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서지반출
도베실산칼슘 정 및 아세피필린 정의 용출시험법 개발
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  • 도베실산칼슘 정 및 아세피필린 정의 용출시험법 개발
저자명
박찬호,이진하,김은정,손경희,김영옥,김동섭,송영미,사홍기,최후균,Park. Chan-Ho,Lee. Jin-Ha,Kim. Eun-Jung,Sohn. Kyung-Hee,Kim. Young-Ok,Kim. Dong-Sup,Song. Yo
간행물명
약학회지
권/호정보
2011년|55권 2호|pp.131-137 (7 pages)
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대한약학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The dissolution test method and an analytical procedure by HPLC were developed and validated for dobesilate calcium tablets and acepifylline tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for dobesilate calcium tablets was carried out under sink conditions as following: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for acepifylline tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of dobesilate calcium tablets and acepifylline tablets.