의약품 품질 규격 개선에 관한 연구 : 항생물질 의약품 = Study on Improving the Specifications of Drugs : Anti-biotic Drugs

다국어 초록 (Multilingual Abstract)

The KFDA uses the Korean Pharmacopoeia (KP) and the Korean Pharmaceutical Codex (KPC) to establish specifications for quality control of drug products. At present, the KPC has about 1,000 monographs for effective and efficient quality control of drug products. However, consistent update is needed to take account of modern analytical technologies and internationally accepted specifications. In this study, oral solid drug products listed in the KPC were investigated to identify drug products with dissolution test not established. Then, the possibility of establishing dissolution test and their marketing information were considered to select the drug products for revision of monographs. As a result, 6 drug products (Prothionamide Tablets, Cefroxadine Capsules, Doxycycline Tablets, Roxythromycin Tablets, Erdosteine Capsules, Rifaximin Tablets) were selected and dissolution specifications were established for these products. In addition, the revised method (draft) for assay of Diethylaminoethyl Theophylline HCl Tablets was prepared. Dissolution specifications were established according to the KFDA' s Guidelines on Establishment of Dissolution Specifications for Oral Solid Drug Products (KFDA, 2005) and dissolution and assay test methods were reviewed while considering the Guidelines on Validation of Analytical Procedures for Drug Products (KFDA, 2009). Many meetings with internal and external experts were held to collect advices and opinions on validation of dissolution test apparatus, selection of products, preliminary studies, analytical method validation, main study and cross-study. The developed test methods were re-validated through a cross-study at several laboratories. The newly established dissolution specifications and assay methods will be included in the revised KPC, which will contribute to quality control of the relevant drug products, improve the quality level of drug products distributed

국문 초록 (Abstract)

식품의약품안전청에서는 「대한민국약전」 및「대한민국약전외의약품기준」을고시하여 의약품 품질관리에 필요한 규격들을 설정하고 있다. 현재 「대한민국약전외의약품기준」은 약 1,000여 품목을 수재하여 의약품의 품질관리에 기여하고 있으며 지속적인 개정을 통해 최신 분석기술 및 세계적인 기준·규격을 반영하고 있다. 이에 본 연구사업에서는 「대한민국약전외의약품기준」 수재경구용고형제제중용출시험 미설정 품목을 조사하여 용출시험 설정 가능 여부 및 유통현황을 확인하여 개정대상 품목을 선정하였다. 그 결과 프로티온아미드 정, 독시사이클린 정, 세프록사딘 캡슐, 록시트로마이신정, 에르도스테인 캡슐 및 리팍시민 정 의 6품목을 선정하여 용출규격을 설정하였으며, 품목 중 정량법 개정이 필요한 1 품목의 정량법 개정(안)을 마련하였다. 용출규격 설정은 “경구용의약품의용출규격설정지침KFDA, 2005)”에 따라 설정하였으며 용출시험 및 정량법은 “의약품등분석법밸리데이션지침KFDA, 2009)"에 따라 검토하였다 내·외부전문가회의를 통해 용출시험장치 밸리데이션 대상품목선정 예비시험 분석법 밸리데이션, 본시험 및 교차시험 등 전반적인 과정의 자문 및 의견 수렴을 하였으며, 개발된 분석법은 실험실 간 교차시험을 통해 재검증하였다. 실험 결과를 바탕으로 설정된 용출 규격 및 정량법은 「대한민국약전외의약품기준」개정(안)으로 도출되어 고시될 예정이며, 해당 품목의 품질관리에 기여하여 국내에서 유통되는 의약품의 품질을 향상시킬 것이며, 나아가 국민보건증진에 기여할 것으로 기대된다.