• Journal of Pharmaceutical Investigation
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• v.3 no.4
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• pp.39-43
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• 1973

완충액(緩衝液)에서의 caffeine, niacinamide, pyridoxine hydrochloride, thiamine hydrochloride의 여과조제(濾過助劑)에 의(依)한 흡착(吸着)현상을 비교검토(比較檢討)하였다. 실험(實驗)에 사용(使用)한 vitamin 류(類)의 흡착(吸着)은 Langmvir 흡착식(吸着式)의 pattern 에 따랐으며 caffeine 은 거의 흡착(吸着)되지 않았다. 여과조제중(濾過助劑中) Dawsonite는 Celite 545 보다 큰 흡착(吸着)현상을 나타냈으며 pH변화(變化)에 따른 영향(影響)은 niacinamide가 가장 예민하였고 pH의 증가(增加)는 흡착량(吸着量)을 현저히 감소시켰다.

• Journal of the Korean Chemical Society
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• v.55 no.6
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• pp.936-939
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• 2011

Thiamine hydrochloride (VB1) has been used as an acid catalyst in organic synthesis. One pot three component Biginelli condensation of dimedone, urea/thiourea and substituted aromatic aldehydes catalyzed by 10 mol % of thiamine hydrochloride (VB1) in solvent free condition under microwave irradiation in good to excellent yields has been investigated. Utilization of microwave irradiation, simple reaction conditions, short reaction time, ease of product isolation, and purification makes this manipulation very interesting from an economic and environmental perspective.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.9
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• pp.3951-3954
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• 2014

Objective: To investigate the electronic anti-nausea instrument (EANI) combined with hydrochloride palonosetron for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Methods: Patients who received highly emetogenic chemotherapy were randomly assigned to a treatment group (60 patients) treated with EANI combined with hydrochloride palonosetron, and control group (also 60 patients) given only hydrochloride palonosetron. Chemotherapy related nausea and vomiting were observed and recorded in both groups of patients from the start till the end of chemotherapy. Results: Complete control rates of vomiting in treatment and control group were 40%, and 35%, respectively, without any statistical ly significant difference (p>0.05); however the response rates are 95.0%, 78.3%, respectively, with statistical difference (p<0.05). Complete control rates of nausea in treatment and control group were 36.7%, 30%, respectively, without statistical difference (p>0.05); but the response rates are 90.0%, 76.7%, respectively, with statistical difference (p<0.05). Conclusion: EANI combined with hydrochloride palonosetron for prevention of nausea and vomiting induced by chemotherapy could be more effective than hydrochloride palonosetron alone, and can be recommended for use in prevention and treatment of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy.

• Korean Journal of Clinical Pharmacy
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• v.16 no.1
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• pp.34-39
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• 2006

Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 120 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration(KFDA). The test product was Hanmi Fexofenadine Hydrochloride Tablet $120mg^{(R)}$ made by Hanmi Pharm. Co. and the reference product was Allegra Tablet $120mg^{(R)}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2{\times}2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t\;and\;C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t\;and\;C_{max}$ were log $0.844{\sim}log$ 1.149 and log $0.833{\sim}log$ 1.109, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet 120 mg is bioequivalent to Allegra Tablet 120 mg.

• Korean Journal of Clinical Pharmacy
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• v.22 no.1
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• pp.9-12
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• 2012

Background: Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized $2{\times}2$ crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as $AUC_{last}$, $AUC_{inf}$ and $C_{max}$, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for $AUC_{last}$ in test and reference drug was $4053.1{\pm}876.5\;ng{\cdot}hr/mL$ and $3595.7{\pm}1029.1\;ng{\cdot}h/mL$, respectively. The mean value for $C_{max}$ in test and reference drug was $1324.9{\pm}321.4$ ng/mL and $1159.1{\pm}335.9$ ng/mL, respectively. The 90% confidence intervals of the $AUC_{last}$ and $C_{max}$ ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride.

• Journal of Pharmaceutical Investigation
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• v.34 no.5
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• pp.419-425
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• 2004

The purpose of the present study was to evaluate the bioequivalence of two propiverine hydrochloride tablets, BUP-4 (Jeil Pharm. Co., Ltd.) and Kuhnil Propiverine Hydrochloride (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The propiverine release from the two propiverine hydrochloride 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 solutions, water and blend of polysorbate 80 into pH 6.8). Twenty six healthy male subjects, $23.73{\pm}2.79$ years in age and $67.04{\pm}7.93\;kg$ in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 20 mg as propiverine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of propiverine 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 BUP-4 were 0.17%, 7.98% and 4.55% 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) $(e.g.,\;log(0.88){\sim}log(1.l2)\;and\;log(0.90){\sim}log(1.l5)\;for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil Propiverine Hydrochloride tablet was bioequivalent to BUP-4 tablet.

• Journal of Dairy Science and Biotechnology
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• v.34 no.3
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• pp.187-191
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• 2016

Biogenic amines have been used as chemical indicators of fermented foods. So far, several chromatography methods have been developed to detect biogenic amines in foods. However, few methods have identified these compound in domestic cheese. We analyzed the biogenic amines (histamine dihydrochloride, tyramine hydrochloride, ${\beta}$-phenylethylamine hydrochloride, putrescine dihydrochloride, cadaverine, spermidine, tryptamine hydrochloride, ethanolamine hydrochloride and butylamine) in cheese by using HPLC. The calibration curves of the biogenic amines were found to be linear over the concentration range of 10-50 ppm with a correlation coefficient of above 0.99. The limit of detection (LOD) and limit of quantitation (LOQ) of the biogenic amines in the given order were 3.7 and 11.3 ppm, 3.4 and 10.4ppm, 3.4 and 10.3 ppm, 4.0 and 12.2 ppm, 3.4 and 10.4 ppm, 3.4 and 10.5 ppm, 3.5 and 10.7 ppm, 4.1 and 12.5 ppm, and 3.4 and 10.4 ppm, respectively. Recovery rates of the biogenic amines in the given order were 112, 104, 93, 108, 91, 102, 101, and 92%, respectively. The findings of this study suggest that HPLC is a suitable method for the determination of biogenic amines, thereby indicating its potential application in the quality control of aging cheese.

• Journal of the Korean Chemical Society
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• v.52 no.6
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• pp.622-629
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• 2008

• Korean Journal of Clinical Pharmacy
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• v.20 no.3
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• pp.235-241
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• 2010

Bambuterol hydrochloride, dimethylcarbamic acid 5-[2-(1,1-dimethylethyl)amino-1-hydroxyethyl]-1,3-phenylene ester hydrochloride, is the prodrug of active ${\beta}_2$-adrenergic metabolite terbutaline. The purpose of the present study was to evaluate the bioequivalence of two bambuterol hydrochloride tablets, $Bambec^{(R)}$ tablet 10 mg (Yuhan Co., Ltd.) and Bambucol tablet 10 mg (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). In vitro release of bambuterol from two bambuterol hydrochloride formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male Korean volunteers, $23.86{\pm}1.65$ years in age and $68.98{\pm}9.58$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 10 mg as bambuterol hydrochloride were orally administered, blood samples were taken at predetermined time intervals, and the concentrations of bambuterol in serum were determined using column switching HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test with K-BE Test 2002 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, $Bambec^{(R)}$, were -8.10%, -3.82% and 12.65% 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 (i.e., log 0.8093~log 1.0302 and log 0.8564~log 1.1280 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Bambucol tablet 10 mg was bioequivalent to $Bambec^{(R)}$ tablet 10 mg.

• Biomolecules & Therapeutics
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• v.1 no.2
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• pp.275-279
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• 1993

Single oral administration to SD rats of both sexes were performed to investigate the acute toxicity of two new cough and cold remedies, WHS-1 and WHS-2. WHS-1 is composed of acetaminophen, chlorpheniramine maleate, cloperastine hydrochloride, dl-methylephedrine hydrochloride, caffein anhydrous, thiamine hydrochloride, riboflavin and serratiopeptidase. WHS-2 is composed of similar formula except that thiamine hydrochloride and riboflavin is not added. The results were as follows. $LD_{50}$ values of WHS-1 were 4295.5 mg/kg for males and 4606.3 mg/kg for females, and $LD_{50}$ values of WHS-2 were 3236.7 mg/kg for males and 4360.5 mg/kg for females. Death occurred within 2~3 hours after administration at doses up to 2900 mg/kg in WHS-1 and 2500 mg/kg in WHS-2, the main cause of deaths seemed to be respiratory disturbance. General symptoms included decreased motor activity, salivation and loss of consciousness which were commonly observed in all dead animals treated with WHS-1 and WHS-2. No significant gross finding and body weight changes were observed at any dose level in the groups treated with WHS-1 and WHS-2.