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HPLC에 의한 Zea mays 불검화추출물과 그의 함유제제 중 beta-시토스테롤의 정량
김경호(Kyeong Ho Kim),박우선(Woo Sun Park),심창구(Chang Gu Shim) 대한약학회 1996 약학회지 Vol.40 No.2
A high-performance liquid chromatographic method for the determination of beta-sitosterol in the unsaponifiable fraction of Zea mays L. and its related drug preparations using a cholesterol as an internal standard was investigated. They were saponified with 20% methanolic KOH solution. Phytosterols in the reaction mixture were extracted with diethyl ether and separated on silica gel TLC plate with n-hexane-diethyl ether(40:60) as the solvent and then were scraped off. They were separated by reversed phase high perfomance liquid chromatography on Inertsil ODS-2 column with detection at 205nm. Cholesterol and beta-sitosterol were resolved from interferences by adjusting the acetonitrile content in the MeOH-tetrahydrofuran-H2O eluent. The detection limit of beta-sitosterol was 0.43mcg.
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송상호,최영희,심창구,유상호,박영의 대한골절학회 2001 대한골절학회지 Vol.14 No.2
Purpose : Patient age significantly influences the rate of fracture healing. The rate of healing declines with increasing age. The authors compared the aging effect on fracture healing in the callus of rat femur by the light microscopy. Materials and Methods: In this study the unilateral, closed fractures were created in the femur of 18 Sprague-Dawley rats. The rats were killed in three age group(8 weeks:7, 32weeks:6, 70weeks:5) at 2 weeks after fracture. The composition of fracture callus(new bone, cartilage, mesenchymal layer) was measured by image analyzer with H-E stain. Immunohistochemical stain (PCNA, TUNEL, TRAP) positive cells were counted for the comparing of cellular activity according to the aging. Results: The percent of intramembranous new bone in the younger rat(8 week:22.32%) was higher than the older ones(30 week:7.09%, 70 week:5.37%). The percent of PCNA positive osteoblast in the newbone decreased according to the aging(8 week:64.25%, 30 week:57.40%, 70 week:29.54%). The number of osteoclast in the osteochondral junction at the 8 week(43) was more than that of 30 week(25.57) and 72 week(29.87). The number of TRAP positive osteoclast was not different as aging, but the number of osteoclast in the osteochondral junction(5.89) was more than that in the metapyseal area(2.08). Conclusions: More new bone was found in younger rat. There was a strong correlation (p$lt;0.05) between age and PCNA activity. More number of active osteoblast and osteoclast was found in younger rat femoral fracture callus, which indicated rapid fracture healing in younger age.
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의약품 등의 제제평가에 관한 연구(Ⅱ) : 반고형제제의 방출시험을 통한 제제평가 Evaluation of semisolid dosage forms using release test
김호정,강신정,윤미옥,이수정,최현철,김지영,심창구 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-
기존의 반고형제제의 픔질은 확인, 함량 등의 기준 및 시험방법에 의하여 평가되어 찼으나 이 시험법으로는 제제의 롯트간, 끌품간 등의 제제동등성을 평카하기에는 어려움이 있어 방출시험 등을 통한 제제평가법 개발이 필요하다. 따라서 본 연구에서는 시잔중인 케토프로펜 겔제를 가지고 용해도시험 및 Franz diffusion cell을 사용하여 방출시험을 하여 rH7.4 인산옇완충액예서 70rm nylon woven filter 합성막을 사용하고 infinite dose를 결정하여 방출시험을 선정하였다. 이 방출시험법들 검증하기 위하여 겔제의 주성분 함유량에 따라 방출시험한 결파 주성분 함량에 따라 비례적으로 방출량을 나타내어, 본 연구에저 선정한 시험법이 제제중 주성분의 양이 달라졌을 때 이 변화를 반영할 수 있는 시험법으로 평가되었다. 또한 동일 제조사의 3롯트에 대하여 방출시험한 결파 롯트간 차이가 적게 나타났으며. 케토프로펜 겔제 5개 제조사의 제품별로 방출양상이 다르게 나타나 본 시험법은 부형제의 종룬 및 양, 제조방법 변경에 따른 제품간의 동등성을 평가한 있는 타당한 방출시험법으로 사료되었다. 이상의 결과로 반고형.쩨제의 제품간의 품질 동등성 확보를 위한 간편하고, 재현성이 있으며 롯트간의 균질성을_확보할 수-있는 in vifro 방출시험의 퐁가법을 개발하여 후발의약품의 제제학적 품질평가 법으로 제시하고자 하다 This study presents steps that are useful in the development and validation of an in vitro release test method using FranB diffusion tell system and synthetic rnembrafes for ketoprofen gel formulation as a model system. We developed a method for the determination ofthe in vitro release of ke%oprofen from gel uslng Franz Diffusion Cells, an aqueous pH 7.4receptor medium, and a 70 #m woven nylon rrlesh support membrane. The support membranewas shown to have no measurable resistance to the free difHsion of ketoprofen. The lot-to-lotvariabilit)'in the release pl☞I'ile of ketoprofen was low for 3 lots of commercial product tested. The results of this stud?'demonstrated that in vitro release test could be used as a pc)verfultool to ald in the determiration of lot-to-lot variability of a semisolid formulation. In vitr()release test can be performed in conjunction tt·ith traditional QA test methods to detennineproduct quality and conslsttncy.
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