• Title/Summary/Keyword: serum profiles

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Bioequivalence of Acer Capsule to Airtal Tablet (Aceclofenac 100 mg) (에어탈 정(아세클로페낙 100 mg)에 대한 에이서 캅셀의 생물학적 동등성)

  • Cho, Hea Young;Kim, Soo Jin;Oh, In Joon;Moon, Jai Dong;Lee, Yong Bok
    • Korean Journal of Clinical Pharmacy
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    • v.12 no.1
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    • pp.22-28
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    • 2002
  • Aceclofenac, 2-[(2',6'-dichlorphenyl)amino]phenylacetoxiacetic acid, is a new nonsteroidal anti-inflammatory drug that belongs to the family of phenylacetic acids. It shows good tolerance and potent analgesic/antiinflammatory properties, and acts on cartilaginous chondriocytes, stimulating their repair mechanism. The purpose of the present study was to evaluate the bioequivalence of two aceclofenac products, $Airtal^{TM}$ tablet (Daewoong Pharmaceutical Co.) and $Acer^{TM}$ capsule (Kyungdong Pharmaceutical Co.), according to the guideliner of Korea Food and Drug Administration (KFDA). The aceclofenac release from the two aceclofenac products in vitro was tested using KP VII Apparatus II method at pH 7.8 dissolution media. Sixteen normal male volunteers, $23.13\pm2.03$ years in age and $66.33\pm7.08$ kg in body weight, were divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet or capsule containing 100 mg of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentrations of aceclofenac in serum were determined using HPLC with UV detector. The dissolution profiles of the two aceclofenac products were very similar at pH 7.8 dissolution media. 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. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two products were $6.50\%,\;-1.06\%\;and\;11.96\%$ respectively, when calculated against the $Airtal^{TM}$ tablet. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;were\;89.82\%\;and\;82.84\%$, respectively. Minimum detectable differences $(\Delta)\;at\;\alpha=0.05\;and\;1-\beta=0.8$ were less than $20\%\;(e.g.,\;17.51\%\;and\;19.30\%\;for\;AUC_t,\;C_{max}$, ). The $90\%$ confidence intervals were within $\pm20\%\;(e.g.,\;-3.73\%\sim16.73\%\;and\;-12.34\%\sim10.22\%\;for\;AUC_t,\;C_{max},\;respectively)$. Two parameters met the criteria of KFDA for bioequivalence, indicating that $Acer^{TM}$ capsule is bioequivalent to $Airtal^{TM}$ tablet.

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Safety Evaluation of 30 kGy-Irradiated Dakgalbi (30 kGy 감마선 조사된 닭갈비의 안전성 평가)

  • Jeon, Young Eun;Yin, Xing Fu;Kim, Tae-Keun;Kang, Il-Jun
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.42 no.9
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    • pp.1475-1481
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    • 2013
  • The aim of this study was to determine the potential toxicity of gamma-irradiated Dakgalbi keeping in mind its future use as a space food. Dakgalbi was irradiated at a dose of 30 kGy at $-20^{\circ}C$. AIN-93G was used as a control diet in the animal study. Both irradiated and non-irradiated Dakgalbi diets were administered to two groups of ICR mice (ten male and ten female mice per group) for 3 months. During the experimental period, we observed that the mice fed the 30 kGy-irradiated Dakgalbi did not show any changes in appearance, behavior, mortality, body weight, organ weight, or food consumption compared to the control mice group. In addition, all biochemical parameters of these mice, including hematology profiles, erythrocyte counts, and serum biochemical values, remained in the normal range. The histopathological examinations of liver and kidney tissues showed no significant differences between the control group and the group fed the 30 kGy-irradiated Dakgalbi. These results indicate that Dakgalbi irradiated at 30 kGy did not cause any toxic effects in mice and therefore it can be considered as safe and hygienic space food.

Bioequivalence of Alpit Tablet to Algiron Tablet (Cimetropium Bromide 50 mg) (알기론 정(브롬화 시메트로피움 50 mg)에 대한 알피트 정의 생물학적 동등성)

  • Cho, Hea-Young;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.32 no.1
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    • pp.47-54
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    • 2002
  • Cimetropium bromide, a quaternary ammonium compound which is chemically related to scopolamine, exhibits its antispasmodic activity by competing with acetylcholine for the muscarinic receptors of the smooth muscle of gastrointestinal tract. The drug has been used for the treatment of various disorders involving spasms of the musculature of the gastrointestinal, biliary and genitourinary tracts. The purpose of the present study was to evaluate the bioequivalence of two cimetropium bromide tablets, $Algiron^{TM}$ (Boehringer Ingelheim Korea Ltd.) and $Alpit^{TM}$ (Hana Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The cimetropium bromide release from the two cimetropium bromide tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, $25.25{\pm}2.10$ years in age and $65.76{\pm}6.39$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three tablets containing 50 mg of cimetropium bromide per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of cimetropium bromide in serum were determined using HPLC method with UV detector. The dissolution profiles of two cimetropium bromide tablets were very similar at all dissolution media. 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 non-transformed and logarithmically transformed $AUC_t\;and\;C_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on the $Algiron^{TM}$ were 2.19%, -5.97% and 3.49%, respectively. Minimum detectable differences $({\Delta})\;at \;{\alpha}=0.05\;and\;1-{\beta}=0.8$ were less than 20% (e.g., 13.71 %, 19.05% and 15.11% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The powers $(1-{\beta})\;at\;{\alpha}=0.05,\;{\Delta}=0.2\;for\;AUC_t$, $C_{max}\;and\;T_{max}$ were 97.79%, 83.22% and 95.60%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.84{\sim}10.21,\;-17.11{\sim}5.18\;and\;-5.35{\sim}12.33\;for\;AUC_t,\;C_{max}\;and\;T_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t\;and\;C_{max}$. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.94{\sim}1.10\;and\;0.85{\sim}1.05\;for\;AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Alpit^{TM}$ tablet is bioequivalent to $Algiron^{TM}$ tablet.

Bioequivalence of Rispen Tablet to Risperdal Tablet (Risperidone 2 mg) (리스페달 정(리스페리돈 2mg)에 대한 리스펜 정의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Lee, Suk;Park, Chan-Ho;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.2
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    • pp.139-145
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd.) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperidone release from the two risperidone formulations in vitro was tested using KP VIII Apparatus II method with various of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $23.33\;{\pm}2.10$ years in age and $69.24{\pm}8.05\;kg$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross over study was employed. After one tablet containing 2 mg as risperidone was orally administered, blood was taken at predetermined time intervals and the concentrations of risperidone in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$,$C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the analysis of the parameters using logarithmically transformed $AUC_t$,$C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Risperdal were 0.20, -1.29 and -11-09% for $AUC_t$,$C_{max},\;and\;T_{max}$, respectively There were no sequence effects two formulations in parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g.,$log(0.90){\sim}log(1.30)$ and $log(0.84){\sim}log(1.09)$ for$AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.

Bioequivalence of Glimed Tablet to Amaryl Tablet (Glimepiride 2 mg) (아마릴 정(글리메피리드 2mg)에 대한 글리메드 정의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Lee, Suk;Kim, Se-Mi;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.2
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    • pp.147-153
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two glimepiride tablets, $Amaryl^{\circledR}$ (Handok/Aventis Pharm. Co., Ltd.) and Glimed (Kuhn II Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The glimepiride release from the two glimepiride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB 80 into each dissolution medium). Twenty six healthy male subjects, $22.65{\pm}2.19$ years in age and $66.55{\pm}8.85$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 2 mg as glimepiride was orally administered, blood was taken at predetermined time intervals and the concentrations of glimepiride in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Amaryl were -3.70, -8.28 and 0.61% 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 range of log(0.8) to log(1.25) (e.g., $log(0.84){\sim}log(1.04)$ for $log(0.82){\sim}log(1.03)$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Glimed tablet and Amaryl tablet were bioequivalent.

Effect of Functional Beverage on Weight Control and Body Fat Mass in Overweight Women

  • Chae, Jey-Sook;Lee, Jong-Ho;Koh, Soo-Jeong;Jang, Yong-Soo;Lee, Jin-Hee
    • Biomolecules & Therapeutics
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    • v.11 no.4
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    • pp.257-264
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    • 2003
  • Carnitine, hydroxycitric acid, and soy peptide have been known to be anti-obesity agents. The purpose of this study was to evaluate the combined effects of carnitine, hydroxycitric acid, and soy peptide mixture as a potential anti-obesity supplement in overweight women. Overweight premenopausal women (n=33; PIBW>110; 20 to 39 years) were randomized into two groups: the placebo group and the functional beverage group (the test group). Functional beverage was composed of 2000 mg soy peptide, 20 mg L-carnitine and 300 mg garcinia(40% hydroxycitric acid). Body weight and 3 day food dimes, biochemical measurements and computerized tomography were measured at baseline and 8-week. After 8-week consumption of functional beverage with usual diet and exercise, body weight fell an average of 1.4 kg (2.1%). Visceral fat area reduced an average of 7.8% at L1($69.6{\pm}8.7\;vs\;64.2{\pm}7.5\;\textrm{cm}^2$) and 5.1% ($60.7{\pm}4.9\;vs\;57.6{\pm}4.8\;\textrm{cm}^2$, p<0.05) at L4level after weight loss in the test group. Calf fat area in the test group showed about 10% reduction ($31.0{\pm}2.7\;vs=\;27.7{\pm}1.7\;\textrm{cm}^2$, p<0.05) after weight loss. These reductions in fat areas were not shown in the placebo group. There were tendencies of increase in serum levels of $\beta-hydroxybutyrate$, acetoacetate, and total ketones in the test group. There were 7% and 17% insignificant increase in fasting free fatty acid (FFA) and response area of FFA during oral glucose tolerance test(OGTT), respectively, in this group. ill addition, little weight loss in the test group showed 8% but not significant reduction in insulin response area during OGTT. In conclusion, this study shows that taking a mixture of carnitine, hydroxycitric acid, and soy peptide as a potential anti-obesity supplement for 8-week produced advantageous changes in the weight and visceral fat accumulation of overweight women.

Bioequivalence Test of Gabapentin 400 mg Capsules (가바펜틴 400밀리그람 캡슐의 생물학적동등성시험)

  • Kim, Se-Mi;Kang, Hyun-Ah;Cho, Hea-Young;Shin, Sae-Byeok;Yoo, Hee-Doo;Yoon, Hwa;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.195-200
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    • 2008
  • Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% 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 range of log 0.8 to log 1.25 (e.g., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

Bioequivalence Test of Fexofenadine Hydrochloride 120 mg Tablets (염산펙소페나딘 120밀리그람 정제의 생물학적동등성시험)

  • Cho, Hea-Young;Kang, Hyun-Ah;Kim, Se-Mi;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.188-194
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    • 2008
  • Fexofenadine, ($\pm$)-4-1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}-butyl-a,a-dimethyl benzeneacetic acid, is a selective histamine $H_1$ receptor antagonist, and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent. The purpose of the present study was to evaluate the bioequivalence of two fexofenadine hydrochloride tablets, $Allegra^{(R)}$ (Handok Pharmaceuticals Co., Ltd.) and Alecort (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of fexofenadine from the two fexofenadine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty six healthy male subjects, 25.62$\pm$3.35 years in age and 70.05$\pm$11.71 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After a single tablet containing 120 mg as fexofenadine hydrochloride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of fexofenadine in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The harmacokinetic 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Allegra^{(R)}$, were -1.37, 5.22 and 16.50% 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 range of log 0.8 to log 1.25 (e.g., log 0.83$\sim$log 1.08 and log 0.81$\sim$log 1.03 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Alecort tablet was bioequivalent to $Allegra^{(R)}$ tablet.

Reference intervals for blood metabolic profiles of Holstein cows in Korea (국내 젖소의 혈액 대사인자 프로파일 분석)

  • Jung, Suk-Han;Jung, Young-Hun;Choe, Changyong;Do, Yoon Jung;Cho, Ara;Oh, Sang-Ik;Kim, Eunju;Ha, Seungmin;Jeong, Ha Yeon;Yoo, Jae Gyu;Kim, Suhee
    • Korean Journal of Veterinary Service
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    • v.42 no.2
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    • pp.121-126
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    • 2019
  • Metabolic profile test is used to evaluate nutritional imbalance and metabolic disease in dairy cows. The reference intervals of metabolic parameters may change according to nation, region, decades, and maintenance system. Despite the need to be periodically updated for the reference intervals of metabolic parameters, it has rarely been investigated in Korea. Therefore, this aim of study was to provide the reference intervals of metabolic parameters using dairy cows surveyed in Korea during recent years. A metabolic profile test was conducted for 2,976 clinically healthy dairy cows in Korea. Blood samples were collected for the analysis of serum metabolites. This study provided reference intervals of thirteen metabolic parameters (${\beta}$-hydroxybutyrate [${\beta}-HB$], non-esterified fatty acids [NEFA], glucose, total cholesterol [T-COL], total protein, albumin, globulin, blood urea nitrogen [BUN], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT], calcium, phosphorus, and magnesium). BUN and AST values of the current study were higher than those of previous studies. In the present study, the other metabolic parameters showed low or similar value compared to previous results. Moreover, ${\beta}-HB$, NEFA, T-COL, ALB, BUN, AST, and GGT values were affected by lactation period. This study provided information on the reference intervals of metabolites in healthy dairy cows in Korea. The reference intervals from the present study would be useful in managing and diagnosing disease of dairy cows. However, careful attention should be given in interpreting disease condition for metabolites affected by lactation.

Effects of dietary glycerol inclusion on growth performance, carcass and meat quality characteristics, glycogen content, and meat volatile compounds in Korean cattle steers

  • Piao, Minyu;Jung, Da Jin Sol;Kang, Hyeok Joong;Park, Seung Ju;Lee, Jin Oh;Kim, Minsu;Kim, Hyun Jin;Kim, Do Hyun;Seo, Ja Kyeom;Jo, Cheorun;Haque, Md Najmul;Baik, Myunggi
    • Animal Bioscience
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    • v.34 no.4
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    • pp.603-612
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    • 2021
  • Objective: We have tested our hypothesis that inclusion of purified glycerol as a replacer of portions of dried distillers grain with solubles (DDGS) would affect growth performance, rumen fermentation and blood parameters, carcass and sensory traits, reducing sugar and glycogen contents, and volatile compound profiles in longissimus thoracis (LT) in Korean cattle steers. Methods: A total of 20 Korean cattle steers (27.0±0.2 months old; 647±10.5 kg body weight [BW]) were assigned to a conventional control group or a glycerol group (3.17% purified glycerol addition as a replacement for DDGS and molasses). The steers were individually allowed to receive the experimental concentrate at the daily amount of 1.5% of their individual BW and a total 1.0 of kg/d of rice straw twice daily. The feeding trial was conducted for a period of 20 weeks. Results: Glycerol supplementation (GS) increased (p = 0.001) concentrate intake. However, GS did not affect (p>0.05) average daily gain, feed efficiency, and ruminal volatile fatty acid concentrations. GS tended to increase (p≤0.10) serum glucose concentrations at the 16th and 20th weeks. GS decreased (p = 0.001) LT pH. GS did not affect (p>0.05) carcass traits and the chemical or physicochemical compositions, reducing sugar or glycogen contents, sensory traits, and most of volatile compounds in the LT. Conclusion: The inclusion of purified glycerol as a replacement for DDGS in the finishing diet did not affect growth performance, rumen fermentation parameters, and carcass quality in Korean cattle. The purified glycerol could be used as a substitute for other energy sources such as DDGS in beef cattle, depending on the price.