YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Establishment of Quantitative Method for Generic Drugs in Korea Pharmaceutical Codex Monograph

공정서 수재 의약품의 정량법 개선에 관한 연구

  • Song, JaeYong (Pharmaceuticals Analysis Devision, Incheon Metropolitan City Institute of Health and Environment) ;
  • Jang, JinSeob (Pharmaceuticals Analysis Devision, Incheon Metropolitan City Institute of Health and Environment) ;
  • Jang, SeungEun (Pharmaceuticals Analysis Devision, Incheon Metropolitan City Institute of Health and Environment) ;
  • Kim, SunHoi (Pharmaceuticals Analysis Devision, Incheon Metropolitan City Institute of Health and Environment) ;
  • Kim, InKyu (Pharmaceutical Standardization Research and Testing Division, National Institute of Food Drug Safety Evaluation) ;
  • Lee, GilBong (Pharmaceuticals Analysis Devision, Incheon Metropolitan City Institute of Health and Environment) ;
  • Lee, JeaMan (Pharmaceuticals Analysis Devision, Incheon Metropolitan City Institute of Health and Environment) ;
  • Kim, YongHee (Pharmaceuticals Analysis Devision, Incheon Metropolitan City Institute of Health and Environment)
  • 송재용 (인천광역시 보건환경연구원 약품분석과) ;
  • 장진섭 (인천광역시 보건환경연구원 약품분석과) ;
  • 장승은 (인천광역시 보건환경연구원 약품분석과) ;
  • 김선회 (인천광역시 보건환경연구원 약품분석과) ;
  • 김인규 (식품의약품안전평가원 의약품규격연구과) ;
  • 이길봉 (인천광역시 보건환경연구원 약품분석과) ;
  • 이제만 (인천광역시 보건환경연구원 약품분석과) ;
  • 김용희 (인천광역시 보건환경연구원 약품분석과)
  • Received : 2012.09.20
  • Accepted : 2012.10.30
  • Published : 2012.10.31
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Abstract

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.

Keywords

Acknowledgement

Supported by : 식품의약품안전청

References

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  2. 식품의약품안전청 : 대한약전외의약품등기준 제3개정 (2007).
  3. 식품의약품안전청 : 의약품등 시험방법 밸리데이션에 대한 가이 드라인 적용을 위한 해설서.