• 제목/요약/키워드: ticlopidine hydrochloride tablets

검색결과 2건 처리시간 0.016초

염산부플로메딜 정과 염산티클로피딘 정의 용출시험법 개발 (Development of Dissolution Test Method for Buflomedil Hydrochloride Tablets and Ticlopidine Hydrochloride Tablets)

  • 이륜경;정경록;오현숙;심지연;서상철;이효정;김민아;박성민;이규하;손경희;김인규;사홍기;최후균;조태용;홍충만
    • 약학회지
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    • 제56권4호
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    • pp.211-216
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    • 2012
  • Drug dissolution test has been used for the purpose of both quality control of solid oral dosage forms and predicting in vivo drug release profiles. In this study, the dissolution profiles of buflomedil hydrochloride tablets and ticlopidine hydrochloride tablets were investigated according to the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korean Pharmacopoeia (KP). The analytical method using HPLC was validated. The validation was performed in terms of specificity, linearity, accuracy, precision and limit of quantitation.

공정서 수재 의약품의 정량법 개선에 관한 연구 (Establishment of Quantitative Method for Generic Drugs in Korea Pharmaceutical Codex Monograph)

  • 송재용;장진섭;장승은;김선회;김인규;이길봉;이제만;김용희
    • 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.