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- 주제어 : dissolution profiles (검색결과 4 건)
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유사인자를 사용하여 용출양상 유사성을 비교하는 방법에 대한 고찰
조미현,김정호,이현태,사홍기 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3
Dissolution profile comparsions can be done virtue of the similarity factor (f₂). It is a logarithmic reciprocal square root transformation of the sum of squared error of % dissolution differences between profiles at several time points. It gives information on the degree of similarity between the two profiles: An f₂ value between 50 and 100 suggests the similarity/equivalence of the two dissolution curves being compared. The objective of this report was to provide a careful examination on the f₂metrics in detail. It was shown that f₂values exceeded 50, when relative differences in % dissolved between two products were less than 15% at all time points. The similarity factor value was also found to be greater than 50, in cases when absolute % dissolution differences were below 10% at all time points. Interestingly, the f₂value was changed by the number of the time points selected for calculation. In particular, f₂tended to have higher values, when the f₂metrics used a large number of time points in which % dissolved reached plateau. Finally, since the similarity factor was a sample statistics, it was impossible to infer type Ⅰ/Ⅱ errors and sampling error. Despite certain limitations inherited in the f₂metrics, it was easy and convenient to evaluate how similar the two dissolution profiles were.
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김민수,이시범,이태완,전재일,황성주 충남대학교 약학대학 의약품개발연구소 2004 藥學論文集 Vol.19 No.-
We have studied the dissolution kinetics of three extended release commercial tablets of acetaminoPhen in simulated gastric juice, and the dissolution profiles were compared. The applied methods for the comparison of in vitro dissolution profiles are model independent methods including difference factor (f₁) and similarity factor (f₂), and statistical methods based on the analysis of variance and in t-test. The comparison of the dissolution profile, using difference factor (f₁), and similarity factor (f₂), indicates that the three tablets are equivalent in their dissolution. But, statistical methods based on the analysis of variance and in t-test indicate that the three tablets are not equivalent in their dissolution. The results show that statistical methods are better indicator of discrimination than the f-factors.
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폴리메타크릴레이트를 이용한 케토로락 트로메타민 서방성 정제의 제조와 용출평가
전일순,윤재남,이은미,박용근,김동우,이계원,지웅길 충남대학교 약학대학 의약품개발연구소 2003 藥學論文集 Vol.18 No.-
To improve administration of ketolorac tromethamine, we prepared matrix tablets with Eudragit (RS 100 or 30D), diluents (avicel:lactose=l:l or Ca phosphate) and Mg stearate using wet-granulation method. Sustained release matrix tablets using Eudragit® RS 100 7 and 10% decreased dissolution rate at pH 1.2 and 68 Ca. phosphate as diluents showed more decreased dissolution rate than that of avicel:lactose (1:l). Sustained release matrix tablets using Eudragit® RS 30D also showed very effective sustained release of KT.
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알긴산 나트륨이 장용코팅된 란소프라졸 제제의 저장안정성 및 용출률에 미치는 영향에 관한 연구
김정훈,오정민,강길선,정제교,이정식,정상영,이해방 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.4
Lansoprazole, pharmaceutics for acid-related diseases, is unstable in low pH environments and generally coated with enteric polymer to obtain gastroresistance in stomach. Because its storage stability is influenced by acidic substitutes of enteric polymer, alkaline chemicals were generally added to dosage form as a stabilizer. In this experience, we coated lansoprazole bead with sodium alginate and evaluated the effect of bead size and sodium alginate coating on the storage stability and dissolution profile of lansoprazole. Sodium alginate solution containing lansoprazole was sprayed as a droplet into 3% (w/v) CaCl_2 solution and the resultant bead was coated with starch, sodium alginate, and hydroxypropyl methylcellulose phthalate. The content of lansoprazole granule not coated with sodium alginate decreased to 57.96% of initial content when stored at a severe condition for 4 weeks, but that of lansoprazole granule coated with sodium alginate before enteric coating decreased little and as the thickness of sodium alginate film increased, the content of bead didn't decreased for 4 weeks. Sodium alginate film also improved the gastroresistance without much influencing the maximum dissolution rate.
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