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경구용 항원 수송체 모델로서 폴리락티드 - 글리콜리드 마이크로스피어의 입자도 조절
송일용(Il Yong Song),송세현(Seo Hyun Song),송우헌(Woo Heon Song),조성완(Seong Wan Cho),최영욱(Young Wook Choi) 한국약제학회 1999 Journal of Pharmaceutical Investigation Vol.29 No.4
Poly (lactide-co-glycolide) (PLGA) microspheres containing ovalbumin (OVA) as a model protein drug were prepared by double emulsification method, and various conditions such as mixing rate, volume of outer phase and isopropyl alcohol concentration in outer phase during secondary emulsification were observed to control the size of microspheres. In addition, entrapment efficiency of OVA and protein denaturation were also evaluated. As the rate of stirring was increased, the size of particles was decreased. But excessive stirring increased the particle size of microspheres. In a preparation condition of small volume of outer phase, the particle size was decreased but the entrapment efficiency was increased. Adding isopropyl alcohol to outer phase decreased the size of particles, but increased the entrapment efficiency. Microparticles should have smaller size than 10 ㎛ to be uptaked by Peyer`s patch in small intestine. High speed of mixing and relatively small volume of outer phase are needed to reduce the size. In addition, appropriate amount of isopropyl alcohol in outer phase also plays an important role in size reduction of PLGA microspheres.
바난 정 ( 세프포독심 프로세틸 100mg ) 에 대한 포독수 정의 생물학적 동등성
조성완(Seong Wan Cho),이지혜(Ji Hye Lee),송일용(Il Yong Song),이상길(Sang Kil Lee),차영주(Young Joo Cha),최영욱(Young Wook Choi) 한국약제학회 1999 Journal of Pharmaceutical Investigation Vol.29 No.3
Bioequivalence study of two cefpodoxime preparations, the test drug (Banan^ⓡ: Hanil Pharmaceutical Co., Ltd.) and the reference drug (Podox^ⓡ: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 23.81±2.13 years old and 63.34 ±4.84 ㎏ of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 200 ㎎ as cefpodoxime proxetil in a 2×2 crossover study. Plasma concentrations of cefpodoxime were analysed by HPLC method for 12 hr after administration. The AUC_(0-12hr) was calculated by the linear trapezoidal rule method, The C_(max) and T_(max) were compiled directly from the plasma drug concentration-time data. Student`s t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there were no differences in AUC, C_(max), and T_(max) between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 4.31, 1.99 and 4.30% for AUC, C_(max), and T_(max), respectively). Minimum detectable differences (%) between the formulations at α = 0.05 and 1-β=0.8 were less than 20% (e.g., 13.89, 13.88, and 16.97% for AUC, C_(max), and T_(max), respectively). The 90% confidence intervals for these parameters were also within ±20% (e.g., -5.58∼14.20, -7.89∼11.88, and -7.78∼16.38% for AUC, C_(max), and T_(max), respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cefpodoxime were bioequivalent.