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강원구 한국전기기술인협회 1998 電力技術人 Vol.194 No.10
일본에서 자가용 전기서비 기술자들에게 제일 소중하게 여겨지는 전기설비에 관한 기술기준을 정한 통칭 전기설비 기술기준이 1997년 3월 27일에 전면 개정되어 공포되었다.
강원구,이창현,우종수,권광일 충남대학교 약학대학 의약품개발연구소 1998 藥學論文集 Vol.14 No.-
This study was designed to compare the absorption fraction and extent of ketoprofen gels and a matrix typed ketoprofen plaster patch. 3 g (90 ㎎ as ketoprofen) of the two gels which has oleohydrogel or hydrogel as a base, respectively, and 3 pieces of plaster patches (90 ㎎ as ketoprofen) were applied in the area of 210 ㎠ on forearm in 12 volunteers by cross over design. Blood samples were collected serially up to 24 hours and the plasma concentrations of ketoprofen were analyzed by HPLC using flurbiprofen as an internal standard. The detection limit of the assay was 1 ng/㎖ of ketoprofen in plasma. The pharmacokinetic parameters (e.g. AUC_24hr, AUMC_24hr, MRT. Fraction Absorbed) were caculated from the plasma concentrations time data of each volunteer. The oleo-hy-drogel showed significantly higher absorption fraction and extent of ketoprofen than the current hydrogel. The mean plasma concentrations of the oleo-hydrogel were increased to 98.46±23.15 ng/㎖ by 6 hour after application, and increase futher to 100.61±18.65 ng/㎖ at 24 hour. On the other hand, those of the hydrogel were increased 17.61±4.65 ng/㎖ at 5 hour to 34.68±9.65 ng/㎖ at 24 hour gradually. Therefore the plasma concentrations of oleo-hydrogel at each measured time were 3~7 times greater than those of the hydrogel with statistical significance. The AUC_24hr (1797.26±352.09 ng·h/㎖) of the oleo-hydrogel was 3.5 times greater (P<0.05) than that (516.17±4104.52 ng·h/㎖) of the hydrogel. The plaster patches showed higher bioavailability (AUC_24hr 2877.37±578.27 ng·h/㎖) than the oleo-hy-drogel (AUC_24hr 1797.26±352.09 ng·h/㎖) without statistical significance. But the absorption fraction of the oleo-hydrogel was rather higher than that of the plaster patches during the first 6 hours after administration. These results suggest that newly developed ketoprofen gel which is used oleo-hydrogel as a base would show excellent skin permeation on topical application for the corresponding clinical indications and could be absorbed as well as plater patches.
지원자의 Cefixime캅셀제 생체이용율에 대한 생물학적동등성 연구
강원구,우종수,권광일 충남대학교 약학대학 의약품개발연구소 1998 藥學論文集 Vol.14 No.-
Cefixime is an orally absorbed 3rd generation cephalosporin with a broad spectrum of activity against Gram-positive and Gram-negative bacteria and is highly resisitant to β-lactamase degradation. This study was carried out to evaluate the bioavailability of a new test drug of cefixime (100 ㎎/capsule) relative to the reference drug. The bioavailability was conducted on 20 healthy volunteers who received a single dose (400 ㎎) of the test and the reference drugs in the fasting state, in a randomized balanced 2-way crossover design. After dosing, serial blood samples were collected for a period of 12 hours. Plasma was analyzed for cefixime by a sensitive and validated HPLC assay. The major phamacokinetic parameters (AUC_0-12hr, C_max, T_max) were calculated from the plasma concentration-time data of each volunteer. The AUC_0-12hr, C_max, and T_max of the test drug were 36.91±11.85 ㎍·hr/㎖, 5.47±1.61 ㎍/㎖, and 4.00±0.65 hr, respectively, and those of the reference drug were 34.08±8.81 ㎍·hr/㎖, 5.25±1.40 ㎍/㎖, and 4.20±0.62 hr, respectively. Mean differences of those parameters were 8.32, 4.29, and 4.76%, respectively, and the least significant differences at α=0.05 for AUC_0-12hr, C_max, T_max were 16.02, 13.78, and 11.76%, respectively. In conclusion, the test drug was bioequivalent with the reference drug. (Kor. J. Clin. Pharm. 1998;8(1): 19-22)