소염진통제의 경피투여 제제의 개발과 평가

이계주(Gye Ju Lee),홍석천(Seok Cheon Hong),우종수(Jong Su Woo),이덕근(Duck Kun Lee),김은희(Eun Hee Kim),남진경(Jin Kyung Nam),박종범(Jong Bum Park),황성주(Sung Joo Hwang) 한국약제학회 1998 한국약제학회 총회 및 학술대회 요지집 Vol.- No.28

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플루비크로펜 함유 경피 패취제의 제제설계 및 약제학적 성질

이계주(Gye Ju Rhee),고유현(Yu Hyun Ko),우종수(Jong Su Woo),황성주(Sung Joo Hwang) 대한약학회 1999 약학회지 Vol.43 No.4

The purpose of this study is to prepare the adhesive type patch containing flurbiprofen, and to demonstrate the feasibility of flurbiprofen administration through the intact skin using adhesive type patch preparation. For this purpose, two pressure sensitive adhesives, Polyisobutylene(PIB) and Gelvan 737, were selected from the chemical grade of polymers, and the adhesive type patches of flurbiprofen were prepared. The release rate of flurbiprofen from the PIB-based adhesive patch was higher than that from Gelva 737 based adhesive patch. The release rate of flurbiprofen from the PIB-based A-type patch with 1.0mm, 1.5mm or 2.0mm thicknesses followed the first order kinetics. In the skin permeation study, using male hairless mouse skin, a monophasic skin permeation profile was observed with 1% flurbiprofen loading dose. The inclusion of palmitic acid or SLS(0.25~0.5%) as an enhancer produced a remarkable enhancement in the skin permeation rate of flurbiprofen, and the percentile ratio of drug and enhancer appeared to be important for the effective enhancement. In the in vivo percutaneous absorption study, the plasma concentration of the optimal formulation was significantly (p<0.01) higher than that of the conventional cataplasma(Bifen). These studies demonstrate a good feasibility of flurbiprofen administration through the intact skin using a transdermal patch, and show a possibility of the development of flurbiprofen patches.

족부 우회로술의 임상경험

우종수,조광조 대한혈관외과학회 2001 Vascular Specialist International Vol.17 No.2

Purpose: Bypasses to the infra-inguinal arteries using autologous vein are now routinely used for limb salvage and as this technique has evolved, the distal limits of revascularization have been extended to near the ankle or in the foot. As the prevelances of chronic renal failure, diabetes and Buergers disease increased, the more infrapopliteal arterial occlusions were detected. But the safety and effect of pedal bypass was not reported so much in our society. So we studied our cases of ankle bypass to find out its effect on preventing from primary amputation in infrapopliteal arterial occlusive diseases. Method: From July 2000 to December 2000, 12 cases of ankle bypasses were performed and followed most of them up to May 2001. The underlying diseases included 6 cases of atherosclerosis obliterance and 6 cases of Buerger`s disease. Surgical indications were 9 minor toe gangrene, 2 major gangrene and 1 intractable resting pain. The surgical procedures were 3 popliteo-distal bypasses, 3 popliteo-distal bypasses after femoral thrombectomy, 2 above knee popliteo-below knee popliteo-distal sequential bypasses, 2 combined bypasses of femoro-above knee popliteal bypass and below knee popliteo-distal bypass, and 2 femoro-above knee popliteo-below knee popliteo-distal sequential bypasses. The distal bypass sites were 8 posterior tibial artery (PTA) near medial malleolous, 2 dorsalis pedis (DP) and 2 PTA-DP sequentially. Result: There were 2 cases of early occlusion from graft thrombosis and 1 case of late occlusion from inflow embolism. These 3 cases were revised and rebypassed. There was one case of amputation due to deep metatarsal infection. One patient with atherosclerosis died of acute myocardial infarction a month after bypass operation. One patient who underwent bilateral bypass was lost to follow up. The others showed patent graft unil may 2001. 3 patients underwent toe amputation but they didn't have any problem in bipedal ambulation. Conclusion: Ankle bypass is safe and promising procedure in infrainguinal arterial occlusive disease.

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)

플루비프로펜 함유 경피 패쥐제의 제제설계 및 약제학적 성질

이계주,고유현,우종수,황성주 충남대학교 약학대학 의약품개발연구소 1999 藥學論文集 Vol.15 No.-

The purpose of this study it to prepare the adhesive type patch containing flurbiprofen, and demonstrate the feasibility of flurbiprofen administration through the intact skin using adhesive type patch preparation. For this purpose, two pressure sensitive adhesives, Polyisobutylene (PIB) and Gelva® 737, were selected from the chemical grade of polymers, and the adhesive type patches of flurbiprofen were prepared. The release rate of flurbiprofen from the PIB-based adhesive patch was higher than that from Gelva® 737 based adhesive patch. The release rate of flurbiprofen from the PIB-based A-type patch with 1.0mm, 1.5mm or 2.0mm thickness followed the first order kinetics. In the skin permeation study, using male hairless mouse skin, a monophasic skin permeation profile was observed with 1% flurbiprofen loading dose. The inclusion of palmitic acid or SLS (0.25∼0.5%) as an enhancer produced a remarkable enhancement in the skin permeation rate of flurbiprofen, and the percentile ratio of drug and enhancer appeared to be important for the effective enhancement. In the in vivo percutaneous absorption study, the plasma concentration of the optimal formulation was significantly (p<0.01) higher than that of the conventional cataplasma (Bifen®). These studies demonstrate a good feasibility of flurbiprofen administration through the intact skin using a transdermal patch, and show a possibility of the development of flurbiprofen patches.

Clarithromycin 정제의 생물학적 동등성 및 약물동태

강원구,박선영,박용순,우종수,최경업,권광일 충남대학교 약학대학 의약품개발연구소 1999 藥學論文集 Vol.15 No.-

This study was carried out to compare the bioavailability of Hanmi clarithromycin (250mg/tablet) with that of Klaricid®. The bioavailability was examined on 20 volu nteers who received a single dose (500mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 12 hours. Plasma samples were analyzed for clarithromycin and roxithromycin(internal standard) by HPLC/Coulometric ECD. The pharmacokinetic parameters (AUC_0-12h, Cmax, Tmax, AUC_inf, Ka, Kel, t_12, Vd/F and Cl/F) were calculated from the plasma clarithromycin concentration-time data of each volunteer. The computer program “WinNonlin” was used for compartmental analysis. One compartment model with first-order input, first-order output with lag time, weighting factor 1/y2 was chosen as the appropriate pharmacokinetic model. The major pharmacokinetic parameters (AUC_0-12h, AUC_inf, Cmax and Tmax) of Hanmi clarithromycin were 10.7±0.5μg·hr·ml^-1, 12.7±0.7μg·hr·ml^-1, 1.7±0.1μg/ml and 2.0±0.2hr, respectively, and those of Klaricid(R) were 9.8±0.5μg·hr·ml^-1, 11.7±0.6μg·hr·ml^-1, 1.6±0.1μg/ml and 2.1 ±0.1hr, respectively. The differences in mean values of AUC_0-12hr, AUC_inf and Cmax between two products were 9.88%, 8.94% and 6.59%, respectively. The least significant differences at alpha=0.05 for AUCO-12h, AUCinf and Cmax were 16.08%, 17.81% and 18.94%, respectively. Though the plasma clarithromycin concentrations of Hanmi clarithromycin were higher than those of Klaricid® at all observed times, the bioavailability of Hanmi clarithromycin appeared to be bioequivalent with that of Klaricid®. The Ka, Kel, t_1/2, Vd/F and Cl/F of the Hanmi clarithromycin were 2.69±0.53hr^-1, 0.18±0.01hr^-1, 3.9hr, 248.8±11.4L and 43.7±2.6L/hr, respectively, and those of Klaricid® were 2.19±0.51hr^-1, 0.18±0.02hr^-1, 3.7hr, 266.7±22.4L and 45.3±2.8L/hr, respectively. There were no statistically significant differences between two drugs in all pharmacokinetic parameters.