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손영택,박미영,김상린,단현광 德成女子大學校 藥學硏究所 2003 藥學論文誌 Vol.14 No.1
Cefaclor is a semisynthetic cephalosporin for oral administration. It is absorbed 50∼75% after oral administration and having a biological half life of 0.6∼0.9hours. To maintain therapeutic range, the drug should be administrated 3∼4 times a day, which leads to the saw both kinetic of the absorption and resulting in ineffective therapy. Hence many authors attempted to develop sustained/extended release dosage forms for cefaclor in order to achieve effective administrated regimens. In this study we attempted to formulate cefaclor sustained release tablet by using HPMC(hydroxypropyl methylcellulose) and vinyl pyrrolidone vinyl acetate complex, which can provide convenient administration and are economic and the drug release from HPMC matrix is uniform irrespective of the pH. The cefaclor sustained release tablets were prepared by wet granulation techinique. The wet granules were dried at 50℃ for 5 hours in a tray drier. The dried granules were passed through sieve #20, lubricated with magnesium stearate by mixing in rapid mixer granulator and compressed using 7kgf/cm² punch to get tablets. In vitro release of cefaclor form formulated tablets was carried out in 0.1N HCl for 30 minute at 37±0.5℃ and 100rpm. The formulated cefaclor tablets were kept for a short term accelerated stability study in high temperature at 20℃, 50℃ for 4 weeks. And the formulation 16 18 carried out long term stability study for 24 months.
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이영환,이완하,지웅길,김상린 한국약제학회 1985 Journal of Pharmaceutical Investigation Vol.15 No.2
Pivampicillin hydrochloride is a kind of broad spectrum antibiotics with bactericidal action, and is used in many countries, although it has bitter taste, unpleasant odour and side effects of irritating gastric mucosa, nausea, penicillin allergy, etc. For the improvement of such side effects of pivampicillin hydrochloride, microcapsules, with wall of ethylcellulose, have been prepared by coacervation method. The shape was observed through the scanning electron microscope, the release of the drug into an aqueous medium was studied and the effects of core: ethylcellulose ratio were interpreted as well as making sensory evaluation of taste and odour. There was decreasing trend in dissolution rate of the drug with the increase of core: ethylcellulose ratios, and the smaller microcapsules released their contents more rapidly. A linear relationship was established between the amount of ethylcellulose and the time for 60% release of the drug, and the release pattern was found to have similar characteristics to the release of the drug from an insoluble porous matrix. The release of the drug in the artificial intestinal fluids (pH 6.8) was found to be similar to that in water, while the release in the artificial gastric juice (pH 1.2) was slightly slower. Bioavailability of microcapsule was compared with that of pivampicillin hydrochloride in rabbits using serum concentration and urinary excretion measurements. Microcapsule gave showed slightly higher serum level than pivampicillin hydrochloride from 2 hours after administration, while no significant difference was observed in the accumulated urinary excretion rate between pivampicillin hydrochloride and microcapsule. The ulcer index of pivampicillin hydrochloride administered group was 2.6, and microcapsule administered group was 1.5, while control group was 0.8. Therefore it may be concluded that microencapsulation of pivampicillin hydrochloride is a useful pharmaceutical approach to protect the gastrointestinal tract from being injured by direct contact of pivampicillin hydrochloride without any significant difference of bioavailability.
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건강 피험자에서 lafutidine의 약동학 특성에 관한 연구
김보형,김정렬,임경수,김재우,김상린,조주연,유경상,장인진,신상구 대한임상약리학회 2007 Translational and Clinical Pharmacology Vol.15 No.1
Background: Lafutidine(Stogar®) is a novel histamine H2 receptor antagonist with gastroprotective activity. It exhibited potent and long-lasting H2 receptor antagonism and showed a gastroprotective effect against noxious agents-induced gastric mucosal damage through capsaicin-sensitive afferent nerves. Our objective was to determine the pharmacokinetic (PK) characteristics and safety of rising, single oral doses of lafutidine 10 mg, 20 mg, and 40 mg in healthy Korean subjects. Methods: A double-blind, dose block randomized, placebo-controlled, parallel group, single oral dose study was conducted in 30 healthy male subjects. Three groups of ten subjects received 10 mg, 20 mg, or 40 mg dosage, respectively. Two subjects in each dose group were administered matching placebo. Serial blood samples were collected for lafutidine assay during 24 h after drug administration. Pharmacokinetic parameters were determined using noncompartmental methods. Clinical safety evaluations were performed. Results: Lafutidine was rapidly absorbed with individual Tmax values ranging from 0.5 to 2 h. Mean values by dose group for oral clearance and apparent volume of distribution were similar. Lafutidine AUC and Cmax appeared to increase proportionally with dose, and dose-normalized AUC and Cmax were similar among 10 mg, 20 mg, or 40 mg dosing groups (analysis of variance, P=0.163 and 0.244, respectively). All 5 adverse events (AEs) reported were mild. No clinically significant laboratory abnormalities, vital signs or ECG measurements were observed. Conclusions: PK linearity was demonstrated up to 40 mg dosing. Lafutidine was generally safe and well tolerated with only mild AE.
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李琬夏,智雄吉,李暎煥,金祥麟 충남대학교 약학대학 의약품개발연구소 1985 藥學論文集 Vol.1 No.-
Pivampicillin hydrochloride is a kind of broad spectrum antibiotics with bactericidal action, and is used in many countries, although it has bitter taste, unpleasant odour and side effects of irritating gastric mucosa, naucosa, penicillin allergy, etc. For the improvement of such side effects of pivampicillin hydrochloride, microcapsules, with wall of ethylcellulose, have been prepared by coacervation method. The shape was observed through the scanning electron microscope, the release of the drug into an aqueous medium was studied and the effects of core: ethylcellulose ratio ere interpreted as well as making sensory evaluation of taste and odour. There was decreasing trend in dissolution rate of the drug with the increase of core: ethylcellulose ratios, and the smaller microcapsules released their contents more rapidly. A linear relationship was established between the amount of ethylcellucose and the time for 60% release of the drug, and the release pattern was found to have similar characteristics to the release of the drug from an insoluble porous matrix. The release of the drug in the artificial intestinal fluids (pH 6.8) was found to be similar to that in water, while the release in the artificial gastric juice (pH 1.2) was slightly slower. Bioavailability of microcapsule was compared with that of pivampicillin hydrochloride in rabbits using serum concentration and urinary excretion measurements. Microcapsule gave showed slightly higher serum level than pivampicillin hydrochloride from 2 hours after administration, while no significant difference was observed in the accumulated urinary excretion rate between pivampicillin hydrochloride and microcapsule. The ulcer index of pivampicillin hydrochloride administered group was 2,6, and microcapsule administered group was 1.5,, while control group was 0.8. Therefore it may be concluded that microencapsulation of pivampicillin hydrochloride is a useful pharmaceutical approach to protect the gastrointestinal tract from being injured by direct contact of pivampicillin hydrochloride without any significant difference of bioavailability.
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마우스에서 BR92021(정제 브이아이 장티푸스 백신)의 감염 방어 효과
임상민(Sang Min Lim),정한선(Hahn Sun Jung),이윤경(Youn Kyeong Lee),조증근(Zeung Keun Cho),김상린(Sang Lin Kim),이영순(Yong Sun Lee) 한국독성학회 1999 Toxicological Research Vol.15 No.3
This study was performed to confirm the immunological efficacy of BR92021, vi polysaccharide typhoid vaccine, in mice. The BR92021 producing strain was less pathogenic than the challenging organism, S. typhi ty2 N4446. BR92021 completely protected the death caused by S. typhi ty2 at above 1.25 ㎍/0.5 ml/dose vaccinized by one time. At the optimally effective dose of 25 ㎍/0.5 ml of BR92021, one immunization was necessary for complete protection against S. typhi ty2-induced death. In potency test, we injected S. typhi ty2 N4446 (LD50=7.9)for the purpose of challenge to immunized mice. When injected to mice, the number of bacteria was about 1,000 CFU/0.5 ml, we observed challenged mouse for 3 days and calculated the ED50 by probits method. It was 0.037 (BR92021 ,lot No. 980001), 0.036 (BR92021, lot No. 980002), 0.032 (BR92021, lot No. 980003) and 0.045 (reference standard) ㎍/0.5 ml/mouse. This result showed that BR92021 vaccine was effective for the protection from desease caused by S. typhi ty2 infection.
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말산클레보프리드 서방성 제제의 제조 및 약물동태학적 평가
류해원(Hae Won Ryou),이주한(Joo Han Lee),지용하(Yong Ha Chi),한양희(Yang Hee Hahn),단현광(Hyun Kwang Tan),이규흥(Kyu Heung Lee),김상린(Sang Lin Kim),전승윤(Seung Yoon Jeon),최영욱(Young Wook Choi) 한국약제학회 2000 Journal of Pharmaceutical Investigation Vol.30 No.3
Clebopride malate(Cm) is a new benzamide drug which has a potent central antidopaminergic activity possessing antiemetic and anxiolytic properties. A purpose of this study was to assess the feasibility of formulating sustained release preparation by dispersing a drug in hydrophilic polymeric matrices and double layered tablets(DLT), using HPMC, carbopol, PEO, PVP/VA and other polymers as a rate controlling barrier. The matrix and DLT showed optimum dissolution pattern up to 8 hours and the contents of polymer were optimized at 30% level in this preparation. After an oral administration in beagle dog, Cm concentration was determined by use of GC-ECD and pharmacokinetic parameters were calculated by Vallner`s method. The AUC of DLT showed similar results and the duration of action was increased 55% compared to that of regular release dosage form. The calculated absorption rate effectiveness(ARE) and controlled release effectiveness(CRE) for DLT increased 50% compared to that of matrix, the overall effectiveness(E) of this product appears to be about 70%. in vivo effectiveness test, DLT showed significant differences from control on antiemetic action of Cm. In consequence, it was possible to conclude that double layered tablet might be a good candidate for the sustained release dosage forms.
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기니픽을 이용한 BR92021 ( 정제 브이아이 장티푸스 백신 ) 의 항원성 평가
정태천(Tae Cheon Jeong),김갑호(Kap Ho Kim),배주현(Ju Hyun Bae),구희경(Hee Kyoung Gu),서정은(Jeong Eun Suh),박종일(Jong Il Park),차신우(Shin Woo Cha),임상민(Sang Min Lim),정한선(Hahn Sun Jung),김상린(Sang Lin Kim) 한국응용약물학회 1999 Biomolecules & Therapeutics(구 응용약물학회지) Vol.7 No.3
To study the antigenicity of BR92021(Vi polysaccharide typhoid vaccine), active systemic anaphylaxis and passive cutaneous anaphylaxis were tested in guinea pigs. The groups were as follows: group I(low dose, 30 ㎕/kg), group II(high dose, 300 ㎕/kg), group III(300 ㎕/kg plus complete Freund`s adjuvant), group IV(positive control, ovalbumin plus complete Freund`s adjuvant) and group V(saline-treated control). Male Hartley guinea pigs at 7 weeks of age were sensitized subcutaneously with the test article or saline three times per week for three weeks(i.e., total 9 times). For groups III and IV, animals were sensitized subcutaneously with either the test article or ovalbumin plus complete Freund`s adjuvant once per three week for 6 weeks(i.e., total 3 times). Twelve days after the last sensitization, the blood was collected from the sensitized animals for the passive cutaneous anaphylaxis test. In addition, the sensitized animals were subjected to the active systemic anaphylaxis test on fourteen days after the 1st sensitization by an intravenous challenge with either the test article or ovalbumin. In group I, mild(1/5) or moderate(4/5) symptoms of anaphylactic shock were observed. In group II, no sign(1/5), moderate(3/5) and severe(1/5) symptoms were observed. In group III, four animals of 5 revealed moderate signs and one of 5 showed no signs of anaphylactic shock. In group IV, all 5 animals showed severe signs of shock. In group V, one of 5 revealed moderate and four of 5 showed no signs. The necropsy findings related to the active systemic anaphylaxis were observed in most animals of groups I to V. In the passive cutaneous anaphylaxis test, the antiserum was diluted 10- to 5120- fold and was injected intradermally on the clipped back of recipient animals, followed by an intravenous challenge with either the test article or ovalbumin. No animals in groups I, II, III and V showed the positive reaction, whereas all animals in group IV, the positive control, showed the positive reaction at the dilution range of x1280 to x5120. Our results indicate that the test article, BR92021, may have weak antigenic potential in male guinea pigs.
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