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정상 성인에 경구 투여한 Cefixime 두 정제의 생물학적 동등성 비교
강진양,서성훈,이경태,문창훈,강진한,이동건,최정현,신완식 대한화학요법학회 2000 대한화학요법학회지 Vol.18 No.4
목적 : 식품의약안전청 고시 제 1998-86호(1998. 8.26) "생물학적 동등성 시험 기준"에 의하여 섹심 캅셀(시험약, 한국유나이트제약)과 슈프락스 캅셀(대조약, 동아제약)의 생물학적 동등성을 비교 검토하였다. 방법 : 2×2 라틴 방격법에 따라 건강한 성인 남성 지원자 20명에게 cefixime 100㎎씩 경구투여하였다. 약제투여 후 12시간까지 일정간격으로 채혈하였고 각 피험자들의 혈중약물농도 데이터로부터 구한 Area under the concentration (AUC), C_(max), T_(max) 등의 생체이용률 파라미터에 대해 통계학적으로 고찰하여 두 제제간의 생물학적 동등성을 평가하였다. 결과 : AUC, C_(max), T_(max)에 대한 평균값의 차가 각각 1.26%, 3.73%, 6.21%로서 모두 대조약의 20% 이내에 들어 생물학적 동등성 판정기준의 전제조건을 만족하였다. 분산분석 결과 AUC, C_(max), T_(max)의 각 비교 항목에 있어서 모두 유의수준 α=0.05의 군/순서효과 검정에서 F비가 F 분석표의 한계값보다 작아 교차시험이 제대로 이루어졌음을 확인할 수 있었으며, AUC, C_(max), T_(max) 각 비교항목에 있어서 유의수준 α=0.05에서 대조약에 대한 최소검출차(Δ)가 각각 17.74%, 17.05%, 15.67%로 모두 20% 이내이었으며, 검출력(1-β)도 모두 0.8 이상으로 나타나 생물학적 동등성 판정기준을 만족시켰다. 또 AUC, C_(max), T_(max) 각 비교항목에 있어서 대조약에 대한 생체이용률 차이의 신뢰한계(δ)가 ±20% 이내이어야 한다는 생물학적 동등성 판정기준을 모두 만족시켰다. 결론 : 이상의 실험결과로 시험약은 대조약에 대하여 생물학적 동등성 평가항목인 AUC, C_(max), T_(max)에서 모두 판정기준을 만족시켜 시험약은 대조약과 생물학적으로 동등하다고 사료된다. Background : The study was designed to compare the bioeqivalence between the test (CEXIME®. United Korea. Co., Ltd) and control (SUPRAX®. Dong-a Pharm. Co.. Ltd) capsules of cefixime. Methods : Twenty. healthy, male volunteers completed the study Each subject ingested single dose (100 ㎍) of the control and test drugs in 2?2 crossover design with a week drug-free interval between the doses. Blood samples were collected serially up to 12 hours and plasma concentrations of cefixime were measured by high-performance liquid chromatography with UV detection. A non-compartmental approach was used for analysis of the concentration-time data. Results : The area under the curve (AUC), the maximum concentration of drug (C_(max)). and time to reach C_(max)(T_(max)) did not show any significant difference between the two preparations by ANOVA. The mean differences of AUC, C_(max), and T_(max) were within 20% of the control drug, those were 1.26%. 3.73%. and 6.21%. respectively. The confidence limits of three parameters were satisfied the bioeqivalence criteria. Conclusion : These results suggest that the test drug was bioequivalent with the control drug.
강진양(Chin Yang Kang),이경태(Kyung Tae Lee),서성훈(Seong Hoon Seo) 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.2
N/A This study is purposed to develop the sustained release and bioavailability of piracetam(PA). The use of alginate beads as a means to achieve sustained release of piracetam was evaluated in comparison with that of piracetam alone. In the PA-sodium alginate(SA) beads was confirmed by differential scanning calorimetry thermogram(DSC), indicating a relative shift of an endometric peak of PA to higher temperature. The changes in dissolution rates from PA-SA beads and PA-SA beads coated by chitosan(CHO) were significantly slower than that of intact PA. The release rate of PA-SA in the gastric fluid was markedly decreased compared with that in the intestinal fluid, suggesting that PA is mostly released in the intestinal fluid. However, the PA/SA ratio scarcely affected the release profile. The blood concentration- time curves of PA. PA-SA and PA-SA-CHO were obtained by oral administration to rats. T_(max) of PA, PA-SA and PA-SA-CHO were 1, 10 and 6 hours, respectively. It was confirmed that the release of PA was prolonged by the formulation of PA-SA beads and PA-SA-CHO beads.
강진경,박인서,문영명,정재복,이세준,양우익,박찬일,송시영,이명래 대한소화기내시경학회 1996 Clinical Endoscopy Vol.16 No.2
Primary gastric lymphorna represents one to 7% of all gastric cancer and is the most common type of extranodal lymphoma. In attempt to evaluate the endoscopic characteristics, we analysed clinical and endoscopic findings in 35 patients with primary gastric lymphoma between January 1980 and August 1994 at the Yonsei Medical Center. The results were as follows: 1) The mean age of patients was 47.1 years with male to female ratio of 1.5:1. 2) Gastroscopy was performed in all 35 patienits, which revealed polypoid lesion in one case(2.9%), ulcerative lesion in 15 cases(42.9%), ulcero-infiltrative lesion in 6 cases(17.1%) and diffuse infiltrative lesion in 2 cases(5.7%). Gastric lymphoma was suggested in 6 cases, advanced gastric cancer in 21 cases, early gastric cancer in 5 cases and benign gastric ulcer in 3 cases. Pathologic diagnosis of biopsy specimens were gastric lymphoma in 24 cases, adenocarcinoma in 5 cases and chronic superficial gastritis in one case. 3) The characteristics of the endoscopic findings in gastric lymphoma were intractable or recurrent ulcer in 10 cases, thickened and mounded ulcer margin in 9 cases, multiple ulcers in 9 cases, giant rugae in 7 cases and polypoid or depressed lesion with central ulceration in 4 cases. In conclusion, recognition of specific endoscopic findings such as intractable or recurrent ulcer, volcano-like ulcer, multiple ulcers, giant rugae and combined lesion, the possibility of a lymphoma should be considered and vigorous biopsy attempts should be carried out. Then if the first microscopic report does not suggest this diagnosis, a second investigation including jumbo biopsies, perhaps by diathermy, should be undertaken.