Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by meas of a direct, selective action on smooth muscle in arterial resistance vessels. Futhermore, it have been approved for the effective in angina pectoris and cardiac failure. The purpose of the present study was to evaluate the bioequivalence of two felodipine extended release (ER) tablets, Splendil (YuHan Corporation) and Stapin (Hana Pharmaceutial Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The felodipine release from the two felodipine formulations in vitro was tested using KP VIII Apparatus II method at pH 6.5 buffer solution. Twenty six healthy male subjects, $22.73{\pm}1.78$ years in age and $66.66{\pm}7.28\;kg$ in body weight, were divided into two groups and a radomized $2{\times}2$ cross-over study was employed. After two tablets containing 5 mg as felodipine were orally administered, blood sample was taken at predetermined time intervals and the concentrations of felodipine in serum were determined using column-switching HPLC method with UV detector. The dissolution profiles of two formulations were similar at pH 6.5 buffer solution. Besides, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Splendil were 2.53%, 1.32% and 18.32% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance rage of log(0.86) to log(1.25) $(e.g.,\;log(0.86){\sim}log(1.20)\;and\;log(0.89){\sim}log(1.23)\;for\;AUC_t,\;C_{max},\;respectively)$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Stapin ER tablet and Splendil ER tablet are bioequivalent.
Lee, Jeong Won;Kim, Yi Soon;Kim, Chang Tae;Kwak, Yi Sub;Lee, Hai Woong;Han, Cho Ryang;Oh, Mi Jung;Kim, Gyeong Cheol
Journal of Physiology & Pathology in Korean Medicine
/
v.27
no.4
/
pp.465-470
/
2013
The purpose of this study is to observe clinically the effects of red onion prescription on type 2 diabetes. The subject of this study were middle-aged people. We measured clinically physiological index, body composition, radial arterial pulse wave before taking medicine and after taking medicine for 4 month (the prescription of red onion). The study results were as follows. In physiological Index, diastolic blood pressure(mmHg)(p<0.001), Fasting blood glucose(mg/dL)(p=0.001), and HbA1c(%)(p<0.001) were decreased significantly after taking medicine. In body Composition, waist-hip ratio(p=0.031), body fat percentage(p=0.006), fat mass(kg)(p=0.005), and muscle mass(kg)(p=0.001) were decreased significantly after taking medicine. Blood Circulation Index, ECO(L/min)(p=0.038) and ECI($L/min/m^2$)(p=0.007) were increased significantly after taking medicine, ECR($dyne^*sec^*cm^{-5}$)(p=0.002), and ECRI($dyne^*sec/cm$)(p=0.001) were decreased significantly after taking medicine for 4 month. The prescription of red onion was showed significant change in physiological index, character of body composition, blood circulation index. Based on this result, it is considered that red onion prescription has the positive effects on type 2 diabetes and blood circulation clinically. In the future, diversified studies on the effects of red onion prescription are needed.
Kim Woo-Shik;An Jae-Bum;Song Chang-Min;Kim Mi-Jung;Jung Sung-Chol;Shin Yong-Chul;Kim Byung-Yul;Kim In-Sub
Journal of Chest Surgery
/
v.39
no.8
s.265
/
pp.633-636
/
2006
The partial endocardial cushion defect including ostium primum atrial septal defect and anterior mitral leaflet cleft, presents less significant clinical symptoms than complete endocardial cushion defect. But, as mitral insufficiency develops, cardiomegaly, congestive heart failure, pulmonary arterial hypypertension appear. So, partial endocardial cushion defect has poor prognosis and is rarely seen in elderly patients. A 67 years old woman admitted at our hospital for operative treatment with partial endocardial cushion defect. She had increased pulmonary pressure of 45/22 mmHg, mean 32 mmHg. She had repair of ostium primum defect with patch, and the mitral valve was treated with valve replacement. Because advanced atrioventricular block developed postoperatively, she received permanent pacemaker.
Lee, Jong Won;Jun, Jong Hun;Kim, Young Sun;Cheong, Mi Ae;Shim, Jae Chol;Kim, Kyo Sang
The Korean Journal of Pain
/
v.18
no.2
/
pp.165-170
/
2005
Background: It is difficult to treat tourniquet-induced hypertension despite adequate anesthesia, and the mechanism of that is not known. And it may be possible that intraoperative continuous infusion of opioid induces preemptive analgesia postoperatively. We investigated the effect of intraoperative continuous i.v. fentanyl on tourniquet induced cardiovascular changes and postoperative preemptive analgesia in total knee replacements. Methods: Sixty patients were randomly assigned to two groups; In study group ($1.5{\mu}g/kg$ loading and $0.5{\mu}g/kg/hr$ continuous infusion of fentanyl before skin incision and tourniquet inflation) and control group (no treatment). Anesthesia was maintained with enflurane (1-2 MAC) and 50% nitrous oxide in oxygen. Arterial pressure and heart rate were compared between two groups. They received postoperative pain treatment with patient-controlled analgesia (PCA) with fentanyl during the postoperative 48 hours after total knee replacement. Visual analog scale (VAS) scores at either rest or movement were used to assess pain. Total fentanyl dose delivered, number of PCA requests, supplemental analgesics, overall satisfaction score and adverse events were evaluated. Results: There were no significant differences between the two groups on cardiovascular changes by tourniquet induced pain effect. VAS, PCA delivered dose and PCA demands at movement in the 24-48 hour decreased in study group compared with control group (P < 0.05). But there were no significant differences between the two groups on the other time periods except 24-48 hour's patient satisfaction and adverse events. Conclusions: We suggest that intraoperative continuous i.v. fentanyl infusion dose not affect cardiovascular change by tourniquet induced pain. But it may induce preemptive analgesia postoperatively.
The tension-length relationships and reactivity of vascular smooth muscle in longitudinal strips from portal vein ana in helical strips from thoracic aorta and pulmonary artery of normotensive control and cadmium-hypertensive rabbits were studied in vitro. 1. The mean arterial pressures of non-poisoned control rabbits was $87.0{\pm}4.7 mmHg$. However, Cd-poisoned group revealed the significant increase in pressure by $109.04{\pm}2.8 mmHg$ (p<0.005). 2. By tension-length studies, strips from portal vein of Cd-poisoned group stretched a greater percent increase in length in response to an applied resting force from 0.25 to 5 g than did those from non-poisoned group. On the contrary, strips from thoracic aorta of Cd-poisoned group showed less compliant than those from control, i.e. the former underwent a less percent increase in length than the latter. Passive tension-length relations of pulmonary artery was unaffected by Cd-hypertension. 3. The force of contraction(active tension) was significantly lowered in strips from aorta of Cd-hypertensive group throughout the range of $0.5{\sim}2g$ passive tension. However, there was no significant difference in the development of active tension of portal vein or pulmonary artery of both groups. 4. The $K^+$-contraction in the portal vein, aorta and pulmonary artery of Cd-poisoned group made no difference in the active force from those of control group. 5. The force of contraction in the strips from aorta of Cd-poisoned group was significanty decreased compared to that of control. The results suggested that the alterations in vascular reactivity to contracting substances and in distensibility to passive tension were induced in the Cd-hypertensive rabbits.
Song, Sun-Ok;Carr, Daniel B.;Park, Dae-Pal;Jee, Dae-Lim;Kim, Sae-Yeon
Journal of Yeungnam Medical Science
/
v.14
no.2
/
pp.350-358
/
1997
We studied the effects of adding a single bolus(500 mg) of sodium thiopental to a continuous infusion of low-dose fentanyl on plasma beta-endorphin immunoreactivity(iBE) responses to cardiopulmonary bypass(CPB) in 28 patients undergoing elective coronary artery bypass grafting or valve procedures. Thiopental was injected just prior to the initiation of CPB. The iBE levels and the hemodynamic indices such, as mean arterial pressure, cardiac output and systemic vascular resistance were measured before CPB, at 30 min and again at 60 min after the initiation of the bypass. The results were as follows. After the initiation of CPB, iBE levels increased at 30 min and 60 min(P=0.006, P=0.004 respectively) in the control group, but not in the thiopental group. There were significant differences in the changes of iBE levels between the groups(F=8.7, G-G=0.002, P=0.001). The hemodynamic indices were similar in both groups. In conclusion, pretreatment with thiopental just before the initiation of CPB prevents the stress-induced beta-endorphin response to CPB.
The normal physiological values of Korean mongrel dogs were studied, comparing them with foreign references, on the basis of control physiological data measured on 110 cases out of the dogs submitted to the experiments in our department. The hemodynamic measurements varied widely between the both limits of reported normal control data, with the mean value of heart rate $140.4{\pm}26.6$/min., and both the systolic and diastolic arterial blood pressures $137.2{\pm}31.7$mmHg and $104.7{\pm}14.4$ mmHg, as well as the venous pressure of $9.11{\pm}2.18$ cm.$H_2O$. Hematologically, the number of red blood cells $4,571,000{\pm}767,000$per cu.mm., the amount of hemoglobin $11.57{\pm}3.74$ gm/dl and the hematocrit $37.3{\pm}7.2$ per cent, were equally the values a little lower than the reported normal means. However, the white blood cells were within the reported normal limits both in number, $10,384{\pm}4,877$ per cu. mm and their differential counts with slightly broader ranges of variation. The platelet count was $149,800{\pm}47,000 $per cu. mm and was also far below the normal, while the coagulation time $9.03{\pm}2.69$min. and the prothrombin time $13.17{\pm}6.52$sec were within normal limits, though a little prolonged. The serum electrolytes, Na $146.6{\pm}10.44$mEq/L.,K $4.46{\pm}0.84$mEq/L., CI $118.3{\pm}7.88$mEq/L. and Ca $11.45{\pm}5.62$mg./dl, and the blood glucose level of $94.9{\pm}31.79$mg./dl were essentially not different from the reported normal values. The serum proteins, total protein $7.15{\pm}1.41$gm/dl., albumin $4.09{\pm}0.77$gm./dl. and globulin $3.18{\pm}0.88$gm/dl. were included near the higher limits of the reported normal levels. The thymol turbidity 0.1-3.04 units were normal in 10 cases, and the cephaline flocculation was within normal range except 2 cases out of 26 dogs, showing two positive in 24 hours. And the nitrogen series, NPN $34.61{\pm}10.29$mg/dl. and BUN $12.77{\pm}6.37$mg./dl. were normal. It may be concluded that from the point of view of hereby measured physiological data compared with the foreign references, the Korean mongrel dogs have a compatible laboratory data with only the special regards to their tendency toward anemia in red blood cell series.
Background: The endothelium-dependent vasorelaxation has been largely accounted for by the release of nitric oxide (NO). Three distinct isoforms of NO synthases (NOS) have been characterized, i.e., brain(bNOS), inducible (iNOS), and endothelial constitutive (ecNOS). Although hypertension hasbeen associated with a vascular endothelial dysfunction, changes in the vascular expression of NOS isoforms have not been established. The present study was aimed at exploring the vascular expression of NOS isozymes in hypertension. Material and Method: Two-kidney, one clip (2K1C) and deoxycorticosterone acetate (DOCA)-salt hypertension were induced in rats. The expression of different NOS isozymes in the thoracic aorta was determined by Western blot analysis. The vascular tissue contents of nitrites were measured by colorimetric assay. Result: Arterial blood pressure was significantly higher in experimental groups of 2K1C and DOCA-salt rats compared with their corresponding control rats. The vascular expression of bNOS as well as that of ecNOS was decreased in both models of hypertension. iNOS was not changed in DOCA-salt hypertension, but was also decreased in 2K1C hypertension. The vascular contents of nitrites were significantly decreased in DOCA-salt as well as in 2K1C hypertension. Conclusion: These results suggest that 2K1C and DOCA-salt hypertension are associated with decreases in the vascular expression of NOS isozymes and nitrite contents.
Background: Bronchoalveolar lavage (BAL) is a necessary procedure for diagnosis of various lung diseases. High-flow nasal cannula (HFNC) oxygen delivery was recently introduced. This study aimed to investigate the safety and effectiveness of HFNC oxygen supply during BAL procedure in patients with acute respiratory failure (ARF). Methods: Patients who underwent BAL while using HFNC at a partial pressure of oxygen in arterial blood/fraction of inspired oxygen ($PaO_2/FiO_2$; PF) ratio of 300 or below among patients who had been admitted from March 2013 to May 2017 were retrospectively investigated. Results: Thirty-three BAL procedures were confirmed. Their baseline PF ratio was $166.1{\pm}46.7$. $FiO_2$ values before, during, and after BAL were $0.45{\pm}0.12$, $0.74{\pm}0.19$, and $0.57{\pm}0.14$, respectively. Flow (L/min) values before, during, and after BAL were $26.5{\pm}20.3$, $49.0{\pm}7.2$, and $40.8{\pm}14.2$, respectively. Both $FiO_2$ and flow during and after the procedure were significantly different from those before the procedure (both p<0.001). Oxygen saturation levels before, during, and after BAL measured by pulse oximeter were $94.8{\pm}2.9$, $94.6{\pm}3.5$, and $95.2{\pm}2.8%$, respectively. There were no significant differences in oxygen saturation among the three groups. Complications of BAL procedure included transient hypoxemia, hypotension, and fever. However, there was no endotracheal intubation within 24 hours. Baseline PF ratio in "without HFNC" group was significantly higher than that in "with HFNC" group. There were no differences in complications between the two groups. Conclusion: The use of HFNC during BAL procedure in ARF patients was effective and safe. However, there were no significant differences in oxygen saturation level and complications comparing "without HFNC" group in mild ARF. More studies are needed for moderate to severe ARF patients.
This study was performed to evaluate the sedative and analgesic effects of intravenous (IV) administration of detomidine (D) and tramadol (T) to horses. Six warmblood horses each received D (10 ${\mu}g/kg$), T (2 mg/kg), and a combination of DT (10 ${\mu}g/kg$ and 2 mg/kg). No significant differences in the heart rate, respiratory rate, rectal temperature, indirect arterial pressure, and gastrointestinal motility between D and DT were observed. The sedative effect was evident within 5 min after D and DT administration, but no significant difference between D and DT was observed. D and DT induced a similar analgesic effect up to 50 min after injection and DT maintained a longer analgesic effect than D. A significant increase in blood glucose was shown for D after the injection, but not for DT. A horse with T and DT showed an excited behavior within 5 min of the injection. This study suggests that the DT combination could be used for diagnostic procedures and simple surgeries in standing horses, with caution for excitement in the early phase after the administration.
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