및 확인시험법에 대한 체계적이고 효율적인 검토, 재정비 필요
○ 유연물질 표준품은 별도 합성을 해야 하는 등 확보에 장애(예산,시간)가 크므로 대체시험법의 개발이 필요
○ 일본, 영국약전 등 외국약전에서는 확인시험을 위한 UV, IR표준스펙트럼을 제공하고 있음
○ 대한민국약전 등재 의약품 각조 확인시험법 및 유연물질시험법 개선

방 법 및 결 과
○ 대한민국약전 의약품 각조 유연물질시험법 대체시험법 개발(총 20종)
- 벤지다민염산염 유연물질 3종, 클로피도그렐황산수소염 유연물질 3종, 발사르탄 유연물질 3종, 니페디핀 유연물질 2종, 페니토인나트륨 유연물질 2종, 글리클라지드 유연물질 2종, 니모디핀 유연물질 1종, 온단세트론 유연물질 1종, 옥살리플라틴 유연물질 3종
○ 대한민국약전 의약품 각조 확인시험을 위한 표준스펙트럼 마련(총 44종)
- 날록손염산염 등 IR 표준스펙트럼 22종, 날록손염산염 등 UV표준스펙트럼 22종

기대성과
○ 대한민국약전 유연물질시험법 개선 및 표준스펙트럼 마련을 통한 국내 의약품 품질관리 향상

Abstract ▼

The Korean Pharmacopoeia (KP) is an official compendium established by the Ministry of Food and Drug Safety to ensure the appropriateness of the properties, conditions, quality, and storage methods of drugs.
The purity test listed in KP is set forth to test for impurities in drugs, and the starti

The Korean Pharmacopoeia (KP) is an official compendium established by the Ministry of Food and Drug Safety to ensure the appropriateness of the properties, conditions, quality, and storage methods of drugs.
The purity test listed in KP is set forth to test for impurities in drugs, and the starting materials, intermediates, by-products and degradation products present as impurities and defined as related substances. The related substances management criteria are set forth for raw materials and drug products, and interest in the purity test of related substances associated with drug safety has been growing recently. The method of using the reference standards of related substances in purity test is accurate, but its complex structure greatly impedes (in terms of cost and time) the process as it requires additional synthesis, which renders quality management difficult. Thus, the relative retention time (RRT) and the relative response factor (RRF) were used to develop a test method that does not employ a total of 20 reference substances, including of Benzydamine HCl related substancesⅠ∼Ⅲ, Clopidogrel hydrogen sulphate related substancesⅠ∼Ⅲ, Valsartan related substancesⅠ∼Ⅲ, Nifedipine related substancesⅠ∼Ⅱ, Phenytoin sodium related substancesⅠ∼Ⅱ, Gliclazide related substancesⅠ∼Ⅱ, Nimodipine related substancesⅠ, Ondansetron related substancesⅠ, and Oxaliplatin related substancesⅡ∼Ⅳ. The test method was validated according to the 「Manual for analytical method validation for pharmaceutical products(MFDS, 2012)」.
The identification test defined in KP is set forth to identify an active pharmaceutical ingredients(API) in drug substances and products, based on its characteristics, and the primary method used is based on UV or IR spectral analysis. As the spectrum of each API is determined by its chemical structure, the spectrum is assessed together with a standard product within a set range, or in comparison with an existing standard spectrum to identify the substance concerned.In order to facilitate the identification of the items listed in KP, 22 standard UV spectrums and 22 standard IR spectrums were prepared for 22 substances including naloxone hydrochloride, and expert opinions were collected from advisors.
There are plans to turn the improved purity test method and the standard IR and UV spectrums, obtained as a result of this experiment, into a proposal for the revision of KP (draft) to be issued as a ministerial notice. Also, it is expected that these results will contribute to the quality management of the items concerned by eliminating hindrances of budget and time.