• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.99-116
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• 2016

We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.

• The Korean Journal of Nuclear Medicine
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• v.38 no.4
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• pp.300-305
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• 2004

Purpose: We underwent this study to evaluate the factors which influence labeling efficiency when modified in vivo erythrocyte labeling technique was used. Materials and methods: Thirty healthy volunteers (M:F=19:11, age:$25{\pm}2$ yrs) were enrolled in this study. Totally, two hundred ten samples were obtained from them. The 1 mg of stannous pyrophosphate was injected intravenously at the beginning of labeling. After suitable tinning time (5 min, 20 min, 35 min) passed by, blood (5 mL, 3 mL or 1 mL) was withdrawn into 10 mL syringe previously containing Tc-99m (740 MBq) and anticoagulant (heparin, ACD or CPDA) through 19-gauged scalp needle. The generator ingrowth time of Tc-99m was within 24 hrs in each case. The blood samples were placed on rotating invertor during incubation (10 min, 25 min, 40 min) but some of them were not. Immediately after the conclusion of incubation, the labeled blood specimens to analyze were centrifuged. and then %Unbound Tc-99m was calculated. Statical analysis was used paired T-test and one way ANOVA with SPSS 10.0. Results: The binding efficiency at 1 mL of blood volume was $73{\pm}32%,\;91{\pm}10%$ at 3 mL and $96{\pm}7%$ at 5 mL (p<0.01). The binding efficiency at 5 min of tinning time was $45{\pm}23%,\;98{\pm}6%$, at 20 min and $97{\pm}8%$ at 35 min (p<0.001). The binding efficiency at 10 min of incubation time was $96{\pm}7%,\;95{\pm}12%$ at 25 min and $98{\pm}3%$ at 40 min (p>0.05). The binding efficiency in case of using rotating invertor was $96{\pm}7%$ and the binding efficiency in case of not using it was $87{\pm}18%$ (p>0.05). There was no significant difference between them. In binding efficiency according to kinds of anticoagulants, ACD was $98{\pm}4%$, CPDA was $97{\pm}6%$ and heparin was $89{\pm}20%$ (p<0.001). Conclusion: When modified in vivo erythrocyte labeling technique is used with Tc-99m, the methods to obtain the highest labeling efficiency are as follow. The withdrawing blood volume should be over 3 mL, tinning time should be kept between 20 min and 35 min, and incubation time should be kept between 10 min and 40 min. ACD or CPDA have to be used as a anticoagulant except heparin and the blood samples should be placed on rotating invertor during incubation.

• Journal of Chest Surgery
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• v.41 no.1
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• pp.34-40
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• 2008

Background: Off-pump coronary artery bypass grafting (OPCAB) shows fewer side effects than cardiopulmonary by. pass, and other benefits include myocardial protection, pulmonary and renal protection, coagulation, inflammation, and cognitive function. We analyzed the clinical results of our cases of OPCAB. Material and Method: From May 1999 to August 2007, OPCAB was performed in 100 patients out of a total of 310 coronary artery bypass surgeries. There were 63 males and 37 females, from 29 to 82 years old, with a mean age of $62{\pm}10$ years. The preoperative diagnoses were unstable angina in 77 cases, stable angina in 16, and acute myocardial infarction in 7. The associated diseases were hypertension in 48 cases, diabetes in 42, chronic renal failure in 10, carotid artery disease in 6, and chronic obstructive pulmonary disease in 5. The preoperative cardiac ejection fraction ranged from 26% to 74% (mean $56.7{\pm}11.6%$). Preoperative angiograms showed three-vessel disease in 47 cases, two-vessel disease in 25, one-vessel disease in 24, and left main disease in 23. The internal thoracic artery was harvested by the pedicled technique through a median sternotomy in 97 cases. The radial artery and greater saphenous vein were harvested in 70 and 45 cases, respectively (endoscopic harvest in 53 and 41 cases, respectively). Result: The mean number of grafts was $2.7{\pm}1.2$ per patient, with grafts sourced from the unilateral internal thoracic artery in 95 (95%) cases, the radial artery in 62, the greater saphenous vein in 39, and the bilateral internal thoracic artery in 2. Sequential anastomoses were performed in 46 cases. The anastomosed vessels were the left anterior descending artery in 97 cases, the obtuse marginal branch in 63, the diagonal branch in 53, the right coronary artery in 30, the intermediate branch in 11, the posterior descending artery in 9 and the posterior lateral branch in 3. The conversion to cardiopulmonary bypass occurred in 4 cases. Graft patency was checked before discharge by coronary angiography or multi-slice coronary CT angiography in 72 cases, with a patency rate of 92.9% (184/198). There was one case of mortality due to sepsis. Postoperative arrhythmias or myocardial in-farctions were not observed. Postoperative complications were a cerebral stroke in 1 case and wound infection in 1. The mean time of respirator care was $20{\pm}35$ hours and the mean duration of stay in the intensive care unit was $68{\pm}47$ hours. The mean amounts of blood transfusion were $4.0{\pm}2.6$ packs/patient. Conclusion: We found good clinical outcomes after OPCAB, and suggest that OPCAB could be used to expand the use of coronary artery bypass grafting.

• Journal of the Korean Society of Food Science and Nutrition
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• v.13 no.3
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• pp.251-258
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• 1984

In order to improve the physical properties on moisture sorption of spray dried red ginseng extract powder (SD-RGEP), the various additives and coating agents were treated, and solubility, sedimentation rate and storage stability of RGEPs treated were investigated. For the moisture-proofing, additive itself was effective in the order casein>dextrin>starch>avicell, but RGEPs treated with additives were effective in the order cord oil+tween-40>starch>casein. But there was no significant difference between RGEP treated less than 1% additive and the moisture-proofing. The coating effect of AEA and CAP on RGEP could not be recognized for the moisture-proofing, whereas that of HPC, corn oil, lecithin and HPC+corn oil was proved to be very effective for the moisture-proofing of RGEP. Also it is required to control the initial moisture content of RGEP. The sedimentation rate of RGEP nontreated was 65.1 seconds, whereas that of RGEPs coated with 1% HPC, 1% corn oil, 1% lecithin and 1% HPC+0.5% corn oil was in the range of 96.2 to 114.3 seconds. The sedimentation rate of RGEPs coated was 1.5 to 1.8 times higher than that of RGEP nontreated, and there was significant difference between solubility and sedimentation rate. Therefore it was no matter for the keeping quality. The sorption rates of RGEPs coated with lecithin $(0.5{\sim}1.0%$), corn oil(0.8%) and cellulose acetate (0.8%) were ranged 54 to 56%, 51 to 55% and 52 to 54%, respectively, and it is found that the moisture-proofing effect of RGEPs coated was about 2 times higher than that of RGEP nontreated. From the result of storage experiment during 3 months under the maltreated condition of $48{\pm}2^{\circ}C$, 75% RH, the moisture sorption of RGEPs coated with corn oil$(0.5{\sim}1.0%$), cellulose acetate(DES, $0.5{\sim}0.8%$) and lecithin (DES, 1.0%) was not at all observed. Therefore it is considered that the circulating period of RGEPs coated with these coating agents could to give more than 3 years.

• Journal of Preventive Medicine and Public Health
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• v.22 no.4 s.28
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• pp.555-577
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• 1989

This study was conducted to compare the delivery management including laboratory tests, medication and surgical procedures for the delivery in various medical facilities. Two university hospitals, two general hospitals, three hospitals, two private obstetric clinics, and two midwifery clinics in a large city were selected as they permitted the investigators to abstract the required data from the medical and accounting records. The total number of deliveries occurred at these 11 facilities between 15 January and 15 February, 1989 was 789 among which 606(76.8%) were vaginal deliveries and 183 (23.3%) were C-sections. For the normal vaginal deliveries, CBC, Hb/Hct level, blood typing, VDRL, hepatitis B antigen and antibody, and urinalysis were routinely done except the private clinics and midwifery clinics which did not test for hepatitis B and Hb/Hct level at all. In one university hospital ultrasonography was performed in 71.4% of the mothers and in one general hospital liver function test was done in 76.7% of the mothers. For the C-section, chest X-ray, bleeding/clotting time and liver function test were routinely done in addition to the routine tests for the normal vaginal deliveries. Episiotomy was performed in 97.2% of the vaginal deliveries. The type and duration of fluid infused and antibiotics administered showed a wide variation among the medical facilities. In one university hospital antibiotics was not administered after C-section at all while in the general hospitals and hospitals one or two antibiotics were administered for one week on the average. In one private clinic one pint of whole blood was transfused routinely. A wide variation was observed among the medical facilities in the use of vitamin, hemostatics, oxytocics, antipyreptics, analgesics, anti-inflammatory agents. sedatives. digestives. stool softeners. antihistamines. and diuretics. Mean hospital day for the normal vaginal deliveries of primipara was 2.6 days with little variation except one hospital with 3.5 days. Mean hospital day for the C-section of primipara was 7.5 days and that of multipara was 7.6 days and it ranged between 6.5 days and 9.4 days. Average hospital fee for a normal vaginal delivery without the medical insurance coverage was 182,100 Won for the primipara and 167,300 Won for the multipara. In case of the primipara covered by the medical insurance a mother paid 82,400 Won and a multiparous mother paid 75,600 Won. Average hospital fee for a C-section without the medical insurance was 946,500 Won for the primipara and 753,800 Won for the multipara. In case of the primipara covered by the medical insurance a mother paid 256,200 Won and a multiparous mother paid 253,700 Won. Average hospital fee for a normal vaginal delivery in the university hospitals showed a remarkable difference, 268,000 Won vs 350,000 Won, as well as for the C-section. A wide variation in the laboratory tests performed for a normal vaginal delivery and a C-section as well as in the medication and hospital days brought about a big difference in the hospital fee and some hospitals were practicing the case payment system. Thus, standardization of the medical care to a certain level is warranted for the provision of adequate medical care for delivery.